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

目的评价我国血液筛查实验室所使用的不同HBsAg ELISA检测系统性能。方法由卫生部临床检验中心（临检中心）于2015年组织13家采供血机构血液筛查实验室（a—m）使用7种HBsAg ELISA试剂（A—G）对1 473（人）份标本检测的结果（多中心评估）,与同期临检中心组织的全国第3次采供血机构血液检验室间质量评价计划中的HBsAg项目结果（室间质评）做横向比较和分析。结果 1）13家实验室的7种HBsAg ELISA试剂灵敏度为84.82%（486/573）—95.85%（554/578）,特异性为93.20%（617/662）—99.04%（828/836）,其中6种试剂的准确率〉93%,D试剂相对较差,仅为89.91%（617/693）。2）7种HBsAg ELISA试剂室间质量评价结果均为正确率〉99%,多中心评估中表现良好的A、C、E 3种试剂在室间质评中的正确率也为100%。3）13家实验室所有标本的准确度较好（AUC为0.929—0.997）;而真阳性标本的检出正确率参差不齐：m实验室准确性最低仅为78.53%（450/573）,j实验室自身错误率最低为0.52%（3/572）,E试剂错误率最低为2.60%—3.63%,B、F和G试剂的错误率相对较高,分别为11.11%—13.37%、12.06%—13.11%和13.44%—17.10%。4）c实验室在试剂评估和室间质评中均表现为检测存在假阴性风险,有待进一步提高。结论多中心评估及室间质评结果显示13家实验室HBsAg检测正确率〉87%,7种HBsAg ELISA试剂检测的准确率〉89%;但有1个实验室、3种试剂的检测性能存在一定的问题。

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 were93. 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 were0. 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.