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宽范围高灵敏度C反应蛋白免疫测定仪的转移

Analyzer transfer of a broad range high-sensitivity C-reactive protein immunoassay.

作者信息

Cotton F, Thiry P, Hsaïn A B, Boeynaems J M

机构信息

Department of Clinical Chemistry, Hĵpital Erasme, Université Libre de Bruxelles, Belgium.

出版信息

Clin Lab. 2001;47(7-8):405-9.

PMID:11499804
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.

摘要

C反应蛋白(CRP)主要在两种临床情况下进行检测:一是炎症,预期其水平在5 - 300mg/L范围内;二是最近用于评估心血管风险,需测定浓度在0.1至10mg/L之间。市面上很少有能覆盖这两个区间测量范围的方法,实验室不得不使用两种不同的检测方案甚至两种不同的方法。本研究的目的是将最初为罗氏Cobas Integra分析仪开发的罗氏C反应蛋白(乳胶)试剂盒适配到日立模块化P800分析仪上,以便在该仪器上获得用于CRP测量的宽范围检测方法。该方法已成功适配,并针对高灵敏度检测和传统检测进行了验证。所得方法与其他两种方法相关性良好,测量范围为0.10 - 171mg/L,不精密度低于5.5%。这种检测方法在常规临床实验室中可能特别实用,适用于CRP测量的各种用途。

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