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"ProductSpec": [ { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0005991978190c701", "ProductName": "AAT2", "ProductLongName": "Tina-quant α1-Antitrypsin ver.2", "Language": "en", "DocumentVersion": "6", "DocumentObjectID": "FF000000046B190E", "DocumentOriginID": "FF0000000019BA0E", "MaterialNumbers": [ "05991978190" ], "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 α1‑antitrypsin in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Immunoturbidimetric assay.

Human α1‑antitrypsin forms a precipitate with a specific antiserum which is determined turbidimetrically.

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

Limits and ranges

Measuring range

0.2‑6.0 g/L (3.68‑110.4 µmol/L, 20‑600 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

Lower detection limit of the test

0.2 g/L (3.68 µmol/L, 20 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

Values below the lower detection limit (< 0.2 g/L) will not be flagged by the instrument.

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

Expected values

Expected values
LREFDati F, Schumann G, Thomas L, et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996;34:517-520.

0.9‑2.0 g/L (16.6‑36.8 µmol/L, 90‑200 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 value at an α1‑antitrypsin concentration of 0.9 g/L (16.6 µmol/L, 90 mg/dL).

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 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 500. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors up to 1200 IU/mL do not interfere.

High dose hook-effect: No false result occurs up to an α1‑antitrypsin concentration of 12 g/L (221 µmol/L, 1200 mg/dL).

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.

Elevated estrogen levels (oral contraceptives; third trimester of pregnancy) give rise to increased values. CRP and haptoglobin should therefore also be determined.

LREFNielsen CH, Poulsen HK, Teisner B, et al. Changes in blood levels of proteinase inhibitors, pregnancy zone protein, steroid carriers and complement factors induced by oral contraceptives. Eur J Obstet Gynecol Reprod Biol 1993;51:63-71.

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 not required. The latest version of the carry‑over evasion list can also 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

05991978 190

Tina-quant α1-Antitrypsin ver.2 (150 tests)

System-ID 03 9008 7

Roche/Hitachi cobas c 701/702

Materials required (but not provided):

11355279 216

Calibrator f.a.s. Proteins (5 x 1 mL)

Code 656

11355279 160

Calibrator f.a.s. Proteins (5 x 1 mL, for USA)

Code 656

10557897 122

Precinorm Protein (3 x 1 mL)

Code 302

10557897 160

Precinorm Protein (3 x 1 mL, for USA)

Code 302

11333127 122

Precipath Protein (3 x 1 mL)

Code 303

11333127 160

Precipath Protein (3 x 1 mL, for USA)

Code 303

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

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

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

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

Code 392

05172152 190

Diluent NaCl 9 % (119 mL)

System-ID 08 6869 3

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

System information

AAT2: ACN 8048

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

Reagent handling

Ready for use

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

Application for serum and plasma

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 18‑38

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R3

45 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

9 µL

180 µL

Decreased

6 µL

4 µL

164 µL

Increased

6 µL

15 µL

150 µL

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

Storage and stability

AAT2

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

S2-S6: C.f.a.s. Proteins

Multiply the lot-specific C.f.a.s. Proteins calibrator value by the factors below to determine the standard concentrations for the 6-point calibration curve:

S2: 0.233

S5: 1.56

S3: 0.467

S6: 2.28

S4: 0.952

Calibration mode

RCM2

Calibration frequency

Full calibration

• after reagent lot change

• as required following quality control procedures

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

Traceability: This method has been standardized against the certified reference material in human serum of the IRMM (Institute for Reference Materials and Measurements) ERM‑DA470k/IFCC.

", "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

g/L
(µmol/L, mg/dL)

SD

g/L
(µmol/L, mg/dL)

CV

%

Precinorm Protein

1.21 (22.3, 121)

0.02 (0.4, 2)

1.5

Precipath Protein

2.04 (37.5, 204)

0.02 (0.4, 2)

0.9

Human serum A

1.94 (35.7, 194)

0.02 (0.4, 2)

0.9

Human serum B

0.519 (9.55, 51.9)

0.006 (0.11, 0.6)

1.2

Human serum C

5.33 (98.1. 533)

0.07 (1.3, 7)

1.4

Intermediate precision

Mean

g/L
(µmol/L, mg/dL)

SD

g/L
(µmol/L, mg/dL)

CV

%

Precinorm Protein

1.12 (20.6, 112)

0.01 (0.2, 1)

1.1

Precipath Protein

1.86 (34.2, 186)

0.02 (0.4, 2)

1.2

Human serum 3

1.05 (19.3, 105)

0.01 (0.2, 1)

1.4

Human serum 4

1.76 (32.4, 176)

0.03 (0.6, 3)

1.5

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

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

Method comparison

α1-Antitrypsin values for human serum and plasma samples obtained 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) = 95

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 = 0.993x + 0.002 g/L

y = 0.988x + 0.020 g/L

τ = 0.962

r = 0.998

The sample concentrations were between 1.14 and 5.56 g/L (21.0 and 102 µmol/L, 114 and 556 mg/dL).

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

Summary

Summary
LREFLievens M, Bienvenu J, Buitrago JMG, et al. Evaluation of four new Tina-quant assays for determination of α1-acid glycoprotein, α1-antitrypsin, haptoglobin and prealbumin. Clin Lab 1996;42:515-520.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:231-232.
,
LREFSchneider M, Pott G, Gerlach U. Alpha-1-Antitrypsin-Mangel. Klin Wschr 1986;64:197-205.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;66-67.
,
LREFJohnson AM, Alper CA. Deficiency of α1-antitrypsin in childhood liver disease. Pediatrics 1970;46(6):921-925.
,
LREFSilverman EK, Pierce JA, Province MA, et al. Variability of pulmonary function in alpha-1-antitrypsin deficiency: Clinical correlates. Ann Intern Med 1989;111(12):982-991.

α1‑Antitrypsin is a glycoprotein consisting of a polypeptide chain to which 3 oligosaccharide chains are bonded (54000 daltons). It is synthesized in hepatocytes. α1‑Antitrypsin is quantitatively the most important proteinase inhibitor (Pi) in serum and plasma. It specifically inactivates serine proteases (e.g. trypsin, chymotrypsin, collagenase, leukocyte elastase, plasmin and thrombin), with which it reversibly forms an enzyme-inhibitor complex. α1‑Antitrypsin constitutes the major fraction of the electrophoretic α1‑globulin fraction. Because it is a small molecule, α1‑antitrypsin diffuses rapidly into other body fluids including bronchial secretions.

α1‑Antitrypsin is an important, positive acute phase reactant found in elevated concentrations in inflammatory processes (e.g. infectious and rheumatoid diseases), tissue necrosis, malignancy and traumas. Inflammation of the liver parenchymal cells is often accompanied by elevated α1‑antitrypsin levels, although levels of other acute phase reactants are not affected.

Acute hereditary α1‑antitrypsin deficiency is suspected in cases of neonatal hepatitis accompanied by progressive liver cirrhosis in early childhood. It is also suspected when severe pulmonary emphysema occurs in adults due to the prevalence of leukocyte elastase, which can lead to unrestrained proteolytic degradation of the pulmonary parenchymal cells.

Various methods are available for assaying α1‑antitrypsin, such as kinetic nephelometry or radial immunodiffusion. Roche’s automated α1‑antitrypsin assay is based upon the immunological agglutination test principle.

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

Reagents - working solutions

R1

Phosphate buffer: 12.7 mmol/L, pH 7.2; NaCl: 0.13 mol/L; PEG: 40 g/L; preservative

R3

Anti-human α1‑antitrypsin antibody (rabbit): > 2 g/L; NaCl: 0.1 mol/L; preservative

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

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

Precautions and warnings

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

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

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

Safety data sheet available for professional user on request.

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

", "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.

Serum.

Plasma: Li‑heparin and K2‑EDTA plasma

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

Stability:

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

7 days at 15‑25 °C

3 months at 2‑8 °C

3 months at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0003005771322c501", "ProductName": "AAT2", "ProductLongName": "Tina-quant α1-Antitrypsin ver.2", "Language": "en", "DocumentVersion": "12", "DocumentObjectID": "FF000000046B140E", "DocumentOriginID": "FF0000000019B70E", "MaterialNumbers": [ "03005771322" ], "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 α1‑antitrypsin in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Immunoturbidimetric assay.

Human α1‑antitrypsin forms a precipitate with a specific antiserum which is determined turbidimetrically.

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

Limits and ranges

Measuring range

0.2‑6.0 g/L (3.68‑110.4 µmol/L, 20‑600 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

Lower detection limit of the test

0.2 g/L (3.68 µmol/L, 20 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

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

Expected values

Expected values
LREFDati F, Schumann G, Thomas L, et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996;34:517-520.

0.9‑2.0 g/L (16.6‑36.8 µmol/L, 90‑200 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 value at an α1-antitrypsin concentration of 0.9 g/L (16.6 µmol/L, 90 mg/dL).

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: (1000 mg/dL or 621 µmol/L).

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 350. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors up to 1200 IU/mL do not interfere.

High dose hook-effect: No false result occurs up to an α1‑antitrypsin concentration of 12 g/L (221 µmol/L, 1200 mg/dL).

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.

Elevated estrogen levels (oral contraceptives; third trimester of pregnancy) give rise to increased values. CRP and haptoglobin should therefore also be determined.

LREFNielsen CH, Poulsen HK, Teisner B, et al. Changes in blood levels of proteinase inhibitors, pregnancy zone protein, steroid carriers and complement factors induced by oral contraceptives. Eur J Obstet Gynecol Reprod Biol 1993;51:63-71.

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 not required.

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

03005771 322

Tina-quant α1-Antitrypsin ver.2, 100 tests

System-ID 07 9008 7

Roche/Hitachi cobas c 311, cobas c 501/502

Materials required (but not provided):

11355279 216

Calibrator f.a.s. Proteins (5 x 1 mL)

Code 656

11355279 160

Calibrator f.a.s. Proteins (5 x 1 mL, for USA)

Code 656

10557897 122

Precinorm Protein (3 x 1 mL)

Code 302

10557897 160

Precinorm Protein (3 x 1 mL, for USA)

Code 302

11333127 122

Precipath Protein (3 x 1 mL)

Code 303

11333127 160

Precipath Protein (3 x 1 mL, for USA)

Code 303

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

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

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

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

Code 392

04489357 190

Diluent NaCl 9 % (50 mL)

System-ID 07 6869 3

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

System information

For cobas c 311/501 analyzers:

AAT2: ACN 048

For cobas c 502 analyzer:

AAT2: ACN 8048

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

Reagent handling

Ready for use

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

Application for serum and plasma

cobas c 311 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 6-24

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

45 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

9 µL

180 µL

Decreased

6 µL

4 µL

164 µL

Increased

6 µL

9 µL

180 µL

cobas c 501 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 10-48

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

45 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

9 µL

180 µL

Decreased

6 µL

4 µL

164 µL

Increased

6 µL

9 µL

180 µL

cobas c 502 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 10-48

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

45 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6 µL

9 µL

180 µL

Decreased

6 µL

4 µL

164 µL

Increased

6 µL

18 µL

180 µL

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

Storage and stability

AAT2

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: C.f.a.s. Proteins

Multiply the lot-specific C.f.a.s. Proteins calibrator value by the factors below to determine the standard concentrations for the 6-point calibration curve:

S2: 0.233

S5: 1.56

S3: 0.467

S6: 2.28

S4: 0.952

Calibration mode

RCM2

Calibration frequency

Full calibration

• after reagent lot change

• as required following quality control procedures

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

Traceability: This method has been standardized against the certified reference material in human serum of the IRMM (Institute for Reference Materials and Measurements) ERM‑DA470k/IFCC.

", "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

g/L

(µmol/L, mg/dL)

SD

g/L

(µmol/L, mg/dL)

CV

%

Precinorm Protein

1.14 (21.0, 114)

0.01 (0.2, 1)

0.8

Precipath Protein

1.89 (34.8, 189)

0.02 (0.4, 2)

0.9

Human serum 1

1.04 (19.1, 104)

0.01 (0.2, 1)

0.8

Human serum 2

1.58 (29.1, 158)

0.01 (0.2, 1)

0.8

Intermediate precision

Mean

g/L

(µmol/L, mg/dL)

SD

g/L

(µmol/L, mg/dL)

CV

%

Precinorm Protein

1.12 (20.6, 112)

0.01 (0.2, 1)

1.1

Precipath Protein

1.86 (34.2, 186)

0.02 (0.4, 2)

1.2

Human serum 3

1.05 (19.3, 105)

0.01 (0.2, 1)

1.4

Human serum 4

1.76 (32.4, 176)

0.03 (0.6, 3)

1.5

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

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

Method comparison

α1‑Antitrypsin values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Sample size (n) = 119

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 = 0.972x - 0.029 g/L

y = 0.979x - 0.043 g/L

τ = 0.976

r = 0.998

The sample concentrations were between 0.880 and 3.35 g/L (16.2 and 61.6 µmol/L, 88.0 and 335 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
LREFLievens M, Bienvenu J, Buitrago JMG, et al. Evaluation of four new Tina-quant assays for determination of α1-acid glycoprotein, α1-antitrypsin, haptoglobin and prealbumin. Clin Lab 1996;42:515-520.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:231-232.
,
LREFSchneider M, Pott G, Gerlach U. Alpha-1-Antitrypsin-Mangel. Klin Wschr 1986;64:197-205.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;66-67.
,
LREFJohnson AM, Alper CA. Deficiency of α1-antitrypsin in childhood liver disease. Pediatrics 1970;46(6):921-925.
,
LREFSilverman EK, Pierce JA, Province MA, et al. Variability of pulmonary function in alpha-1-antitrypsin deficiency: Clinical correlates. Ann Intern Med 1989;111(12):982-991.

α1‑Antitrypsin is a glycoprotein consisting of a polypeptide chain to which 3 oligosaccharide chains are bonded (54000 daltons). It is synthesized in hepatocytes. α1‑Antitrypsin is quantitatively the most important proteinase inhibitor (Pi) in serum and plasma. It specifically inactivates serine proteases (e.g. trypsin, chymotrypsin, collagenase, leukocyte elastase, plasmin and thrombin), with which it reversibly forms an enzyme‑inhibitor complex. α1‑Antitrypsin constitutes the major fraction of the electrophoretic α1‑globulin fraction. Because it is a small molecule, α1‑antitrypsin diffuses rapidly into other body fluids including bronchial secretions.

α1‑Antitrypsin is an important, positive acute phase reactant found in elevated concentrations in inflammatory processes (e.g. infectious and rheumatoid diseases), tissue necrosis, malignancy and traumas. Inflammation of the liver parenchymal cells is often accompanied by elevated α1‑antitrypsin levels, although levels of other acute phase reactants are not affected.

Acute hereditary α1‑antitrypsin deficiency is suspected in cases of neonatal hepatitis accompanied by progressive liver cirrhosis in early childhood. It is also suspected when severe pulmonary emphysema occurs in adults due to the prevalence of leukocyte elastase, which can lead to unrestrained proteolytic degradation of the pulmonary parenchymal cells.

Various methods are available for assaying α1‑antitrypsin, such as kinetic nephelometry or radial immunodiffusion. Roche’s automated α1‑antitrypsin assay is based upon the immunological agglutination test principle.

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

Reagents - working solutions

R1

Phosphate buffer: 12.7 mmol/L, pH 7.2; NaCl: 0.13 mol/L; PEG: 40 g/L; preservative

R2

Anti‑human α1‑antitrypsin antibody (rabbit): > 2 g/L; NaCl: 0.1 mol/L; preservative

R1 is in position B and R2 is in position C.

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

Precautions and warnings

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

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

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

Safety data sheet available for professional user on request.

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

", "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.

Serum.

Plasma: Li‑heparin and K2‑EDTA plasma

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

Stability:

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

7 days at 15‑25 °C

3 months at 2‑8 °C

3 months at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0003005771322COIN", "ProductName": "AAT2", "ProductLongName": "Tina-quant α1-Antitrypsin ver.2", "Language": "en", "DocumentVersion": "8", "DocumentObjectID": "FF000000046B160E", "DocumentOriginID": "FF0000000065A30E", "MaterialNumbers": [ "03005771322" ], "InstrumentReferences": [ { "ID": "302", "BrandName": "COBAS INTEGRA 400 plus" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative immunological determination of human α1‑antitrypsin in human serum and plasma on COBAS INTEGRA systems.

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

Test principle

Immunoturbidimetric assay
Human α1‑antitrypsin forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.

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

Limits and ranges

Measuring range

0.25‑5.50 g/L (4.60‑101 µmol/L or 25‑550 mg/dL) (typical measuring range)

The upper and lower limits of the measuring range depend on the actual calibrator value.

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:3 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 3.

Determine samples having lower concentrations via the rerun function. For samples with lower concentrations, the rerun function reduces the sample predilution factor to 10.5. The results are automatically multiplied by the reduced predilution factor.

Lower limits of measurement

Lower detection limit of the test:
0.2 g/L (3.68 µmol/L or 20.0 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of a zero sample (zero sample + 3 SD, repeatability, n = 21).

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

Expected values

Expected values
LREFDati F, Schumann G, Thomas L, et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996;34:517-520.

0.9‑2.0 g/L (16.6‑36.8 µmol/L or 90.0‑200 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 value.

Serum, plasma

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).

Lipemia:

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 1200. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of  1200 IU/mL.

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.

Elevated estrogen levels (oral contraceptives; third trimester of pregnancy) give rise to increased values. CRP and haptoglobin should therefore also be determined.

LREFNielsen CH, Poulsen HK, Teisner B, et al. Changes in blood levels of proteinase inhibitors, pregnancy zone protein, steroid carriers and complement factors induced by oral contraceptives. Eur J Obstet Gynecol Reprod Biol 1993;51:63-71.

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 INTEGRA analyzers. Refer to the CLEAN Method Sheet for further instructions and for the latest version of the Extra wash cycle list.
Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test.

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

Orderinformation_INT

Order information

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

03005771 322

Tina-quant α1-Antitrypsin ver.2 (100 tests)

System-ID 07 9008 7

COBAS INTEGRA 400 plus

Materials required (but not provided):

11355279 216

C.f.a.s. Proteins (5 × 1 mL)

System-ID 07 6557 0

11355279 160

C.f.a.s. Proteins (5 × 1 mL, for USA)

System-ID 07 6557 0

10557897 122

Precinorm Protein (3 × 1 mL)

System-ID 07 9105 9

10557897 160

Precinorm Protein (3 × 1 mL, for USA)

System-ID 07 9105 9

11333127 122

Precipath Protein (3 × 1 mL)

System-ID 07 9106 7

11333127 160

Precipath Protein (3 × 1 mL, for USA)

System-ID 07 9106 7

05117003 190

PreciControl ClinChem Multi 1 (20 × 5 mL)

System-ID 07 7469 3

05947626 190

PreciControl ClinChem Multi 1 (4 × 5 mL)

System-ID 07 7469 3

05947626 160

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

System-ID 07 7469 3

05117216 190

PreciControl ClinChem Multi 2 (20 × 5 mL)

System-ID 07 7470 7

05947774 190

PreciControl ClinChem Multi 2 (4 × 5 mL)

System-ID 07 7470 7

05947774 160

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

System-ID 07 7470 7

20756350 322

NaCl Diluent 9 % (6 × 22 mL)

System-ID 07 5635 0

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

System information

Test AAT2, test ID 0‑008.

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

Reagent handling

Ready for use

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

Application for serum and plasma

Test definition

Measuring mode

Absorbance

Abs. calculation mode

Endpoint

Reaction mode

D-R1-S-SR

Reaction direction

Increase

Wavelength A/B

340 nm

Calc. first/last

33/55

Typical prozone effect

> 13.0 g/L (> 239 µmol/L or > 1300 mg/dL)

Antigen excess check

No

Predilution factor

21

Unit

g/L

Pipetting parameters

Diluent (H2O)

R1

100 µL

Sample

6 µL

14 µL

SR

45 µL

Total volume

165 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 at 10‑15 °C

12 weeks

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

Calibration

Calibrator

Calibrator f.a.s. Proteins

Calibration dilution ratio

1:9.2, 1:13.5, 1:22, 1:45, 1:90, 1:200, performed automatically by the instrument

Calibration mode

Logit/log 5

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.

Enter the assigned lot-specific α1-antitrypsin value of the undiluted calibrator, indicated in the package insert of the C.f.a.s. Proteins.

Traceability: This method has been standardized against an internal method traceable to the certified reference material in human serum of the IRMM (Institute for Reference Materials and Measurements) ERM-DA470k/IFCC.

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

Specific performance data

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

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

Precision

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

Repeatability

Mean
g/L (µmol/L, mg/dL)

SD
g/L (µmol/L, mg/dL)

CV
%

Precinorm Protein

1.24 (22.8, 124)

0.01 (0.2, 1)

0.7

Precipath Protein

2.54 (46.8, 254)

0.02 (0.4, 2)

0.6

Human serum 1

1.20 (22.1, 120)

0.01 (0.2, 1)

0.8

Human serum 2

2.80 (51.6, 280)

0.02 (0.4, 2)

0.9

Intermediate precision

Mean
g/L (µmol/L, mg/dL)

SD
g/L (µmol/L, mg/dL)

CV
%

Precinorm Protein

1.19 (21.9, 119)

0.01 (0.2, 1)

1.2

Precipath Protein

2.50 (46.0, 250)

0.05 (0.9, 5)

0.3

Human serum 1

1.03 (19.0, 103)

0.01 (0.2, 1)

3.3

Human serum 2

2.52 (46.4, 252)

0.02 (0.4, 2)

3.5

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

Method comparison

α1‑Antitrypsin values for human serum and plasma samples obtained on a COBAS INTEGRA 700 analyzer using the COBAS INTEGRA Tina-quant  α1‑Antitrypsin ver.2 reagent (y) were compared with those determined using the same reagent on a COBAS INTEGRA 400 analyzer (x) and to those determined on a commercially available alternative automated system (nephelometric determination) (x).

COBAS INTEGRA 400 analyzer

Sample size (n)

75

Correlation coefficient (r)

0.999

Linear regression

y = 0.99 x + 0.01 g/L

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.

y = 0.99 x + 0.01 g/L

Alternative system

Sample size (n)

67

Correlation coefficient (r)

0.974

Linear regression

y = 0.97 x - 0.04 g/L

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.

y = 1.02 x - 0.12 g/L

The sample concentrations were between 0.19 and 3.52 g/L (3.50 and 64.8 µmol/L or 19.0 and 352 mg/dL).

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

Summary

Summary
LREFLievens M, Bienvenu J, Buitrago JMG, et al. Evaluation of four new Tina-quant assays for determination of α1-acid glycoprotein, α1-antitrypsin, haptoglobin and prealbumin. Clin Lab 1996;42:515-520.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:231-232.
,
LREFSchneider M, Pott G, Gerlach U. Alpha-1-Antitrypsin-Mangel. Klin Wschr 1986;64:197-205.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;66-67.
,
LREFJohnson AM, Alper CA. Deficiency of α1-antitrypsin in childhood liver disease. Pediatrics 1970;46(6):921-925.
,
LREFSilverman EK, Pierce JA, Province MA, et al. Variability of pulmonary function in alpha-1-antitrypsin deficiency: Clinical correlates. Ann Intern Med 1989;111(12):982-991.

α1‑Antitrypsin is a glycoprotein consisting of a polypeptide chain to which 3 oligosaccharide chains are bonded (54000 daltons). It is synthesized in hepatocytes. α1‑Antitrypsin is quantitatively the most important proteinase inhibitor (Pi) in serum and plasma. It specifically inactivates serine proteases (e.g. trypsin, chymotrypsin, collagenase, leukocyte elastase, plasmin and thrombin), with which it reversibly forms an enzyme-inhibitor complex. α1‑Antitrypsin constitutes the major fraction of the electrophoretic α1‑globulin fraction. Because it is a small molecule, α1‑antitrypsin diffuses rapidly into other body fluids including bronchial secretions.

α1‑Antitrypsin is an important, positive acute phase reactant found in elevated concentrations in inflammatory processes (e.g. infectious and rheumatoid diseases), tissue necrosis, malignancy and traumas. Inflammation of the liver parenchymal cells is often accompanied by elevated α1‑antitrypsin levels, although levels of other acute phase reactants are not affected.

Acute hereditary α1‑antitrypsin deficiency is suspected in cases of neonatal hepatitis accompanied by progressive liver cirrhosis in early childhood. It is also suspected when severe pulmonary emphysema occurs in adults due to the prevalence of leukocyte elastase, which can lead to unrestrained proteolytic degradation of the pulmonary parenchymal cells.

Various methods are available for assaying α1‑antitrypsin, such as kinetic nephelometry or radial immunodiffusion. Roche’s automated α1‑antitrypsin assay is based upon the immunological agglutination test principle.

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

Reagents - working solutions

R1

Phosphate buffer: 12.7 mmol/L, pH 7.2; NaCl: 130 mmol/L; PEG: 40 g/L; preservative

SR

Anti-human α1‑antitrypsin antibody (rabbit) > 2 g/L; NaCl: 100 mmol/L; preservative

R1 is in position B and SR is position C.

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

Precautions and warnings

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

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

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

Safety data sheet available for professional user on request.

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

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

Quality control

Reference range

Precinorm Protein or PreciControl ClinChem Multi 1

Pathological range

Precipath Protein or PreciControl ClinChem Multi 2

Control interval

24 hours recommended

Control sequence

User defined

Control after calibration

Recommended

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

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

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

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

Specimen collection and preparation

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

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: heparin (Li-, Na-, NH4+-) or EDTA (K2-, K3-) plasma

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

Samples and controls are automatically prediluted 1:21 (1+20) with NaCl solution by the instrument.

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

Centrifuge samples containing precipitates before performing the assay.

Stability:

LREFGuder WG, Narayanan S, Wisser H, et al. List of Analytes; Preanalytical Variables. Brochure in: Samples: From the Patient to the Laboratory. Darmstadt: GIT-Verlag 1996.

7 days at 15‑25 °C

3 months at 2‑8 °C

3 months at (−15)‑(−20) °C

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

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208101396190c503", "ProductName": "AAT2", "ProductLongName": "Tina-quant α1-Antitrypsin ver.2", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF00000004AC6E0E", "DocumentOriginID": "FF00000003E6820E", "MaterialNumbers": [ "08101396190" ], "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 α1‑antitrypsin in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Immunoturbidimetric assay

Human α1‑antitrypsin forms a precipitate with a specific antiserum which is determined turbidimetrically.

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

Limits and ranges

Measuring range

0.2‑6.0 g/L (3.68‑110.4 µmol/L, 20‑600 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

= 0.2 g/L (3.68 µmol/L, 20 mg/dL)

Limit of Detection

= 0.2 g/L (3.68 µmol/L, 20 mg/dL)

Limit of Quantitation

= 0.3 g/L (5.52 µmol/L, 30 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 α1‑antitrypsin samples.

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

Expected values

Expected values
LREFDati F, Schumann G, Thomas L, et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996;34:517-520.

0.9‑2.0 g/L (16.6‑36.8 µmol/L*, 90‑200 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 an α1‑antitrypsin concentration of 0.9 g/L.

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).

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 350. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High-dose hook effect: No false result occurs up to an α1‑antitrypsin concentration of 12 g/L.

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.

Elevated estrogen levels (oral contraceptives; third trimester of pregnancy) give rise to increased values. CRP and haptoglobin should therefore also be determined.

LREFNielsen CH, Poulsen HK, Teisner B, et al. Changes in blood levels of proteinase inhibitors, pregnancy zone protein, steroid carriers and complement factors induced by oral contraceptives. Eur J Obstet Gynecol Reprod Biol 1993;51:63-71.

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

08101396190

Tina-quant α1-Antitrypsin ver.2 (200 tests)

System‑ID 2003 001

cobas c 303, cobas c 503

11355279160

Calibrator f.a.s. Proteins (5 × 1 mL)

Code 20656

10557897160

Precinorm Protein (3 × 1 mL)

Code 20302

11333127160

Precipath Protein (3 × 1 mL)

Code 20303

05947626160

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05947774160

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

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

System information

AAT2: ACN 20030

", "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)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

75 µL

R3

34 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

4.5 µL

5 µL

100 µL

Decreased

4.5 µL

2 µL

82 µL

Increased

4.5 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-S6: C.f.a.s. Proteins

Calibration mode

Non-linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

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

Traceability: This method has been standardized against the certified reference material in human serum of the IRMM (Institute for Reference Materials and Measurements) ERM‑DA470k/IFCC.

", "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
g/L (mg/dL)

SD
g/L (mg/dL)

CV
%

PCCC1a)

1.04 (104)

0.00556 (0.556)

0.5

PCCC2b)

1.62 (162)

0.00824 (0.824)

0.5

Human serum 1

0.639 (63.9)

0.00460 (0.460)

0.7

Human serum 2

0.948 (94.8)

0.00584 (0.584)

0.6

Human serum 3

2.12 (212)

0.0146 (1.46)

0.7

Human serum 4

2.99 (299)

0.0186 (1.86)

0.6

Human serum 5

5.49 (549)

0.0451 (4.51)

0.8

Intermediate precision

Mean
g/L (mg/dL)

SD
g/L (mg/dL)

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

1.04 (104)

0.0114 (1.14)

1.1

PCCC2

FREFPreciControl ClinChem Multi 2

1.62 (162)

0.0166 (1.66)

1.0

Human serum 1

0.639 (63.9)

0.00921 (0.921)

1.4

Human serum 2

0.948 (94.8)

0.0102 (1.02)

1.1

Human serum 3

2.12 (212)

0.0179 (1.79)

0.8

Human serum 4

2.99 (299)

0.0253 (2.53)

0.8

Human serum 5

5.49 (549)

0.0525 (5.25)

1.0

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

Method comparison

α1‑antitrypsin values for human serum and plasma 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) = 72

Passing/Bablok

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

Linear regression

y = 1.009x + 0.0191 g/L

y = 0.997x + 0.0431 g/L

τ = 0.985

r = 0.999

The sample concentrations were between 0.270 and 5.46 g/L (27.0 and 546 mg/dL).

α1‑antitrypsin values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 71

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 = 0.992x + 0.0369 g/L

y = 0.967x + 0.0825 g/L

τ = 0.985

r = 0.999

The sample concentrations were between 0.207 and 5.61 g/L (20.7 and 561 mg/dL).

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

Summary

Summary
LREFLievens M, Bienvenu J, Buitrago JMG, et al. Evaluation of four new Tina-quant assays for determination of α1-acid glycoprotein, α1-antitrypsin, haptoglobin and prealbumin. Clin Lab 1996;42:515-520.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:231-232.
,
LREFSchneider M, Pott G, Gerlach U. Alpha-1-Antitrypsin-Mangel. Klin Wschr 1986;64:197-205.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;66-67.
,
LREFJohnson AM, Alper CA. Deficiency of α1-antitrypsin in childhood liver disease. Pediatrics 1970;46(6):921-925.
,
LREFSilverman EK, Pierce JA, Province MA, et al. Variability of pulmonary function in alpha-1-antitrypsin deficiency: Clinical correlates. Ann Intern Med 1989;111(12):982-991.

α1‑Antitrypsin is a glycoprotein consisting of a polypeptide chain to which 3 oligosaccharide chains are bonded (54000 daltons). It is synthesized in hepatocytes. α1‑Antitrypsin is quantitatively the most important proteinase inhibitor (Pi) in serum and plasma. It specifically inactivates serine proteases (e.g. trypsin, chymotrypsin, collagenase, leukocyte elastase, plasmin and thrombin), with which it reversibly forms an enzyme‑inhibitor complex. α1‑Antitrypsin constitutes the major fraction of the electrophoretic α1‑globulin fraction. Because it is a small molecule, α1‑antitrypsin diffuses rapidly into other body fluids including bronchial secretions.

α1‑Antitrypsin is an important, positive acute phase reactant found in elevated concentrations in inflammatory processes (e.g. infectious and rheumatoid diseases), tissue necrosis, malignancy and traumas. Inflammation of the liver parenchymal cells is often accompanied by elevated α1‑antitrypsin levels, although levels of other acute phase reactants are not affected.

Acute hereditary α1‑antitrypsin deficiency is suspected in cases of neonatal hepatitis accompanied by progressive liver cirrhosis in early childhood. It is also suspected when severe pulmonary emphysema occurs in adults due to the prevalence of leukocyte elastase, which can lead to unrestrained proteolytic degradation of the pulmonary parenchymal cells.

Various methods are available for assaying α1‑antitrypsin, such as kinetic nephelometry or radial immunodiffusion. Roche’s automated α1‑antitrypsin assay is based upon the immunological agglutination test principle.

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

Reagents - working solutions

R1

Phosphate buffer: 12.7 mmol/L, pH 7.2; NaCl: 0.13 mol/L; PEG: 40 g/L; preservative

R3

Anti‑human α1‑antitrypsin antibody (rabbit): > 2 g/L; NaCl: 0.1 mol/L; preservative

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

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

Precautions and warnings

For in vitro diagnostic use.
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.

", "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

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

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

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

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

7 days at 15‑25 °C

3 months at 2‑8 °C

3 months at (−15)‑(−25) °C

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

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008101396190c503", "ProductName": "AAT2", "ProductLongName": "Tina-quant α1-Antitrypsin ver.2", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF000000046B1D0E", "DocumentOriginID": "FF000000037CF00E", "MaterialNumbers": [ "08101396190" ], "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 α1‑antitrypsin in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Immunoturbidimetric assay

Human α1‑antitrypsin forms a precipitate with a specific antiserum which is determined turbidimetrically.

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

Limits and ranges

Measuring range

0.2‑6.0 g/L (3.68‑110.4 µmol/L)

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

= 0.2 g/L (3.68 µmol/L)

Limit of Detection

= 0.2 g/L (3.68 µmol/L)

Limit of Quantitation

= 0.3 g/L (5.52 µmol/L)

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 α1‑antitrypsin samples.

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

Expected values

Expected values
LREFDati F, Schumann G, Thomas L, et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996;34:517-520.

0.9‑2.0 g/L (16.6‑36.8 µmol/L*)

*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 an α1-antitrypsin concentration of 0.9 g/L.

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).

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 350. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High-dose hook effect: No false result occurs up to an α1‑antitrypsin concentration of 12 g/L.

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.

Elevated estrogen levels (oral contraceptives; third trimester of pregnancy) give rise to increased values. CRP and haptoglobin should therefore also be determined.

LREFNielsen CH, Poulsen HK, Teisner B, et al. Changes in blood levels of proteinase inhibitors, pregnancy zone protein, steroid carriers and complement factors induced by oral contraceptives. Eur J Obstet Gynecol Reprod Biol 1993;51:63-71.

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

08101396 190

Tina-quant α1-Antitrypsin ver.2 (200 tests)

System‑ID 2003 001

Roche/Hitachi cobas c 503

Materials required (but not provided):

11355279 216

Calibrator f.a.s. Proteins (5 × 1 mL)

Code 20656

11355279 160

Calibrator f.a.s. Proteins (5 × 1 mL, for USA)

Code 20656

10557897 122

Precinorm Protein (3 × 1 mL)

Code 20302

10557897 160

Precinorm Protein (3 × 1 mL, for USA)

Code 20302

11333127 122

Precipath Protein (3 × 1 mL)

Code 20303

11333127 160

Precipath Protein (3 × 1 mL, for USA)

Code 20303

05117003 190

PreciControl ClinChem Multi 1 (20 × 5 mL)

Code 20391

05947626 190

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05947626 160

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

Code 20391

05117216 190

PreciControl ClinChem Multi 2 (20 × 5 mL)

Code 20392

05947774 190

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

05947774 160

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

Code 20392

08063494 190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

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

System information

AAT2: ACN 20030

", "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)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

75 µL

R3

34 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

4.5 µL

5 µL

100 µL

Decreased

4.5 µL

2 µL

82 µL

Increased

4.5 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-S6: C.f.a.s. Proteins

Calibration mode

Non-linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

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

Traceability: This method has been standardized against the certified reference material in human serum of the IRMM (Institute for Reference Materials and Measurements) ERM‑DA470k/IFCC.

", "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
g/L

SD
g/L

CV
%

PCCC1a)

1.04

0.00556

0.5

PCCC2b)

1.62

0.00824

0.5

Human serum 1

0.639

0.00460

0.7

Human serum 2

0.948

0.00584

0.6

Human serum 3

2.12

0.0146

0.7

Human serum 4

2.99

0.0186

0.6

Human serum 5

5.49

0.0451

0.8

Intermediate precision

Mean
g/L

SD
g/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

1.04

0.0114

1.1

PCCC2

FREFPreciControl ClinChem Multi 2

1.62

0.0166

1.0

Human serum 1

0.639

0.00921

1.4

Human serum 2

0.948

0.0102

1.1

Human serum 3

2.12

0.0179

0.8

Human serum 4

2.99

0.0253

0.8

Human serum 5

5.49

0.0525

1.0

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

Method comparison

α1‑antitrypsin values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 72

Passing/Bablok

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

Linear regression

y = 1.009x + 0.0191 g/L

y = 0.997x + 0.0431 g/L

τ = 0.985

r = 0.999

The sample concentrations were between 0.270 and 5.46 g/L.

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

Summary

Summary
LREFLievens M, Bienvenu J, Buitrago JMG, et al. Evaluation of four new Tina-quant assays for determination of α1-acid glycoprotein, α1-antitrypsin, haptoglobin and prealbumin. Clin Lab 1996;42:515-520.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:231-232.
,
LREFSchneider M, Pott G, Gerlach U. Alpha-1-Antitrypsin-Mangel. Klin Wschr 1986;64:197-205.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;66-67.
,
LREFJohnson AM, Alper CA. Deficiency of α1-antitrypsin in childhood liver disease. Pediatrics 1970;46(6):921-925.
,
LREFSilverman EK, Pierce JA, Province MA, et al. Variability of pulmonary function in alpha-1-antitrypsin deficiency: Clinical correlates. Ann Intern Med 1989;111(12):982-991.

α1‑Antitrypsin is a glycoprotein consisting of a polypeptide chain to which 3 oligosaccharide chains are bonded (54000 daltons). It is synthesized in hepatocytes. α1‑Antitrypsin is quantitatively the most important proteinase inhibitor (Pi) in serum and plasma. It specifically inactivates serine proteases (e.g. trypsin, chymotrypsin, collagenase, leukocyte elastase, plasmin and thrombin), with which it reversibly forms an enzyme‑inhibitor complex. α1‑Antitrypsin constitutes the major fraction of the electrophoretic α1‑globulin fraction. Because it is a small molecule, α1‑antitrypsin diffuses rapidly into other body fluids including bronchial secretions.

α1‑Antitrypsin is an important, positive acute phase reactant found in elevated concentrations in inflammatory processes (e.g. infectious and rheumatoid diseases), tissue necrosis, malignancy and traumas. Inflammation of the liver parenchymal cells is often accompanied by elevated α1‑antitrypsin levels, although levels of other acute phase reactants are not affected.

Acute hereditary α1‑antitrypsin deficiency is suspected in cases of neonatal hepatitis accompanied by progressive liver cirrhosis in early childhood. It is also suspected when severe pulmonary emphysema occurs in adults due to the prevalence of leukocyte elastase, which can lead to unrestrained proteolytic degradation of the pulmonary parenchymal cells.

Various methods are available for assaying α1‑antitrypsin, such as kinetic nephelometry or radial immunodiffusion. Roche’s automated α1‑antitrypsin assay is based upon the immunological agglutination test principle.

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

Reagents - working solutions

R1

Phosphate buffer: 12.7 mmol/L, pH 7.2; NaCl: 0.13 mol/L; PEG: 40 g/L; preservative

R3

Anti‑human α1‑antitrypsin antibody (rabbit): > 2 g/L; NaCl: 0.1 mol/L; preservative

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

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

Precautions and warnings

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

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

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

Safety data sheet available for professional user on request.

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

", "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

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

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

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

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

7 days at 15‑25 °C

3 months at 2‑8 °C

3 months at (−15)‑(−25) °C

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

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108101396190c503", "ProductName": "AAT2", "ProductLongName": "Tina-quant α1-Antitrypsin ver.2", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF000000047A8F0E", "DocumentOriginID": "FF000000047A8E0E", "MaterialNumbers": [ "08101396190" ], "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 α1‑antitrypsin in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Immunoturbidimetric assay

Human α1‑antitrypsin forms a precipitate with a specific antiserum which is determined turbidimetrically.

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

Limits and ranges

Measuring range

0.2‑6.0 g/L (3.68‑110.4 µmol/L)

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

= 0.2 g/L (3.68 µmol/L)

Limit of Detection

= 0.2 g/L (3.68 µmol/L)

Limit of Quantitation

= 0.3 g/L (5.52 µmol/L)

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 α1‑antitrypsin samples.

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

Expected values

Expected values
LREFDati F, Schumann G, Thomas L, et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996;34:517-520.

0.9‑2.0 g/L (16.6‑36.8 µmol/L*)

*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 an α1-antitrypsin concentration of 0.9 g/L.

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).

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 350. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High-dose hook effect: No false result occurs up to an α1‑antitrypsin concentration of 12 g/L.

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.

Elevated estrogen levels (oral contraceptives; third trimester of pregnancy) give rise to increased values. CRP and haptoglobin should therefore also be determined.

LREFNielsen CH, Poulsen HK, Teisner B, et al. Changes in blood levels of proteinase inhibitors, pregnancy zone protein, steroid carriers and complement factors induced by oral contraceptives. Eur J Obstet Gynecol Reprod Biol 1993;51:63-71.

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

08101396190

Tina-quant α1-Antitrypsin ver.2 (200 tests)

System‑ID 2003 001

cobas c 303,cobas c 503

11355279216

Calibrator f.a.s. Proteins (5 × 1 mL)

Code 20656

10557897122

Precinorm Protein (3 × 1 mL)

Code 20302

11333127122

Precipath Protein (3 × 1 mL)

Code 20303

05117003190

PreciControl ClinChem Multi 1 (20 × 5 mL)

Code 20391

05947626190

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05117216190

PreciControl ClinChem Multi 2 (20 × 5 mL)

Code 20392

05947774190

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

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

System information

AAT2: ACN 20030

", "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)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

75 µL

R3

34 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

4.5 µL

5 µL

100 µL

Decreased

4.5 µL

2 µL

82 µL

Increased

4.5 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-S6: C.f.a.s. Proteins

Calibration mode

Non-linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

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

Traceability: This method has been standardized against the certified reference material in human serum of the IRMM (Institute for Reference Materials and Measurements) ERM‑DA470k/IFCC.

", "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
g/L

SD
g/L

CV
%

PCCC1a)

1.04

0.00556

0.5

PCCC2b)

1.62

0.00824

0.5

Human serum 1

0.639

0.00460

0.7

Human serum 2

0.948

0.00584

0.6

Human serum 3

2.12

0.0146

0.7

Human serum 4

2.99

0.0186

0.6

Human serum 5

5.49

0.0451

0.8

Intermediate precision

Mean
g/L

SD
g/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

1.04

0.0114

1.1

PCCC2

FREFPreciControl ClinChem Multi 2

1.62

0.0166

1.0

Human serum 1

0.639

0.00921

1.4

Human serum 2

0.948

0.0102

1.1

Human serum 3

2.12

0.0179

0.8

Human serum 4

2.99

0.0253

0.8

Human serum 5

5.49

0.0525

1.0

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

Method comparison

α1‑antitrypsin values for human serum and plasma 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) = 72

Passing/Bablok

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

Linear regression

y = 1.009x + 0.0191 g/L

y = 0.997x + 0.0431 g/L

τ = 0.985

r = 0.999

The sample concentrations were between 0.270 and 5.46 g/L.

α1‑antitrypsin values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 71

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 = 0.992x + 0.0369 g/L

y = 0.967x + 0.0825 g/L

τ = 0.985

r = 0.999

The sample concentrations were between 0.207 and 5.61 g/L.

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

Summary

Summary
LREFLievens M, Bienvenu J, Buitrago JMG, et al. Evaluation of four new Tina-quant assays for determination of α1-acid glycoprotein, α1-antitrypsin, haptoglobin and prealbumin. Clin Lab 1996;42:515-520.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:231-232.
,
LREFSchneider M, Pott G, Gerlach U. Alpha-1-Antitrypsin-Mangel. Klin Wschr 1986;64:197-205.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;66-67.
,
LREFJohnson AM, Alper CA. Deficiency of α1-antitrypsin in childhood liver disease. Pediatrics 1970;46(6):921-925.
,
LREFSilverman EK, Pierce JA, Province MA, et al. Variability of pulmonary function in alpha-1-antitrypsin deficiency: Clinical correlates. Ann Intern Med 1989;111(12):982-991.

α1‑Antitrypsin is a glycoprotein consisting of a polypeptide chain to which 3 oligosaccharide chains are bonded (54000 daltons). It is synthesized in hepatocytes. α1‑Antitrypsin is quantitatively the most important proteinase inhibitor (Pi) in serum and plasma. It specifically inactivates serine proteases (e.g. trypsin, chymotrypsin, collagenase, leukocyte elastase, plasmin and thrombin), with which it reversibly forms an enzyme‑inhibitor complex. α1‑Antitrypsin constitutes the major fraction of the electrophoretic α1‑globulin fraction. Because it is a small molecule, α1‑antitrypsin diffuses rapidly into other body fluids including bronchial secretions.

α1‑Antitrypsin is an important, positive acute phase reactant found in elevated concentrations in inflammatory processes (e.g. infectious and rheumatoid diseases), tissue necrosis, malignancy and traumas. Inflammation of the liver parenchymal cells is often accompanied by elevated α1‑antitrypsin levels, although levels of other acute phase reactants are not affected.

Acute hereditary α1‑antitrypsin deficiency is suspected in cases of neonatal hepatitis accompanied by progressive liver cirrhosis in early childhood. It is also suspected when severe pulmonary emphysema occurs in adults due to the prevalence of leukocyte elastase, which can lead to unrestrained proteolytic degradation of the pulmonary parenchymal cells.

Various methods are available for assaying α1‑antitrypsin, such as kinetic nephelometry or radial immunodiffusion. Roche’s automated α1‑antitrypsin assay is based upon the immunological agglutination test principle.

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

Reagents - working solutions

R1

Phosphate buffer: 12.7 mmol/L, pH 7.2; NaCl: 0.13 mol/L; PEG: 40 g/L; preservative

R3

Anti‑human α1‑antitrypsin antibody (rabbit): > 2 g/L; NaCl: 0.1 mol/L; preservative

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

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

Precautions and warnings

For in vitro diagnostic use.
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. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

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

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

Specimen collection and preparation

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

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

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

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

7 days at 15‑25 °C

3 months at 2‑8 °C

3 months at (−15)‑(−25) °C

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

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108101396190c503", "ProductName": "AAT2", "ProductLongName": "Tina-quant α1-Antitrypsin ver.2", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF00000004E91E0E", "DocumentOriginID": "FF000000047A8F0E", "MaterialNumbers": [ "08101396190" ], "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 α1‑antitrypsin in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Immunoturbidimetric assay

Human α1‑antitrypsin forms a precipitate with a specific antiserum which is determined turbidimetrically.

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

Limits and ranges

Measuring range

0.2‑6.0 g/L (3.68‑110.4 µmol/L)

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

= 0.2 g/L (3.68 µmol/L)

Limit of Detection

= 0.2 g/L (3.68 µmol/L)

Limit of Quantitation

= 0.3 g/L (5.52 µmol/L)

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 α1‑antitrypsin samples.

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

Expected values

Expected values
LREFDati F, Schumann G, Thomas L, et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996;34:517-520.

0.9‑2.0 g/L (16.6‑36.8 µmol/L*)

*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 an α1-antitrypsin concentration of 0.9 g/L.

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L).

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 350. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High-dose hook effect: No false result occurs up to an α1‑antitrypsin concentration of 12 g/L.

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.

Elevated estrogen levels (oral contraceptives; third trimester of pregnancy) give rise to increased values. CRP and haptoglobin should therefore also be determined.

LREFNielsen CH, Poulsen HK, Teisner B, et al. Changes in blood levels of proteinase inhibitors, pregnancy zone protein, steroid carriers and complement factors induced by oral contraceptives. Eur J Obstet Gynecol Reprod Biol 1993;51:63-71.

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

08101396190

Tina-quant α1-Antitrypsin ver.2 (200 tests)

System‑ID 2003 001

cobas c 303, cobas c 503

Materials required (but not provided):

11355279216

Calibrator f.a.s. Proteins (5 × 1 mL)

Code 20656

10557897122

Precinorm Protein (3 × 1 mL)

Code 20302

11333127122

Precipath Protein (3 × 1 mL)

Code 20303

05117003190

PreciControl ClinChem Multi 1 (20 × 5 mL)

Code 20391

05947626190

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05117216190

PreciControl ClinChem Multi 2 (20 × 5 mL)

Code 20392

05947774190

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

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

System information

AAT2: ACN 20030

", "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)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

75 µL

R3

34 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

4.5 µL

5 µL

100 µL

Decreased

4.5 µL

2 µL

82 µL

Increased

4.5 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-S6: C.f.a.s. Proteins

Calibration mode

Non-linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

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

Traceability: This method has been standardized against the certified reference material in human serum of the IRMM (Institute for Reference Materials and Measurements) ERM‑DA470k/IFCC.

", "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
g/L

SD
g/L

CV
%

PCCC1a)

1.04

0.00556

0.5

PCCC2b)

1.62

0.00824

0.5

Human serum 1

0.639

0.00460

0.7

Human serum 2

0.948

0.00584

0.6

Human serum 3

2.12

0.0146

0.7

Human serum 4

2.99

0.0186

0.6

Human serum 5

5.49

0.0451

0.8

Intermediate precision

Mean
g/L

SD
g/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

1.04

0.0114

1.1

PCCC2

FREFPreciControl ClinChem Multi 2

1.62

0.0166

1.0

Human serum 1

0.639

0.00921

1.4

Human serum 2

0.948

0.0102

1.1

Human serum 3

2.12

0.0179

0.8

Human serum 4

2.99

0.0253

0.8

Human serum 5

5.49

0.0525

1.0

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

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

Method comparison

α1‑antitrypsin values for human serum and plasma 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) = 72

Passing/Bablok

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

Linear regression

y = 1.009x + 0.0191 g/L

y = 0.997x + 0.0431 g/L

τ = 0.985

r = 0.999

The sample concentrations were between 0.270 and 5.46 g/L.

α1‑antitrypsin values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 71

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 = 0.992x + 0.0369 g/L

y = 0.967x + 0.0825 g/L

τ = 0.985

r = 0.999

The sample concentrations were between 0.207 and 5.61 g/L.

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

Summary

Summary
LREFLievens M, Bienvenu J, Buitrago JMG, et al. Evaluation of four new Tina-quant assays for determination of α1-acid glycoprotein, α1-antitrypsin, haptoglobin and prealbumin. Clin Lab 1996;42:515-520.
,
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995:231-232.
,
LREFSchneider M, Pott G, Gerlach U. Alpha-1-Antitrypsin-Mangel. Klin Wschr 1986;64:197-205.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;66-67.
,
LREFJohnson AM, Alper CA. Deficiency of α1-antitrypsin in childhood liver disease. Pediatrics 1970;46(6):921-925.
,
LREFSilverman EK, Pierce JA, Province MA, et al. Variability of pulmonary function in alpha-1-antitrypsin deficiency: Clinical correlates. Ann Intern Med 1989;111(12):982-991.

α1‑Antitrypsin is a glycoprotein consisting of a polypeptide chain to which 3 oligosaccharide chains are bonded (54000 daltons). It is synthesized in hepatocytes. α1‑Antitrypsin is quantitatively the most important proteinase inhibitor (Pi) in serum and plasma. It specifically inactivates serine proteases (e.g. trypsin, chymotrypsin, collagenase, leukocyte elastase, plasmin and thrombin), with which it reversibly forms an enzyme‑inhibitor complex. α1‑Antitrypsin constitutes the major fraction of the electrophoretic α1‑globulin fraction. Because it is a small molecule, α1‑antitrypsin diffuses rapidly into other body fluids including bronchial secretions.

α1‑Antitrypsin is an important, positive acute phase reactant found in elevated concentrations in inflammatory processes (e.g. infectious and rheumatoid diseases), tissue necrosis, malignancy and traumas. Inflammation of the liver parenchymal cells is often accompanied by elevated α1‑antitrypsin levels, although levels of other acute phase reactants are not affected.

Acute hereditary α1‑antitrypsin deficiency is suspected in cases of neonatal hepatitis accompanied by progressive liver cirrhosis in early childhood. It is also suspected when severe pulmonary emphysema occurs in adults due to the prevalence of leukocyte elastase, which can lead to unrestrained proteolytic degradation of the pulmonary parenchymal cells.

Various methods are available for assaying α1‑antitrypsin, such as kinetic nephelometry or radial immunodiffusion. Roche’s automated α1‑antitrypsin assay is based upon the immunological agglutination test principle.

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

Reagents - working solutions

R1

Phosphate buffer: 12.7 mmol/L, pH 7.2; NaCl: 0.13 mol/L; PEG: 40 g/L; preservative

R3

Anti‑human α1‑antitrypsin antibody (rabbit): > 2 g/L; NaCl: 0.1 mol/L; preservative

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

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

Precautions and warnings

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

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

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

Safety data sheet available for professional user on request.

", "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

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

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

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

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

7 days at 15‑25 °C

3 months at 2‑8 °C

3 months at (−15)‑(−25) °C

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

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

AAT2

Tina-quant α1-Antitrypsin ver.2

IVD For in vitro diagnostic use.
AAT2

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
    ...

    Technical Documents

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

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