ABSTRACT
Objective To evaluate the consistence in the detection of antibodies against HIV-1 between a new rapid test using oral mucosal transudate (OMT) samples and ELISA using serum samples. Methods Two-hundred patients who were positive for anti-HIV-1 antibodies by serum ELISA and confirmed by Western blot to be infected with HIV, and 600 healthy human controls negative for anti-HIV-1 antibodies by serum ELISA, were eligible for this study. OMT samples were collected from these subjects and subjected to a rapid test for anti-HIV-1 antibodies. The factors influencing the performance of the rapid test were analyzed. Results Of the 200 OMT specimens from HIV-infected patients, 198 showed positive reaction, 2 showed negative reaction. Among the 198 positive reactions, 192 (96%) were "clear" and easy to make decisions, 4 (2%) were "faint", 2(1%) were "very faint" and required professionals to make decisions. The rapid test was negative in all the 600 OMT specimens from the control group. Conclusions The consistence in the detection of anti-HIV-1 antibodies between the OMT rapid test and serum ELISA was 99% in HIV-positive specimens, 100% in HIV-negative specimens, and 99.75% in all the specimens.