Evaluation of performance and acceptability of two rapid oral fluid tests for HIV detection in Mozambique.

ABSTRACT

Simplified HIV testing based on oral fluid (OF) may allow the expansion of HIV infection counseling and testing (CT) while reducing the risk due to exposure to needles and blood collection. This study evaluated the performance and acceptability of two OF tests (the OraQuick Advance Rapid HIV-1/2 and the Chembio DPP HIV-1/2) from May to September 2009 in two CT sites in Maputo City, Mozambique, compared with results for the national testing algorithm. OF testing was conducted in parallel with whole blood-based testing according to the national HIV algorithm. Blood samples were collected as dried blood spot (DBS) specimens from all participants for quality assurance. HIV infection results were delivered according to the national algorithm. According to the national HIV algorithm, 512 (30.5%) samples were reactive, 1,151 (68.7%) were nonreactive, and 13 (0.8%) were discordant. All discordant cases were retested with an enzyme immunoassay followed by Western blotting, and five (38.5%) were confirmed as HIV positive. The OraQuick OF test showed 518 (30.9%) reactive samples and 1,158 (69.1%) nonreactive samples, with a sensitivity and specificity of 99.8% and 99.8%, respectively. The Chembio DPP OF test showed 519 (31.0%) reactive samples and 1,157 (69.0%) nonreactive samples with a sensitivity and specificity of 100% and 99.8%, respectively. The participants perceived blood testing (49.9%) to be more accurate than OF testing (46.8%). The OF tests showed high performance for the diagnosis of HIV infection when examined individually and in an algorithm, compared with results according to the national testing algorithm.