Performance of a Rapid and Simple HIV Testing Algorithm in a Multicenter Phase III Microbicide Clinical Trial
Performance of a Rapid and Simple HIV Testing Algorithm in a Multicenter Phase III Microbicide Clinical Trial
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DOI：
10.1128/cvi.05069-11
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发表时间：
2011-09-01
影响因子：
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通讯作者：
Van Damme, Lut
中科院分区：
文献类型：
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作者：
Crucitti, Tania;Taylor, Doug;Van Damme, Lut
基于快速简单 (R/S) 检测的多重测试序贯算法被应用于 3 期杀菌剂有效性试验参与者的 HIV 感染诊断。对患者参加试验后采集的指尖血样进行了艾滋病毒检测。使用三种不同的快速检测（Determine HIV-1/2 [Abbott]、SD Bioline HIV-1/2 3.0 [Standard Diagnostics] 和 Uni-Gold HIV [Trinity Biotech]）对样本进行连续检测。如果确定 HIV-1/2 和 SD Bioline HIV-1/2 3.0 检测结果不一致，则由第三种检测 (Uni-Gold HIV) 确定最终结果。当最终结果呈阳性时，会收集第二份样本并使用相同的算法进行测试，只有当该样本获得阳性结果时，参与者才会被告知其血清呈阳性状态。总共测试了从 1,398 名女性身上获取的 5,734 份入组后样本。根据对第一个采集样本进行的测试算法，46 名女性的测试结果呈阳性。 ITM 获得的确认检测结果证实，42 名女性确实被感染。在对第二份血液样本进行分析后，四个最初的假阳性结果中有两个呈阴性。另外两人使用当天采集的样本两次检测出假阳性。仅在坎帕拉的研究地点观察到很高比例的标本对“确定 HIV-1/2”检测有反应。这一结果似乎与怀孕或疟疾感染无关。我们的结论是，只要有足够的质量保证程序，HIV 检测算法（仅包括 R/S 检测）适合在临床试验中使用。
A multitest sequential algorithm based on rapid and simple (R/S) assays was applied for the diagnosis of HIV infection among participants in a phase 3 microbicide effectiveness trial. HIV testing was performed on finger-prick blood samples obtained from patients after their enrollment in the trial. The specimens were tested in a serial procedure using three different rapid tests (Determine HIV-1/2 [Abbott], SD Bioline HIV-1/2 3.0 [Standard Diagnostics], and Uni-Gold HIV [Trinity Biotech]). In the event of discordant results between the Determine HIV-1/2 and SD Bioline HIV-1/2 3.0 tests, the third assay (Uni-Gold HIV) determined the final outcome. When the final outcome was positive, a second specimen was collected and tested with the same algorithm, only if a positive result was obtained with this sample the participant was informed of her positive serostatus. A total of 5,734 postenrollment specimens obtained from 1,398 women were tested. Forty-six women tested positive according to the testing algorithm performed on the first collected specimen. Confirmatory testing results obtained at the ITM confirmed that 42 women were truly infected. Two of four initial false positives tested negative upon analysis of a second blood specimen. The other two tested false positive twice using specimens collected the same day. A high percentage of specimens reactive with the Determine HIV-1/2 assay was only observed at the study site in Kampala. This result did not appear to be associated with pregnancy or malaria infection. We conclude that HIV testing algorithms, including only R/S assays, are suitable for use in clinical trials, provided that adequate quality assurance procedures are in place.