Tina-quant Apolipoprotein B ver.2

Catalog Number: 05950694190

SYSTEM INFORMATION

APOBT: ACN 8151

INTENDED USE

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

STORAGE AND STABILITY

APOBT

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition

CALIBRATION

 

 Calibrators S1: H2OS2‑S6: C.f.a.s. Lipids Multiply the lot-specific C.f.a.s. Lipids calibrator value by the factors below to determine the standard concentrations for the 6‑point calibration curve:
S2: 0.323 S5: 2.100
S3: 0.600 S6: 3.500
S4: 1.617
Calibration mode RCM
Calibration frequency Full calibration- after reagent lot change- as required following quality control procedures

S2‑S6: C.F.A.S. LIPIDS MULTIPLY THE LOT-SPECIFIC C.F.A.S. LIPIDS 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

0.2‑4.0 g/L (0.39‑7.8 µmol/L, 20‑400 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:

RESULTS FOR INTERMEDIATE PRECISION WERE OBTAINED ON THE MASTER SYSTEM 501 ANALYZER.

METHOD COMPARISON

Apolipoprotein B 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).

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.