【摘要】 目的对经血传播疾病的筛查试验酶联免疫吸附试验(ELISA)可产生量值结果的定性试验性能指标进行验证,证明方法能够获得准确、稳定的检测结果。方法参照CNAS-CL02:2012《医学实验室质量和能力认可准则》及《血站技术操作规程》(2012版)的要求,对实验室的8种检测方法进行重复性、精密度、灵敏度及特异性、符合性的性能验证。结果 8种检测方法重复性试验:20份阳性结果检测全部为阳性,20份阴性结果检测全部为阴性;8种检测方法精密度试验:批内精密度均<15%,批间精密度均<20%;8种检测方法血清盘结果灵敏度及特异性均为100%,4112份献血者样本检测结果的一致性为优;8种检测方法在参加2015年湖北省和卫生部临检中心室间质评30份标本的检测结果中正确率100%。结论所有性能指标验证结果均满足预期要求,8种检测方法作为实验室血液安全性筛查的检测方法能够保证得到准确、稳定的检测结果。更多还原

【Abstract】 Objective To verify qualitative test performance indexes having quantitative results in enzyme linked immunosorbent assay(ELISA) of blood transmitted diseases screen test, to prove that the method can achieve accurate and stable detection results. Methods Referring to requirements of CNAS-CL02:2012 Accreditation Criteria for Quality and Capability of Medical Laboratories and Technical Operation Regulations of Blood Stations(2012 Edition), verify repeatability, accuracy, sensitivity, specificity and coincidence of 8 laboratory detection methods. Results Repeatability test of 8 detection methods: all 20 positive detection results showed positive, 20 negative results showed negative; precision test of 8 kinds of detection methods: batch precision was <15%, inter batch precision was <20%; serum sensitivity and specificity of 8 detection methods was both 100%. 4112 blood samples test results had excellent consistency; 8 kinds of detection methods has 100% correct rate in detection result of 30 specimens of inspection center EQA in Hubei province and Ministry of Health in 2015. Conclusion All performance indicators verification meets expected requirements, as laboratory blood safety screening methods, 8 detection methods can ensure accurate and stable detection results.更多还原