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"DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of R2 and start of reaction:

    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.122 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Limit of Quantitation

= 0.10 mmol/L (0.243 mg/dL)

Urine

Limit of Blank

= 0.28 mmol/L (0.68 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

Limit of Quantitation

= 0.56 mmol/L (1.36 mg/dL)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration magnesium samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

mmol/L

Serum/plasma:

Newborn:

0.62‑0.91 mmol/L

5 months‑6 years:

0.70‑0.95 mmol/L

6‑12 years:

0.70‑0.86 mmol/L

12‑20 years:

0.70‑0.91 mmol/L

Adults:

0.66‑1.07 mmol/L

60‑90 years:

0.66‑0.99 mmol/L

> 90 years:

0.70‑0.95 mmol/L

Urine (24 h):

3.0‑5.0 mmol/d

mg/dL

Serum/plasma:

Newborn:

1.5‑2.2 mg/dL

5 months‑6 years:

1.7‑2.3 mg/dL

6‑12 years:

1.7‑2.1 mg/dL

12‑20 years:

1.7‑2.2 mg/dL

Adults:

1.6‑2.6 mg/dL

60‑90 years:

1.6‑2.4 mg/dL

> 90 years:

1.7‑2.3 mg/dL

Urine (24 h):

72.9‑121.5 mg/d

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL, 1.4 mval/L).

Serum/plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 496 µmol/L (800 mg/dL)).

Hemolysis elevates results depending on the content of the analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.1 mg/dL, 3.4 mval/L).

Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration of 621 µmol/L or 1000 mg/dL).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08058016 190

Magnesium Gen.2 (690 tests)

System‑ID 2089 001

Roche/Hitachi cobas c 503

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 20401

10759350 360

Calibrator f.a.s. (12 x 3 mL, for USA)

Code 20401

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 20391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 20391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 20392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 20392

08063494 190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

MG2: ACN 20890 (Serum/plasma)

MG2U: ACN 20891 (Urine)

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

505/600 nm

Reagent pipetting

Diluent (H2O)

R1

78 µL

R3

78 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

Decreased

1.2 µL

Increased

2.4 µL

Application for urine

Test definition

Reporting time

10 min

Wavelength (sub/main)

505/600 nm

Reagent pipetting

Diluent (H2O)

R1

78 µL

-

R3

78 µL

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

20 µL

90 µL

Decreased

2.4 µL

10 µL

100 µL

Increased

2.4 µL

20 µL

90 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 15‑25 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Application for serum/plasma (ACN 20890)

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- after 4 weeks on‑board
- as required following quality control procedures

Application for urine (ACN 20891)
Transfer of calibration from serum/plasma application (ACN 20890)

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against atomic absorption spectrometry.

For the USA, this method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).
The following results were obtained:

Serum/plasma

Repeatability

Mean
mmol/L

SD
mmol/L

CV
%

PCCC1b)

0.812

0.00352

0.4

PCCC2c)

1.30

0.00546

0.4

Human serum 1

0.258

0.00386

1.5

Human serum 2

0.624

0.00384

0.6

Human serum 3

0.986

0.00346

0.4

Human serum 4

1.36

0.00567

0.4

Human serum 5

1.74

0.00577

0.3

Intermediate precision

Mean
mmol/L

SD
mmol/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

0.812

0.00940

1.2

PCCC2

FREFPreciControl ClinChem Multi 2

1.30

0.0127

1.0

Human serum 1

0.258

0.00648

2.5

Human serum 2

0.624

0.00699

1.1

Human serum 3

0.986

0.00651

0.7

Human serum 4

1.37

0.00812

0.6

Human serum 5

1.74

0.00896

0.5

Urine

Repeatability

Mean
mmol/L

SD
mmol/L

CV
%

Control 1d)

1.73

0.0231

1.3

Control 2d)

3.67

0.0252

0.7

Human urine 1

1.50

0.0243

1.6

Human urine 2

2.90

0.0238

0.8

Human urine 3

4.08

0.0262

0.6

Human urine 4

5.30

0.0334

0.6

Human urine 5

9.02

0.0425

0.5

Intermediate precision

Mean
mmol/L

SD
mmol/L

CV
%

Control 1

FREFcommercially available control material

1.72

0.0302

1.8

Control 2

FREFcommercially available control material

3.67

0.0313

0.9

Human urine 1

1.50

0.0288

1.9

Human urine 2

2.89

0.0336

1.2

Human urine 3

4.08

0.0298

0.7

Human urine 4

5.27

0.0424

0.8

Human urine 5

9.02

0.0609

0.7

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum, plasma and urine samples obtained on a Roche/Hitachi cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Serum/plasma

Sample size (n) = 97

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.013x - 0.00748 mmol/L

y = 1.011x - 0.00537 mmol/L

τ = 0.984

r = 1.000

The sample concentrations were between 0.100 and 1.96 mmol/L.

Urine

Sample size (n) = 62

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.963x - 0.0757 mmol/L

y = 0.973x - 0.114 mmol/L

τ = 0.974

r = 0.999

The sample concentrations were between 0.670 and 11.0 mmol/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP‑magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS

FREFTRIS = Tris(hydroxymethyl)‑aminomethane
/6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

R3

Xylidyl blue: 0.28 mmol/L; detergent; preservative

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

Serum/plasma:

PreciControl ClinChem Multi 1, PreciControl ClinChem Multi 2

Urine:

Quantitative urine controls are recommended for routine quality control.

The control intervals and limits should be adapted to each laboratory’s individual requirements.

It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks.

Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested.

Chelating anticoagulants such as EDTA, fluoride and oxalate must be avoided.

Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability in serum/plasma:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °C

Urine:

Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesium ammonium phosphate. Collect urine samples in metal‑free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted with 0.9 % NaCl by the instrument. If stabilizers are added to the sample, the sample index feature must not be used.

Stability in urine:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208058016190c503", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF000000065E210E", "DocumentOriginID": "FF00000004C87B0E", "MaterialNumbers": [ "08058016190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of R3 and start of reaction:

    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. For samples with higher concentrations, the rerun function decreases the sample volume by a factor of 2. The results are automatically multiplied by this factor.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.122 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Limit of Quantitation

= 0.10 mmol/L (0.243 mg/dL)

Urine

Limit of Blank

= 0.28 mmol/L (0.68 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

Limit of Quantitation

= 0.56 mmol/L (1.36 mg/dL)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration magnesium samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

mmol/L

Serum/plasma:

Newborn:

0.62‑0.91 mmol/L

5 months‑6 years:

0.70‑0.95 mmol/L

6‑12 years:

0.70‑0.86 mmol/L

12‑20 years:

0.70‑0.91 mmol/L

Adults:

0.66‑1.07 mmol/L

60‑90 years:

0.66‑0.99 mmol/L

> 90 years:

0.70‑0.95 mmol/L

Urine (24 h):

3.0‑5.0 mmol/d

mg/dL

Serum/plasma:

Newborn:

1.5‑2.2 mg/dL

5 months‑6 years:

1.7‑2.3 mg/dL

6‑12 years:

1.7‑2.1 mg/dL

12‑20 years:

1.7‑2.2 mg/dL

Adults:

1.6‑2.6 mg/dL

60‑90 years:

1.6‑2.4 mg/dL

> 90 years:

1.7‑2.3 mg/dL

Urine (24 h):

72.9‑121.5 mg/d

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Serum/plasma

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL, 1.4 mval/L).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 496 µmol/L (800 mg/dL)).

Hemolysis elevates results depending on the content of the analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.1 mg/dL, 3.4 mval/L).

Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration of 621 µmol/L or 1000 mg/dL).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet. For further instructions, refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08058016190

Magnesium Gen.2 (690 tests)

System‑ID 2089 001

cobas c 303, cobas c 503

Materials required (but not provided):

10759350360

Calibrator f.a.s. (12 x 3 mL)

Code 20401

05947626160

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05947774160

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

MG2: ACN 20890 (Serum/plasma)

MG2U: ACN 20891 (Urine)

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

505/600 nm

Reagent pipetting

Diluent (H2O)

R1

78 µL

R3

78 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

Decreased

1.2 µL

Increased

2.4 µL

Application for urine

Test definition

Reporting time

10 min

Wavelength (sub/main)

505/600 nm

Reagent pipetting

Diluent (H2O)

R1

78 µL

-

R3

78 µL

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

20 µL

90 µL

Decreased

2.4 µL

10 µL

100 µL

Increased

2.4 µL

20 µL

90 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 15‑25 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Application for serum/plasma (ACN 20890)

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- every 4 weeks on‑board
- as required following quality control procedures

Application for urine (ACN 20891)
Transfer of calibration from serum/plasma application (ACN 20890)

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).
Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Serum/plasma

Repeatability

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

PCCC1b)

0.812 (1.97)

0.00352 (0.00855)

0.4

PCCC2c)

1.30 (3.16)

0.00546 (0.0133)

0.4

Human serum 1

0.258 (0.627)

0.00386 (0.00938)

1.5

Human serum 2

0.624 (1.52)

0.00384 (0.00933)

0.6

Human serum 3

0.986 (2.40)

0.00346 (0.00841)

0.4

Human serum 4

1.36 (3.30)

0.00567 (0.0138)

0.4

Human serum 5

1.74 (4.23)

0.00577 (0.0140)

0.3

Intermediate precision

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

0.812 (1.97)

0.00940 (0.0228)

1.2

PCCC2

FREFPreciControl ClinChem Multi 2

1.30 (3.16)

0.0127 (0.0309)

1.0

Human serum 1

0.258 (0.627)

0.00648 (0.0157)

2.5

Human serum 2

0.624 (1.52)

0.00699 (0.0170)

1.1

Human serum 3

0.986 (2.40)

0.00651 (0.0158)

0.7

Human serum 4

1.37 (3.33)

0.00812 (0.0197)

0.6

Human serum 5

1.74 (4.23)

0.00896 (0.0218)

0.5

Urine

Repeatability

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

Control 1d)

1.73 (4.20)

0.0231 (0.0561)

1.3

Control 2d)

3.67 (8.92)

0.0252 (0.0612)

0.7

Human urine 1

1.50 (3.65)

0.0243 (0.0590)

1.6

Human urine 2

2.90 (7.05)

0.0238 (0.0578)

0.8

Human urine 3

4.08 (9.91)

0.0262 (0.0637)

0.6

Human urine 4

5.30 (12.9)

0.0334 (0.0812)

0.6

Human urine 5

9.02 (21.9)

0.0425 (0.103)

0.5

Intermediate precision

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

Control 1

FREFcommercially available control material

1.72 (4.18)

0.0302 (0.0734)

1.8

Control 2

FREFcommercially available control material

3.67 (8.92)

0.0313 (0.0761)

0.9

Human urine 1

1.50 (3.65)

0.0288 (0.0700)

1.9

Human urine 2

2.89 (7.02)

0.0336 (0.0816)

1.2

Human urine 3

4.08 (9.91)

0.0298 (0.0724)

0.7

Human urine 4

5.27 (12.8)

0.0424 (0.103)

0.8

Human urine 5

9.02 (21.9)

0.0609 (0.148)

0.7

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum, plasma and urine samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Serum/plasma

Sample size (n) = 97

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.013x - 0.00748 mmol/L

y = 1.011x - 0.00537 mmol/L

τ = 0.984

r = 1.000

The sample concentrations were between 0.100 and 1.96 mmol/L (0.243 and 4.76 mg/dL).

Urine

Sample size (n) = 62

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.963x - 0.0757 mmol/L

y = 0.973x - 0.114 mmol/L

τ = 0.974

r = 0.999

The sample concentrations were between 0.670 and 11.0 mmol/L (1.63 and 26.7 mg/dL).

Magnesium values for human serum, plasma and urine samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Serum/plasma

Sample size (n) = 72

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.011x + 0.000944 mmol/L

y = 1.012x + 0.000238 mmol/L

τ = 0.979

r = 1.000

The sample concentrations were between 0.140 and 1.94 mmol/L (0.340 and 4.71 mg/dL).

Urine

Sample size (n) = 67

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.007x + 0.00729 mmol/L

y = 1.008x + 0.00459 mmol/L

τ = 0.984

r = 1.000

The sample concentrations were between 0.610 and 10.7 mmol/L (1.48 and 26.0 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP‑magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS

FREFTRIS = Tris(hydroxymethyl)‑aminomethane
/6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

R3

Xylidyl blue: 0.28 mmol/L; detergent; preservative

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

Serum/plasma:

PreciControl ClinChem Multi 1, PreciControl ClinChem Multi 2

Urine:

Quantitative urine controls are recommended for routine quality control.

The control intervals and limits should be adapted to each laboratory’s individual requirements.

It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks.

Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested.

Chelating anticoagulants such as EDTA, fluoride and oxalate must be avoided.

Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability in serum/plasma:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °C

Freeze only once.

Urine:

Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesium ammonium phosphate. Collect urine samples in metal‑free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted with 0.9 % NaCl by the instrument. If stabilizers are added to the sample, the sample index feature must not be used.

Stability in urine:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (-15)‑(-25) °C

Freeze only once.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108058016190c503", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "5", "DocumentObjectID": "FF00000004A3730E", "DocumentOriginID": "FF000000046F270E", "MaterialNumbers": [ "08058016190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of R2 and start of reaction:

    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.122 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Limit of Quantitation

= 0.10 mmol/L (0.243 mg/dL)

Urine

Limit of Blank

= 0.28 mmol/L (0.68 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

Limit of Quantitation

= 0.56 mmol/L (1.36 mg/dL)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration magnesium samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

mmol/L

Serum/plasma:

Newborn:

0.62‑0.91 mmol/L

5 months‑6 years:

0.70‑0.95 mmol/L

6‑12 years:

0.70‑0.86 mmol/L

12‑20 years:

0.70‑0.91 mmol/L

Adults:

0.66‑1.07 mmol/L

60‑90 years:

0.66‑0.99 mmol/L

> 90 years:

0.70‑0.95 mmol/L

Urine (24 h):

3.0‑5.0 mmol/d

mg/dL

Serum/plasma:

Newborn:

1.5‑2.2 mg/dL

5 months‑6 years:

1.7‑2.3 mg/dL

6‑12 years:

1.7‑2.1 mg/dL

12‑20 years:

1.7‑2.2 mg/dL

Adults:

1.6‑2.6 mg/dL

60‑90 years:

1.6‑2.4 mg/dL

> 90 years:

1.7‑2.3 mg/dL

Urine (24 h):

72.9‑121.5 mg/d

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL, 1.4 mval/L).

Serum/plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 496 µmol/L (800 mg/dL)).

Hemolysis elevates results depending on the content of the analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.1 mg/dL, 3.4 mval/L).

Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration of 621 µmol/L or 1000 mg/dL).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08058016190

Magnesium Gen.2 (690 tests)

System‑ID 2089 001

cobas c 303, cobas c 503

Materials required (but not provided):

10759350190

Calibrator f.a.s. (12 x 3 mL)

Code 20401

05117003190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 20391

05947626190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05117216190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 20392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

MG2: ACN 20890 (Serum/plasma)

MG2U: ACN 20891 (Urine)

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

505/600 nm

Reagent pipetting

Diluent (H2O)

R1

78 µL

R3

78 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

Decreased

1.2 µL

Increased

2.4 µL

Application for urine

Test definition

Reporting time

10 min

Wavelength (sub/main)

505/600 nm

Reagent pipetting

Diluent (H2O)

R1

78 µL

-

R3

78 µL

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

20 µL

90 µL

Decreased

2.4 µL

10 µL

100 µL

Increased

2.4 µL

20 µL

90 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 15‑25 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Application for serum/plasma (ACN 20890)

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- after 4 weeks on‑board
- as required following quality control procedures

Application for urine (ACN 20891)
Transfer of calibration from serum/plasma application (ACN 20890)

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against atomic absorption spectrometry.

For the USA, this method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).
Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Serum/plasma

Repeatability

Mean
mmol/L

SD
mmol/L

CV
%

PCCC1b)

0.812

0.00352

0.4

PCCC2c)

1.30

0.00546

0.4

Human serum 1

0.258

0.00386

1.5

Human serum 2

0.624

0.00384

0.6

Human serum 3

0.986

0.00346

0.4

Human serum 4

1.36

0.00567

0.4

Human serum 5

1.74

0.00577

0.3

Intermediate precision

Mean
mmol/L

SD
mmol/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

0.812

0.00940

1.2

PCCC2

FREFPreciControl ClinChem Multi 2

1.30

0.0127

1.0

Human serum 1

0.258

0.00648

2.5

Human serum 2

0.624

0.00699

1.1

Human serum 3

0.986

0.00651

0.7

Human serum 4

1.37

0.00812

0.6

Human serum 5

1.74

0.00896

0.5

Urine

Repeatability

Mean
mmol/L

SD
mmol/L

CV
%

Control 1d)

1.73

0.0231

1.3

Control 2d)

3.67

0.0252

0.7

Human urine 1

1.50

0.0243

1.6

Human urine 2

2.90

0.0238

0.8

Human urine 3

4.08

0.0262

0.6

Human urine 4

5.30

0.0334

0.6

Human urine 5

9.02

0.0425

0.5

Intermediate precision

Mean
mmol/L

SD
mmol/L

CV
%

Control 1

FREFcommercially available control material

1.72

0.0302

1.8

Control 2

FREFcommercially available control material

3.67

0.0313

0.9

Human urine 1

1.50

0.0288

1.9

Human urine 2

2.89

0.0336

1.2

Human urine 3

4.08

0.0298

0.7

Human urine 4

5.27

0.0424

0.8

Human urine 5

9.02

0.0609

0.7

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum, plasma and urine samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Serum/plasma

Sample size (n) = 97

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.013x - 0.00748 mmol/L

y = 1.011x - 0.00537 mmol/L

τ = 0.984

r = 1.000

The sample concentrations were between 0.100 and 1.96 mmol/L.

Urine

Sample size (n) = 62

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.963x - 0.0757 mmol/L

y = 0.973x - 0.114 mmol/L

τ = 0.974

r = 0.999

The sample concentrations were between 0.670 and 11.0 mmol/L.

Magnesium values for human serum, plasma and urine samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Serum/plasma

Sample size (n) = 72

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.011x + 0.000944 mmol/L

y = 1.012x + 0.000238 mmol/L

τ = 0.979

r = 1.000

The sample concentrations were between 0.140 and 1.94 mmol/L.

Urine

Sample size (n) = 67

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.007x + 0.00729 mmol/L

y = 1.008x + 0.00459 mmol/L

τ = 0.984

r = 1.000

The sample concentrations were between 0.610 and 10.7 mmol/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP‑magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS

FREFTRIS = Tris(hydroxymethyl)‑aminomethane
/6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

R3

Xylidyl blue: 0.28 mmol/L; detergent; preservative

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

Serum/plasma:

PreciControl ClinChem Multi 1, PreciControl ClinChem Multi 2

Urine:

Quantitative urine controls are recommended for routine quality control.

The control intervals and limits should be adapted to each laboratory’s individual requirements.

It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks.

Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested.

Chelating anticoagulants such as EDTA, fluoride and oxalate must be avoided.

Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability in serum/plasma:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °C

Urine:

Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesium ammonium phosphate. Collect urine samples in metal‑free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted with 0.9 % NaCl by the instrument. If stabilizers are added to the sample, the sample index feature must not be used.

Stability in urine:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0006407358190c701", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "16", "DocumentObjectID": "FF00000003710D0E", "DocumentOriginID": "FF000000002DBB0E", "MaterialNumbers": [ "06407358190", "06407358214" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of R3 and start of reaction:

    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank and Limit of Detection

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.122 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Values below the Limit of Detection (< 0.10 mmol/L) will not be flagged by the instrument.

Urine

Limit of Blank

= 0.28 mmol/L (0.680 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

Values below the Limit of Detection (< 0.56 mmol/L) will not be flagged by the instrument.

The Limit of Blank and Limit of Detection were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

Serum/plasma:

Newborn:

0.62‑0.91 mmol/L

(1.5‑2.2 mg/dL)

5 months‑6 years:

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

6‑12 years:

0.70‑0.86 mmol/L

(1.7‑2.1 mg/dL)

12‑20 years:

0.70‑0.91 mmol/L

(1.7‑2.2 mg/dL)

Adults:

0.66‑1.07 mmol/L

(1.6‑2.6 mg/dL)

60‑90 years:

0.66‑0.99 mmol/L

(1.6‑2.4 mg/dL)

> 90 years:

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

Urine (24 h):

3.0‑5.0 mmol/d

(72.9‑121.5 mg/d)

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL, 1.4 mval/L).

Serum/plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 800 mg/dL or 496 µmol/L).

Hemolysis elevates results depending on the content of the analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.1 mg/dL, 3.4 mval/L).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

06407358 190*

Magnesium Gen.2 (200 tests)

System‑ID 01 7486 3

Roche/Hitachi cobas c 701/702

06407358 214*

Magnesium Gen.2 (200 tests)

System‑ID 01 7486 3

Roche/Hitachi cobas c 701/702

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 401

10759350 360

Calibrator f.a.s. (12 x 3 mL, for USA)

Code 401

12149435 122

Precinorm U plus (10 x 3 mL)

Code 300

12149435 160

Precinorm U plus (10 x 3 mL, for USA)

Code 300

12149443 122

Precipath U plus (10 x 3 mL)

Code 301

12149443 160

Precipath U plus (10 x 3 mL, for USA)

Code 301

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

05172152 190

Diluent NaCl 9 % (119 mL)

System‑ID 08 6869 3

* Some kits shown may not be available in all countries.

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

MG‑2:

ACN 8701 (serum and plasma)

MGU‑2:

ACN 8704 (urine)

SMG2:

ACN 8688 (STAT, serum and plasma, reaction time: 4)

SMG2U:

ACN 8689 (STAT, urine, reaction time: 4)

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 18‑27 (STAT 4 / 6‑15)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

R3 (STAT R2)

97 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

3 µL

Decreased

1.5 µL

Increased

6 µL

Application for urine

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 18‑27 (STAT 4 / 6‑15)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

R3 (STAT R2)

97 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

14 µL

140 µL

Decreased

3 µL

14 µL

140 µL

Increased

12 µL

14 µL

140 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

MG2

Shelf life at 15‑25 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

10 days

On‑board on the Reagent Manager

24 hours

Diluent NaCl 9 %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager

24 hours

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

2‑point calibration
- after 2 days on board
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against atomic absorption spectrometry.

For the USA, this method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 10 days).
The following results were obtained:

Serum/plasma
MG‑2

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.987 (2.40)

0.005 (0.01)

0.5

Precipath U

1.81 (4.40)

0.01 (0.02)

0.5

Human serum A

0.636 (1.55)

0.005 (0.01)

0.8

Human serum B

0.982 (2.39)

0.008 (0.02)

0.8

Human serum C

1.88 (4.57)

0.01 (0.02)

0.8

SMG2

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.972 (2.36)

0.005 (0.01)

0.5

Precipath U

1.79 (4.35)

0.01 (0.02)

0.3

Human serum A

0.624 (1.52)

0.005 (0.01)

0.8

Human serum B

0.976 (2.37)

0.006 (0.01)

0.6

Human serum C

1.86 (4.52)

0.01 (0.02)

0.5

MG‑2/SMG2

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.974 (2.37)

0.013 (0.03)

1.3

Precipath U

1.79 (4.35)

0.02 (0.05)

1.4

Human serum D

0.626 (1.52)

0.011 (0.03)

1.7

Human serum E

0.969 (2.35)

0.013 (0.03)

1.4

Human serum F

1.95 (4.74)

0.03 (0.07)

1.5

Urine
MGU‑2

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Control level 1

2.02 (4.91)

0.02 (0.05)

1.1

Control level 2

4.83 (11.7)

0.02 (0.05)

0.4

Human urine A

1.43 (3.47)

0.03 (0.07)

2.3

Human urine B

3.07 (7.46)

0.02 (0.05)

0.6

Human urine C

8.29 (20.1)

0.04 (0.10)

0.5

SMG2U

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Control level 1

2.01 (4.88)

0.03 (0.07)

1.3

Control level 2

4.78 (11.6)

0.03 (0.07)

0.6

Human urine A

1.41 (3.43)

0.02 (0.05)

1.3

Human urine B

3.03 (7.36)

0.02 (0.05)

0.7

Human urine C

8.23 (20.0)

0.05 (0.12)

0.6

MGU‑2/SMG2U

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Control level 1

13.8 (33.5)

0.2 (0.5)

1.7

Control level 2

3.21 (7.80)

0.12 (0.29)

3.8

Human urine 1

2.89 (7.02)

0.13 (0.32)

4.6

Results for intermediate precision in urine were obtained on the Roche/Hitachi MODULAR P system.

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum/plasma and urine samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Serum/plasma
MG‑2

Sample size (n) = 87

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.027x - 0.02 mmol/L

y = 1.029x - 0.021 mmol/L

τ = 0.958

r = 0.998

The sample concentrations were between 0.560 and 1.94 mmol/L (1.36 and 4.71 mg/dL).

SMG2

Sample size (n) = 86

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.012x - 0.010 mmol/L

y = 1.016x - 0.014 mmol/L

τ = 0.959

r = 0.998

The sample concentrations were between 0.560 and 1.94 mmol/L (1.36 and 4.71 mg/dL).

Urine

Sample size (n) = 86

MGU‑2

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.013x + 0.010 mmol/L

y = 1.013x + 0.016 mmol/L

τ = 0.990

r = 1.000

The sample concentrations were between 0.600 and 10.3 mmol/L (1.46 and 25.0 mg/dL).

SMG2U

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.000x + 0.020 mmol/L

y = 1.002x + 0.021 mmol/L

τ = 0.989

r = 1.000

The sample concentrations were between 0.600 and 10.3 mmol/L (1.46 and 25.0 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP‑magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRISa/6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

R3
(STAT R2)

Xylidyl blue: 0.28 mmol/L; detergent; preservative

a) TRIS = Tris(hydroxymethyl)‑aminomethane

R1 is in position B and R3 (STAT R2) is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Serum/plasma

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

Urine

Quantitative urine controls are recommended for routine quality control.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin plasma.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested.

Chelating anticoagulants such as EDTA, fluoride and oxalate must be avoided.

Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability in serum/plasma:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °C

Urine:

Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesium ammonium phosphate. Collect urine samples in metal‑free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted with 0.9 % NaCl by the instrument.

Stability in urine:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0006407358190c701", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "17", "DocumentObjectID": "FF0000000481A50E", "DocumentOriginID": "FF00000003710D0E", "MaterialNumbers": [ "06407358190", "06407358214" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of R3 and start of reaction:

    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank and Limit of Detection

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.122 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Values below the Limit of Detection (< 0.10 mmol/L) will not be flagged by the instrument.

Urine

Limit of Blank

= 0.28 mmol/L (0.680 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

Values below the Limit of Detection (< 0.56 mmol/L) will not be flagged by the instrument.

The Limit of Blank and Limit of Detection were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

Serum/plasma:

Newborn:

0.62‑0.91 mmol/L

(1.5‑2.2 mg/dL)

5 months‑6 years:

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

6‑12 years:

0.70‑0.86 mmol/L

(1.7‑2.1 mg/dL)

12‑20 years:

0.70‑0.91 mmol/L

(1.7‑2.2 mg/dL)

Adults:

0.66‑1.07 mmol/L

(1.6‑2.6 mg/dL)

60‑90 years:

0.66‑0.99 mmol/L

(1.6‑2.4 mg/dL)

> 90 years:

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

Urine (24 h):

3.0‑5.0 mmol/d

(72.9‑121.5 mg/d)

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL, 1.4 mval/L).

Serum/plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 800 mg/dL or 496 µmol/L).

Hemolysis elevates results depending on the content of the analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.1 mg/dL, 3.4 mval/L).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

06407358 190*

Magnesium Gen.2 (200 tests)

System‑ID 01 7486 3

Roche/Hitachi cobas c 701/702

06407358 214*

Magnesium Gen.2 (200 tests)

System‑ID 01 7486 3

Roche/Hitachi cobas c 701/702

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 401

10759350 360

Calibrator f.a.s. (12 x 3 mL, for USA)

Code 401

12149435 122

Precinorm U plus (10 x 3 mL)

Code 300

12149435 160

Precinorm U plus (10 x 3 mL, for USA)

Code 300

12149443 122

Precipath U plus (10 x 3 mL)

Code 301

12149443 160

Precipath U plus (10 x 3 mL, for USA)

Code 301

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

05172152 190

Diluent NaCl 9 % (119 mL)

System‑ID 08 6869 3

* Some kits shown may not be available in all countries.

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

MG‑2:

ACN 8701 (serum and plasma)

MGU‑2:

ACN 8704 (urine)

SMG2:

ACN 8688 (STAT, serum and plasma, reaction time: 4)

SMG2U:

ACN 8689 (STAT, urine, reaction time: 4)

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 18‑27 (STAT 4 / 6‑15)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

R3 (STAT R2)

97 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

3 µL

Decreased

1.5 µL

Increased

6 µL

Application for urine

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 18‑27 (STAT 4 / 6‑15)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

R3 (STAT R2)

97 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

14 µL

140 µL

Decreased

3 µL

14 µL

140 µL

Increased

12 µL

14 µL

140 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

MG2

Shelf life at 15‑25 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

10 days

On‑board on the Reagent Manager

24 hours

Diluent NaCl 9 %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager

24 hours

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

2‑point calibration
- after 2 days on board
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against atomic absorption spectrometry.

For the USA, this method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 10 days).
The following results were obtained:

Serum/plasma
MG‑2

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.987 (2.40)

0.005 (0.01)

0.5

Precipath U

1.81 (4.40)

0.01 (0.02)

0.5

Human serum A

0.636 (1.55)

0.005 (0.01)

0.8

Human serum B

0.982 (2.39)

0.008 (0.02)

0.8

Human serum C

1.88 (4.57)

0.01 (0.02)

0.8

SMG2

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.972 (2.36)

0.005 (0.01)

0.5

Precipath U

1.79 (4.35)

0.01 (0.02)

0.3

Human serum A

0.624 (1.52)

0.005 (0.01)

0.8

Human serum B

0.976 (2.37)

0.006 (0.01)

0.6

Human serum C

1.86 (4.52)

0.01 (0.02)

0.5

MG‑2/SMG2

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.974 (2.37)

0.013 (0.03)

1.3

Precipath U

1.79 (4.35)

0.02 (0.05)

1.4

Human serum D

0.626 (1.52)

0.011 (0.03)

1.7

Human serum E

0.969 (2.35)

0.013 (0.03)

1.4

Human serum F

1.95 (4.74)

0.03 (0.07)

1.5

Urine
MGU‑2

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Control level 1

2.02 (4.91)

0.02 (0.05)

1.1

Control level 2

4.83 (11.7)

0.02 (0.05)

0.4

Human urine A

1.43 (3.47)

0.03 (0.07)

2.3

Human urine B

3.07 (7.46)

0.02 (0.05)

0.6

Human urine C

8.29 (20.1)

0.04 (0.10)

0.5

SMG2U

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Control level 1

2.01 (4.88)

0.03 (0.07)

1.3

Control level 2

4.78 (11.6)

0.03 (0.07)

0.6

Human urine A

1.41 (3.43)

0.02 (0.05)

1.3

Human urine B

3.03 (7.36)

0.02 (0.05)

0.7

Human urine C

8.23 (20.0)

0.05 (0.12)

0.6

MGU‑2/SMG2U

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Control level 1

13.8 (33.5)

0.2 (0.5)

1.7

Control level 2

3.21 (7.80)

0.12 (0.29)

3.8

Human urine 1

2.89 (7.02)

0.13 (0.32)

4.6

Results for intermediate precision in urine were obtained on the Roche/Hitachi MODULAR P system.

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum/plasma and urine samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Serum/plasma
MG‑2

Sample size (n) = 87

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.027x - 0.02 mmol/L

y = 1.029x - 0.021 mmol/L

τ = 0.958

r = 0.998

The sample concentrations were between 0.560 and 1.94 mmol/L (1.36 and 4.71 mg/dL).

SMG2

Sample size (n) = 86

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.012x - 0.010 mmol/L

y = 1.016x - 0.014 mmol/L

τ = 0.959

r = 0.998

The sample concentrations were between 0.560 and 1.94 mmol/L (1.36 and 4.71 mg/dL).

Urine

Sample size (n) = 86

MGU‑2

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.013x + 0.010 mmol/L

y = 1.013x + 0.016 mmol/L

τ = 0.990

r = 1.000

The sample concentrations were between 0.600 and 10.3 mmol/L (1.46 and 25.0 mg/dL).

SMG2U

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.000x + 0.020 mmol/L

y = 1.002x + 0.021 mmol/L

τ = 0.989

r = 1.000

The sample concentrations were between 0.600 and 10.3 mmol/L (1.46 and 25.0 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP‑magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRISa/6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

R3
(STAT R2)

Xylidyl blue: 0.28 mmol/L; detergent; preservative

a) TRIS = Tris(hydroxymethyl)‑aminomethane

R1 is in position B and R3 (STAT R2) is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Serum/plasma

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

Urine

Quantitative urine controls are recommended for routine quality control.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin plasma.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested.

Chelating anticoagulants such as EDTA, fluoride and oxalate must be avoided.

Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability in serum/plasma:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °C

Urine:

Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesium ammonium phosphate. Collect urine samples in metal‑free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted with 0.9 % NaCl by the instrument.

Stability in urine:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0206407358190c701", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "18", "DocumentObjectID": "FF0000000674710E", "DocumentOriginID": "FF0000000674710E", "MaterialNumbers": [ "06407358190" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of R3 and start of reaction:

    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank and Limit of Detection

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.122 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Values below the Limit of Detection (< 0.10 mmol/L) will not be flagged by the instrument.

Urine

Limit of Blank

= 0.28 mmol/L (0.680 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

Values below the Limit of Detection (< 0.56 mmol/L) will not be flagged by the instrument.

The Limit of Blank and Limit of Detection were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

Serum/plasma:

Newborn:

0.62‑0.91 mmol/L

(1.5‑2.2 mg/dL)

5 months‑6 years:

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

6‑12 years:

0.70‑0.86 mmol/L

(1.7‑2.1 mg/dL)

12‑20 years:

0.70‑0.91 mmol/L

(1.7‑2.2 mg/dL)

Adults:

0.66‑1.07 mmol/L

(1.6‑2.6 mg/dL)

60‑90 years:

0.66‑0.99 mmol/L

(1.6‑2.4 mg/dL)

> 90 years:

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

Urine (24 h):

3.0‑5.0 mmol/d

(72.9‑121.5 mg/d)

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL, 1.4 mval/L).

Serum/plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 800 mg/dL or 496 µmol/L).

Hemolysis elevates results depending on the content of the analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.1 mg/dL, 3.4 mval/L).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

06407358190

Magnesium Gen.2 (200 tests)

System‑ID 01 7486 3

cobas c 701/702

Materials required (but not provided):

10759350360

Calibrator f.a.s. (12 x 3 mL)

Code 401

12149435160

Precinorm U plus (10 x 3 mL)

Code 300

12149443160

Precipath U plus (10 x 3 mL)

Code 301

05947626160

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947774160

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05172152190

Diluent NaCl 9 % (119 mL)

System‑ID 08 6869 3

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

MG‑2: ACN 8701 (Serum/plasma)

MGU‑2: ACN 8704 (Urine)

SMG2: ACN 8688 (STAT, Serum/plasma, reaction time: 4)

SMG2U: ACN 8689 (STAT, Urine, reaction time: 4)

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 18‑27 (STAT 4 / 6‑15)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

R3 (STAT R2)

97 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

3 µL

Decreased

1.5 µL

Increased

6 µL

Application for urine

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 18‑27 (STAT 4 / 6‑15)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

R3 (STAT R2)

97 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

14 µL

140 µL

Decreased

3 µL

14 µL

140 µL

Increased

12 µL

14 µL

140 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 15‑25 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

10 days

On‑board on the Reagent Manager

24 hours

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

2‑point calibration
- every 2 days on‑board
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 10 days). The following results were obtained:

Serum/plasma
MG‑2

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.987 (2.40)

0.005 (0.01)

0.5

Precipath U

1.81 (4.40)

0.01 (0.02)

0.5

Human serum A

0.636 (1.55)

0.005 (0.01)

0.8

Human serum B

0.982 (2.39)

0.008 (0.02)

0.8

Human serum C

1.88 (4.57)

0.01 (0.02)

0.8

SMG2

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.972 (2.36)

0.005 (0.01)

0.5

Precipath U

1.79 (4.35)

0.01 (0.02)

0.3

Human serum A

0.624 (1.52)

0.005 (0.01)

0.8

Human serum B

0.976 (2.37)

0.006 (0.01)

0.6

Human serum C

1.86 (4.52)

0.01 (0.02)

0.5

MG‑2/SMG2

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.974 (2.37)

0.013 (0.03)

1.3

Precipath U

1.79 (4.35)

0.02 (0.05)

1.4

Human serum D

0.626 (1.52)

0.011 (0.03)

1.7

Human serum E

0.969 (2.35)

0.013 (0.03)

1.4

Human serum F

1.95 (4.74)

0.03 (0.07)

1.5

Urine
MGU‑2

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Control level 1

2.02 (4.91)

0.02 (0.05)

1.1

Control level 2

4.83 (11.7)

0.02 (0.05)

0.4

Human urine A

1.43 (3.47)

0.03 (0.07)

2.3

Human urine B

3.07 (7.46)

0.02 (0.05)

0.6

Human urine C

8.29 (20.1)

0.04 (0.10)

0.5

SMG2U

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Control level 1

2.01 (4.88)

0.03 (0.07)

1.3

Control level 2

4.78 (11.6)

0.03 (0.07)

0.6

Human urine A

1.41 (3.43)

0.02 (0.05)

1.3

Human urine B

3.03 (7.36)

0.02 (0.05)

0.7

Human urine C

8.23 (20.0)

0.05 (0.12)

0.6

MGU‑2/SMG2U

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Control level 1

13.8 (33.5)

0.2 (0.5)

1.7

Control level 2

3.21 (7.80)

0.12 (0.29)

3.8

Human urine 1

2.89 (7.02)

0.13 (0.32)

4.6

Results for intermediate precision in urine were obtained on the Roche/Hitachi MODULAR P system.

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum/plasma and urine samples obtained on a cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Serum/plasma
MG‑2

Sample size (n) = 87

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.027x - 0.02 mmol/L

y = 1.029x - 0.021 mmol/L

τ = 0.958

r = 0.998

The sample concentrations were between 0.560 and 1.94 mmol/L (1.36 and 4.71 mg/dL).

SMG2

Sample size (n) = 86

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.012x - 0.010 mmol/L

y = 1.016x - 0.014 mmol/L

τ = 0.959

r = 0.998

The sample concentrations were between 0.560 and 1.94 mmol/L (1.36 and 4.71 mg/dL).

Urine

Sample size (n) = 86

MGU‑2

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.013x + 0.010 mmol/L

y = 1.013x + 0.016 mmol/L

τ = 0.990

r = 1.000

The sample concentrations were between 0.600 and 10.3 mmol/L (1.46 and 25.0 mg/dL).

SMG2U

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.000x + 0.020 mmol/L

y = 1.002x + 0.021 mmol/L

τ = 0.989

r = 1.000

The sample concentrations were between 0.600 and 10.3 mmol/L (1.46 and 25.0 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP‑magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRISa)/6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

R3
(STAT R2)

Xylidyl blue: 0.28 mmol/L; detergent; preservative

a) TRIS = Tris(hydroxymethyl)‑aminomethane

R1 is in position B and R3 (STAT R2) is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Serum/plasma

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

Urine

Quantitative urine controls are recommended for routine quality control.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin plasma.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested.

Chelating anticoagulants such as EDTA, fluoride and oxalate must be avoided.

Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability in serum/plasma:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °C

Freeze only once.

Urine:

Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesium ammonium phosphate. Collect urine samples in metal‑free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted with 0.9 % NaCl by the instrument.

Stability in urine:

LREFWHO Publication: Use of anticoagulants in diagnostic laboratory investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (-15)‑(-25) °C

Freeze only once.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "08902984001", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF000000059EB80E", "DocumentOriginID": "FF000000038E850E", "MaterialNumbers": [ "08900019190" ], "InstrumentReferences": [ { "ID": "307", "BrandName": "cobas c 111" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on the cobas c 111 system.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of SR and start of reaction:
    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection, and Limit of Quantitation:

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.12 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Limit of Quantitation

= 0.10 mmol/L (0.243 mg/dL)

Urine

Limit of Blank

= 0.28 mmol/L (0.68 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

Limit of Quantitation

= 0.56 mmol/L (1.36 mg/dL)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration magnesium samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

Serum/plasma

Newborn:

0.62‑0.91 mmol/L

(1.5‑2.2 mg/dL)

5 months‑6 years

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

6‑12 years

0.70‑0.86 mmol/L

(1.7‑2.1 mg/dL)

12‑20 years

0.70‑0.91 mmol/L

(1.7‑2.2 mg/dL)

Adults:

0.66‑1.07 mmol/L

(1.6‑2.6 mg/dL)

60‑90 years

0.66‑0.99 mmol/L

(1.6‑2.4 mg/dL)

> 90 years

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

Urine (24 h)

3.0‑5.0 mmol/d

(72.9‑121.5 mg/d)

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Serum/plasma

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 496 µmol/L or 800 mg/dL).
Hemolysis elevates results depending on the content of analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.13 mg/dL).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on the cobas c 111 analyzer. For information about test combinations requiring special wash steps, please refer to the latest version of the carry over evasion list found with the CLEAN Method Sheet and the operator’s manual for further instructions.
Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation_111 (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which kit(s) can be used

08900019190

Magnesium Gen.2 (2 × 50 tests)

cobasc 111

Materials required (but not provided):

10759350190

Calibrator f.a.s. (12 × 3 mL)

Code 401

10759350360

Calibrator f.a.s. (12 × 3 mL, for USA)

Code 401

12149435122

Precinorm U plus (10 × 3 mL)

Code 300

12149435160

Precinorm U plus (10 × 3 mL, for USA)

Code 300

12149443122

Precipath U plus (10 × 3 mL)

Code 301

12149443160

Precipath U plus (10 × 3 mL, for USA)

Code 301

05117003190

PreciControl ClinChem Multi 1 (20 × 5 mL)

Code 391

05947626190

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 391

05947626160

PreciControl ClinChem Multi 1 (4 × 5 mL, for USA)

Code 391

05117216190

PreciControl ClinChem Multi 2 (20 × 5 mL)

Code 392

05947774190

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 392

05947774160

PreciControl ClinChem Multi 2 (4 × 5 mL, for USA)

Code 392

04774230190

NaCl Diluent 9 %

Code 951

11930630001

Chimneys

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

MG‑2: ACN 701

MGU‑2: ACN 704

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

Place a chimney in R1 before use.
Absorption of atmospheric CO2 by the opened reagent bottles leads to impaired reagent stability. This kit therefore requires the use of chimneys which reduce the uptake of CO2 by the reagents. The chimneys should be placed directly into the appropriate reagent. The chimneys can be reused for reagent bottles within the same kit. However, to avoid contamination of the reagent with detergent or dilution of the reagent with water it is not permitted to wash the chimneys before reuse.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum, plasma and urine

cobas c 111 test definition

Measuring mode

Absorbance

Abs. calculation mode

Endpoint

Reaction direction

Decrease

Wavelength A/B

629/520 nm

Calc. first/last

16/24

Unit

mmol/L

Serum/plasma

Reaction mode

R1‑S‑SR

Urine

Reaction mode

R1‑S‑SR

Predilution factor

5.5

Pipetting parameters

Serum, plasma and urine

Diluent (H2O)

R1

97 µL

Sample

3 µL

20 µL

SR

97 µL

Total volume

217 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

MG2

Shelf life at 15‑25 °C:

See expiration date on reagent

On‑board in use and refrigerated on the analyzer:

4 weeks

NaCl Diluent 9 %

Shelf life at 2‑8 °C:

See expiration date on reagent

On‑board in use and refrigerated on the analyzer:

4 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrator

Calibrator f.a.s.
Deionized water is used automatically by the instrument as the zero calibrator.

Calibration mode

Linear regression

Calibration replicate

Duplicate recommended

Calibration interval

- each lot
- after 2 weeks on-board
- as required following quality control procedures.

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against atomic absorption spectrometry.

For the USA, this method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the cobas c 111 analyzer are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).
The following results were obtained:

Serum/plasma

Repeatability

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

PCCC1b)

0.860 (2.09)

0.006 (0.015)

0.7

PCCC2c)

1.32 (3.21)

0.010 (0.024)

0.8

Human serum 1

0.316 (0.768)

0.004 (0.010)

1.4

Human serum 2

0.807 (1.96)

0.006 (0.015)

0.8

Human serum 3

1.09 (2.65)

0.008 (0.019)

0.7

Human serum 4

1.28 (3.11)

0.011 (0.027)

0.8

Human serum 5

1.64 (3.99)

0.013 (0.032)

0.8

Intermediate precision

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

0.860 (2.09)

0.012 (0.029)

1.3

PCCC2

FREFPreciControl ClinChem Multi 2

1.32 (3.21)

0.019 (0.046)

1.5

Human serum 1

0.316 (0.768)

0.009 (0.022)

2.9

Human serum 2

0.807 (1.96)

0.012 (0.029)

1.4

Human serum 3

1.09 (2.65)

0.014 (0.034)

1.3

Human serum 4

1.28 (3.11)

0.020 (0.049)

1.6

Human serum 5

1.64 (3.98)

0.027 (0.066)

1.6

Urine

Repeatability

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

Liquicheck 1

1.67 (4.06)

0.018 (0.044)

1.1

Liquicheck 2

3.56 (8.65)

0.031 (0.075)

0.9

Human urine 1

0.814 (1.98)

0.036 (0.087)

4.5

Human urine 2

1.18 (2.87)

0.017 (0.041)

1.5

Human urine 3

4.14 (10.1)

0.044 (1.07)

1.1

Human urine 4

6.22 (15.1)

0.100 (2.43)

1.6

Human urine 5

7.75 (18.8)

0.031 (0.075)

0.4

Intermediate precision

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

Liquicheck 1

1.67 (4.06)

0.045 (0.109)

2.7

Liquicheck 2

3.56 (8.65)

0.053 (0.129)

1.5

Human urine 1

0.814 (1.98)

0.050 (0.122)

6.1

Human urine 2

1.18 (2.87)

0.048 (0.117)

4.1

Human urine 3

4.14 (10.1)

0.075 (0.182)

1.8

Human urine 4

6.22 (15.1)

0.138 (0.335)

2.2

Human urine 5

7.75 (18.8)

0.183 (0.445)

2.4

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum, plasma and urine samples obtained on a cobas c 111 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi COBAS INTEGRA 400 plus analyzer (x).

Serum/plasma
Sample size (n) = 57

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.02x - 0.002 mmol/L

y = 1.02x - 0.002 mmol/L

τ = 0.977

r = 1.000

The sample concentrations were between 0.154 and 1.89 mmol/L (0.374 and 4.59 mg/dL).

Urine
Sample size (n) = 52

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.982x + 0.040 mmol/L

y = 0.984x + 0.035 mmol/L

τ = 0.977

r = 1.000

The sample concentrations were between 0.633 and 10.9 mmol/L (1.54 and 26.5 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP-magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS

FREFTris(hydroxymethyl)‑aminomethane
/6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

SR

Xylidyl blue: 0.28 mmol/L; detergent; preservative

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Serum/plasma

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

Urine

Quantitative urine controls are recommended for routine quality control.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li-heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Chelating anticoagulants such as EDTA, Fluoride and Oxalate must be avoided. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

Urine: Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesiumammonium phosphate. Collect urine samples in metal-free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted 1:5.5 (1+4.5) with 0.9 % NaCl by the instrument.

See the limitations and interferences section for details about possible sample interferences.

Stability in serum/plasma:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (−15)‑(−25) °C

Stability in urine:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (−15)‑(−25) °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208900019190c111", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "5", "DocumentObjectID": "FF0000000674740E", "DocumentOriginID": "FF0000000674740E", "MaterialNumbers": [ "08900019190" ], "InstrumentReferences": [ { "ID": "307", "BrandName": "cobas c 111" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on the cobas c 111 system.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of SR and start of reaction:

    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection, and Limit of Quantitation:

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.12 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Limit of Quantitation

= 0.10 mmol/L (0.243 mg/dL)

Urine

Limit of Blank

= 0.28 mmol/L (0.68 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

Limit of Quantitation

= 0.56 mmol/L (1.36 mg/dL)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration magnesium samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

Serum/plasma

Newborn:

0.62‑0.91 mmol/L

(1.5‑2.2 mg/dL)

5 months‑6 years

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

6‑12 years

0.70‑0.86 mmol/L

(1.7‑2.1 mg/dL)

12‑20 years

0.70‑0.91 mmol/L

(1.7‑2.2 mg/dL)

Adults:

0.66‑1.07 mmol/L

(1.6‑2.6 mg/dL)

60‑90 years

0.66‑0.99 mmol/L

(1.6‑2.4 mg/dL)

> 90 years

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

Urine (24 h)

3.0‑5.0 mmol/d

(72.9‑121.5 mg/d)

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Serum/plasma

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 496 µmol/L or 800 mg/dL).
Hemolysis elevates results depending on the content of analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.13 mg/dL).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on the cobas c 111 analyzer. For information about test combinations requiring special wash steps, please refer to the latest version of the carry-over evasion list found with the CLEAN Method Sheet and the operator’s manual for further instructions.
Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation_111 (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which kit(s) can be used

08900019190

Magnesium Gen.2 (2 × 50 tests)

cobas c 111

Materials required (but not provided):

10759350360

Calibrator f.a.s. (12 × 3 mL)

Code 401

12149435160

Precinorm U plus (10 × 3 mL)

Code 300

12149443160

Precipath U plus (10 × 3 mL)

Code 301

05947626160

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 391

05947774160

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 392

04774230190

NaCl Diluent 9 %

Code 951

11930630001

Chimneys

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

MG‑2: ACN 701

MGU‑2: ACN 704

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

Place a chimney in R1 before use.
Absorption of atmospheric CO2 by the opened reagent bottles leads to impaired reagent stability. This kit therefore requires the use of chimneys which reduce the uptake of CO2 by the reagents. The chimneys should be placed directly into the appropriate reagent. The chimneys can be reused for reagent bottles within the same kit. However, to avoid contamination of the reagent with detergent or dilution of the reagent with water it is not permitted to wash the chimneys before reuse.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum, plasma and urine

cobas c 111 test definition

Measuring mode

Absorbance

Abs. calculation mode

Endpoint

Reaction direction

Decrease

Wavelength A/B

629/520 nm

Calc. first/last

16/24

Unit

mmol/L

Serum/plasma

Reaction mode

R1‑S‑SR

Urine

Reaction mode

R1‑S‑SR

Predilution factor

5.5

Pipetting parameters

Serum, plasma and urine

Diluent (H2O)

R1

97 µL

Sample

3 µL

20 µL

SR

97 µL

Total volume

217 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 15‑25 °C:

See expiration date on reagent

On‑board in use and refrigerated on the analyzer:

4 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrator

Calibrator f.a.s.
Deionized water is used automatically by the instrument as the zero calibrator.

Calibration mode

Linear regression

Calibration replicate

Duplicate recommended

Calibration interval

- after reagent lot change
- every 2 weeks on-board
- as required following quality control procedures.

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the cobas c 111 analyzer are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).
The following results were obtained:

Serum/plasma

Repeatability

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

PCCC1b)

0.860 (2.09)

0.006 (0.015)

0.7

PCCC2c)

1.32 (3.21)

0.010 (0.024)

0.8

Human serum 1

0.316 (0.768)

0.004 (0.010)

1.4

Human serum 2

0.807 (1.96)

0.006 (0.015)

0.8

Human serum 3

1.09 (2.65)

0.008 (0.019)

0.7

Human serum 4

1.28 (3.11)

0.011 (0.027)

0.8

Human serum 5

1.64 (3.99)

0.013 (0.032)

0.8

Intermediate precision

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

0.860 (2.09)

0.012 (0.029)

1.3

PCCC2

FREFPreciControl ClinChem Multi 2

1.32 (3.21)

0.019 (0.046)

1.5

Human serum 1

0.316 (0.768)

0.009 (0.022)

2.9

Human serum 2

0.807 (1.96)

0.012 (0.029)

1.4

Human serum 3

1.09 (2.65)

0.014 (0.034)

1.3

Human serum 4

1.28 (3.11)

0.020 (0.049)

1.6

Human serum 5

1.64 (3.98)

0.027 (0.066)

1.6

Urine

Repeatability

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

Liquicheck 1

1.67 (4.06)

0.018 (0.044)

1.1

Liquicheck 2

3.56 (8.65)

0.031 (0.075)

0.9

Human urine 1

0.814 (1.98)

0.036 (0.087)

4.5

Human urine 2

1.18 (2.87)

0.017 (0.041)

1.5

Human urine 3

4.14 (10.1)

0.044 (1.07)

1.1

Human urine 4

6.22 (15.1)

0.100 (2.43)

1.6

Human urine 5

7.75 (18.8)

0.031 (0.075)

0.4

Intermediate precision

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

Liquicheck 1

1.67 (4.06)

0.045 (0.109)

2.7

Liquicheck 2

3.56 (8.65)

0.053 (0.129)

1.5

Human urine 1

0.814 (1.98)

0.050 (0.122)

6.1

Human urine 2

1.18 (2.87)

0.048 (0.117)

4.1

Human urine 3

4.14 (10.1)

0.075 (0.182)

1.8

Human urine 4

6.22 (15.1)

0.138 (0.335)

2.2

Human urine 5

7.75 (18.8)

0.183 (0.445)

2.4

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum, plasma and urine samples obtained on a cobas c 111 analyzer (y) were compared with those determined using the corresponding reagent on a COBAS INTEGRA 400 plus analyzer (x).

Serum/plasma
Sample size (n) = 57

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.02x - 0.002 mmol/L

y = 1.02x - 0.002 mmol/L

τ = 0.977

r = 1.000

The sample concentrations were between 0.154 and 1.89 mmol/L (0.374 and 4.59 mg/dL).

Urine
Sample size (n) = 52

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.982x + 0.040 mmol/L

y = 0.984x + 0.035 mmol/L

τ = 0.977

r = 1.000

The sample concentrations were between 0.633 and 10.9 mmol/L (1.54 and 26.5 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP-magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS

FREFTris(hydroxymethyl)‑aminomethane
/6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

SR

Xylidyl blue: 0.28 mmol/L; detergent; preservative

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Serum/plasma

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

Urine

Quantitative urine controls are recommended for routine quality control.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li-heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested.

Chelating anticoagulants such as EDTA, fluoride and oxalate must be avoided.

Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability in serum/plasma:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (−15)‑(−25) °C

Freeze only once.

Urine:

Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesiumammonium phosphate. Collect urine samples in metal-free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted 1:5.5 (1+4.5) with 0.9 % NaCl by the instrument.

Stability in urine:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (−15)‑(−25) °C

Freeze only once.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "08543135001", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF00000004E8430E", "DocumentOriginID": "FF0000000314060E", "MaterialNumbers": [ "06407358188" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "", "Language": "en" }, { "Name": "TestPrinciple", "Value": "", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "", "Language": "en" }, { "Name": "OrderInformation", "Value": "", "Language": "en" }, { "Name": "SystemInformation", "Value": "", "Language": "en" }, { "Name": "Handling", "Value": "", "Language": "en" }, { "Name": "TestDefinition", "Value": "", "Language": "en" }, { "Name": "StorageStability", "Value": "", "Language": "en" }, { "Name": "Calibration", "Value": "", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "", "Language": "en" }, { "Name": "Precision", "Value": "", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "", "Language": "en" }, { "Name": "Reagents", "Value": "", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0006481647190COIN", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF000000059EC00E", "DocumentOriginID": "FF00000003A19D0E", "MaterialNumbers": [ "06481647190" ], "InstrumentReferences": [ { "ID": "302", "BrandName": "COBAS INTEGRA 400 plus" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on the COBAS INTEGRA 400 plus system.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of SR and start of reaction:
    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection, and Limit of Quantitation:

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.12 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Limit of Quantitation

= 0.10 mmol/L (0.243 mg/dL)

Urine

Limit of Blank

= 0.28 mmol/L (0.68 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

Limit of Quantitation

= 0.56 mmol/L (1.36 mg/dL)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration magnesium samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

Serum/plasma

Newborn:

0.62‑0.91 mmol/L

(1.5‑2.2 mg/dL)

5 months‑6 years

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

6‑12 years

0.70‑0.86 mmol/L

(1.7‑2.1 mg/dL)

12‑20 years

0.70‑0.91 mmol/L

(1.7‑2.2 mg/dL)

Adults:

0.66‑1.07 mmol/L

(1.6‑2.6 mg/dL)

60‑90 years

0.66‑0.99 mmol/L

(1.6‑2.4 mg/dL)

> 90 years

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

Urine (24 h)

3.0‑5.0 mmol/d

(72.9‑121.5 mg/d)

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Serum/plasma

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 496 µmol/L or 800 mg/dL).
Hemolysis elevates results depending on the content of analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.13 mg/dL).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on COBAS INTEGRA analyzers. Refer to the CLEAN Method Sheet for further instructions and for the latest version of the Extra wash cycle list.
Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

Orderinformation_INT

Order information

Analyzer(s) on which cobas c pack(s) can be used

06481647190

Magnesium Gen.2 (250 tests)

System-ID 07 7486 3

COBAS INTEGRA 400 plus

Materials required (but not provided):

10759350190

Calibrator f.a.s. (12 × 3 mL)

System-ID 07 3718 6

10759350360

Calibrator f.a.s. (12 × 3 mL, for USA)

System-ID 07 3718 6

12149435122

Precinorm U plus (10 × 3 mL)

System-ID 07 7999 7

12149435160

Precinorm U plus (10 × 3 mL, for USA)

System-ID 07 7999 7

12149443122

Precipath U plus (10 × 3 mL)

System-ID 07 8000 6

12149443160

Precipath U plus (10 × 3 mL, for USA)

System-ID 07 8000 6

05117003190

PreciControl ClinChem Multi 1 (20 × 5 mL)

System-ID 07 7469 3

05947626190

PreciControl ClinChem Multi 1 (4 × 5 mL)

System-ID 07 7469 3

05947626160

PreciControl ClinChem Multi 1 (4 × 5 mL, for USA)

System-ID 07 7469 3

05117216190

PreciControl ClinChem Multi 2 (20 × 5 mL)

System-ID 07 7470 7

05947774190

PreciControl ClinChem Multi 2 (4 × 5 mL)

System-ID 07 7470 7

05947774160

PreciControl ClinChem Multi 2 (4 × 5 mL, for USA)

System-ID 07 7470 7

20756350322

NaCl Diluent 9 % (6 × 22 mL)

System‑ID 07 5635 0

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

Test MG‑2, test ID 0‑701; test MGU‑2, test ID 0‑704

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Applications for serum, plasma, and urine

Test definition

Measuring mode

Absorbance

Abs. calculation mode

Endpoint

Reaction direction

Decrease

Wavelength A/B

629/520 nm

Calc. first/last

33/46

Unit

mmol/L

Serum, plasma

Reaction mode

R1‑S‑SR

Urine

Reaction mode

R1‑S‑SR

Predilution factor

5.5

Pipetting parameters

Serum, plasma, and urine

Diluent (H2O)

R1

97 µL

Sample

3 µL

20 µL

SR

97 µL

Total volume

217 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 15‑25 °C

See expiration date on cobas c pack label

On-board in use at 10‑15 °C

12 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrator

Calibrator f.a.s.

Use deionized water as zero calibrator.

Calibration mode

Linear regression

Calibration replicate

Duplicate recommended

Calibration interval

Each lot and as required following quality control procedures.

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against atomic absorption spectrometry.

For the USA, this method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).
The following results were obtained:

Serum/plasma

Repeatability

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

PCCC1b)

0.877 (2.13)

0.011 (0.027)

1.3

PCCC2c)

1.36 (3.30)

0.008 (0.019)

0.6

Human serum 1

0.318 (0.773)

0.009 (0.022)

2.8

Human serum 2

0.818 (1.99)

0.009 (0.022)

1.1

Human serum 3

1.12 (2.72)

0.011 (0.027)

0.9

Human serum 4

1.31 (3.18)

0.011 (0.027)

0.9

Human serum 5

1.67 (4.06)

0.025 (0.061)

1.5

Intermediate precision

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

0.877 (2.13)

0.015 (0.036)

1.7

PCCC2

FREFPreciControl ClinChem Multi 2

1.35 (3.28)

0.011 (0.027)

0.8

Human serum 1

0.318 (0.773)

0.012 (0.029)

3.8

Human serum 2

0.818 (1.99)

0.010 (0.024)

1.2

Human serum 3

1.12 (2.72)

0.011 (0.027)

0.9

Human serum 4

1.31 (3.18)

0.012 (0.029)

0.9

Human serum 5

1.67 (4.06)

0.026 (0.063)

1.5

Urine

Repeatability

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

Liquicheck 1

1.59 (3.86)

0.065 (0.158)

4.0

Liquicheck 2

3.70 (8.99)

0.062 (0.151)

1.7

Human urine 1

0.867 (2.11)

0.043 (0.104)

5.0

Human urine 2

1.25 (3.04)

0.054 (0.131)

4.3

Human urine 3

3.97 (9.65)

0.050 (0.122)

1.3

Human urine 4

6.94 (16.9)

0.098 (0.238)

1.4

Human urine 5

8.79 (21.4)

0.161 (0.391)

1.8

Intermediate precision

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

Liquicheck 1

1.59 (3.86)

0.084 (0.204)

5.2

Liquicheck 2

3.71 (9.02)

0.105 (0.255)

2.8

Human urine 1

0.867 (2.11)

0.053 (0.124)

6.1

Human urine 2

1.25 (3.04)

0.058 (0.141)

4.6

Human urine 3

3.97 (9.65)

0.078 (0.190)

2.0

Human urine 4

6.94 (16.9)

0.163 (0.396)

2.3

Human urine 5

8.79 (21.8)

0.246 (0.598)

2.8

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum, plasma and urine samples obtained on a COBAS INTEGRA 400 plus analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Serum/plasma
Sample size (n) = 57

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.981x + 0.0416 mmol/L

y = 0.983x + 0.0402 mmol/L

τ = 0.976

r = 1.000

The sample concentrations were between 0.130 and 1.86 mmol/L (0.316 and 4.52 mg/dL).

Urine
Sample size (n) = 52

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.016x + 0.0115 mmol/L

y = 1.014x + 0.0236 mmol/L

τ = 0.970

r = 1.000

The sample concentrations were between 0.610 and 10.8 mmol/L (1.48 and 26.2 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP-magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS

FREFTris(hydroxymethyl)‑aminomethane
/6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

SR

Xylidyl blue: 0.28 mmol/L; detergent; preservative

R1 is in position B and SR is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Quality control serum, plasma

Precinorm U plus or PreciControl ClinChem Multi 1

Precipath U plus or PreciControl ClinChem Multi 2

Quality control urine

Quantitative urine controls are recommended for routine quality control.

Control interval

24 hours recommended

Control sequence

User defined

Control after calibration

Recommended

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li-heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Chelating anticoagulants such as EDTA, Fluoride and Oxalate must be avoided. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

Urine: Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesiumammonium phosphate. Collect urine samples in metal-free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted 1:5.5 (1+4.5) with NaCl solution by the instrument.

See the limitations and interferences section for details about possible sample interferences.

Stability in serum/plasma:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (−15)‑(−25) °C

Stability in urine:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (−15)‑(−25) °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0006481647190c501", "ProductName": "MG2", "ProductLongName": "Magnesium Gen.2", "Language": "en", "DocumentVersion": "9", "DocumentObjectID": "FF0000000480C00E", "DocumentOriginID": "FF000000002EC70E", "MaterialNumbers": [ "06481647190" ], "InstrumentReferences": [ { "ID": "308", "BrandName": "cobas c 311" }, { "ID": "2324", "BrandName": "cobas c 502" }, { "ID": "309", "BrandName": "cobas c 501" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of magnesium in human serum, plasma and urine on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Colorimetric endpoint method

  • Sample and addition of R1

  • Addition of R2 and start of reaction:

    In alkaline solution, magnesium forms a purple complex with xylidyl blue, diazonium salt. The magnesium concentration is measured photometrically via the decrease in the xylidyl blue absorbance.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Serum/plasma

0.10‑2.0 mmol/L (0.243‑4.86 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Urine

0.56‑11.0 mmol/L (1.36‑26.7 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank and Limit of Detection

Serum/plasma

Limit of Blank

= 0.05 mmol/L (0.122 mg/dL)

Limit of Detection

= 0.10 mmol/L (0.243 mg/dL)

Urine

Limit of Blank

= 0.28 mmol/L (0.680 mg/dL)

Limit of Detection

= 0.56 mmol/L (1.36 mg/dL)

The Limit of Blank and Limit of Detection were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFWu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. Philadelphia, PA: WB Saunders Company 2006:706-709.

Serum/plasma:

Newborn:

0.62‑0.91 mmol/L

(1.5‑2.2 mg/dL)

5 months‑6 years:

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

6‑12 years:

0.70‑0.86 mmol/L

(1.7‑2.1 mg/dL)

12‑20 years:

0.70‑0.91 mmol/L

(1.7‑2.2 mg/dL)

Adults:

0.66‑1.07 mmol/L

(1.6‑2.6 mg/dL)

60‑90 years:

0.66‑0.99 mmol/L

(1.6‑2.4 mg/dL)

> 90 years:

0.70‑0.95 mmol/L

(1.7‑2.3 mg/dL)

Urine (24 h):

3.0‑5.0 mmol/d

(72.9‑121.5 mg/d)

Roche has not evaluated reference ranges in a pediatric population.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 0.7 mmol/L (1.7 mg/dL, 1.4 mval/L).

Serum/plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 800 (approximate hemoglobin concentration: 496 µmol/L (800 mg/dL)).

Hemolysis elevates results depending on the content of the analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Urine

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Criterion: Recovery within ± 10 % of initial value at a magnesium concentration of 1.7 mmol/L (4.1 mg/dL, 3.4 mval/L).

Urea: No significant interference from urea up to a concentration of 1500 mmol/L (9009 mg/dL).

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. The latest version of the carry‑over evasion list can be found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the operator’s manual. cobas c 502 analyzer: All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

06481647 190

Magnesium Gen.2 (250 tests)

System‑ID 07 7486 3

Roche/Hitachi cobas c 311, cobas c 501/502

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 401

10759350 360

Calibrator f.a.s. (12 x 3 mL, for USA)

Code 401

12149435 122

Precinorm U plus (10 x 3 mL)

Code 300

12149435 160

Precinorm U plus (10 x 3 mL, for USA)

Code 300

12149443 122

Precipath U plus (10 x 3 mL)

Code 301

12149443 160

Precipath U plus (10 x 3 mL, for USA)

Code 301

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

04489357 190

Diluent NaCl 9 % (50 mL)

System‑ID 07 6869 3

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

For cobas c 311/501 analyzers:

MG‑2: ACN 701 (serum and plasma)

MGU‑2: ACN 704 (urine)

SMG2: ACN 688 (STAT, serum and plasma, reaction time: 4)

SMG2U: ACN 689 (STAT, urine, reaction time: 4)

For cobas c 502 analyzer:

MG‑2: ACN 8701 (serum and plasma)

MGU‑2: ACN 8704 (urine)

SMG2: ACN 8688 (STAT, serum and plasma, reaction time: 4)

SMG2U: ACN 8689 (STAT, urine, reaction time: 4)

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 311 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 6‑17 (STAT 4 / 6‑17)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

R2

97 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

Decreased

9 µL

20 µL

100 µL

Increased

3 µL

cobas c 501 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 10‑25 (STAT 4 / 10‑25)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

R2

97 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

Decreased

9 µL

20 µL

100 µL

Increased

3 µL

cobas c 502 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 10‑25 (STAT 4 / 10‑25)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

R2

97 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

Decreased

9 µL

20 µL

100 µL

Increased

6 µL

Application for urine

cobas c 311 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 6‑17 (STAT 4 / 6‑17)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

-

R2

97 µL

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

14 µL

140 µL

Decreased

3 µL

14 µL

140 µL

Increased

6 µL

14 µL

140 µL

cobas c 501 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 10‑25 (STAT 4 / 10‑25)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

-

R2

97 µL

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

14 µL

140 µL

Decreased

3 µL

14 µL

140 µL

Increased

6 µL

14 µL

140 µL

cobas c 502 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 10‑25 (STAT 4 / 10‑25)

Wavelength (sub/main)

505/600 nm

Reaction direction

Decrease

Units

mmol/L (mg/dL, mval/L)

Reagent pipetting

Diluent (H2O)

R1

97 µL

-

R2

97 µL

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

14 µL

140 µL

Decreased

3 µL

14 µL

140 µL

Increased

12 µL

14 µL

140 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

MG

Shelf life at 15‑25 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

12 weeks

Diluent NaCl 9 %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

12 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

2‑point calibration
• after reagent lot change
• as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against atomic absorption spectrometry.

For the USA, this method has been standardized against SRM 956.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institue) EP5 requirements with repeatability and intermediate precision (2 aliquots per run, 2 runs per day, 21 days).
The following results were obtained:

Serum/plasma

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.891 (2.17)

0.008 (0.02)

0.9

Precipath U

1.73 (4.20)

0.01 (0.02)

0.8

Human serum 1

0.588 (1.43)

0.006 (0.01)

1.1

Human serum 2

0.797 (1.94)

0.007 (0.02)

0.8

Human serum 3

1.35 (3.3)

0.01 (0.0)

0.7

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.891 (2.17)

0.009 (0.02)

1.0

Precipath U

1.73 (4.20)

0.02 (0.05)

1.0

Human serum 1

0.588 (1.43)

0.008 (0.02)

1.3

Human serum 2

0.797 (1.94)

0.009 (0.02)

1.1

Human serum 3

1.35 (3.3)

0.01(0.0)

0.9

Urine

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Liquicheck 1

2.16 (5.25)

0.03 (0.07)

1.4

Liquicheck 2

5.16 (12.5)

0.04 (0.1)

0.8

Human urine 1

1.50 (3.65)

0.03 (0.07)

1.8

Human urine 2

6.29 (15.3)

0.05 (0.1)

0.8

Human urine 3

9.59 (23.3)

0.06 (0.2)

0.6

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Liquicheck 1

2.16 (5.25)

0.03 (0.07)

1.5

Liquicheck 2

5.16 (12.5)

0.06 (0.2)

1.1

Human urine 1

1.50 (3.65)

0.03 (0.07)

2.1

Human urine 2

6.29 (15.3)

0.06 (0.2)

0.9

Human urine 3

9.59 (23.3)

0.07 (0.2)

0.8

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Magnesium values for human serum/plasma and urine samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Serum/plasma

Sample size (n) = 75

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.029x - 0.015 mmol/L

y = 1.031x - 0.019 mmol/L

τ = 0.985

r = 0.999

The sample concentrations were between 0.308 and 1.67 mmol/L (0.748 and 4.06 mg/dL).

Urine

Sample size (n) = 57

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.025x + 0.043 mmol/L

y = 1.025x + 0.038 mmol/L

τ = 0.994

r = 1.00

The sample concentrations were between 0.630 and 10.5 mmol/L (1.53 and 25.5 mg/dL).

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFKülpmann WR, Stummvoll HK, Lehmann P, eds. Elektrolyte, Klinik und Labor, 2nd ed. Vienna/New York: Springer-Verlag 1997.
,
LREFZumkley H, Spieker C, eds. Die Magnesiumfibel. Einhorn-Presse-Verlag, Reinbek, 1991.
,
LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
,
LREFEhrhardt V, Appel W, Paschen K, et al. Evaluierung eines Xylidyl-Blau-Reagenz zur Bestimmung von Magnesium. Wien Klin Wschr 1992;104:5-11.
,
LREFMann CK, Yoe JH. Spectrophotometric determination of magnesium with sodium 1-azo-2-hydroxy-3-(2,4-dimethyl-carboxanilido)-napthalene-1'-(2-hydroxy-benzene-5-sulfonate) Anal Chem 1956;28:202-205.

Magnesium along with potassium is a major intracellular cation. Mg2+ is a cofactor of many enzyme systems. Thus, all ATP‑dependent enzymatic reactions require Mg2+ as a cofactor in the ATP‑magnesium complex. Approximately 69 % of magnesium ions are stored in bone. The rest are part of the intermediary metabolism, about 70 % being present in free form while the other 30 % is bound to proteins (especially albumin), citrates, phosphate, and other complex formers. The Mg2+ serum level is kept constant within very narrow limits (0.65‑1.05 mmol/L). Regulation takes place mainly via the kidneys, especially via the ascending loop of Henle.

This assay is used for diagnosing and monitoring hypomagnesemia (magnesium deficiency) and hypermagnesemia (magnesium excess). Numerous studies have shown a correlation between magnesium deficiency and changes in calcium‑, potassium‑ and phosphate‑homeostasis which are associated with cardiac disorders such as ventricular arrhythmias that cannot be treated by conventional therapy, increased sensitivity to digoxin, coronary artery spasms, and sudden death. Additional concurrent symptoms include neuromuscular and neuropsychiatric disorders. Hypermagnesemia is found in acute and chronic renal failure, magnesium excess, and magnesium release from the intracellular space.

In addition to atomic absorption spectrometry (AAS), complexometric methods can also be used to determine magnesium.

The method described here is based on the reaction of magnesium with xylidyl blue in alkaline solution containing EGTA to mask the calcium in the sample.

Urine magnesium levels are determined in magnesium depletion tests.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRISa /6‑aminocaproic acid buffer: 500 mmol/L, pH 11.25; EGTA: 129 µmol/L; preservative

R2

Xylidyl blue: 0.28 mmol/L; detergent; preservative

a) TRIS = Tris(hydroxymethyl)‑aminomethane

R1 is in position B and R2 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H315

Causes skin irritation.

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear protective gloves/ eye protection/ face protection.

Response:

P302 + P352

IF ON SKIN: Wash with plenty of water.

P332 + P313

If skin irritation occurs: Get medical advice/attention.

P337 + P313

If eye irritation persists: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Serum/plasma

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

Urine

Quantitative urine controls are recommended for routine quality control.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested.

Chelating anticoagulants such as EDTA, fluoride and oxalate must be avoided.

Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability in serum/plasma:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °C

Urine:

Urine samples should be acidified to pH 1 with concentrated HCl to prevent precipitation of magnesium ammonium phosphate. Collect urine samples in metal‑free container.

LREFEhrhardt V, Paschen K, Vogt W, et al. Magnesium-Bestimmung im Serum und Urin mit einer verbesserten Xylidyl-Blau-Methode. Workshop Kaiserslautern. Workshop Report Magnesium 1989.
Urine samples are automatically prediluted with 0.9 % NaCl by the instrument.

Stability in urine:

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

3 days at 15‑25 °C

3 days at 2‑8 °C

1 year at (-15)‑(-25) °C

", "Language": "en" } ] } } ] }

MG2

Magnesium Gen.2

IVD For in vitro diagnostic use.
MG2

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

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    Technical Documents

    Access Material Data Sheets, Certificates of Analysis, and other product documentation.

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