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

Abstract Background: 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. Methods: 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. Results: Analytical performance, including precision and linearity, was excellent. The correlation coefficient for linear regression was r2=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 r2>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. Conclusions: 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. Clin Chem Lab Med 2007;45:402–6.