The recognition that IgG is present in oral fluid at levels sufficient to allow serological diagnosis of HIV infection has led to the development of rapid HIV tests based on oral fluid [1]. In June 2004, the OraQuick

Objective: The OraQuick Advance Rapid HIV-1/2 Test is a point-of-care test capable of detecting HIV-specific antibodies in blood and oral fluid. To understand test performance and factors contributing to false-negative (FN) results in longitudinal studies, we examined results of participants enrolled in the TDF2 study, the Bangkok Tenofovir Study, and the Bangkok MSM Cohort Study (BMCS), three separate clinical studies of high-risk, HIV-negative persons conducted in Botswana and Thailand. Design: Retrospective observational analysis Methods: We compared oral fluid OraQuick (OFOQ) results among participants becoming HIV-infected to results obtained retrospectively using enzyme immunoassay and nucleic acid amplification tests on stored specimens. We categorized negative OFOQ results as true-negative or false-negative relative to NAAT and/or EIA, and determined the delay in OFOQ conversion relative to the estimated time of infection. We used generalized estimating equations to examine the association between FN results and participant, clinical and testing-site factors. Results: Two-hundred and thirty-three FN OFOQ results occurred in 80 of 287 seroconverting individuals. Estimated OFOQ conversion delay ranged from 14.5-547.5

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