Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, 1600 Clifton Rd, NE MS E-46, Atlanta, GA 30333, USA.
J Clin Virol. 2011 Dec;52 Suppl 1:S45-9. doi: 10.1016/j.jcv.2011.09.026. Epub 2011 Oct 12.
The HIV-1 Western blot (WB) and immunofluorescence assay used to confirm HIV infections are less sensitive during seroconversion than immunoassays (IAs) used for screening. An alternative diagnostic algorithm has been proposed to detect early HIV-1 infection and differentiate HIV-1 from HIV-2.
We evaluated the performance of an algorithm with a third generation IA that when reactive was followed by a rapid test (Multispot) that differentiates HIV-1 from HIV-2. Multispot-reactive specimens were considered HIV-infected. Multispot-negative specimens were tested with a nucleic acid amplification test (NAAT) for resolution.
WB-positive specimens [serum (n=2202), plasma (n=1109) and peripheral blood mononuclear cells (PBMCs) (n=1065)] were obtained from HIV-infected persons not taking antiretrovirals. HIV-uninfected specimens [plasma (n=1517) and PBMCs (n=1508)] with negative IA and NAAT results were obtained from blood donors. Specimens were tested with third generation IAs (Abbott rDNA, ADVIA Centaur, GS HIV1-2 Plus O, Ortho VITROS) in singlet, Multispot, and NAAT (APTIMA (RNA) and AMPLICOR (DNA)). We calculated algorithm sensitivity and specificity and the proportion of IA-reactive specimens requiring NAAT.
Algorithm sensitivity was 99.95% with APTIMA and 100% with AMPLICOR. One WB-positive specimen reactive by all IAs and AMPLICOR was negative by Multispot and APTIMA. Algorithm specificity was 100% using APTIMA or AMPLICOR as NAAT. From 0.10% (Abbott) to 2.43% (VITROS) of IA-reactive specimens required NAAT.
The proposed algorithm performs with high sensitivity and specificity in specimens from persons with established HIV infection and uninfected blood donors and appears to be a good alternative to the current algorithm.
与用于筛查的免疫测定相比，用于确认 HIV 感染的 HIV-1 免疫印迹（WB）和免疫荧光检测在血清转换期间的敏感性较低。已经提出了一种替代的诊断算法来检测早期 HIV-1 感染并区分 HIV-1 与 HIV-2。
我们评估了一种算法的性能，该算法使用第三代免疫测定，如果反应阳性，则进行快速检测（Multispot），该检测可区分 HIV-1 与 HIV-2。Multispot 反应性标本被认为是 HIV 感染。Multispot 阴性标本通过核酸扩增试验（NAAT）进行检测以确定结果。
从未服用抗逆转录病毒药物的 HIV 感染者中获得 WB 阳性标本（血清（n=2202）、血浆（n=1109）和外周血单核细胞（PBMC）（n=1065））。从血液供者获得阴性 IA 和 NAAT 结果的 HIV 未感染标本（血浆（n=1517）和 PBMC（n=1508））。使用第三代 IA（雅培 rDNA、ADVIA Centaur、GS HIV1-2 Plus O、Ortho VITROS）、Multispot 和 NAAT（APTIMA（RNA）和 AMPLICOR（DNA））对标本进行检测。我们计算了算法的敏感性和特异性以及需要 NAAT 的 IA 反应性标本的比例。
使用 APTIMA 时算法的敏感性为 99.95%，使用 AMPLICOR 时为 100%。所有 IA 和 AMPLICOR 反应阳性的 1 份 WB 阳性标本 Multispot 和 APTIMA 检测结果为阴性。使用 APTIMA 或 AMPLICOR 作为 NAAT 时，算法的特异性为 100%。IA 反应性标本的 0.10%（雅培）至 2.43%（VITROS）需要 NAAT。
该算法在具有明确 HIV 感染的个体和未感染的血液供者的标本中表现出高敏感性和特异性，似乎是当前算法的良好替代方案。
