HIV TP同步金标法快速检测结果的比较分析

Analysis of dual rapid test for HIV and syphilis by synchronized gold label method

目的为了对目标人群及临床疑似病人进行艾滋病毒(HIV)、梅毒螺旋体(TP)血清快速筛查诊断,并确保HIV、TP快速诊断试剂血清学的检测效果。方法采用Bioline同步HIV、TP胶体金快速检测试剂对浦东新区6个社区的≥60岁的老年人血清共10 000份进行TP、HIV血清学筛查,TP检测阳性者再用梅毒螺旋体明胶颗粒凝集试验(TPPA)试剂进行验证,阴性者随机抽取1 000例;HIV快速检测阳性者用Determine胶体硒免疫层析试剂进行比对,阴性者随机抽取1 000例分别TPPA试剂进行验证、用Determine胶体硒免疫层析试剂进行比对;另抽取2016-2019年确证实验室HIV筛查阳性待确证样本同时Determine胶体硒免疫层析方法阳性并蛋白印迹试验(WB)确证为阳性样本1 000例,对Bioline同步快速检测试剂进行验证。结果 1)Bioline同步HIV、TP金标快速诊断法相对于TPPA法的敏感性为98.94%,特异性为100%,其检测结果与TPPA一样包含了既往和现症感染;2)Bioline同步HIV、TP同步金标快速诊断法相对于WB确证实验敏感性100%,特异性99.84%,与Determine胶体硒快速法相比较(两种快诊试剂均以WB为"金标准"),差异均无统计学意义(P> 0.01)。结论 Bioline同步HIV、TP金标快速诊断法可以取代Determine胶体硒免疫层析快速诊断用于门诊基层等医疗机构及个人自测,同时可以取代TPPA法用于梅毒筛查。

Objective To rapidly screen and diagnose HIV and TP serum in the target population and clinical suspected patients,and to ensure the serological detection effect of HIV and TP rapid diagnostic reagents. Methods Ten thousand elderly people over 60 years old in six communities of Pudong new area were screened for TP serology with Bioline synchronous HIV and TP colloidal gold rapid detection reagent. The TP positive patients were verified by TPPA reagent, and 1 000 negative patients were randomly selected. The HIV positive cases rapidly detected were compared by Determine colloidal selenium immune-chromatography reagent, and 1 000 negative cases randomly selected were verified too with TPPA reagent and compared with determine colloidal selenium immune-chromatographic reagent. Another 1 000 HIV positive samples by laboratory screening during 2016-2019 by Determine colloidal selenium immunk-chromatographic method and WB(immunoblotting test) were used to verify the Bioline cynchronous rapid detection reagent. Results(1) The sensitivity and specificity of Bioline synchronous gold labeling for HIV and TP were 98.94% and 100% respectively, compared with the results of TPPA including both past and present infections as well as TPPA.(2) The sensitivity and specificity of Bioline synchronous gold labeling for HIV and TP were 100% and 99.84% respectively, compared with those of WB confirmatory test, with no significant difference between the two rapid diagnostic reagents and Determine colloidal selenium rapid method(both of which were based on immune-blot WB as the "gold standard")(P< 0.01). Conclusion Bioline synchronous gold-label rapid diagnosis of HIV and TP can replace Determine colloidal selenium immuno-chromatography and TPPA method of syphilis screening for rapid diagnosis of outpatients, and those from primary medical institutions and personal self-test.