AAT2 Tina-quant α1-Antitrypsin ver.2 • Indicates cobas c systems on which reagents can be used Order information Roche/Hitachi cobas c systems Tina-quant α1-Antitrypsin ver.2 cobas c 311 cobas c 501 100 tests Cat. No. 03005771 322 System-ID 07 9008 7 • • Calibrator f.a.s. Proteins (5 x 1 mL) Cat. No. 11355279 216 Code 656 Calibrator f.a.s. Proteins (5 x 1 mL, for USA) Cat. No. 11355279 160 Code 656 Precinorm Protein (3 x 1 mL) Cat. No. 10557897 122 Code 302 Precipath Protein (3 x 1 mL) Cat. No. 11333127 122 Code 303 NaCl Diluent 9% (50 mL) Cat. No. 04489357 190 System-ID 07 6869 3
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System information AAT2 AAT2: ACN 048 Shelf life at 2-8°C: See expiration date on Intended use cobas c pack label. In vitro test for the quantitative determination of α1-antitrypsin in human On-board in use and refrigerated on the analyzer: 12 weeks serum and plasma on Roche/Hitachi cobas c systems. NaCl Diluent 9% Summary1,2,3,4,5,6 Shelf life at 2-8°C: See expiration date on α1-Antitrypsin is a glycoprotein consisting of a polypeptide chain to which cobas c pack label. 3 oligosaccharide chains are bonded (54000 daltons). It is synthesized in On-board in use and refrigerated on the analyzer: 12 weeks hepatocytes. α1-Antitrypsin is quantitatively the most important proteinase inhibitor (Pi) in serum and plasma. It specifically inactivates serine proteases Specimen collection and preparation (e.g. trypsin, chymotrypsin, collagenase, leukocyte elastase, plasmin and For specimen collection and preparation, only use suitable thrombin), with which it reversibly forms an enzyme-inhibitor complex. tubes or collection containers. α1-Antitrypsin constitutes the major fraction of the electrophoretic α1-globulin Only the specimens listed below were tested and found acceptable. fraction. Because it is a small molecule, α1-antitrypsin diffuses rapidly Serum. into other body fluids including bronchial secretions. Plasma: Li-heparin and K2-EDTA plasma α1-Antitrypsin is an important, positive acute phase reactant found in elevated The sample types listed were tested with a selection of sample collection tubes concentrations in inflammatory processes (e.g. infectious and rheumatoid that were commercially available at the time of testing, i.e. not all available diseases), tissue necrosis, malignancy and traumas. Inflammation of the liver tubes of all manufacturers were tested. Sample collection systems from parenchymal cells is often accompanied by elevated α1-antitrypsin levels, various manufacturers may contain differing materials which could affect although levels of other acute phase reactants are not affected. the test results in some cases. When processing samples in primary tubes Acute hereditary α1-antitrypsin deficiency is suspected in cases of neonatal (sample collection systems), follow the instructions of the tube manufacturer. hepatitis accompanied by progressive liver cirrhosis in early childhood. It Centrifuge samples containing precipitates before performing the assay. is also suspected when severe pulmonary emphysema occurs in adults Stability:7 7 days at 15-25°C due to the prevalence of leukocyte elastase, which can lead to unrestrained 3 months at 2-8°C proteolytic degradation of the pulmonary parenchymal cells. 3 months at (-15)-(-25°C) Various methods are available for assaying α1-antitrypsin, such as kinetic nephelometry or radial immunodiffusion. Roche’s automated α1-antitrypsin Materials provided assay is based upon the immunological agglutination test principle. See “Reagents - working solutions” section for reagents. Test principle Materials required (but not provided) Immunoturbidimetric assay. See “Order information” section. Human α1-antitrypsin forms a precipitate with a specific antiserum Distilled water which is determined turbidimetrically. General laboratory equipment Reagents - working solutions Assay R1 Phosphate buffer: 12.7 mmol/L, pH 7.2; NaCl: 0.13 mol/L; PEG: 40 g/L; For optimum performance of the assay, follow the directions given in preservative this document for the analyzer concerned. Refer to the appropriate R2 Anti-human α1-antitrypsin antibody (rabbit): >2 g/L; NaCl: 0.10 mol/L; operator manual for analyzer-specific assay instructions. preservative The performance of applications not validated by Roche is not warranted and must be defined by the user. Precautions and warnings For in vitro diagnostic use. Exercise the normal precautions required for handling all laboratory reagents. Safety data sheet available for professional user on request. Disposal of all waste material should be in accordance with local guidelines. Reagent handling Ready for use.
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AAT2 Tina-quant α1-Antitrypsin ver.2 Application for serum and plasma Calculation cobas c 311 test definition Roche/Hitachi cobas c systems automatically calculate the analyte Assay type 2 Point End concentration of each sample. Reaction time / Assay points 10 / 6-24 Conversion factors:9 g/L x 18.4 = µmol/L Wavelength (sub/main) 700/340 nm g/L x 100 = mg/dL Reaction direction Increase Limitations - interference10 Units g/L (µmol/L, mg/dL) Criterion: Recovery within ±10% of initial value at an α1-antitrypsin Reagent pipetting Diluent (H2O) concentration of 0.9 g/L (16.6 µmol/L, 90 mg/dL). R1 100 µL – Icterus: No significant interference up to an I index of 60 (approximate R2 45 µL – conjugated and unconjugated bilirubin concentration: 1026 µmol/L (60 mg/dL)). Sample volumes Sample Sample dilution Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L (1000 mg/dL)). Sample Diluent (NaCl) Lipemia (Intralipid): No significant interference up to an L index Normal 6 µL 9 µL 180 µL of 350. There is poor correlation between the L index (corresponds Decreased 6 µL 4 µL 164 µL to turbidity) and triglycerides concentration. Increased 6 µL 18 µL 180 µL Rheumatoid factors up to 1200 IU/mL do not interfere. cobas c 501 test definition No high-dose hook effect is seen up to an α1-antitrypsin concentration Assay type 2 Point End of 12 g/L (221 µmol/L, 1200 mg/dL). Reaction time / Assay points 10 / 10-48 Drugs: No interference was found using common drug panels. 11 Wavelength (sub/main) 700/340 nm Elevated estrogen levels (oral contraceptives; third trimester of Reaction direction Increase pregnancy) give rise to increased values. CRP and haptoglobin Units g/L (µmol/L, mg/dL) should therefore also be determined.12 In very rare cases gammopathy, in particular type IgM (Waldenström’s Reagent pipetting Diluent (H2O) macroglobulinemia), may cause unreliable results. R1 100 µL – – For diagnostic purposes, the results should always be assessed in conjunction R2 45 µL with the patient’s medical history, clinical examination and other findings. Sample volumes Sample Sample dilution Special wash requirements Sample Diluent (NaCl) The determination of certain analytes interferes with this assay requiring Normal 6 µL 9 µL 180 µL a special wash step. Refer to the NaOHD/SMS/Multiclean method sheet Decreased 6 µL 4 µL 164 µL and the operator manual for further instructions. Increased 6 µL 18 µL 180 µL Measuring range 0.2-6.0 g/L (3.68-110.4 µmol/L, 20-600 mg/dL) Calibration Extended measuring range (calculated) Calibrators S1: H2O 0.2-12.0 g/L (3.68-220.8 µmol/L, 20-1200 mg/dL) S2: C.f.a.s. Proteins Lower detection limit Multiply the lot-specific C.f.a.s. Proteins 0.2 g/L (3.68 µmol/L, 20 mg/dL) calibrator value by the factors below to The lower detection limit represents the lowest measurable analyte determine the standard concentrations for level that can be distinguished from zero. It is calculated as the value the six-point calibration curve: lying three standard deviations above that of the lowest standard S2: 0.233 S5: 1.56 (standard 1 + 3 SD, within-run precision, n = 21). S3: 0.467 S6: 2.28 Expected values13 S4: 0.952 0.9-2.0 g/L (16.6-36.8 µmol/L, 90-200 mg/dL) Calibration mode RCM2 Each laboratory should investigate the transferability of the expected values to Calibration frequency Full calibration its own patient population and if necessary determine its own reference ranges. - after reagent lot change - and as required following quality control procedures Traceability: This method has been standardized against the reference preparation of the IRMM (Institute for Reference Materials and Measurements) BCR470/CRM470 (RPPHS - Reference Preparation for Proteins in Human Serum).8 Quality control For quality control, use control materials as listed in the “Order information” section. Other suitable control material can be used in addition. 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 limits.
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AAT2 Tina-quant α1-Antitrypsin ver.2 Specific performance data References Representative performance data on the analyzers are given below. 1. Lievens M, Bienvenu J, Buitrago JMG et al. Evaluation of four new Results obtained in individual laboratories may differ. Tina-quant assays for determination of α1-acid glycoprotein, α1-antitrypsin, haptoglobin and prealbumin. Clin Lab 1996;42:515-520. Precision 2. Greiling H, Gressner AM, eds. Lehrbuch der klinischen Chemie und Reproducibility was determined using human samples and controls in Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer 1995:231-232. an internal protocol (within-run n = 21, total n = 63). 3. Schneider M, Pott G, Gerlach U. Alpha-1-Antitrypsin Mangel. The following results were obtained: Klin Wschr 1986;64:197-205. Within-run Mean SD CV 4. Tietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. g/L g/L % Philadelphia, PA: WB Saunders 1995:66-67. (µmol/L, mg/dL) (µmol/L, mg/dL) 5. Johnson AM, Alper CA. Deficiency of α1-antitrypsin in childhood Precinorm Protein 1.14 (21.0, 114) 0.01 (0.2, 1) 0.8 liver disease. Pediatrics 1970;46:921-925. Precipath Protein 1.89 (34.8, 189) 0.02 (0.4, 2) 0.9 6. Silverman EK, Pierce JA, Province MA et al. Variability of pulmonary function in alpha-1-antitrypsin deficiency: Clinical correlation. Human serum 1 1.04 (19.1, 104) 0.01 (0.2, 1) 0.8 Ann Intern Med 1989;111:982-991. Human serum 2 1.58 (29.1, 158) 0.01 (0.2, 1) 0.8 7. Use of Anticoagulants in Diagnostic Laboratory Investigations. WHO Total Mean SD CV Publication WHO/DIL/LAB/99.1 Rev.2. 2002. g/L g/L % 8. Baudner S, Bienvenu J, Blirup-Jensen S, Carlstrom A, Johnson AM, (µmol/L, mg/dL) (µmol/L, mg/dL) Milford-Ward A, Ritchie R, Svendsen PJ, Whicher JT. The certification of a Matrix Reference Material for Immunochemical Measurement of Precinorm Protein 1.12 (20.6, 112) 0.01 (0.2, 1) 1.1 14 Human Serum Proteins, CRM470, Report EUR 15243 EN, 1993:1-186. Precipath Protein 1.86 (34.2, 186) 0.02 (0.4, 2) 1.2 9. Young DS, Huth EJ. SI Units For Clinical Measurement. Human serum 3 1.05 (19.3, 105) 0.01 (0.2, 1) 1.4 American College of Physicians, 1998. Human serum 4 1.76 (32.4, 176) 0.03 (0.6, 3) 1.5 10. Glick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-474. Method comparison 11. Report on the Symposium “Drug effects in clinical chemistry methods”, α1-Antitrypsin values for human serum and plasma samples obtained on a Breuer J, Eur J Clin Chem Clin Biochem 1996;34:385-386. Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined 12. Nielsen CH, Poulsen HK, Teisner B, Thorsen P, Hau J and Westergaard, using the same reagent on a Roche/Hitachi 917 analyzer (x). JG. Changes in blood levels of proteinase inhibitors, pregnancy zone Sample size (n) = 119 protein, steroid carriers and complement factors induced by oral Passing/Bablok14 Linear regression contraceptives. Eur J Obstet Gynecol Reprod Biol 1993; 51:63-71. y = 0.972x - 0.03 g/L y = 0.979x - 0.04 g/L 13. Consensus values of the “Deutsche Gesellschaft für τ = 0.976 r = 0.998 Laboratoriumsmedizin”, the “Deutsche Gesellschaft für Klinische The sample concentrations were between 0.880 and 3.35 g/L Chemie” and the “Verband der Diagnostica-Industrie e.V.” (VDGH). (16.2 and 61.6 µmol/L, 88.0 and 335 mg/dL). DG Klinische Chemie Mitteilungen 1995;26:119-122. 14. Bablok W et al. A General Regression Procedure for Method Transformation. J Clin Chem Clin Biochem 1988;26:783-790. FOR US CUSTOMERS ONLY: LIMITED WARRANTY Roche Diagnostics warrants that this product will meet the specifications stated in the labeling when used in accordance with such labeling and will be free from defects in material and workmanship until the expiration date printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES.
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