Abstract
There is currently an absence of products which are cleared by the FDA to provide supplemental testing for oral fluid for HIV antibody. We created a procedure for the use of the BioRad Geenius HIV-1/2 as a supplemental antibody test for oral fluid specimens. The modified procedure was evaluated for its ability to detect HIV-1 antibody in oral fluid in specimens that were found to be repeatedly reactive for HIV-1 antibody by way of the Avioq HIV-1 enzyme immunoassay (EIA). Evaluated were oral fluid specimens analyzed at a local public health laboratory which were stored frozen and oral fluid specimens collected prospectively. Prospectively collected specimens were from patients whose HIV status was subsequently assessed through blood-based testing. For retrospective specimens found repeatedly EIA reactive, and positive by Western blot, the modified Geenius was found positive in 37/38 instances (97.4 %). Those specimens with a mean EIA signal-to-cutoff (S/CO) greater than 3.00 were found to be positive by Geenius in 34/34 (100 %) of instances. For specimens found repeated reactive by EIA and positive by Western blot with mean S/CO less than or equal to 3.00, the Geenius was positive in 4/5 instances (80 %) of instances. For prospectively collected specimens, the Geenius accurately confirmed infection in 22/24 cases (92 %) while prospective specimens found repeatedly reactive by EIA without supplemental Geenius testing were confirmed positive in 29/37 instances (78 %). A modified usage of the Geenius HIV-1/2 Supplemental Assay antibody test may provide utility in the supplementation of testing of oral fluid for the presence of HIV-1 antibody.