临床实验室对定量检测产品精密度的评价

Evaluating the precision of products for quantitative assay in clinical laboratories

随着体外诊断(IVD)行业的不断发展以及临床实验室对IVD定量检测产品精密度验证活动的不断实践和认识的加深,国家、行业、用户对产品质量要求不断提高。为了使临床实验室对于IVD定量检测产品精密度验证达成统一标准,笔者依据美国临床和实验室标准化协会(CLSI)EP15-A3文件,编制了临床实验室定量测量项目精密度验证程序,旨在为临床实验室IVD定量检测产品精密度的验证提供参考。

With the development of in vitro diagnosis(IVD)industry,increasing practice and cognition of precision verification activities for IVD products of quantitative assay in clinical laboratories,the quality requirements of national authority,IVD industry and clinical laboratories(end-users)are continuous up-grading.In order to reach a unified standard for the precision verification of IVD products for quantitative assay in clinical laboratories,the author developed a precision verification procedure for quantitative measurement items in clinical laboratory based on the document EP15-A3 of CLSI,aiming at providing reference for the precision verification of IVD products for quantitative assay in clinical laboratories.