![]() However, the effectiveness of HIV diagnosis using RTs has not been adequately explored. It is of great need to explore a fast and accurate strategy of HIV diagnosis by using RT centered testing. Health authorities have recommended diagnosis strategies to replace traditional WB confirmatory test ( 13– 15), using either combinations of HIV antibody RT reagents or combinations of RT reagents and ELISA reagents.Ĭhina relies on a traditional HIV testing algorithm that requires WB confirmation to date. The FDA recommends that the sensitivity and specificity of RTs should exceed 98% ( 12). These tests can offer prompt test results and receipt of a “preliminary positive” test result, and therefore have greatly enhanced both the awareness rate and result notification rate of the infected and the coverage of antiretroviral therapy (ART) ( 11). ![]() 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). Blood-based rapid tests (RTs) targeting HIV antibody are convenient tests that require minimal laboratory infrastructure and expertise training compared with WB assay. Compared with WB assay, a rapid and accurate diagnosis in 15–30 min strategy is required. However, simple and rapid blood-based HIV tests other than ELISA that target HIV antibodies have become available, enabling testing in outreach settings outside the laboratory at the point of client contact ( 8). Such late diagnoses are mainly caused by lack of access to fast and accurate HIV testing, particularly in settings that continue to rely on traditional WB confirmatory testing ( 6, 7). 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). Surveys indicate that roughly 40–50% of HIV cases progressed to AIDS within the first year of diagnosis largely due to late diagnosis ( 3, 4). Moreover, WB tests can only be performed by lab-professionals, which greatly restrict the accessibility of HIV testing. It usually takes up to 7–14 days to get the result and costs a lot ( 1, 2). Western blot (WB) is regarded as the gold standard for a definitive confirmatory test for HIV infection.
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