中国输血杂志2018，Vol.31Issue(1)：6-11,6.DOI:10.13303/j.cjbt.issn.1004-549x.2018.01.003
我国血液筛查实验室HBsAg ELISA检测系统性能评估与室间质评结果的关联分析
A relationship analysis between the performance of the HBsAg ELISA detection system and the result of external quality assessment in blood screening laboratories in China
常乐 1王芳 2郑伟 3曾劲峰 4李维 5释艳华 6魏超 7蒋建民 8王露楠 1黄力勤 9王瑞 9葛红卫 9潘彤 10韩卫 11方建华 12朱海峰 13何敏14
作者信息
- 1. 北京医院国家老年医学中心卫生部临床检验中心北京市临床检验工程技术研究中心,北京100730
- 2. 辽宁省血液中心
- 3. 黑龙江省血液中心
- 4. 深圳市血液中心
- 5. 重庆市血液中心
- 6. 襄阳市中心血站
- 7. 沧州市中心血站
- 8. 菏泽市中心血站
- 9. 北京市红十字血液中心
- 10. 天津市血液中心
- 11. 河北省血液中心
- 12. 河南省红十字血液中心
- 13. 山东省血液中心
- 14. 吉林省血液中心
- 折叠
摘要
Abstract
Objective To evaluate the performance of the current detection systems of 7 different HBsAg ELISA in 13 blood screening laboratories in China and map out potential links from these evaluation to the result of external quality assessment in blood screening.Methods National Center for Clinical Laboratories organized 13 blood screening laboratories (referred as in lab a-lab m) using 7 different HBsAg ELISA reagents (referred as in reagent A-reagent G) to detect the HBsAg in 1473 serum samples in 2015 (abbreviated as in "the multi-center evaluation study").These results were compared with that of the HBsAg external quality assessment (EQA) program conducted at the same time.Results 1) The sensitivity ratings of the 7 HBsAg ELISA reagents varied from 84.82％ (486/573) to 95.85％ (554/578).The specificity values were 93.20％ (617/662)-99.04％ (828/836).6 of the 7 reagents scored good accuracy ratings (93.16％-97.15％) while reagent D fail to meet our standards [89.91％(617/693)].2) All the reagents yielded good performance results in the HBsAg EQA program (accuracy rate varied from 99.43％ to 100％).3 reagents (A,C,E),which performed well in the multi-center evaluation study,also received full scores in the EQA.3) The accuracy of all the 13 laboratories was good (AUCs were 0.929-0.997).Nevertheless,the accuracy ratings of true reactive samples were quite different:the accuracy rating of lab m was only at 78.53％ (450/573) while lab j made the fewest mistakes by itself [0.52％ (3/572)].Reagent E presented the lowest rate of error (2.60％-3.63％).Reagent B,F and G were the higher rating ones in the error evaluation (11.11％-13.37％,12.06％-13.11％,13.44％-17.10％).4) The results from lab c,both in the multi-center evaluation study and EQA,showed a risk of high false negative rates,which should be taken care of.Conclusions Based on the data,the accuracy in the 13 laboratories and the 7 HBsAg ELISA reagents have been quite satisfying.However,one lab and 3 reagents did presented some issues in advanced statistical analysis and ought to be improved.关键词
血液筛查实验室/乙肝表面抗原/ELISA试剂/检测系统性能/多中心评估/室间质量评价Key words
performance evaluation/HBsAg/blood screening laboratory/enzyme-linked immunosorbent assay (ELISA)/external quality assessment (EQA)分类
医药卫生引用本文复制引用
常乐,王芳,郑伟,曾劲峰,李维,释艳华,魏超,蒋建民,王露楠,黄力勤,王瑞,葛红卫,潘彤,韩卫,方建华,朱海峰,何敏..我国血液筛查实验室HBsAg ELISA检测系统性能评估与室间质评结果的关联分析[J].中国输血杂志,2018,31(1):6-11,6.
