血液筛查实验室酶联免疫法性能验证的探讨  

Study on performance verification of enzyme-linked immunosorbent assay in blood screening laboratory

作　　者：邬林枫[1] 杜丹丹[1] 李然 赵钰 刘衡[1] 许晓绚[1] 曾劲峰[1] WU Lin-feng;DU Dandan;LI Ran;ZHAO Yu;LIU Heng;XU Xiaoxuan;ZENG Jinfeng(Shenzhen Blood Center,Shenzhen 518035,China)

机构地区：[1]深圳市血液中心,广东深圳518035

出　　处：《中国输血杂志》2021年第9期1036-1039,共4页Chinese Journal of Blood Transfusion

基　　金：深圳市科创委课题(JCYJ20170307092008192);深圳市医学重点学科建设经费资助(SZXK070);深圳市医疗卫生三名工程项目(SZSM201811092)。

摘　　要：目的验证经血传播疾病的抗原抗体检测的酶联免疫吸附方法的性能,以符合血液筛查实验室的使用要求。方法结合相关标准及试剂说明书,验证不同检测程序下ELISA试剂的重复性、精密度、灵敏度、特异性、符合性、检出限。结果检测程序的性能验证结果均符合相关标准和实验室使用要求。结论本实验室采用的酶联免疫方法的性能能够满足相关标准要求,同时也符合实验室的使用要求;通过对性能验证数据的分析对比,提高血筛实验室对检测系统性能指标的认识,不断改进和提高检测系统性能,保证临床用血安全。Objective To validate the performance of enzyme-linked immunosorbent assay(ELISA) for the detection of antigens and antibodies for blood-borne diseases, so as to meet the requirements of blood screening laboratories. Methods The reproducibility, precision, sensitivity, specificity, conformance and detection limit of ELISA reagents under different detection procedures were verified according to relevant standards and reagent instructions. Results The performance verification results of the test procedures were in line with the relevant standards and laboratory requirements. Conclusion The performance of ELISA method can meet the relevant standards and requirements, as well as the application requirements of the laboratory. Through the analysis and comparison of the performance verification data, the blood screening laboratory can better understand the performance indicators of the detection system, continuously improve the performance of the detection system, and ensure the safety of clinical blood use.

关 键 词：性能验证 酶联免疫 血液筛查 检测系统 

分 类 号：R446.112[医药卫生—诊断学]