Abstract
Western blot (WB) assay is considered the gold standard test for HIV infection confirmation. However, it requires technical expertise and is quite time-consuming. WHO recommends blood-based rapid diagnosis to achieve same-day test and treatment. However, this rapid testing strategy has not been promoted worldwide due to inadequate research evaluating the effectiveness of rapid tests (RTs) as an alternative confirmatory HIV test for WB. This study aims to compare the diagnostic performance of rapid HIV tests compared with WB. PubMed and Web of Science were searched for publications on rapid HIV tests using blood specimen. A meta-analysis was performed to quantitatively evaluate the diagnostic performance of rapid HIV tests compared with the WB assay in terms of pooled sensitivity, specificity, area under summary receiver operating characteristic (SROC) curve, and diagnostic odds ratio (DOR). Twenty articles involving 27,343 fresh specimens for rapid HIV tests were included in the meta-analysis. Regarding Capillus HIV-1/HIV-2, the pooled sensitivity, specificity, area under SROC curve, and DOR derived from six studies were 0.999 (95% CI, 0.956-1.000), 0.999 (95% CI, 0.991-1.00), 1.00 (95% CI, 0.99-1.00), and 1.0 × 106 (95% CI, 2.6 × 104-3.9 × 107) compared with the WB assay, respectively. With respect to Determine HIV-1/2, the pooled sensitivity, specificity area under SROC, and DOR derived from eight studies were 1.00 (95% CI, 0.789-1.000), 0.992 (95% CI, 0.985-0.996), 1.00 (95% CI, 0.99-1.00), and 1.8 × 106 (95% CI 406.049-7.8 × 109) compared with the WB assay, respectively. Regarding two-step serial RTs, the pooled sensitivity, specificity area under SROC, and DOR derived from eight studies were 0.998 (95% CI, 0.991-1.000), 0.998 (95% CI, 0.994-0.999), and 1.00 (95% CI 0.99-1.00) compared with the WB assay, respectively. Our meta-analysis results may provide evidenced-based support for substituting RT for WB. Blood-based rapid HIV tests have comparable sensitivity and specificity to WB for HIV early therapy.
Highlights
Western blot (WB) is regarded as the gold standard for a definitive confirmatory test for HIV infection
This study aims to compare the diagnostic performance of rapid HIV tests compared with WB assay in terms of pooled sensitivity, specificity, area under summary receiver operating characteristic (SROC) curve, and diagnostic odds ratio (DOR) among different populations
The work was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis PRISMA guidelines [see RPISMA checklist in Supplementary Material [16]]
Summary
Western blot (WB) is regarded as the gold standard for a definitive confirmatory test for HIV infection. According to the Chinese integrated HIV/ AIDS database, about 25% of newly diagnosed HIV/AIDS cases reported in China were already AIDS patients when they were first identified [5] Such late diagnoses are mainly caused by lack of access to fast and accurate HIV testing, in settings that continue to rely on traditional WB confirmatory testing [6, 7]. Test results can be available in less than 30 min, so WHO recommends its serial use in different clinical settings to achieve same-day test and treatment [9, 10]. WHO recommends blood-based rapid diagnosis to achieve same-day test and treatment This rapid testing strategy has not been promoted worldwide due to inadequate research evaluating the effectiveness of rapid tests (RTs) as an alternative confirmatory HIV test for WB. A meta-analysis was performed to quantitatively evaluate the diagnostic performance of rapid HIV tests compared with the WB assay in terms of pooled sensitivity, specificity, area under summary receiver operating characteristic (SROC) curve, and diagnostic odds ratio (DOR)
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