Ceruloplasmin

Catalog Number: 05950848190

SYSTEM INFORMATION

CER: ACN 8707

INTENDED USE

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

STORAGE AND STABILITY

 CERU
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board in use and refrigerated on the analyzer: 4 weeks
On‑board on the Reagent Manager: 24 hours

APPLICATION FOR SERUM AND PLASMA

 cobas c 701/702 test definition
Assay type 2‑Point End
Reaction time / Assay points 10/19‑33
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units g/L (µmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 100 µL
R3 20 µL

CALIBRATION

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

 Calibrators S1: H2OS2-S6: C.f.a.s. PAC
Multiply the lot‑specific C.f.a.s. PAC calibrator value by the factors below to determine the standard concentrations for the 6‑point calibration curve:
S2: 0.600 S5: 3.20
S3: 1.25 S6: 4.00
S4: 2.10
Calibration mode RCM2
Calibration frequency Full calibration• after reagent lot change• as required following quality control procedures

MULTIPLY THE LOT‑SPECIFIC C.F.A.S. PAC 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

0.03‑1.4 g/L (0.22‑10.44 µmol/L, 3‑140 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

Ceruloplasmin 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.