C-Reactive Protein Gen.3

Catalog Number: 05172373190

SYSTEM INFORMATION

CRPL3: ACN 8210

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: 4 weeks
On‑board on the Reagent Manager: 24 hours
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: 4 weeks
On‑board on the Reagent Manager: 24 hours
 

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

 cobas c 701/702 test definition
Assay type 2‑Point End
Reaction time / Assay points 10 / 21‑29
Wavelength (sub/main) 800/570 nm
Reaction direction Increase
Units mg/L (nmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 150 µL
R3 48 µL 24 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 4 µL 25 µL 75 µL
Increased 4 µL

Calibration

COBAS C TEST 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: H2OS2‑S6: 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 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, Limit of Detection and Limit of Quantitation

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 accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5 requirements with repeatability (n = 21) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN ACCORDANCE WITH THE CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE) EP5 REQUIREMENTS WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (2 ALIQUOTS PER RUN, 2 RUNS 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 701 analyzer (y) were compared to 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.