HIV抗体快速诊断试剂评估

Evaluation of the quality of rapid diagnostic reagents for human immunodeficiency virus antibody

目的为了解试剂质量、选择HIV抗体筛查试剂提供依据,对云南省市售的3种国产和3种进口HIV抗体筛查快速诊断试剂进行试剂质量评估。方法用各参评试剂对已知阳性样本和阴性样本进行检测,统计各试剂敏感性、特异性、功效率等相关指标。结果各评估试剂的敏感性为99.9%~100%,特异性为97.18%~99.53%,功效率为99.52%~99.84%,假阳性率为0.47%~2.82%,假阴性率在0.1%以下,阳性预示值(PPV)为99.42%~99.9%,阴性预示值(NPV)为99.52%~100%。结论被评估试剂均有很高的敏感性和特异性。

Objective To evaluate the quality of rapid diagnostic reagents of three domestic and three inported for Human Immunodificiency Virus(HIV)antibody in Yunnan province,providing basis for selecting antibody reagent and understanding its quality.Methods The known positive and negative samples were tested with the candidate rapid diagnostic reagents.The sensitivity,specificity,efficiency and other correlative parameters of the reagents were compared.Results The sensitivities of the rapid reagents were from 99.9%to 100%,and the specificities were from 97.18%to 99.53%,the efficiencies were from 99.52%to 99.84%.The false positive rates were from 0.47%to 2.82%,the false negative rates were below 0.1%,the positive predicted values were from 99.42%to 99.9%,and the negative predicted values were from 99.52%to 100%.Conclusion The evaluated rapid reagents have higher sensitivities and specificities.