Evaluation of the high-sensitivity, full-range Olympus CRP OSR6199 application on the Olympus AU640®

Abstract

Implementation of high-sensitivity C-reactive protein (hs-CRP) assays as a routine laboratory parameter may be necessary. A single CRP method giving reliable results for the whole concentration range (0.1-160 mg/L) is the most practical solution for a laboratory. The aim of this study was to assess the Olympus CRP full-range immunoturbidimetric assay on an Olympus AU640 biochemistry analyser. CRP was determined in a population of patients simultaneously with the Randox CRP immunoturbidimetric assay and two immunonephelometric assays, the Dade Behring and Beckman Coulter CRP, on BN 100 and Immage systems, respectively. Analytical performance, including precision and linearity, was excellent. The correlation coefficient for linear regression was r(2)=0.998, indicating that the assay method exhibited good linearity in the working range 0-160 mg/L. The intra- and inter-assay CVs for the Olympus CRP method were <3.6% over a wide range of CRP concentrations. Linear regression analysis indicated excellent agreement between CRP values for all patients, with correlation coefficients of r(2)>0.996, 0.993 and 0.989 for the Randox, Dade Behring and Beckman methods, respectively. Bland-Altman analyses demonstrated the excellent concordance of the CRP methods for patient samples. This study demonstrates that the new full-range Olympus method can be applied to measure CRP as a marker of inflammation and of cardiovascular risk.