C-Reactive Protein Gen.3

Catalog Number: 04956842190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

Immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

 CRPL3
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 / 8‑18
Wavelength (sub/main) 800/570 nm
Reaction direction Increase
Units mg/L (nmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 150 µL
R2 48 µL 24 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 4 µL 25 µL 75 µL
Increased 2 µL

 

COBAS CTEST DEFINITION

COBAS CTEST DEFINITION

COBAS CTEST DEFINITION

CALIBRATION

Traceability: This method has been standardized against an internal method traceable to CRM 470 (RPPHS - Reference Preparation for Proteins in Human Serum).12

 Calibrators S1: H2O
S2: C.f.a.s. Proteins
Multiply the lot‑specific C.f.a.s. Proteins calibrator values by the factors below to determine the standard concentrations for the 6‑point calibration curve:
S2: 0.10000 S5: 2.0000
S3: 0.3325 (c 501/502)    0.3500 (c 311) S6: 4.0000
S4: 1.0000
Calibration mode 6‑point spline
Calibration frequency Full calibration• after reagent lot change• as required following quality control procedures

MULTIPLY THE LOT‑SPECIFIC C.F.A.S. PROTEINS CALIBRATOR VALUES BY THE FACTORS BELOW TO DETERMINE THE STANDARD CONCENTRATIONS FOR THE 6‑POINT CALIBRATION CURVE:

CALIBRATION MODE

CALIBRATION FREQUENCY

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.3‑350 mg/L (2.9‑3333 nmol/L)

LOWER LIMITS OF MEASUREMENT

Limit of blank and Limit of Detection

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:

INTERMEDIATE PRECISION

METHOD COMPARISON

CRP values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared to those determined with the Tina‑quant CRP (Latex) assay 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, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.