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.
出处
《中国药事》
CAS
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)
关键词
定量体外诊断试剂
EP6-A
CLSI指南
注册检验
线性评价
quantitative in vitro diagnostic products
EP6-A
CLSI Standards
registration testing
linearity evaluation
