Kline R L, Dada A, Blattner W, Quinn T C
Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
J Acquir Immune Defic Syndr (1988). 1994 Jun;7(6):623-6.
We evaluated the reliability, sensitivity, and specificity of two rapid assays, TestPack HIV-1/HIV-2 and Genie HIV-1/HIV-2, in Lagos, Nigeria. An alternative algorithm to EIA and Western blot was then examined with the TestPack HIV-1/HIV-2 used as the screening test and the Genie HIV-1/HIV-2 used as the supplemental test to differentiate HIV-1 and HIV-2 infection. In all, 845 prostitutes were evaluated for HIV-1 and HIV-2 infection using one of the two rapid tests and compared to EIA and Western blot results. Of these 845 cases, 437 samples were analyzed by both assays. Overall, 109 (12.7%) prostitutes were antibody positive for HIV-1, 13 (1.5%) for HIV-2, and six (0.7%) were dually reactive for both HIV-1 and HIV-2. Compared to Western blot, the Genie HIV-1/HIV-2 had a slightly higher sensitivity and specificity (98.4% and 99.7%) than the TestPack HIV-1/HIV-2 (97.6% and 99.3%). The alternative algorithm using both rapid assays had a sensitivity of 96.9% and a specificity of 99.9%. The Genie HIV-1/HIV-2 correctly identified 104 of 108 HIV-1 positive sera, 12 of 13 HIV-2 positive sera, and all six dually positive sera. Both assays performed well in the field. They required < 10 min to complete, no equipment, and little training. An algorithm incorporating two rapid assays can be used as a less expensive alternative to traditional testing strategies comparable in reliability to ELISA and Western blot; it provides the additional advantage of differentiating between HIV-1 and HIV-2.
我们在尼日利亚拉各斯评估了两种快速检测方法（TestPack HIV-1/HIV-2和Genie HIV-1/HIV-2）的可靠性、敏感性和特异性。然后研究了一种替代酶免疫分析（EIA）和蛋白质印迹法的算法，该算法以TestPack HIV-1/HIV-2作为筛查试验，Genie HIV-1/HIV-2作为补充试验，用于区分HIV-1和HIV-2感染。总共对845名妓女进行了HIV-1和HIV-2感染评估，使用两种快速检测方法之一，并与EIA和蛋白质印迹法的结果进行比较。在这845例病例中，437份样本由两种检测方法进行了分析。总体而言，109名（12.7%）妓女HIV-1抗体呈阳性，13名（1.5%）HIV-2抗体呈阳性，6名（0.7%）对HIV-1和HIV-2均呈双重反应性。与蛋白质印迹法相比，Genie HIV-1/HIV-2的敏感性和特异性（分别为98.4%和99.7%）略高于TestPack HIV-1/HIV-2（分别为97.6%和99.3%）。使用两种快速检测方法的替代算法敏感性为96.9%，特异性为99.9%。Genie HIV-1/HIV-2正确识别出108份HIV-1阳性血清中的104份、13份HIV-2阳性血清中的12份以及所有6份双重阳性血清。两种检测方法在现场表现良好。它们完成检测所需时间不到10分钟，无需设备，且几乎无需培训。一种包含两种快速检测方法的算法可作为一种成本较低的替代传统检测策略的方法，其可靠性与酶联免疫吸附测定（ELISA）和蛋白质印迹法相当；它还具有区分HIV-1和HIV-2的额外优势。
