Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.
Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.
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DOI：
10.1371/journal.pone.0080629
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
Pandori MW
中科院分区：
文献类型：
--
作者：
Pilcher CD;Louie B;Facente S;Keating S;Hackett J Jr;Vallari A;Hall C;Dowling T;Busch MP;Klausner JD;Hecht FM;Liska S;Pandori MW
目前的 HIV 实验室和护理点检测检测不同的分析物并使用不同的样本类型。有些的周转时间很快（<1 小时）。我们调查了艾滋病毒检测选择如何影响检测项目的病例发现。我们分析了 2003 年至 2008 年旧金山 HIV 检测项目获得的 21,234 份连续的 HIV 检测静脉血。对于一个子集，还获取了口腔液 (n = 6446) 或指尖采血 (n = 8127) 样本进行快速检测。在所有情况下，HIV 状态都是使用 HIV 抗体加 RNA 测试算法确定的。我们评估了筛选抗体测试的单独执行情况与完整算法的黄金标准的比较。然后，我们通过重新测试在初步筛查中抗体结果呈阴性/不一致的所有样本，评估其他测试（包括新测试）检测更多病例的潜在能力。抗体-RNA 算法识别出 58 例急性 HIV 感染病例和 703 例确诊 HIV 感染病例。第一代 (Vironostika) 和第三代 (Genetic Systems) 免疫测定的灵敏度分别为 92% 和 96%。 Oraquick 快速检测对口腔液样本的临床敏感性仅为 86%，但对指尖采血的临床敏感性为 92%。较新的第四代抗原抗体组合快速免疫分析 (ARCHITECT) 在所有急性病例中检测到了 87% 的 HIV，而之前的筛查分析中漏掉了这一点。护理点第四代抗原抗体组合快速检测（Determine）检测出约 54% 的此类急性病例。我们的研究表明，一些快速抗体血液检测可以提供与实验室抗体检测类似的病例检测，但口腔液检测大大降低了检测艾滋病毒的能力。新的第四代组合检测可以检测出大多数可通过 HIV RNA 检测到的急性感染，但结果很快。在高风险 HIV 检测项目中使用这些检测作为主要筛查方法可以减少或消除对 HIV RNA 检测的需要。
Current laboratory and point-of-care tests for HIV detect different analytes and use different sample types. Some have fast turnaround times (<1 hour). We investigated how HIV test choice could impact case finding by testing programs. We analyzed 21,234 consecutive HIV tests with venous blood obtained by San Francisco HIV testing programs from 2003 to 2008. For a subset, oral fluid (n = 6446) or fingerstick blood (n = 8127) samples were also obtained for rapid testing. In all cases, HIV status was determined using an HIV antibody-plus-RNA test algorithm. We assessed how the screening antibody tests performed individually versus the gold standard of the full algorithm. We then evaluated the potential ability of other tests (including new tests) to detect more cases, by re-testing all specimens that had negative/discrepant antibody results on initial screening. The antibody-RNA algorithm identified 58 acute and 703 established HIV infection cases. 1st-generation (Vironostika) and 3rd-generation (Genetic Systems) immunoassays had 92 and 96 percent sensitivity, respectively. The Oraquick rapid test had clinical sensitivity of only 86 percent on oral fluid samples, but 92 percent on finger-stick blood. Newer 4th-generation, antigen-antibody combo rapid immunoassay (ARCHITECT) detected HIV in 87 percent of all the acute cases that had been missed by one of the previous screening assays. A point-of-care 4th generation antigen-antibody combo rapid test (Determine) detected about 54 percent of such acute cases. Our study suggests that some rapid antibody blood tests will give similar case detection to laboratory antibody tests, but that oral fluid testing greatly reduces ability to detect HIV. New 4th-generation combo tests can detect the majority of acute infections detectable by HIV RNA but with rapid results. Using these tests as a primary screening assay in high-risk HIV testing programs could reduce or eliminate the need for HIV RNA testing.
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