Bredberg-Rådén U, Kiango J, Mhalu F, Biberfeld G
Department of Immunology, National Bacteriological Laboratory, Stockholm, Sweden.
AIDS. 1988 Aug;2(4):281-5. doi: 10.1097/00002030-198808000-00007.
Sera from 622 blood donors collected in 1986 and 1987 in Tanzania were screened for antibodies to HIV-1 by seven different commercial enzyme-linked immunosorbent assay (ELISA) kits. All ELISA-positive sera were tested by Western blot analysis and many of them also by radioimmunoprecipitation assay (RIPA). Sixty-seven sera were confirmed positive. Eight sera, which were repeatedly positive on only one or two of the ELISA kits and showed weak, doubtful reactions on Western blot and RIPA, were considered indeterminate and were not included in the calculations of sensitivity and specificity of the various ELISA kits. The sensitivity of the ELISAs was as follows: Organon Vironostika: low cut-off 74.6%; Organon Vironostika: high cut-off 62.7%; Du Pont: 85.1%; Pasteur: 78.7%; Abbott: 80.8%; Abbott recombinant: 94.0%; Wellcozyme: 82.1%; Wellcozyme monoclonal: 98.5%. The specificity was as follows: Organon Vironostika: low and high cut-off 100%; Du Pont: 94.7%; Pasteur: 99.3%; Abbott: 100%; Abbott recombinant 98.7%; Wellcozyme: 99.8%; Wellcozyme monoclonal: 98.5%. In conclusion, the two new generation kits tested, Wellcozyme monoclonal and Abbott recombinant, had the highest sensitivity whereas the sensitivity of the first-generation tests was unexpectedly low.
1986年和1987年在坦桑尼亚采集的622名献血者的血清，使用7种不同的商用酶联免疫吸附测定（ELISA）试剂盒进行了HIV-1抗体筛查。所有ELISA阳性血清均通过蛋白质印迹分析进行检测，其中许多血清还通过放射免疫沉淀测定（RIPA）进行检测。67份血清被确认为阳性。8份血清仅在一两种ELISA试剂盒上反复呈阳性，在蛋白质印迹和RIPA上显示出微弱、可疑的反应，被视为不确定，未纳入各种ELISA试剂盒敏感性和特异性的计算。ELISA的敏感性如下：Organon Vironostika：低临界值74.6%；Organon Vironostika：高临界值62.7%；杜邦：85.1%；巴斯德：78.7%；雅培：80.8%；雅培重组：94.0%；Wellcozyme：82.1%；Wellcozyme单克隆：98.5%。特异性如下：Organon Vironostika：低临界值和高临界值均为100%；杜邦：94.7%；巴斯德：99.3%；雅培：100%；雅培重组：98.7%；Wellcozyme：99.8%；Wellcozyme单克隆：98.5%。总之，所测试的两种新一代试剂盒Wellcozyme单克隆和雅培重组具有最高的敏感性，而第一代检测的敏感性出乎意料地低。
