Evaluation of a Turbidimetric Denka Seiken C-Reactive Protein Assay for Cardiovascular Risk Estimation and Conventional Inflammation Diagnosis

[摘要] Measurement of C-reactive protein (CRP) is used for conventional inflammation diagnosis (1) and diagnosis of low-grade inflammation for risk estimation of cardiovascular events (2)(3). Because diagnostic measurement ranges for those two indications differ by two orders of magnitude, different methods or different applications of one method must be used at present to cover both diagnostic measurement ranges (4)(5). The aim of this study was to evaluate the analytical performance of the Denka Seiken turbidimetric CRP assay compared with the Dade Behring nephelometric assay across a concentration range of 0.2–300 mg/L. For this evaluation, leftover material was used, which is in concordance with the European Law for Medical and Diagnostic Products.For precision and linearity studies, we prepared serum pools from blood samples with previously measured CRP (BN II nephelometer; Dade Behring). The low and high pools were prepared by combining samples with CRP <1 and 200–300 mg/L, respectively. The high pool was diluted with the low pool to the following final percentages of high pool: 100%, 33%, 11%, 3.7%, 1.2%, 0.41%, 0.14%, and 0%. The dilutions were aliquoted and stored at −20 …

[学科分类] 过敏症与临床免疫学