Evaluation of Denka-Seiken Turbidimetric High-Sensitivity C-Reactive Protein Assay

Abstract

C-reactive protein measured with a high sensitivity method (hsCRP) is an important prognostic indicator in patients with an acute coronary syndrome. We evaluated hsCRP measurement with regard to its precision, functional sensitivity, linearity, and interferences using Denka-Seiken CRP II Latex X2 turbidimetric method on two chemistry autoanalyzers: Olympus AU 640 and Hitachi 747. The coefficients of variation (CV) for within-run and between-run precision of hsCRP were satisfactory on both autoanalyzers. Functional sensitivities, expressed as concentrations associated with 10% total interassay CV, were 0.19 mg/l for the Hitachi 747 analyzer and 0.41 mg/l for the Olympus AU 640. The assay was linear up to 300 mg/l with a wide measuring range, which suggested the possibility of using this hsCRP measurement as an inflammation marker and as a risk marker for coronary heart disease (CHD). No significant interference was observed up to a triglyceride concentration of 34 mmol/l, and up to hemoglobin concentration of 4 g/l. The determination of hsCRP by turbidimetric method was satisfactory and acceptable for CHD risk assessment, as well as for use as a marker of inflammation.