EVALUATION OF A SYSTEM USING ORAL MUCOSAL TRANSUDATE FOR HIV-1 ANTIBODY SCREENING AND CONFIRMATORY TESTING

Objective.-To determine accuracy of a human immunodeficiency virus typ e 1 (HIV-1) antibody testing system using a device to collect and stab ilize oral mucosal transudate (OMT), a fluid with increased levels of IgG; an enzyme immunoassay (EIA) screening test optimized for OMT; and a Western blot confirmatory test designed for use with OMT, Design.-T he OMT specimens were tested by EIA and, if indicated, confirmatory We stern blot according to a standard testing algorithm. The OMT results were compared with true HIV status as determined by serum testing and/ or clinical diagnosis. Patients.-Specimens from 3570 subjects (2382 at low risk, 698 at high risk, 242 with acquired immunodeficiency syndro me [AIDS], and 248 ''nonspecificity'' [persons with diseases associate d with an increased frequency of false-positive results in HIV testing ]) were collected at If geographically diverse sites (including blood banks, public health clinics, general medical clinics, HIV clinics, se xually transmitted disease clinics, and a hemophilia center) in the Un ited States. Main Outcome Measures.-Overall accuracy of testing OMT fo r HIV-1 antibodies compared with true HIV-1 antibody status; sensitivi ty and specificity of OMT EIA and Western blot, Results-Sensitivity of OMT EIA testing in 673 true-positive subjects was 99.9% (672/673). Th e OMT Western blot results in the 673 true-positive subjects were posi tive in 665 and indeterminate in 8. The EIA followed by Western blot ( a EIA was repeatedly reactive) yielded a negative result in 99.9% (289 3/2897) of OMT samples from true negatives and an indeterminate result in 4. The OMT testing system provided the correct result or would tri gger appropriate follow-up testing in 3569 (>99.9%) of 3570 cases, Con clusion.-HIV-1 antibody testing of OMT samples is a highly accurate al ternative to serum testing.