部分国产艾滋病病毒抗体检测试剂临床应用质量评价

Quality evaluation of locally-prepared kits for HIV antibody detection in clinical applications

目的 为掌握国产艾滋病病毒（ＨＩＶ） 抗体筛选酶免试剂的实际应用状况，对８ 种主要的国产ＨＩＶ抗体筛选酶免试剂进行了临床应用质量评价。方法 以一种进口ＨＩＶ 抗体筛选酶免试剂为参比，用８ 种考评试剂对２００ 份标本进行了统一的检测。２００ 份标本包括１００ 份经过确认的ＨＩＶ抗体阳性、阴性、可疑标本和１００ 份新疆吸毒人群的血清标本。结果 参比试剂可以检出全部７４ 份阳性标本，敏感性为１００ ％ ，而考评试剂有６ ～１８ 份不等的假阴性结果，敏感性为８１．１％ ～９１．９％ 。假阴性结果主要发生于来自吸毒人群的ＨＩＶ 抗体弱阳性标本。考评试剂的特异性相对较好，在１０７ 份阴性标本中，参比试剂将２ 份错判为阳性，特异性为９８ ．１ ％ ，考评试剂有０～８ 份标本错判为阳性，特异性为９２．５ ％ ～１００％ 。结论 考评试剂的主要问题是敏感性低，这可能与检测原理是间接法、抗原组成不全面、反应条件不合理等因素有关。

Objective To evaluate the quality of eight kinds of locally prepared enzyme-linked immunosorbent assay (ELISA) kits for HIV antibody (anti-HIV) detection and study their current status in clinical applications. Methods Two hundred serum specimens were tested with eight kinds of locally prepared ELISA kits for anti-HIV screening, with an imported kit as reference, including 100 specimens with confirmed positive,negative or undetermined anti-HIV and 100 specimens collected from the drug abusers in Xinjiang Region. Results Anti-HIV could be detected in all the 74 confirmed positive specimens with the imported reference kit, with sensitivity of 100%. But, six to eighteen specimens were false negative detected with local prepared kits, with sensitivities of 81.1%～91.9%, mainly in those collected from the drug abusers with weak positive for anti-HIV. Two of the 107 confirmed negative specimens were false positive by the imported reference kit, with a specificity of 98.2 %, and 0～8 specimens were false positive by locally prepared kits, with specificities of 92.5% ～100%. Conclusion The sensitivity of locally prepared ELISA kits for anti-HIV screening should be improved further to ensure the safety of blood transfusion and the control of AIDS/HIV.