title: Analyzer transfer of a broad range high-sensitivity C-reactive protein immunoassay.
abstract: C-reactive protein (CRP) is measured in two main clinical situations: inflammation, where levels in the range of 5-300 mg/L are expected, and, more recently, assessment of the cardiovascular risk, where concentrations between 0.1 and 10 mg/L shoud be determined. Few commercially available methods display a measuring range covering both zones and laboratories are compelled to use two different assay protocols or even two different methods. The aim of the study was to adapt the Roche C-Reactive Protein (Latex) kit, initially developed for the Roche Cobas Integra analyzers, to the Hitachi Modular P800 analyzer in order to obtain on this instrument a broad range assay for CRP measurement. The method was successfully adapted and validated against a high-sensitivity and a traditional assay. The resulting method correlates well with the other two and displays a measuring range of 0.10-171 mg/L with an imprecision lower than 5.5%. This assay could be particularly practical in the routine clinical laboratory, being suitable for every use of CRP measurements.
authors.affiliation: Department of Clinical Chemistry, Hĵpital Erasme, Université Libre de Bruxelles, Belgium. fcotton@ulb.ac.be
authors.forename: F
authors.initials: F
authors.lastname: Cotton
authors.forename: P
authors.initials: P
authors.lastname: Thiry
authors.forename: A B
authors.initials: AB
authors.lastname: Hsaïn
authors.forename: J M
authors.initials: JM
authors.lastname: Boeynaems
mesh_terms: D002097:C-Reactive Protein / Q000032:analysis*; D002138:Calibration; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000592:standards; D007249:Inflammation / Q000097:blood / Q000175:diagnosis; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013057:Spectrum Analysis
chemical_list: D011933:Reagent Kits, Diagnostic; D002097:C-Reactive Protein