In December, 1994, the FDA approved Epitope's saliva test for HIV. However, Epitope's test system (which includes an oral specimen collection device, as well as the HIV test itself) is not as accurate as HIV-antibody tests from blood samples. Studies show that for every 100 people infected with HIV, the oral-fluid-based test will miss one or two. The test also gives false positives about two percent of the time.
To confirm the HIV-positive saliva-test results, Epitope developed a Western blot confirmatory device. The FDA approved this confirmatory test in December of 1995.