HIV抗体快速诊断试剂的评估

目的 通过对艾滋病病毒(HIV)抗体快速诊断试剂的质量评估，筛选检测性能好的试剂，为艾滋病自愿咨询检测(VCT)提供依据。方法 用国家艾滋病参比实验室提供的50份参比样品、来自不同人群的400份样品、两套BBI(BOSTON BIOMEDICA，INC)抗体阳转血清盘(包括10份样品)，对8个厂家的HIv抗体快速诊断试剂的敏感性、特异性进行了评估。结果 被评价的各种快速诊断试剂的敏感性为97．71％～100％，特异性为81．78％～99．63％；阳性预示值为72．78％～99．22％，阴性预示值为98.89％～100％；用BBI血清盘检测时的试剂敏感性及特异性均为100％。结论 HIV抗体快速诊断试剂有较好的检测性能，有些试剂的敏感性及特异性均在95％以上，适合在发展中国家的VCT场所、仪器设备缺乏的实验室、偏远地区的血液筛查及职业暴露后的快速诊断中使用。

Evaluation of rapid tests of HIV antibody

Objective To evaluate rapid tests of HIV-1/2 antibody so as to select test kits of high quality and provide information for VCT(voluntary counseling and testing)services.Methods In order to determine the specificity,sensitivity,positive and negative predictive values(PPV amd NPV)of rapid tests for HIV-1/2,eight test kits from different manufacturers were evaluated by using 400 sera samples(including 269 HIV-1 negative specimen and 131 HIV-1 positive specimen)and two seroconversion panel from BBI(including 10 samples).Results The eight test kits had the sensitivity ranging from 97.71% to 100%;their specificity ranged from 81.78% to 99.63%;their PPV ranged from 72.78% to 99.22%;and the NPV was from 98.89% to 100%.The seroconversion sensitivities and specificities of the eight test kits tested with seroconversion panel from BBI were all 100%.Conclusion Simple rapid test kits for HIV-1/2 are easy to perform,and some of them have sensitivity and specificity over 95%.It is well suitable for their use in the settings of the developing world.It can be used for VCT services,blood screening in remote areas,as well as in case of occupational exposure.