Abstract
BackgroundRapid HIV assays are the mainstay of HIV testing globally. Delivery of effective biomedical HIV prevention strategies such as antiretroviral pre-exposure prophylaxis (PrEP) requires periodic HIV testing. Because rapid tests have high (>95%) but imperfect specificity, they are expected to generate some false positive results.MethodsWe assessed the frequency of true and false positive rapid results in the Partners PrEP Study, a randomized, placebo-controlled trial of PrEP. HIV testing was performed monthly using 2 rapid tests done in parallel with HIV enzyme immunoassay (EIA) confirmation following all positive rapid tests.ResultsA total of 99,009 monthly HIV tests were performed; 98,743 (99.7%) were dual-rapid HIV negative. Of the 266 visits with ≥1 positive rapid result, 99 (37.2%) had confirmatory positive EIA results (true positives), 155 (58.3%) had negative EIA results (false positives), and 12 (4.5%) had discordant EIA results. In the active PrEP arms, over two-thirds of visits with positive rapid test results were false positive results (69.2%, 110 of 159), although false positive results occurred at <1% (110/65,945) of total visits.ConclusionsWhen HIV prevalence or incidence is low due to effective HIV prevention interventions, rapid HIV tests result in a high number of false relative to true positive results, although the absolute number of false results will be low. Program roll-out for effective interventions should plan for quality assurance of HIV testing, mechanisms for confirmatory HIV testing, and counseling strategies for persons with positive rapid test results.
Highlights
The use of antiretroviral-based approaches to HIV prevention, including antiretroviral treatment of HIV-infected partners of HIV-uninfected individuals [1], antiretroviral-based topical microbicides [2], and oral antiretrovirals as pre-exposure prophylaxis (PrEP) [3,4,5,6], has significant promise for reducing the scale of the HIV epidemic
Of the 266 visits with 1 positive rapid result, 99 (37.2%) had confirmatory positive enzyme immunoassay (EIA) results, 155 (58.3%) had negative EIA results, and PLOS ONE | DOI:10.1371/journal.pone
When HIV prevalence or incidence is low due to effective HIV prevention interventions, rapid HIV tests result in a high number of false relative to true positive results, the absolute number of false results will be low
Summary
The use of antiretroviral-based approaches to HIV prevention, including antiretroviral treatment of HIV-infected partners of HIV-uninfected individuals [1], antiretroviral-based topical microbicides [2], and oral antiretrovirals as pre-exposure prophylaxis (PrEP) [3,4,5,6], has significant promise for reducing the scale of the HIV epidemic. Implementation of these HIV prevention interventions will be accompanied by periodic HIV testing; for PrEP, testing is a critical step for continued usage of the intervention, since ongoing PrEP exposure with incident HIV infection may facilitate resistance. Because rapid tests have high (>95%) but imperfect specificity, they are expected to generate some false positive results
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