五种不同厂家抗-HIV试剂的质量评价

Assessment of Five Different HIV ELISA Kits

目的选择一种优质、高效和实用的抗-HIVELISA血液筛选试剂。方法采用五种不同厂家的抗-HIVELISA试剂(其中三种国产试剂,两种进口试剂)分别对国家参比品、卫生部质控品和无偿献血者标本进行检测,分析比较五种试剂的符合率、阳性检出率、假阳性率、最低检测限、稳定性和前带效应。结果五种试剂盒用于检测抗-HIV国家参比品的总符合率都达到100%;常规标本的阳性检出率均达到100%;21658份无偿献血标本抗-HIV阳性率为0.01%;进口试剂C假阳性率低于进口试剂D和国产A、B、E试剂(P<0.05);C试剂的精密度和批间稳定性分别为5.985%和5.93%,明显低于A、B、D、E试剂(P<0.05);国产试剂A、B、E试剂的最低检测限降低至0.125NCU,但其假阳性率较高;C试剂也不存在前带效应。结论五种试剂的总符合率均达到国家要求,阳性率均为0.01%;国产试剂的假阳性率高于进口试剂,最低检测限低于进口试剂;C试剂的稳定性最优,也不存在前带效应。选择C试剂进行抗-HIV血液筛选效果最佳。

Objective The aim of this study was to evaluate the reliability of five different ELISA kits for the testing of HIV in blood samples. Methods ELISA kits obtained from local （Kit-A, B, and E） and oversea （Kit-C and D） manufactures were used in this study. Bloods, either obtained from the volunteers or provided by the Health Ministry, were used for the testing of HIV. The following parameters were compared： the compliance rate, positive identification rate,false positive identification rate, stability,detection limit and pro-zone phenomena.Results All 5 ELISA kits achieved national standard with a compliance rate of 100%. For the standard samples, the positive identification rate was 100% .The positive identification rate of the 21 658 blood donor samples was 0.01% .ELISA kit-C had a lower false positive identification rate than the ELISA Kit-D, A, B and E （P〈0.05）. The accuracy （5.98%） and stability （5.93%） of the ELISA Kit-C were lower than the ELISA Kit-A,B,D,and E （P〈0.05）. Although the detection limit of the ELISA Kit-A, B and E is 0.125NCU, the false positive identification rate for this ELISA kit is high. Pro-zone effect was not observed in the ELISA Kit-C. Conclusion All the ELISA kits used in this study meet the national standard. The false positive identification rate of the three locally made ELISA kits was higher than the two imported ELISA kits, the minimum detectable limit of these locally made ELISA kits was lower than the other two kits. The ELISA Kit-C should be used for the screening of HIV.