Evaluation of four automated high-sensitivity C-reactive protein methods: Implications for clinical and epidemiological applications

Background: C-reactive protein (CRP) can provide prognostic information about the risk of developing atherosclerotic complications in apparently healthy patients. This new clinical application requires quantification of CRP concentrations below those traditionally measured in the clinical laboratory. Methods: The Dade Behring BN II, the Abbott IMx, the Diagnostic Products Corporation IMMULITE, and the Beckman Coulter IMMAGE are four automated analyzers with high-sensitivity CRP (hs-CRP) methods. We evaluated these assays for precision, linearity, and comparability with samples from 322 apparently healthy blood donors. Results: The imprecision (CV) of the BN II, IMx, IMMULITE, and IMMAGE methods was ≤7.6%, ≤12%, ≤9.8%, and ≤9.7% at 3.5 mg/L, respectively. The BN II, IMx, IMMULITE, and IMMAGE methods were linear down to ≤0.30, ≤0.32, ≤0.85, and 2.26 mg/L, respectively. CRP concentrations demarcating each quartile in a healthy population were method dependent. The IMx method gave results comparable to the BN II method for values in the reference interval. The IMMULITE method had a positive intercept compared with the BN II method. The IMMAGE method demonstrated more scatter and a positive intercept compared with the BN II method, which may reflect the fact that it is a less sensitive assay. Conclusions: The four hs- CRP methods exhibited differences in results for a healthy population. Additional standardization efforts are required to ensure that hsCRP results can be related to large-scale epidemiologic studies. (C) 2000 American Association for Clinical Chemistry.