Li J, Bao Z, Lu F
Institute for Microbiology and Epidemiology, Academy of Military Medical Sciences, Beijing.
Zhonghua Liu Xing Bing Xue Za Zhi. 1999 Aug;20(4):230-3.
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.
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.
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%.
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.
评估8种国产人类免疫缺陷病毒抗体（抗-HIV）酶联免疫吸附试验（ELISA）试剂盒的质量，并研究其临床应用现状。
采用8种国产ELISA试剂盒对200份血清标本进行抗-HIV筛查，以进口试剂盒作为对照，其中包括100份抗-HIV确诊阳性、阴性或不确定标本以及100份来自新疆地区吸毒人员的标本。
进口对照试剂盒对74份确诊阳性标本均能检测出抗-HIV，灵敏度为100%。而国产试剂盒检测出6至18份假阴性标本，灵敏度为81.1% - 91.9%，主要集中在抗-HIV弱阳性的吸毒人员标本中。107份确诊阴性标本中，进口对照试剂盒出现2例假阳性，特异性为98.2%，国产试剂盒出现0至8例假阳性，特异性为92.5% - 100%。
应进一步提高国产ELISA试剂盒抗-HIV筛查的灵敏度，以确保输血安全及艾滋病/ HIV的防控。
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