Tina-quant Apolipoprotein B ver.2

Catalog Number: 03032574122

SYSTEM INFORMATION

Test APOBT:

INTENDED USE

In vitro test for the quantitative immunological determination of human apolipoprotein B in serum and plasma on COBAS INTEGRA systems.

STORAGE AND STABILITY

Shelf life at 2-8 °C See expiration date on cobas c pack label
COBAS INTEGRA 400 plus system
On-board in use at 10-15 °C 12 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 12 weeks

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 plus test definition

COBAS INTEGRA 400 PLUS TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode D-R1-S-SR
Reaction direction Increase
Wavelength A/B 340/659 nm
Calc. first/last 33/68
Typical prozone effect > 6 g/L (> 600 mg/dL or > 11.7 µmol/L)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 100 µL
Sample 6 µL 20 µL
SR 25 µL 10 µL
Total volume 161 µL

Diluent (H2O)
R1 100 µL
Sample 6 µL 20 µL
SR 25 µL 10 µL
Total volume 161 µL

Calibration

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode D-R1-S-SR
Reaction direction Increase
Wavelength A/B 340/659 nm
Calc. first/last 44/96
Typical prozone effect > 6 g/L (> 600 mg/dL or > 11.7 µmol/L)
Antigen excess check No
 Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 100 µL
Sample 6 µL 20 µL
SR 25 µL 10 µL
Total volume 161 µL

Calibration

CALIBRATION

Enter the assigned lot specific apolipoprotein B value of the undiluted calibrator, indicated in the package insert of the calibrator C.f.a.s. Lipids.

Calibrator Calibrator f.a.s. Lipids
Calibration dilution ratio 1:6, 1:10, 1:13, 1:35, 1:65 NaCl 0.9 % is used as zero calibrator performed automatically by the instrument.
Calibration mode Logit/log 4
Calibration replicate Duplicate recommended
Calibration interval Each lot and as required following quality control procedures.

CALIBRATION DILUTION RATIO

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.20-4.0 g/L (0.39-7.8 µmol/L or 20-400 mg/dL) (typical measuring range)

0.20-4.0 G/L (0.39-7.8 ΜMOL/L OR 20-400 MG/DL) (TYPICAL MEASURING RANGE)

THE UPPER LIMIT OF THE MEASURING RANGE DEPENDS ON THE ACTUAL CALIBRATOR VALUE.

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:

SPECIFIC PERFORMANCE DATA

Representative performance data on the COBAS INTEGRA 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 (1 aliquot per run, 1 run per day, 21 days). The following results were obtained:

CV INTERMEDIATE PRECISION

METHOD COMPARISON

Apolipoprotein B values for human serum samples obtained on a COBAS INTEGRA 400 analyzer with the COBAS INTEGRA Tina-quant Apolipoprotein B ver.2 (APOBT) reagent (y) were compared with those determined on a COBAS INTEGRA 400 analyzer using the previous COBAS INTEGRA Apolipoprotein B (APOB) reagent (x), and with those obtained with the same reagent on a Roche/Hitachi 917 analyzer (x).