国产人类免疫缺陷病毒抗体诊断试剂质量评价

Evaluation of reagent kit for detection of HIV antibodies

目的 对不同原理的人类免疫缺陷病毒 (HIV)抗体诊断试剂盒的质量评价。方法3 745份特殊人群血样 ,各种试剂盒同时测定 ,对检测结果不一致的样品经HIV抗体免疫印迹法试剂盒确证 ,比较各试剂盒的检测敏感性 ;用亲和层析纯化的HIVgp41抗体 ,测定各不同试剂盒的最低检出量 ;用 10份系列稀释的阳性血清测定试剂盒的综合检测能力。结果 国产间接法抗HIV诊断试剂检测敏感性较第一代同类试剂提高约 2～ 8倍 ;双抗原夹心法诊断试剂较间接法其敏感性有显著提高 ,最低检出量提高了 4～ 32倍。结论 国产抗HIV诊断试剂的质量已有了显著提高 ,尤其是双抗原夹心法诊断试剂 ,其质量已达到国际先进试剂的水平。

Objective To evaluate the quality of diagnostic kits with different rationale.Methods 3745 samples were selected with different kits to be tested in parallel. The sensitivities of the tested kits were compared with the conformation tests for those samples with different test results. The detection limit was measured by using antibody to HIV-gp 41 purified from human sera with affinity chromatography. Ten-fold serial diluted samples from 10 individual donors were used for the evaluation of the general antibody detection ability.Results The sensitivity of current indirect assay was 2～8 times higher than that of the previous one. The sensitivity of double antigen sandwich assay was raised significantly which was 4～32 times higher than that of indirect assy. Conclusions The quality of the domestic HIV antibody diagnosis kit has been improved greatly, especially the sensitivity of double antigen sandwich assay, which has met that of international advanced diagnostic kits.