第四代人类免疫缺陷病毒抗原抗体诊断试剂特异性及灵敏度的比较及其意义

Comparison and significance of domestic and foreign Ⅳ generation HIV antigen-antibody diagnostic reagents in specificity and sensitivity

目的比较和分析国产、进口第四代人类免疫缺陷病毒(HIV)抗原抗体诊断试剂的特异性及灵敏度。方法用2种第四代HIV诊断试剂分别检测8093份献血者标本和HIV-1 p24抗原国家参考品,并进行分析和评价。结果试剂A的阴性符合率为100%(8085/8085),阳性符合率为100%(8/8),总符合率为100%(8093/8093),试剂B的阴性符合率为99.94%(8080/8085),阳性符合率为100%(8/8),总符合率为99.94%(8088/8093)。结论国产第四代HIV诊断试剂在特异性及灵敏度与进口同类产品具有较高的一致性,可以同时检测HIV1/2抗体和HIV-1 p24抗原,可降低成本。

Objective To compare and analyze the specificity and sensitivity of domestic and foreign Ⅳ generation HIV antigen-antibody diagnostic reagents.Methods Two kinds of Ⅳ generation HIV diagnostic reagents were used to test 8093 specimens of blood donors and HIV-1 p24 antigen national reference materials.Tests were analysed and evaluated.Results Negative consistent rate of reagent A was 100%（8085/8085）,positive consistent rate was 100%（8/8）,the total consistent rate was 100%（8093/8093）.Negative consistent rate of reagent B was 99.94%（8080/8085）,positive consistent rate was 100%（8/8）,the total consistent rate was 99.94%（8088/8093）.Conclusion Domestic and foreign Ⅳgeneration HIV diagnostic reagents are highly similar in specificity and sensitivity.HIV1/2 antibodies and HIV-1 p24 antigen can be detected simultaneously.Costs can be reduced.