Tina-quant α1-Antitrypsin ver.2

Catalog Number: 03005771322

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of α1‑antitrypsin in human serum and plasma on Roche/Hitachi cobas c systems.

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

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

CALIBRATION

 Calibrators S1: H2OS2: 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

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:

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

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

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

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

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:

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:

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).

BABLOK 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.