Accuracy performance of an oral fluid-based HIV rapid diagnostic test to scale up the opportunity for treatment and prevention in Thailand
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Abstract
Background: Rapid HIV tests increase an opportunity to access HIV testing, especially for high risk groups. One of the interesting approaches is oral HIV self-testing. However, performance of oral HIV test has not yet been evaluated in Thailand.
Objectives: To evaluate the performance of an oral fluid HIV rapid test for detecting recent HIV infection
Materials and methods: Men who have sex with men (MSM), transgender (TG) and female sex workers (FSW) were recruited in Bangkok, Chonburi, and Phuket. All participants were screened HIV status by oral fluid (OraQuick), whole blood (Alere Determine HIV-1/2 Ab), and plasma (Elecsys HIV combiPT). Discordant results were confirmed by nucleic acid amplification test. Performance of oral fluid and whole blood HIV rapid tests were evaluated by MedCalc’s Diagnostic test. MacNemar’s exact test was used to compare the numbers of detected HIV-infected participants.
Results: Five hundred and twenty nine participants were enrolled to perform HIV testing, including MSM/TG (n=289, 54.63%) and FSW (n=240, 45.37%). There were 68, 69 and 71 reactive cases from oral fluid, whole blood and plasma, respectively. Concordant reactive results among three tests were found in 64 participants, whereas 11 participants showed discordant results. Four false positive and seven false negative cases with oral fluid test were exhibited. Among false negative participants, two cases were recent infection, by which one case has received antiretroviral drugs during last 60 days. Oral fluid test had 90.14% (95% CI 80.74-95.94) sensitivity, 99.13% (95% CI 97.78-99.76) specificity and 97.92% (95% CI 96.31-98.96) accuracy. This test could detect fewer infections than those of whole blood (p=0.0019) and plasma (p=0.0057).
Conclusion: This study demonstrated that oral fluid test could detect fewer HIV infections than blood-based HIV tests since recent HIV-infected MSM/FSW were undiagnosed. Thus, this test might be inappropriate for high risk and general populations who receiving antiretroviral therapy.
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Personal views expressed by the contributors in their articles are not necessarily those of the Journal of Associated Medical Sciences, Faculty of Associated Medical Sciences, Chiang Mai University.
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