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"FF00000000996B0E", "MaterialNumbers": [ "05841941190" ], "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 lithium in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Test principle
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Colorimetric test.

Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.

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

Limits and ranges

Measuring range

0.05‑3.00 mmol/L (0.03‑2.08 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

Limit of Blank:

= 0.03 mmol/L (0.02 mg/dL)

Limit of Detection:

= 0.05 mmol/L (0.03 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 %).

Values below the Limit of Detection (< 0.05 mmol/L) will not be flagged by the instrument.

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

Expected values

Lithium

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

Therapeutic conc.:
Toxic range:

0.6‑1.2 mmol/L (0.42‑0.83 mg/dL)
> 2.0 mmol/L (> 1.39 mg/dL)

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 values at therapeutic concentrations.

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

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 43 for conjugated bilirubin and 37 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 735 µmol/L or 43 mg/dL; approximate unconjugated bilirubin concentration: 633 µmol/L or 37 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 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

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.

Key interferences:

Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.

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.

NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),
CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),
Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).

No significant interference was found in the physiological key interference range.

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.

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

05841941 190

Lithium (100 tests)

System‑ID 01 6934 7

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

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

System information

LI: ACN 8136

", "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

1‑Point

Reaction time / Assay points

10 / 6

Wavelength (sub/main)

480/505 nm

Reaction direction

Decrease

Unit

mmol/L (mg/dL)

Reagent pipetting

Diluent

R1

100 µL

-

R3

-

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

4 µL

5 µL

100 µL

Decreased

2 µL

5 µL

100 µL

Increased

4 µL

10 µL

100 µL

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

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

12 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

Blank calibration
- after 24 hours on board
2‑point calibration
- after cobas c pack change
- as required following quality control procedures

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

Traceability: The lithium calibrator C.f.a.s. is traceable against AAS.

US only: The lithium calibrator C.f.a.s. is traceable against SRM 956b.

", "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, 21 days). The following results were obtained:

Repeatability

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

PreciControl CC Multi 1

1.01 (0.701)

0.01 (0.007)

0.9

PreciControl CC Multi 2

2.83 (1.96)

0.02 (0.01)

0.6

Human serum A

0.166 (0.115)

0.006 (0.004)

3.5

Human serum B

1.20 (0.833)

0.01 (0.007)

0.8

Human serum C

2.49 (1.73)

0.02 (0.01)

0.7

Intermediate precision

Mean
mmol/L (mg/dL)

SD
mmol/L (mg/dL)

CV
%

Precinorm U

0.79 (0.548)

0.02 (0.014)

2.2

Precipath U

2.42 (1.68)

0.03 (0.02)

1.3

Human serum 1

0.64 (0.444)

0.01 (0.007)

2.3

Human serum 2

1.62 (1.12)

0.03 (0.02)

1.6

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

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

Method comparison

Lithium values for human serum samples obtained with the lithium reagent on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 238

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 + 0.010

y = 1.009x + 0.005

τ = 0.959

r = 0.998

The sample concentrations were between 0.05 and 2.79 mmol/L (0.035 and 1.94 mg/dL).

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

Summary

Summary
LREFMonitoring of Lithium. Tietz Fundamentals of Clinical Chemistry. 5th edition, Edited by CA Burtis, ER Ashwood, WB Saunders Co. 2001;631-632(ISBN 0-7216-8634-6).
,
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro-intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.

Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.

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

Reagents - working solutions

R1

Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent

R1 is in position C and position B is empty.

", "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:

Danger

H290

May be corrosive to metals.

H314

Causes severe skin burns and eye damage.

Prevention:

P280

Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response:

P301 + P330 + P331

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

P303 + P361 + P353

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

P304 + P340

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P310

Immediately call a POISON CENTER /doctor.

P390

Absorb spillage to prevent material damage.

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.

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

Specimen collection and preparation
LREFLaborparameter Lithium. MTA Dialog 1 (2005): 29.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFInfinity Lithium Liquid Stable Reagent. Thermo Electron Corporation. P/N: PI660040en.02 Revised December 2003.

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

Only the specimens listed below were tested and found acceptable.

Serum.

Plasma: K2‑EDTA and Na‑heparin plasma.

Do not use lithium heparinized plasma.

The specimen should be separated from cells if storage for more than 4 hours is anticipated.

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. 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.

Invert thawed specimens several times prior to testing.

Stability:

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

1 day at 15‑25 °C
7 days at 2‑8 °C
6 months at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208057974190c503", "ProductName": "LI", "ProductLongName": "Lithium", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF00000004D4600E", "DocumentOriginID": "FF00000003E0BB0E", "MaterialNumbers": [ "08057974190" ], "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 lithium in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Test principle
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Colorimetric test.

Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.

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

Limits and ranges

Measuring range

0.10‑3.00 mmol/L (0.07‑2.08 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

Limit of Blank

= 0.03 mmol/L (0.02 mg/dL)

Limit of Detection

= 0.05 mmol/L (0.03 mg/dL)

Limit of Quantitation

= 0.10 mmol/L (0.07 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 lithium samples.

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

Expected values

mmol/L

Lithium

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

Therapeutic conc.:

0.6‑1.2 mmol/L

Toxic range:

> 2.0 mmol/L

mg/dL*

Lithium

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

Therapeutic conc.:

0.42‑0.83 mg/dL

Toxic range:

> 1.39 mg/dL

* calculated by unit conversion factor

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 lithium concentration of 1.0 mmol/L.

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

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 43 for conjugated and 37 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 735 µmol/L or 43 mg/dL, and approximate unconjugated bilirubin concentration: 633 µmol/L or 37 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 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

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.

Key interferences:

Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.

NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),

CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),

Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).

No significant interference was found in the physiological key interference range.

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.

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

08057974190

Lithium (500 tests)

System‑ID 2084 001

cobas c 303, cobas c 503

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

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

System information

LIX: ACN 20841

", "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)

480/505 nm

Reagent pipetting

Diluent

R1

80 µL

-

R2

-

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

3.2 µL

5 µL

100 µL

Decreased

1.6 µL

5 µL

100 µL

Increased

3.2 µL

5 µL

100 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 2‑8 °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

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Full calibration
- after 7 days on‑board
- after cobas c pack change
- 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: The lithium calibrator C.f.a.s. is traceable against SRM 956b.

", "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.

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

PCCC1a)

0.904 (0.627)

0.00825 (0.00573)

0.9

PCCC2b)

1.72 (1.19)

0.00748 (0.00519)

0.4

Human serum 1

0.149 (0.103)

0.00755 (0.00524)

5.1

Human serum 2

0.628 (0.436)

0.00694 (0.00482)

1.1

Human serum 3

1.25 (0.868)

0.00824 (0.00572)

0.7

Human serum 4

1.54 (1.07)

0.00859 (0.00596)

0.6

Human serum 5

2.64 (1.83)

0.0127 (0.00882)

0.5

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

PCCC1

FREFPreciControl ClinChem Multi 1

0.904 (0.627)

0.0103 (0.00715)

1.1

PCCC2

FREFPreciControl ClinChem Multi 2

1.72 (1.19)

0.0129 (0.00895)

0.8

Human serum 1

0.149 (0.103)

0.00883 (0.00613)

5.9

Human serum 2

0.621 (0.431)

0.00851 (0.00591)

1.4

Human serum 3

1.25 (0.868)

0.00992 (0.00689)

0.8

Human serum 4

1.54 (1.07)

0.0114 (0.00791)

0.7

Human serum 5

2.64 (1.83)

0.0160 (0.0111)

0.6

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

Method comparison

Lithium values for human serum samples obtained with the lithium reagent on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 105

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 = 1.022x - 0.00332 mmol/L

y = 1.019x - 0.00146 mmol/L

τ = 0.983

r = 1.000

The sample concentrations were between 0.156 and 2.99 mmol/L (0.108 and 2.08 mg/dL).

Lithium values for human serum samples obtained with the lithium reagent on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 104

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 - 0.0148 mmol/L

y = 1.025x - 0.0128 mmol/L

τ = 0.986

r = 1.000

The sample concentrations were between 0.140 and 2.80 mmol/L (0.097 and 1.94 mg/dL).

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

Summary

Summary
LREFMonitoring of Lithium. Tietz Fundamentals of Clinical Chemistry. 5th edition, Edited by CA Burtis, ER Ashwood, WB Saunders Co. 2001;631-632(ISBN 0-7216-8634-6).
,
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro‑intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.

Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.

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

Reagents - working solutions

R1

Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent

R1 is in position B.

", "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:

Danger

H290

May be corrosive to metals.

H314

Causes severe skin burns and eye damage.

Prevention:

P280

Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.

Response:

P301 + P330 + P331

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

P303 + P361 + P353

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

P304 + P340 + P310

IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Immediately call a POISON CENTER/doctor.

P305 + P351 + P338
+ P310

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.

P390

Absorb spillage to prevent material damage.

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.

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

Specimen collection and preparation
LREFLaborparameter Lithium. MTA Dialog 1 (2005): 29.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFInfinity Lithium Liquid Stable Reagent. Thermo Electron Corporation. P/N: PI660040en.02 Revised December 2003.

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

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: K2‑EDTA and Na‑heparin plasma.

Do not use lithium heparinized plasma.

The specimen should be separated from cells if storage for more than 4 hours is anticipated.

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. 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:

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

1 day at 15‑25 °C

7 days at 2‑8 °C

6 months at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108057974190c503", "ProductName": "LI", "ProductLongName": "Lithium", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF0000000497310E", "DocumentOriginID": "FF0000000460670E", "MaterialNumbers": [ "08057974190" ], "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 lithium in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Test principle
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Colorimetric test.

Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.

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

Limits and ranges

Measuring range

0.05‑3.00 mmol/L (0.03‑2.08 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

Limit of Blank

= 0.03 mmol/L (0.02 mg/dL)

Limit of Detection

= 0.05 mmol/L (0.03 mg/dL)

Limit of Quantitation

= 0.10 mmol/L (0.07 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 lithium samples.

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

Expected values

mmol/L

Lithium

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

Therapeutic conc.:

0.6‑1.2 mmol/L

Toxic range:

> 2.0 mmol/L

mg/dL*

Lithium

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

Therapeutic conc.:

0.42‑0.83 mg/dL

Toxic range:

> 1.39 mg/dL

* calculated by unit conversion factor

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 lithium concentration of 1.0 mmol/L.

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

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 43 for conjugated and 37 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 735 µmol/L or 43 mg/dL, and approximate unconjugated bilirubin concentration: 633 µmol/L or 37 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 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

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.

Key interferences:

Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.

NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),

CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),

Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).

No significant interference was found in the physiological key interference range.

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.

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

08057974190

Lithium (500 tests)

System‑ID 2084 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

05947774190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

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

System information

LI: ACN 20840

", "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)

480/505 nm

Reagent pipetting

Diluent

R1

80 µL

-

R2

-

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

3.2 µL

5 µL

100 µL

Decreased

1.6 µL

5 µL

100 µL

Increased

3.2 µL

5 µL

100 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 2‑8 °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

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Full calibration
- after 7 days on‑board
- after cobas c pack change
- 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: The lithium calibrator C.f.a.s. is traceable against AAS.

", "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.

Repeatability

Mean

mmol/L

SD

mmol/L

CV

%

PCCC1a)

0.904

0.00825

0.9

PCCC2b)

1.72

0.00748

0.4

Human serum 1

0.149

0.00755

5.1

Human serum 2

0.628

0.00694

1.1

Human serum 3

1.25

0.00824

0.7

Human serum 4

1.54

0.00859

0.6

Human serum 5

2.64

0.0127

0.5

Intermediate precision

Mean

mmol/L

SD

mmol/L

CV

%

PCCC1

FREFPreciControl ClinChem Multi 1

0.904

0.0103

1.1

PCCC2

FREFPreciControl ClinChem Multi 2

1.72

0.0129

0.8

Human serum 1

0.149

0.00883

5.9

Human serum 2

0.621

0.00851

1.4

Human serum 3

1.25

0.00992

0.8

Human serum 4

1.54

0.0114

0.7

Human serum 5

2.64

0.0160

0.6

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

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

Method comparison

Lithium values for human serum samples obtained with the lithium reagent on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 108

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 = 1.022x - 0.00392

y = 1.019x - 0.00186

τ = 0.983

r = 1.000

The sample concentrations were between 0.0500 and 2.99 mmol/L.

Lithium values for human serum samples obtained with the lithium reagent on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 104

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 = 1.031x - 0.0139

y = 1.028x - 0.0113

τ = 0.986

r = 1.000

The sample concentrations were between 0.140 and 2.80 mmol/L.

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

Summary

Summary
LREFMonitoring of Lithium. Tietz Fundamentals of Clinical Chemistry. 5th edition, Edited by CA Burtis, ER Ashwood, WB Saunders Co. 2001;631-632(ISBN 0-7216-8634-6).
,
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro‑intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.

Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.

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

Reagents - working solutions

R1

Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent

R1 is in position B.

", "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:

Danger

H290

May be corrosive to metals.

H314

Causes severe skin burns and eye damage.

Prevention:

P280

Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.

Response:

P301 + P330 + P331

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

P303 + P361 + P353

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

P304 + P340 + P310

IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Immediately call a POISON CENTER/ doctor.

P305 + P351 + P338
+ P310

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.

P390

Absorb spillage to prevent material damage.

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.

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

Specimen collection and preparation
LREFLaborparameter Lithium. MTA Dialog 1 (2005): 29.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFInfinity Lithium Liquid Stable Reagent. Thermo Electron Corporation. P/N: PI660040en.02 Revised December 2003.

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

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: K2‑EDTA and Na‑heparin plasma.

Do not use lithium heparinized plasma.

The specimen should be separated from cells if storage for more than 4 hours is anticipated.

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. 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:

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

1 day at 15‑25 °C

7 days at 2‑8 °C

6 months at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008057974190c503", "ProductName": "LI", "ProductLongName": "Lithium", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF00000004606F0E", "DocumentOriginID": "FF000000037CCF0E", "MaterialNumbers": [ "08057974190" ], "InstrumentReferences": [ { "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 lithium in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Test principle
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Colorimetric test.

Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.

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

Limits and ranges

Measuring range

0.05‑3.00 mmol/L (0.03‑2.08 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

Limit of Blank

= 0.03 mmol/L (0.02 mg/dL)

Limit of Detection

= 0.05 mmol/L (0.03 mg/dL)

Limit of Quantitation

= 0.10 mmol/L (0.07 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 lithium samples.

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

Expected values

mmol/L

Lithium

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

Therapeutic conc.:

0.6‑1.2 mmol/L

Toxic range:

> 2.0 mmol/L

mg/dL*

Lithium

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

Therapeutic conc.:

0.42‑0.83 mg/dL

Toxic range:

> 1.39 mg/dL

* calculated by unit conversion factor

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 lithium concentration of 1.0 mmol/L.

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

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 43 for conjugated and 37 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 735 µmol/L or 43 mg/dL, and approximate unconjugated bilirubin concentration: 633 µmol/L or 37 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 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

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.

Key interferences:

Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.

NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),

CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),

Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).

No significant interference was found in the physiological key interference range.

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.

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

08057974 190

Lithium (500 tests)

System‑ID 2084 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

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

System information

LI: ACN 20840

", "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)

480/505 nm

Reagent pipetting

Diluent

R1

80 µL

-

R2

-

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

3.2 µL

5 µL

100 µL

Decreased

1.6 µL

5 µL

100 µL

Increased

3.2 µL

5 µL

100 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 2‑8 °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

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Full calibration
- after 7 days on‑board
- after cobas c pack change
- 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: The lithium calibrator C.f.a.s. is traceable against AAS.

US only: The lithium calibrator C.f.a.s. is traceable against SRM 956b.

", "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:

Repeatability

Mean

mmol/L

SD

mmol/L

CV

%

PCCC1a)

0.904

0.00825

0.9

PCCC2b)

1.72

0.00748

0.4

Human serum 1

0.149

0.00755

5.1

Human serum 2

0.628

0.00694

1.1

Human serum 3

1.25

0.00824

0.7

Human serum 4

1.54

0.00859

0.6

Human serum 5

2.64

0.0127

0.5

Intermediate precision

Mean

mmol/L

SD

mmol/L

CV

%

PCCC1

FREFPreciControl ClinChem Multi 1

0.904

0.0103

1.1

PCCC2

FREFPreciControl ClinChem Multi 2

1.72

0.0129

0.8

Human serum 1

0.149

0.00883

5.9

Human serum 2

0.621

0.00851

1.4

Human serum 3

1.25

0.00992

0.8

Human serum 4

1.54

0.0114

0.7

Human serum 5

2.64

0.0160

0.6

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

Method comparison

Lithium values for human serum samples obtained with the lithium reagent 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).

Sample size (n) = 108

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 = 1.022x - 0.00392

y = 1.019x - 0.00186

τ = 0.983

r = 1.000

The sample concentrations were between 0.0500 and 2.99 mmol/L.

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

Summary

Summary
LREFMonitoring of Lithium. Tietz Fundamentals of Clinical Chemistry. 5th edition, Edited by CA Burtis, ER Ashwood, WB Saunders Co. 2001;631-632(ISBN 0-7216-8634-6).
,
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro‑intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.

Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.

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

Reagents - working solutions

R1

Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent

R1 is in position B.

", "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:

Danger

H290

May be corrosive to metals.

H314

Causes severe skin burns and eye damage.

Prevention:

P280

Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response:

P301 + P330 + P331

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

P303 + P361 + P353

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

P304 + P340

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P310

Immediately call a POISON CENTER /doctor.

P390

Absorb spillage to prevent material damage.

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.

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

Specimen collection and preparation
LREFLaborparameter Lithium. MTA Dialog 1 (2005): 29.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFInfinity Lithium Liquid Stable Reagent. Thermo Electron Corporation. P/N: PI660040en.02 Revised December 2003.

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

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: K2‑EDTA and Na‑heparin plasma.

Do not use lithium heparinized plasma.

The specimen should be separated from cells if storage for more than 4 hours is anticipated.

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. 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:

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

1 day at 15‑25 °C

7 days at 2‑8 °C

6 months at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0004679598190c501", "ProductName": "LI", "ProductLongName": "Lithium", "Language": "en", "DocumentVersion": "12", "DocumentObjectID": "FF0000000463AB0E", "DocumentOriginID": "FF0000000028350E", "MaterialNumbers": [ "04679598190" ], "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 lithium in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Test principle
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Colorimetric test.

Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance which is directly proportional to the concentration of lithium in the sample.

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

Limits and ranges

Measuring range

0.05‑3.00 mmol/L (0.03‑2.08 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

Limit of Blank:

= 0.03 mmol/L (0.02 mg/dL)

Limit of Detection:

= 0.05 mmol/L (0.03 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 %).

Values below the Limit of Detection (< 0.05 mmol/L or 0.03 mg/dL) will not be flagged by the instrument.

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

Expected values

Lithium

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

Therapeutic conc.:

0.6‑1.2 mmol/L (0.42‑0.83 mg/dL)

Toxic range:

> 2.0 mmol/L (> 1.39 mg/dL)

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 values at therapeutic concentrations.

LREFReference Values for Therapeutic and Toxic Drugs. Tietz Fundamentals of Clinical Chemistry. Fifth Edition, Edited by Carl A. Burtis, Edward R. Ashwood, W.B. Saunders Company, 2001: 1023 (ISBN 0-7216-8634-6).

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 43 for conjugated and 37 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 735 µmol/L or 43 mg/dL and approximate unconjugated bilirubin concentration: 633 µmol/L or 37 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 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

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.

Key interferences:

Criterion: Recovery within ± 5 % of initial values at therapeutic concentrations.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.

NH4Cl (19.8 µmol/L), NaCl (140 mmol/L), KCl (4 mmol/L),

CaCl2 (2.4 mmol/L), MgCl2 (0.9 mmol/L), FeCl3 (1.04 mg/L),

Cu(NO3)2 (1.15 mmol/L), ZnCl2 (1.07 mmol/L).

No significant interference was found in the physiological key interference range.

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.

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

04679598 190

Lithium (100 tests)

System‑ID 07 6934 7

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

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

System information

For cobas c 311/501 analyzers:

LI: ACN 136

For cobas c 502 analyzer:

LI: ACN 8136

", "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

1‑Point

Reaction time / Assay points

10 / 7

Wavelength (sub/main)

480/505 nm

Reaction direction

Decrease

Unit

mmol/L (mg/dL)

Reagent pipetting

Diluent

R1

100 µL

-

R2

-

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

4 µL

5 µL

100 µL

Decreased

2 µL

5 µL

100 µL

Increased

4 µL

5 µL

100 µL

cobas c 501 test definition

Assay type

1‑Point

Reaction time / Assay points

10 / 11

Wavelength (sub/main)

480/505 nm

Reaction direction

Decrease

Unit

mmol/L (mg/dL)

Reagent pipetting

Diluent

R1

100 µL

-

R2

-

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

4 µL

5 µL

100 µL

Decreased

2 µL

5 µL

100 µL

Increased

4 µL

5 µL

100 µL

cobas c 502 test definition

Assay type

1‑Point

Reaction time / Assay points

10 / 11

Wavelength (sub/main)

480/505 nm

Reaction direction

Decrease

Unit

mmol/L (mg/dL)

Reagent pipetting

Diluent

R1

100 µL

-

R2

-

-

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

4 µL

5 µL

100 µL

Decreased

2 µL

5 µL

100 µL

Increased

4 µL

10 µL

100 µL

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

Storage and stability

LI

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

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

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

2‑point calibration
• after 7 days on‑board
• after cobas c pack change
• 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: The lithium calibrator C.f.a.s. is traceable against AAS.

US only: The lithium calibrator C.f.a.s. is traceable against SRM 956b.

", "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, 21 days). The following results were obtained:

Repeatability

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.77 (0.534)

0.01 (0.007)

1.7

Precipath U

2.38 (1.65)

0.02 (0.01)

1.0

Human serum 1

0.46 (0.319)

0.01 (0.007)

1.9

Human serum 2

1.40 (0.972)

0.02 (0.014)

1.2

Intermediate precision

Mean

mmol/L (mg/dL)

SD

mmol/L (mg/dL)

CV

%

Precinorm U

0.79 (0.548)

0.02 (0.014)

2.2

Precipath U

2.42 (1.68)

0.03 (0.02)

1.3

Human serum 1

0.64 (0.444)

0.01 (0.007)

2.3

Human serum 2

1.62 (1.12)

0.03 (0.02)

1.6

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

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

Method comparison

Lithium values for human serum samples obtained with the lithium reagent 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) and with the lithium ion‑selective electrode on a COBAS INTEGRA 400 analyzer (x).

x = Roche/Hitachi 917 analyzer, y = cobas c 501 analyzer

Sample size (n) = 50

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 = 1.034x - 0.013

y = 1.032x - 0.016

τ = 0.959

r = 0.996

The sample concentrations were between 0.434 and 1.36 mmol/L (0.301 and 0.944 mg/dL).

x = COBAS INTEGRA 400 analyzer, y = cobas c 501 analyzer

Sample size (n) = 78

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 = 0.989x + 0.037

y = 0.961x + 0.060

τ = 0.958

r = 0.998

The sample concentrations were between 0.120 and 3.35 mmol/L (0.083 and 2.323 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
LREFMonitoring of Lithium. Tietz Fundamentals of Clinical Chemistry. 5th edition, Edited by CA Burtis, ER Ashwood, WB Saunders Co. 2001;631-632(ISBN 0-7216-8634-6).
,
LREFRumbelow B and Peake M. Performance of a novel spectrophotometric lithium assay on a routine biochemistry analyser. Ann Clin Biochem 2001;38:684-686.

Lithium is widely used in the treatment of manic depressive psychosis. Administered as lithium carbonate, it is completely absorbed by the gastro‑intestinal tract; peak serum levels occur 2 to 4 hours after an oral dose. The half life in serum is 48 to 72 hours and it is cleared through the kidneys (excretion parallels that of sodium). Reduced renal function can prolong clearance time. Lithium acts by enhancing the uptake of neurotransmitters, which produces a sedative effect on the central nervous system. Serum lithium concentrations are measured essentially to ensure compliance and to avoid toxicity. Early symptoms of intoxication include apathy, sluggishness, drowsiness, lethargy, speech difficulties, irregular tremors, myoclonic twitchings, muscle weakness and ataxia.

Levels higher than 1.5 mmol/L (12 hours after a dose) indicate a significant risk of intoxication. In the diagnostic laboratory, lithium has traditionally been measured using either flame emission photometry, atomic absorption spectrometry, or ion selective electrodes. These methods require specific and often dedicated instrumentation. This lithium test is a colorimetric method.

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

Reagents - working solutions

R1

Sodium hydroxide: 0.5 mol/L; EDTA: 50 µmol/L; substituted porphyrin: 15 µmol/L; preservative; detergent

R1 is in position B.

", "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:

Danger

H290

May be corrosive to metals.

H314

Causes severe skin burns and eye damage.

Prevention:

P280

Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response:

P301 + P330 + P331

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

P303 + P361 + P353

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

P304 + P340

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P310

Immediately call a POISON CENTER /doctor.

P390

Absorb spillage to prevent material damage.

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.

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

Specimen collection and preparation
LREFLaborparameter Lithium. MTA Dialog 1 (2005): 29.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFInfinity Lithium Liquid Stable Reagent. Thermo Electron Corporation. P/N: PI660040en.02 Revised December 2003.

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

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: K2‑EDTA and Na‑heparin plasma.

Do not use lithium heparinized plasma.

The specimen should be separated from cells if storage for more than 4 hours is anticipated.

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. 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:

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

1 day at 15‑25 °C

7 days at 2‑8 °C

6 months at (-15)‑(-25) °C

", "Language": "en" } ] } } ] }

LI

Lithium

IVD For in vitro diagnostic use.
LI

Overview

Detailed Specifications

Ordering Information

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    Access Material Data Sheets, Certificates of Analysis, and other product documentation.

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