Accuracy Evaluation of Diagnostic HIV Rapid Tests with Oral Fluid and Whole Blood in Hard to Reach High-risk Groups
DOI:
https://doi.org/10.14456/reg11med.2020.4Keywords:
Oral fluid HIV test, HIV rapid test, Diagnostic test evaluationAbstract
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, the performance of oral HIV test has not yet been evaluated in Thailand.
Method: This study aims to evaluate the performance of an oral fluid HIV rapid test for detecting recent HIV infection. Men who have sex with men (MSM), transgender (TG) and female sex worker (FSW) in Bangkok, Chonburi and Phuket were recruited to be participated in this study. All participants were screened by using 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. The performance of oral fluid and whole blood HIV rapid tests were evaluated by using MedCalc’s Diagnostic test. MacNemar’s exact test was used to compare the numbers of detected HIV-infected participants.
Results: 578 participants to perform HIV testing, including MSM/TG (n=338) and FSW (n=240). 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 sensitivity 94.12% (95% CI: 85.62-98.37), specificity 98.6%(95%CI: 97.19-99.45) and accuracy 98.10% (95%CI: 96.62-99.05). This test could detect fewer infections than those of whole blood (p=0.002) and plasma (p=0.006). 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. This test might thus be inappropriate for the high risk and general populations who receiving antiretroviral therapy.
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