Malone J D, Smith E S, Sheffield J, Bigelow D, Hyams K C, Beardsley S G, Lewis R S, Roberts C R
Infectious Disease Division, National Naval Medical Center, Bethesda, MD 50014-5000.
J Acquir Immune Defic Syndr (1988). 1993 Feb;6(2):115-9.
Six commercial rapid test kits for HIV-1 antibody were evaluated. Four laboratory technologists tested sera from four groups of U.S. military personnel or dependents: 202 subjects positive for HIV-1 antibody by Western blot, 200 seronegative voluntary blood donors, 199 seronegative obstetrics/gynecology patients, and 99 subjects with sera reactive by ELISA but negative by recombinant protein EIA and indeterminate by Western blot. The three tests using solid-phase immunoassay technology demonstrated the highest mean sensitivity (> 99%) and specificity (> 91%) for all groups tested, including sera indeterminate by Western blot. Two dot-immunoblot assays were less specific, possibly due to indistinct reaction end points, and a latex agglutination assay was also less specific because of difficulty distinguishing reactive results from the granular background. In an "ease-of-use" assessment, solid-phase capture immunoassays required less time and equipment and were easier to interpret than other testing methods. Solid-phase capture immunoassays for HIV-1 antibody may be suitable for use in emergency situations and in developing countries because they are highly sensitive and specific and are rapidly performed with minimal laboratory equipment.
对六种用于检测HIV-1抗体的商用快速检测试剂盒进行了评估。四名实验室技术人员检测了四组美国军事人员或其家属的血清：202名经免疫印迹法检测HIV-1抗体呈阳性的受试者、200名血清学阴性的自愿献血者、199名血清学阴性的妇产科患者，以及99名ELISA检测血清反应性呈阳性但重组蛋白EIA检测呈阴性且免疫印迹法检测结果不确定的受试者。使用固相免疫测定技术的三种检测方法对所有检测组，包括免疫印迹法检测结果不确定的血清，均显示出最高的平均灵敏度（>99%）和特异性（>91%）。两种斑点免疫印迹检测方法特异性较低，可能是由于反应终点不清晰，而乳胶凝集试验特异性也较低，因为难以将反应结果与颗粒状背景区分开来。在“易用性”评估中，固相捕获免疫测定法所需时间和设备较少，且比其他检测方法更易于解读。用于检测HIV-1抗体的固相捕获免疫测定法可能适用于紧急情况和发展中国家，因为它们高度灵敏且特异，并且使用最少的实验室设备就能快速完成检测。
