人棘球蚴病血清学诊断试剂检测效能评价

Evaluation of diagnostic reagent for echinococcosis in humans in China

目的了解我国现有的人群棘球蚴病血清学诊断试剂的检测效能,为全国中央转移支付地方棘球蚴病防治项目进行人群棘球蚴病血清流行病学调查与监测,筛选适宜的检测试剂提供参考。方法选择我国目前已用于防治实践或研制比较成熟的血清学诊断试剂共9种(A、B、C、D、E、F、G、H、I),对收集的400份标本血清,采用双盲法进行检测,计算并比较各试剂检测效能的有关指标。结果参评的9种血清学诊断试剂敏感性42.4%～95.8%,特异性48.6%～100.0%,阳性预测值86.7%～100.0%之间,阴性预测值27.2%～82.6%之间,正确指数0.285～0.802之间,一致性64.2%～90.1%之间。与囊虫病的交叉反应最低为25%,最高达82.5%。综合考虑各项指标,试剂A(ELISA间接法)的检测效能最高。结论我国目前人群棘球蚴病血清学诊断试剂的检测效能较低,试剂的敏感性和特异性有待进一步提高,且与囊虫病普遍存在较强的交叉反应性,需进一步加强研制灵敏、特异、便于现场应用的血清学诊断试剂,以用于棘球蚴病病人的早期诊断。

The purpose of this study is to evaluate detection level of existing serological diagnostic reagents of human echinococcosis in China,and to offer reference for reagent screening in national echinococcosis control programme.Nine serological diagnostic reagents used generally（A,B,C,D,E,F,G,H,and I） were evaluated through detection of 400 sera specimens by double-blind method,and the related indicators were calculated and compared within reagents.The result showed that sensitivity of above reagents ranged from 42.4% to 95.8%,specificity from 48.6% to 100%,positive predictive values from 86.7% to 100.0%,negative predictive value from 27.2% to 82.6%,correct index from 0.285 to 0.802,consistency from 64.2% to 90.1%,and cross-reactivity with cysticercosis from 25% to 82.5%.All validity indicators have been synthetically considered and the reagent A was the best.In general,the detection level of current serological diagnostic reagents was low and there existed high cross reactivity with cysticercosis especially.Thus,we need to further strengthen the development of sensitive,specific and field eligible serological diagnostic reagent of human echinococcosis.