Prealbumin - Application for C.f.a.s. PAC

Catalog Number: 20764655322

SYSTEM INFORMATION

Test PREA3, test ID 0‑665

INTENDED USE

In vitro test for the quantitative immunological determination of human prealbumin in serum 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 8 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 8 weeks

Specimen collection and preparation

APPLICATION FOR SERUM

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 340 nm
Calc. first/last 33/55
Typical prozone effect > 14.0 g/L (> 255 µmol/L or> 1400 mg/dL)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R1 90 µL
Sample 25 µL 5 µL
SR 10 µL 5 µL
Total volume 135 µL

  Diluent (H2O)
R1 90 µL
Sample 25 µL 5 µL
SR 10 µL 5 µL
Total volume 135 µL

COBAS INTEGRA 800 test definition

Calibration

COBAS INTEGRA 800 TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode D-R1-S-SR
Reaction direction Increase
Wavelength A 340 nm
Calc. first/last 44/82
Typical prozone effect > 14.0 g/L (> 255 µmol/L or> 1400 mg/dL)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R1 90 µL
Sample 25 µL 5 µL
SR 10 µL 5 µL
Total volume 135 µL

Calibration

CALIBRATION

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

 Calibrator C.f.a.s. PAC
Calibrator dilution ratio 1:5.5, 1:7.5, 1:9.5, 1:18, 1:40, 1:120, performed automatically by the instrument
Calibration mode Logit/log 5
Calibration replicate Duplicate recommended
Calibration interval Each lot and as required following quality control procedures.

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

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

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.06‑1.35 g/L (1.09‑24.6 µmol/L or 6.00‑135 mg/dL) (typical measuring range)

0.06‑1.35 G/L (1.09‑24.6 ΜMOL/L OR 6.00‑135 MG/DL) (TYPICAL MEASURING RANGE)

THE UPPER AND LOWER LIMITS OF THE MEASURING RANGE DEPEND ON THE ACTUAL CALIBRATOR VALUE.

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:0.03 g/L (0.55 µmol/L or 3 mg/dL)

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 and intermediate precision (1 aliquot per run, 2 runs per day, 20 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY AND INTERMEDIATE PRECISION (1 ALIQUOT PER RUN, 2 RUNS PER DAY, 20 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

CV INTERMEDIATE PRECISION

METHOD COMPARISON

Prealbumin values for human serum samples obtained on a COBAS  INTEGRA 400 analyzer using the COBAS INTEGRA Prealbumin reagent (x) were compared with those determined using the same reagent on a COBAS INTEGRA 800 analyzer (y) and using the Tina‑quant Prealbumin reagent on a Roche/Hitachi 917 analyzer (y).

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.