Tina-quant Apolipoprotein B ver.2

Catalog Number: 03032574122

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

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
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

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

cobas c 311 test definition
Assay type 2‑Point End
Reaction time / Assay points 10 / 6‑31
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units g/L (µmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 100 µL
R2 25 µL 30 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 6 µL 9 µL 180 µL
Decreased 6 µL 9 µL 180 µL
Increased 6 µL 9 µL 180 µL

 

CALIBRATION

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

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

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• AFTER REAGENT LOT CHANGE• AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

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.

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:

INTERMEDIATE PRECISION

METHOD COMPARISON

Apolipoprotein B 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,