Stetler H C, Granade T C, Nunez C A, Meza R, Terrell S, Amador L, George J R
Division of AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
AIDS. 1997 Mar;11(3):369-75. doi: 10.1097/00002030-199703110-00015.
To determine the ability of simple, rapid tests to identify HIV-1 antibody-positive specimens in field settings using the World Health Organization's (WHO) alternative testing strategies.
Three-phase evaluation of simple, rapid assays using banked specimens and prospectively collected serum specimens at regional hospitals and rural clinics.
Seven test (Retrocell, Genie, HIVCHEK, SUDS HIV-1, Testpack, Serodia HIV-1, and HIV-1/2 RTD) were evaluated and results compared with standard enzyme immunoassay (EIA) and Western blot results (phase 1). Further evaluation consisted of prospective testing of routine specimens at regional (phase 2; n = 900) and rural, peripheral laboratories (phase 3; n = 1266) throughout Honduras with selected assays.
Sensitivity and specificity were calculated for each assay and combination of assays for each phase to evaluate the effectiveness of the WHO alternative testing strategies. All tests in all phases were > 99% sensitive after correcting for technical errors, with two exceptions (SUDS, phase 1; HIVCHEK, phase 3). In phase 3, where the testing algorithm was diagnostic, several combinations of assays were 100% sensitive and specific using WHO strategy II or III. For the Honduras Ministry of Health, the combination of Retrocell and Genie was found to be equally sensitive, more specific (no indeterminate results), and less expensive than EIA/Western blot.
Combinations of rapid, simple HIV antibody assays provide sensitivity and specificity performance comparable to EIA/Western blot. Application of these combinations in the WHO alternative testing strategies provides an inexpensive and effective method of determining HIV status. Assay combinations using these strategies can be easily performed in small, rural laboratories and have been implemented in routine HIV screening in Honduras.
使用世界卫生组织（WHO）的替代检测策略，确定简单、快速检测在现场环境中识别HIV-1抗体阳性标本的能力。
使用储存标本以及在地区医院和农村诊所前瞻性收集的血清标本，对简单、快速检测进行三阶段评估。
评估了七种检测方法（Retrocell、Genie、HIVCHEK、SUDS HIV-1、Testpack、Serodia HIV-1和HIV-1/2 RTD），并将结果与标准酶免疫测定（EIA）和免疫印迹结果进行比较（第一阶段）。进一步评估包括在洪都拉斯各地的地区实验室（第二阶段；n = 900）和农村周边实验室（第三阶段；n = 1266）使用选定的检测方法对常规标本进行前瞻性检测。
计算每个阶段每种检测方法和检测方法组合的敏感性和特异性，以评估WHO替代检测策略的有效性。在纠正技术错误后，所有阶段的所有检测方法敏感性均> 99%，有两个例外（第一阶段的SUDS；第三阶段的HIVCHEK）。在第三阶段，检测算法具有诊断性，使用WHO策略II或III时，几种检测方法组合的敏感性和特异性均为100%。对于洪都拉斯卫生部而言，发现Retrocell和Genie的组合同样敏感、更具特异性（无不确定结果）且比EIA/免疫印迹成本更低。
快速、简单的HIV抗体检测方法组合提供了与EIA/免疫印迹相当的敏感性和特异性表现。这些组合在WHO替代检测策略中的应用提供了一种廉价且有效的确定HIV状态的方法。使用这些策略的检测方法组合可以在小型农村实验室轻松进行，并且已在洪都拉斯的常规HIV筛查中实施。
