Cardiac C-Reactive Protein (Latex) High Sensitive

Catalog Number: 05950864190

SYSTEM INFORMATION

CRPHS: ACN 8217

INTENDED USE

In vitro test for the quantitative determination of C‑reactive protein (CRP) in human serum and plasma on Roche/Hitachi cobas c systems. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.

STORAGE AND STABILITY

 CRPHS
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
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 Rate A
Reaction time / Assay points 10 / 22‑38
Wavelength (sub/main) – /546 nm
Reaction direction Increase
Units mg/L (nmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 82 µL 42 µL
R3 28 µL 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 6 µL
Decreased 6 µL 10 µL 140 µL
Increased 12 µL
 

Calibration

COBAS CTEST DEFINITION

CALIBRATION

Traceability: This method has been standardized against the reference preparation of the IRMM (Institute for Reference Materials and Measurements) BCR470/CRM470 (RPPHS - Reference Preparation for Proteins in Human Serum).25

 Calibrators S1: H2OS2‑S6: C.f.a.s. Proteins
Multiply the lot‑specific C.f.a.s. Proteins calibrator value by the factors below to determine the standard concentrations for the 6‑point calibration curve:
S2: 0.0125 S5: 0.100
S3: 0.0250 S6: 0.200
S4: 0.0500
Calibration mode Line Graph
Calibration frequency Full calibration- after reagent lot change- as required following quality control procedures

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

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.15‑20.0 mg/L (1.43‑190 nmol/L, 0.015‑2.0 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:

PRECISION

METHOD COMPARISON

CRP values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined with 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,