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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

Reagent to measure A1M Levels in human urine samples.

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

Test principle

Immunoturbidimetric assay

Anti‑α1‑microglobulin antibodies sensitized to latex particles react with antigen in the sample to form an antigen/antibody complex which, after agglutination, can be determined turbidimetrically. This agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of A1M in the sample. The actual concentration is determined by interpolation from a calibration curve prepared from calibrators of known concentration.

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

Limits and ranges

Measuring range

5.0‑200 mg/L

No automatic re‑run defined. Samples exceeding the measuring range must be diluted manually with 0.9 % NaCl solution; e.g. 1:2.

Lower limits of measurement

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

Limit of Blank

= 1 mg/L

Limit of Detection

= 2.5 mg/L

Limit of Quantitation

= 5 mg/L

These data were generated on cobas c 701 at Denka, based on the Clinical and Laboratory Standards Institute (CLSI) Protocol EP17‑A2. The precision goal for the Limit of Quantitation was a CV % of less than 16 %.

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

Expected values

2nd morning urine:

LREFHofmann W, Guder WG. Präanalytische und analytische Faktoren bei der Bestimmung von IgG, Albumin, a1-Mikroglobulin und Retinol-bindendem Protein im Urin mit dem Behring Nephelometer System(BNS). Lab med 1989; 13: 470-8.
< 12 mg/L

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: deviation from initial value: ≤ 20 mg/L: ≤ ± 2 mg/L, > 20 mg/L: ≤ ± 10 %

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 250 (approximate hemoglobin concentration: 250 mg/dL).

Urea: No significant interference from urea up to a concentration of 2700 mmol/L.

Drugs:

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

High‑dose hook effect: No false result occurs up to a α1‑Microglobulin concentration of 500 mg/L.

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

08944547190

α1-Microglobulin (150 tests)

System‑ID 03 7627 0

cobas c 701, cobas c 702

08944474190

α1-Microglobulin Calibrator Set (5 × 1 mL)

Code 620‑625

03121313122

Precinorm PUC (4 × 3 mL)


Code 240

03121291122

Precipath PUC (4 × 3 mL)


Code 241

05172152190

Diluent NaCl 9 % (119 mL)

System‑ID 08 6869 3

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

System information

For cobas c 701/702 analyzers:

A1MGU: ACN 8696

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

Reagent handling

Ready for use

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

Application for urine

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 22‑38

Wavelength (sub/main)

800/570 nm

Reaction direction

Increase

Units

mg/L

Reagent pipetting

Diluent (H2O)

R1

100 µL

R3

33 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

10 µL

10 µL

90 µL

Decreased

10 µL

10 µL

90 µL

Increased

10 µL

10 µL

90 µL

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

Storage and stability

A1MGU

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

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 (Cal Code 620)

S2‑S6: α1-Microglobulin Calibrator Set (Cal Code 621‑625)

Calibration mode

Spline

Calibration frequency

Full calibration
• after reagent lot change
• Every 84 days a new calibration for one lot.
• as required following quality control

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

Traceability: This method has been standardized against an internal standard traceable to a nephelometric method.

", "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 data using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained.

Repeatability

Mean
mg/L

SD
mg/L

CV
%

Precinorm PUC

43.5

0.258

0.6

Precipath PUC

181

1.13

0.6

Human urine 1

7.82

0.221

2.8

Human urine 2

14.1

0.57

4.1

Human urine 3

103

1.62

1.6

Intermediate precision

Mean
mg/L

SD
mg/L

CV
%

Control Low

43.7

0.592

1.4

Control High

180

3.08

1.7

Human urine 1

7.82

0.347

4.4

Human urine 2

14.1

0.703

5.0

Human urine 3

103

2.78

2.7

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

Method comparison

α1‑Microglobulin values for urine samples obtained on a cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 116

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 = 0.999x - 1.04 mg/L

r = 0.999

The sample concentrations were between 5.7 mg/L and 194 mg/L.

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

Summary

α1-Microglobulin (α1‑M) is a low molecular weight, pH stable glycoprotein. It has a molar mass of 30000 daltons and is synthesized by the hepatocytes and lymphocytes. It is almost entirely filtered in the glomeruli with approximately 99.8 % of the reabsorption and catabolism taking place in the proximal tubules.

Increased excretion of α1‑microglobulin in tubular proteinuria is indicative of reduced tubular reabsorption under normal glomerular filtration conditions. This form of proteinuria is typical for chronic interstitial nephropathy and for acute and chronic tubular damage caused by endogenous and exogenous tubular toxins. In renal failure, the plasma levels of this microprotein increase from an early stage. The resultant protein hyperfiltration in the residual nephron causes increased renal excretion as reabsorption capacity is exceeded (overflow proteinuria). α1‑Microglobulin can be used as a marker for the diagnosis of tubule‑interstitial nephropathy, for example, at an early stage or rule it out with a high degree of certainty; the detection limit is approximately 10‑20 mg/L (333‑666 nmol/L). Acute and chronic forms of tubular insufficiency (all forms of primary and secondary Fanconi syndrome), heavy metal intoxication, nephrotoxic side‑effects of pharmaceuticals, and rejection reactions following kidney transplantation can also be excluded.

LREFKurrle-Weittenhiller A, Engel W. AACC Poster Abstract. Clin Chem 1992;38:1090-1091.
,
LREFWeber MH, Scholz P, Stibbe W, et al. α1-Mikroglobulin im Urin und Serum bei Proteinurie und Niereninsuffizienz. Klin Wschr 1985;63:711-713.
,
LREFColombo JP, ed. Klinisch-chemische Urindiagnostik. Rotkreuz: LABOLIFE-Verlagsgemeinschaft 1994:180.
,
LREFGuder W, Zawta B. Basiswissen Labordiagnostik Niere (Boehringer Mannheim 1994) 1994.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.

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

Reagents - working solutions

R1

Glycine buffer: 170 mmol/L, pH 7.0; NaCl: 1.1 mol/L; preservative

R3

Latex particles coated with anti‑human α1‑microglobulin antibodies (rabbit): 0.2‑0.3 %; glycine buffer: 150 mmol/L, pH 7.3; NaCl: 90 mmol/L; preservative

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

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

Precautions and warnings

For professional 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.

", "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

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

Only the specimens listed below were tested and found acceptable.
Urine

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.

Stability:

5 days at 15‑25 °C

4 weeks at 2‑8 °C

3 months at ~(-70) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108944539190COIN", "ProductName": "A1MGU", "ProductLongName": "α1-Microglobulin", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF00000004507A0E", "DocumentOriginID": "FF0000000434200E", "MaterialNumbers": [ "08944539190" ], "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

Reagent to measure A1M Levels in human urine samples.

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

Test principle

Immunoturbidimetric assay

Anti‑α1‑microglobulin antibodies sensitized to latex particles react with antigen in the sample to form an antigen/antibody complex which, after agglutination, can be determined turbidimetrically. This agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of A1M in the sample. The actual concentration is determined by interpolation from a calibration curve prepared from calibrators of known concentration.

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

Limits and ranges

Measuring range

5.0‑200 mg/L

Lower limits of measurement

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

Limit of Blank

= 2 mg/L

Limit of Detection

= 3.5 mg/L

Limit of Quantitation

= 5 mg/L

These data were generated on COBAS INTEGRA 400 plus based on the Clinical and Laboratory Standards Institute (CLSI) Protocol EP17‑A2. The precision goal for the Limit of Quantitation was a CV % of less than 16 %.

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

Expected values

2nd morning urine:

LREFHofmann W, Guder WG. Präanalytische und analytische Faktoren bei der Bestimmung von IgG, Albumin, a1-Mikroglobulin und Retinol-bindendem Protein im Urin mit dem Behring Nephelometer System(BNS). Lab med 1989; 13: 470-8.
< 12 mg/L

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: deviation from initial value: ≤ 20 mg/L: ≤ ± 2 mg/L, > 20 mg/L: ≤ ± 10 %

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 250 (approximate hemoglobin concentration: 250 mg/dL).

Urea: No significant interference from urea up to a concentration of 2700 mmol/L.

Drugs:

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

High‑dose hook effect: No false result occurs up to a α1‑microglobulin concentration of 500 mg/L.

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 (CC Reagents - cobas + Integra)

Order information

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

08944539190

α1-Microglobulin (100 tests)

System‑ID 07 7627 0

COBAS INTEGRA 400 plus

08944474190

α1-Microglobulin Calibrator Set (5 × 1 mL)

System‑ID 07 7628 9

03121313122

Precinorm PUC (4 × 3 mL)

System‑ID 07 6756 5

03121291122

Precipath PUC (4 × 3 mL)

System‑ID 07 6757 3

20756350322

NaCl Diluent 9 % (50 mL)

System‑ID 07 5635 0

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

System information

For COBAS INTEGRA 400 plus analyzers:

A1MGU: test ID: 0‑299

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

Reagent handling

Ready for use

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

Application for urine

COBAS INTEGRA 400 plus test definition

Measuring mode

Absorbance

Abs. calculation mode

Endpoint

Reaction mode

R1-S-SR

Reaction direction

Increase

Wavelength A/B

583

Calc. first/last

35/65

Typical prozone effect

> 500 mg/L

Antigen excess check

No

Unit

mg/L

Pipetting parameters

Diluent (H2O)

R1

100 µL

-

Sample

10 µL

-

SR

33 µL

5

Total volume

148 µL

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

Storage and stability

Shelf life at 2‑8 °C

See expiration date on cobas c pack label

COBAS INTEGRA 400 plus system

On-board in use at 10‑15 °C

12 weeks

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

Calibration

Calibrators

S1: H2O

S2‑S6: α1‑Microglobulin Calibrator Set

Calibration mode

Spline

Calibrator dilution ratio

1:10, performed automatically by the instrument

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.

The assigned α1‑Microglobulin values are:

Zerocalibrator: H2O = 0.0 mg/L
α1‑Microglobulin Calibrator Set: 10, 25, 50,100, 200 mg/L

Traceability: This method has been standardized against an internal standard traceable to a nephelometric method.

", "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 data using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained.

Repeatability

Mean
mg/L

SD
mg/L

CV
%

Precinorm PUC

34.8

0.719

2.1

Precipath PUC

108

0.950

0.9

Human urine 1

10.8

0.652

6.0

Human urine 2

14.7

0.590

4.0

Human urine 3

101

2.19

2.2

Intermediate precision

Mean
mg/L

SD
mg/L

CV
%

Control Low

13.7

0.591

4.3

Control High

111

1.36

1.2

Human urine 1

5.34

0.649

12.1

Human urine 2

16.2

0.521

3.2

Human urine 3

107

1.62

1.5

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

Method comparison

α1‑Microglobulin values for 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).
Sample size (n) = 117

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 = 1.018x − 0.832 mg/L

r = 0.999

The sample concentrations were between 5.60 mg/L and 194 mg/L.

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

Summary

α1-Microglobulin (α1‑M) is a low molecular weight, pH stable glycoprotein. It has a molar mass of 30000 daltons and is synthesized by the hepatocytes and lymphocytes. It is almost entirely filtered in the glomeruli with approximately 99.8 % of the reabsorption and catabolism taking place in the proximal tubules.

Increased excretion of α1‑microglobulin in tubular proteinuria is indicative of reduced tubular reabsorption under normal glomerular filtration conditions. This form of proteinuria is typical for chronic interstitial nephropathy and for acute and chronic tubular damage caused by endogenous and exogenous tubular toxins. In renal failure, the plasma levels of this microprotein increase from an early stage. The resultant protein hyperfiltration in the residual nephron causes increased renal excretion as reabsorption capacity is exceeded (overflow proteinuria). α1‑Microglobulin can be used as a marker for the diagnosis of tubule‑interstitial nephropathy, for example, at an early stage or rule it out with a high degree of certainty; the detection limit is approximately 10‑20 mg/L (333‑666 nmol/L). Acute and chronic forms of tubular insufficiency (all forms of primary and secondary Fanconi syndrome), heavy metal intoxication, nephrotoxic side‑effects of pharmaceuticals, and rejection reactions following kidney transplantation can also be excluded.

LREFKurrle-Weittenhiller A, Engel W. AACC Poster Abstract. Clin Chem 1992;38:1090-1091.
,
LREFWeber MH, Scholz P, Stibbe W, et al. α1-Mikroglobulin im Urin und Serum bei Proteinurie und Niereninsuffizienz. Klin Wschr 1985;63:711-713.
,
LREFColombo JP, ed. Klinisch-chemische Urindiagnostik. Rotkreuz: LABOLIFE-Verlagsgemeinschaft 1994:180.
,
LREFGuder W, Zawta B. Basiswissen Labordiagnostik Niere (Boehringer Mannheim 1994) 1994.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.

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

Reagents - working solutions

R1

Glycine buffer: 170 mmol/L, pH 7.0; NaCl: 1.1 mol/L; preservative

SR

Latex particles coated with anti‑human α1‑microglobulin antibodies (rabbit): 0.2‑0.3 %; glycine buffer: 150 mmol/L, pH 7.3; NaCl: 90 mmol/L; preservative

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

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

Precautions and warnings

For professional 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.

", "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

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

Only the specimens listed below were tested and found acceptable.
Urine

Centrifuge samples containing precipitates before performing the assay.

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

Stability:

5 days at 15‑25 °C

4 weeks at 2‑8 °C

3 months at ~(-70) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108944539190c501", "ProductName": "A1MGU", "ProductLongName": "α1-Microglobulin", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF0000000450820E", "DocumentOriginID": "FF00000004342B0E", "MaterialNumbers": [ "08944539190" ], "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

Reagent to measure A1M Levels in human urine samples.

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

Test principle

Immunoturbidimetric assay

Anti‑α1‑microglobulin antibodies sensitized to latex particles react with antigen in the sample to form an antigen/antibody complex which, after agglutination, can be determined turbidimetrically. This agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of A1M in the sample. The actual concentration is determined by interpolation from a calibration curve prepared from calibrators of known concentration.

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

Limits and ranges

Measuring range

5.0‑200 mg/L

No automatic re‑run defined. Samples exceeding the measuring range must be diluted manually with 0.9 % NaCl solution; e.g. 1:2.

Lower limits of measurement

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

Limit of Blank

= 1 mg/L

Limit of Detection

= 2.5 mg/L

Limit of Quantitation

= 5 mg/L

These data were generated on cobas c 501 at Denka, based on the Clinical and Laboratory Standards Institute (CLSI) Protocol EP17‑A2. The precision goal for the Limit of Quantitation was a CV % of less than 16 %.

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

Expected values

2nd morning urine:

LREFHofmann W, Guder WG. Präanalytische und analytische Faktoren bei der Bestimmung von IgG, Albumin, a1-Mikroglobulin und Retinol-bindendem Protein im Urin mit dem Behring Nephelometer System(BNS). Lab med 1989; 13: 470-8.
< 12 mg/L

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: deviation from initial value: ≤ 20 mg/L: ≤ ± 2 mg/L, > 20 mg/L: ≤ ± 10 %

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 250 (approximate hemoglobin concentration: 250 mg/dL).

Urea: No significant interference from urea up to a concentration of 2700 mmol/L.

High dose hook‑effect: No false result occurs up to an α1‑microglobulin concentration of 500 mg/L.

Drugs:

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

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. 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

08944539190

α1-Microglobulin (100 tests)

System‑ID 07 7627 0

cobas c 311, cobas c 501/502

08944474190

α1-Microglobulin Calibrator Set (5 × 1 mL)

Code 620‑625

03121313122

Precinorm PUC (4 × 3 mL)


Code 240

03121291122

Precipath PUC (4 × 3 mL)


Code 241

04489357190

Diluent NaCl 9 % (50 mL)

System‑ID 07 6869 3

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

System information

For cobas c 311/501 analyzer:

A1MGU: ACN 696

For cobas c 502 analyzer:

A1MGU: ACN 8696

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

Reagent handling

Ready for use

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

Application for urine

cobas c 311 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 27‑57

Wavelength (sub/main)

800/570 nm

Reaction direction

Increase

Units

mg/L

Reagent pipetting

Diluent (H2O)

R1

100 µL

R3

33 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

10 µL

10 µL

90 µL

Decreased

10 µL

10 µL

90 µL

Increased

10 µL

10 µL

90 µL

cobas c 501/502 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 40‑70

Wavelength (sub/main)

800/570 nm

Reaction direction

Increase

Units

mg/L

Reagent pipetting

Diluent (H2O)

R1

100 µL

R3

33 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

10 µL

10 µL

90 µL

Decreased

10 µL

10 µL

90 µL

Increased

10 µL

10 µL

90 µL

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

Storage and stability

A1MGU

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

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‑S6: α1-Microglobulin Calibrator Set

Calibration mode

Spline

Calibration frequency

Full calibration
• after reagent lot change
• Every 84 days a new calibration for one lot.
• as required following quality control

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

Traceability: This method has been standardized against an internal standard traceable to a nephelometric method.

", "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 data using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained.

Repeatability

Mean
mg/L

SD
mg/L

CV
%

Precinorm PUC

43.7

0.360

0.8

Precipath PUC

181

1.66

0.9

Human urine 1

6.90

0.266

3.9

Human urine 2

15.4

0.252

1.6

Human urine 3

97.3

2.12

2.2

Intermediate precision

Mean
mg/L

SD
mg/L

CV
%

Control Low

14.1

0.185

1.3

Control High

109

1.37

1.3

Human urine 1

4.99

0.231

4.6

Human urine 2

15.0

0.357

2.4

Human urine 3

96.2

3.07

3.2

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

Method comparison

α1‑Microglobulin values for 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).
Sample size (n) = 117

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 = 1.018x − 0.832 mg/L

r = 0.999

The sample concentrations were between 5.60 mg/L and 194 mg/L.

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

Summary

α1-Microglobulin (α1‑M) is a low molecular weight, pH stable glycoprotein. It has a molar mass of 30000 daltons and is synthesized by the hepatocytes and lymphocytes. It is almost entirely filtered in the glomeruli with approximately 99.8 % of the reabsorption and catabolism taking place in the proximal tubules.

Increased excretion of α1‑microglobulin in tubular proteinuria is indicative of reduced tubular reabsorption under normal glomerular filtration conditions. This form of proteinuria is typical for chronic interstitial nephropathy and for acute and chronic tubular damage caused by endogenous and exogenous tubular toxins. In renal failure, the plasma levels of this microprotein increase from an early stage. The resultant protein hyperfiltration in the residual nephron causes increased renal excretion as reabsorption capacity is exceeded (overflow proteinuria). α1‑Microglobulin can be used as a marker for the diagnosis of tubule‑interstitial nephropathy, for example, at an early stage or rule it out with a high degree of certainty; the detection limit is approximately 10‑20 mg/L (333‑666 nmol/L). Acute and chronic forms of tubular insufficiency (all forms of primary and secondary Fanconi syndrome), heavy metal intoxication, nephrotoxic side‑effects of pharmaceuticals, and rejection reactions following kidney transplantation can also be excluded.

LREFKurrle-Weittenhiller A, Engel W. AACC Poster Abstract. Clin Chem 1992;38:1090-1091.
,
LREFWeber MH, Scholz P, Stibbe W, et al. α1-Mikroglobulin im Urin und Serum bei Proteinurie und Niereninsuffizienz. Klin Wschr 1985;63:711-713.
,
LREFColombo JP, ed. Klinisch-chemische Urindiagnostik. Rotkreuz: LABOLIFE-Verlagsgemeinschaft 1994:180.
,
LREFGuder W, Zawta B. Basiswissen Labordiagnostik Niere (Boehringer Mannheim 1994) 1994.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.

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

Reagents - working solutions

R1

Glycine buffer: 170 mmol/L, pH 7.0; NaCl: 1.1 mol/L; preservative

R3

Latex particles coated with anti‑human α1‑microglobulin antibodies (rabbit): 0.2‑0.3 %; glycine buffer: 150 mmol/L, pH 7.3; NaCl: 90 mmol/L; preservative

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

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

Precautions and warnings

For professional 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.

", "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

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

Only the specimens listed below were tested and found acceptable.
Urine

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.

Stability:

5 days at 15‑25 °C

4 weeks at 2‑8 °C

3 months at ~(-70) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108944555190c503", "ProductName": "A1MGU", "ProductLongName": "α1-Microglobulin", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF00000004500E0E", "DocumentOriginID": "FF0000000434280E", "MaterialNumbers": [ "08944555190" ], "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

Reagent to measure A1M Levels in human urine samples.

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

Test principle

Immunoturbidimetric assay

Anti‑α1‑microglobulin antibodies sensitized to latex particles react with antigen in the sample to form an antigen/antibody complex which, after agglutination, can be determined turbidimetrically. This agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of A1M in the sample. The actual concentration is determined by interpolation from a calibration curve prepared from calibrators of known concentration.

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

Limits and ranges

Measuring range

5.0‑200 mg/L

No automatic re‑run defined. Samples exceeding the measuring range must be diluted manually with 0.9 % NaCl solution; e.g. 1:2.

Lower limits of measurement

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

Limit of Blank

= 1 mg/L

Limit of Detection

= 2.5 mg/L

Limit of Quantitation

= 5 mg/L

These data were generated on cobas c 503 at Denka, based on the Clinical and Laboratory Standards Institute (CLSI) Protocol EP17‑A2. The precision goal for the Limit of Quantitation was a CV % of less than 16 %.

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

Expected values

2nd morning urine:

LREFHofmann W, Guder WG. Präanalytische und analytische Faktoren bei der Bestimmung von IgG, Albumin, a1-Mikroglobulin und Retinol-bindendem Protein im Urin mit dem Behring Nephelometer System(BNS). Lab med 1989; 13: 470-8.
< 12 mg/L

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: deviation from initial value: ≤ 20 mg/L: ≤ ± 2 mg/L, > 20 mg/L: ≤ ± 10 %

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 250 (approximate hemoglobin concentration: 250 mg/dL).

Urea: No significant interference from urea up to a concentration of 2700 mmol/L.

Drugs:

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

High‑dose hook effect: No false result occurs up to a α1‑Microglobulin concentration of 500 mg/L.

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

08944555190

α1-Microglobulin (200 tests)

System‑ID 2131 001

cobas c 503

08944474190

α1-Microglobulin Calibrator Set (5 × 1 mL)

Code 20620‑20625

03121313122

Precinorm PUC (4 × 3 mL)


Code 20240

03121291122

Precipath PUC (4 × 3 mL)


Code 20241

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

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

System information

For cobas c 503 analyzers:

A1MGU: ACN 21310

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

Reagent handling

Ready for use

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

Application for urine

cobas c 503 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 20‑34

Wavelength (sub/main)

800/570 nm

Reaction direction

Increase

Units

mg/L

Reagent pipetting

Diluent (H2O)

R1

73 µL

R3

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

10 µL

7.3 µL

90 µL

Decreased

10 µL

7.3 µL

90 µL

Increased

10 µL

7.3 µL

90 µL

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

Storage and stability

A1MGU

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

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:

26 weeks

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

Calibration

Calibrators

S1: H2O (Cal Code 20620)

S2‑S6: α1-Microglobulin Calibrator Set (Cal Code 20621‑20625)

Calibration mode

Spline

Calibration frequency

Full calibration
• after reagent lot change
• Every 84 days a new calibration for one lot.
• as required following quality control

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

Traceability: This method has been standardized against an internal standard traceable to a nephelometric method.

", "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 data using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained.

Repeatability

Mean
mg/L

SD
mg/L

CV
%

Precinorm PUC

40.8

0.183

0.4

Precipath PUC

161

0.816

0.5

Human urine 1

7.56

0.184

2.4

Human urine 2

19.5

0.228

1.2

Human urine 3

110

0.577

0.5

Intermediate precision

Mean
mg/L

SD
mg/L

CV
%

Control Low

40.2

0.402

1.0

Control High

161

1.93

1.2

Human urine 1

7.38

0.212

2.9

Human urine 2

19.5

0.287

1.5

Human urine 3

109

0.889

0.8

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

Method comparison

α1‑Microglobulin values for 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).

Sample size (n) = 116

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 = 0.940x - 0.294 mg/L

r = 0.999

The sample concentrations were between 5.6 mg/L and 194 mg/L.

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

Summary

α1-Microglobulin (α1‑M) is a low molecular weight, pH stable glycoprotein. It has a molar mass of 30000 daltons and is synthesized by the hepatocytes and lymphocytes. It is almost entirely filtered in the glomeruli with approximately 99.8 % of the reabsorption and catabolism taking place in the proximal tubules.

Increased excretion of α1‑microglobulin in tubular proteinuria is indicative of reduced tubular reabsorption under normal glomerular filtration conditions. This form of proteinuria is typical for chronic interstitial nephropathy and for acute and chronic tubular damage caused by endogenous and exogenous tubular toxins. In renal failure, the plasma levels of this microprotein increase from an early stage. The resultant protein hyperfiltration in the residual nephron causes increased renal excretion as reabsorption capacity is exceeded (overflow proteinuria). α1‑Microglobulin can be used as a marker for the diagnosis of tubule‑interstitial nephropathy, for example, at an early stage or rule it out with a high degree of certainty; the detection limit is approximately 10‑20 mg/L (333‑666 nmol/L). Acute and chronic forms of tubular insufficiency (all forms of primary and secondary Fanconi syndrome), heavy metal intoxication, nephrotoxic side‑effects of pharmaceuticals, and rejection reactions following kidney transplantation can also be excluded.

LREFKurrle-Weittenhiller A, Engel W. AACC Poster Abstract. Clin Chem 1992;38:1090-1091.
,
LREFWeber MH, Scholz P, Stibbe W, et al. α1-Mikroglobulin im Urin und Serum bei Proteinurie und Niereninsuffizienz. Klin Wschr 1985;63:711-713.
,
LREFColombo JP, ed. Klinisch-chemische Urindiagnostik. Rotkreuz: LABOLIFE-Verlagsgemeinschaft 1994:180.
,
LREFGuder W, Zawta B. Basiswissen Labordiagnostik Niere (Boehringer Mannheim 1994) 1994.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.

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

Reagents - working solutions

R1

Glycine buffer: 170 mmol/L, pH 7.0; NaCl: 1.1 mol/L; preservative

R3

Latex particles coated with anti‑human α1‑microglobulin antibodies (rabbit): 0.2‑0.3 %; glycine buffer: 150 mmol/L, pH 7.3; NaCl: 90 mmol/L; preservative

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

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

Precautions and warnings

For professional 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.

", "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

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

Only the specimens listed below were tested and found acceptable.
Urine

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.

Stability:

5 days at 15‑25 °C

4 weeks at 2‑8 °C

3 months at ~(-70) °C

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

A1MGU

α1-Microglobulin

IVD For in vitro diagnostic use.
A1MGU

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

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    Technical Documents

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