Ceruloplasmin

Catalog Number: 20764663322

SYSTEM INFORMATION

Test CERU3, test ID 0‑666

INTENDED USE

In vitro test for the quantitative immunological determination of ceruloplasmin in human 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 8 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 8 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 340 nm
Calc. first/last 33/55
Typical prozone effect > 12.8 g/L (> 1280 mg/dL or > 95.5 µmol/L)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R1 100 µL
Sample 20 µL 5 µL
SR 20 µL 5 µL
Total volume 150 µL

  Diluent (H2O)
R1 100 µL
Sample 20 µL 5 µL
SR 20 µL 5 µL
Total volume 150 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 340 nm
Calc. first/last 44/82
Typical prozone effect > 13.2 g/L (> 1320 mg/dL or > 98.5 µmol/L)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R1 100 µL
Sample 20 µL 5 µL
SR 20 µL 5 µL
Total volume 150 µL

Calibration

CALIBRATION

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

 Calibrator C.f.a.s. PAC
Calibration dilution ratio 1:6.3, 1:8.5, 1:11, 1:21, 1:40, 1:105, 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 DILUTION RATIO

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

0.08‑1.4 g/L (0.597‑10.4 μmol/L or 8.00‑140 mg/dL) (typical measuring range)

0.08‑1.4 G/L (0.597‑10.4 ΜMOL/L OR 8.00‑140 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 (0.224 μmol/L or 3.00 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 (2 aliquots 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 (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 20 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

CV INTERMEDIATE PRECISION

METHOD COMPARISON

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