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部分国产艾滋病病毒抗体检测试剂临床应用质量评价 |
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李敬云 鲍作义 吕富双 王宏霞
【摘要】 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。
【关键词】 艾滋病病毒抗体 吸毒人群 酶免疫试剂
Quality evaluation of locally-prepared kits for HIV antibody detection in clinical applications
LI Jingyun,BAO Zuoyi,LU Fushuang,et al.
Institute for Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing 100071
【Abstract】 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 [1] [2] 下一页
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