定量检测体外诊断试剂的线性评价方法介绍及其在肿瘤标志物试剂盒检验中的应用  

Introduction of Linearity Evaluation of Quantitative invitro Diagnostic Products and Its Application on the Registration Testing of Quantitative Diagnostic Kit for Tumor Markers

作　　者：石大伟[1,2] 沈舒[1,2] 王菲菲[1,2] 张春涛[1,2] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]卫生部生物技术产品检定方法及其标准化重点实验室

出　　处：《中国药事》2013年第9期928-931,941,共5页Chinese Pharmaceutical Affairs

基　　金：国家高技术研究发展计划(863计划)新型体外诊断试剂质量评价体系和国家参考物质研究(编号2011AA02A115)

摘　　要：目的建立和评价定量体外诊断试剂注册检验中评价数据线性的方法。方法参考CLSI指南EP6-A并结合注册检验工作中的实际情况和相关规定,提出了线性评价的建议方法,并应用该方法从试剂盒校准品和样品两个方面对某企业糖类抗原19-9（CA19-9）定量检测试剂盒进行了线性评价。结果试剂盒校准品回归方程相关系数r的绝对值为0.9989,符合相应要求。线性评价用样品检测结果的最优回归方程为直线方程,测定值在10~500U·mL-1范围内呈现线性,符合企业声明的线性范围。结论被评价试剂盒线性符合相应要求;本文提出的建议方法在肿瘤标志物定量检测试剂盒注册检验线性评价中显示出较好的适用性,可供从事该类工作的检验人员参考。Objective To establish and evaluate a method for linearity evaluation of quantitative in vitro diagnostic product during the registration tests. Methods A method was established with reference to CLSI Standards EP6-A in combination with actual working situations and related regulations. And a qIVD product, CA19-9 quantitative diagnostic kit （including the kit calibrator and the kit sample）, was evaluated with this method. Results For the kit calibrator, the absolute value of r of the regression equator was 0. 9989 and for the evaluation sample, the best-fit regression model was first-order and the linearity range was 10-500 U mU1. All the results met the specifications stated by the manufacturer. Conclusion The evaluated kit was in accordance with related requirements. The proposed method showed good applicability for quantitative diagnostic kit for tumor markers, which can provide references for inspection personal conducting the evaluation work.

关 键 词：定量体外诊断试剂 EP6-A CLSI指南 注册检验 线性评价 

分 类 号：R446[医药卫生—诊断学]