EVALUATION OF TWO NOVEL IMMUNOASSAYS DESIGNED TO DETECT HIV ANTIBODIES IN ORAL FLUIDS

The testing of oral fluid samples for the detection of HIV antibodies offers several advantages over the testing of blood. Our objective was to evaluate a new generation of rapid and simple assays designed spec ifically to detect HIV-1 and HIV-2 antibodies in oral fluids (saliva). Serum and oral fluid pairs were collected from 615 high- and low-risk individuals in the United States, Peru, and the Ivory Coast. Two diff erent oral fluid collection devices and rapid assay systems included: (1) the Orapette/SalivaCard HIV-1/HIV-2 and (2) the Omni-Sal/ImmunoCom b II HIV-1 and HIV-2. The corresponding serum pairs were analyzed by c onventional ELISAs, and all reactive sera were confirmed with HIV-1 an d HIV-2 Western blots. The results indicated a 100% sensitivity for bo th oral fluid assays, including successful detection of HIV-2 antibodi es. Specificities ranged from 99.8% to 100%. One sample produced a rea ctive result by the SalivaCard while being nonreactive by the other as says including that antibodies to HIV can be detected reliably in oral fluids by simple and rapid assays. This combination of rapid testing technology and the use of easily collected oral fluid samples offers a n efficient and accurate alternative to conventional testing and can b e appropriately applied to a variety of testing situations for the lab oratory diagnosis of HIV infection. J. Clin. Lab. Anal. 11:63-68.