title: Evaluation of two novel immunoassays designed to detect HIV antibodies in oral fluids.
abstract: 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 specifically 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 different oral fluid collection devices and rapid assay systems included: (1) the Orapette/SalivaCard HIV-1/ HIV-2 and (2) the Omni-Sal/ImmunoCcmb II HIV-1 and HIV-2. The corresponding serum pairs were analyzed by conventional ELISAs, and all reactive sera were confirmed with HIV-1 and HIV-2 Western blots. The results indicated a 100% sensitivity for both rapid oral fluid assays, including successful detection of HIV-2 antibodies. Specificities ranged from 99.8% to 100%. One sample produced a reactive result by the SalivaCard while being nonreactive by the other assays including the Western blots. Both assays performed excellently, indicating 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 an efficient and accurate alternative to conventional testing and can be appropriately applied to a variety of testing situations for the laboratory diagnosis of HIV infection.
authors.affiliation: Department of Microbiology, University of Maryland School of Dentistry, Baltimore, USA.
authors.forename: R D
authors.initials: RD
authors.lastname: Saville
authors.forename: N T
authors.initials: NT
authors.lastname: Constantine
authors.forename: C
authors.initials: C
authors.lastname: Holm-Hansen
authors.forename: C
authors.initials: C
authors.lastname: Wisnom
authors.forename: L
authors.initials: L
authors.lastname: DePaola
authors.forename: W A
authors.initials: WA
authors.lastname: Falkler
mesh_terms: D015153:Blotting, Western; D004797:Enzyme-Linked Immunosorbent Assay; D005069:Evaluation Studies as Topic; D015483:HIV Antibodies / Q000032:analysis* / Q000097:blood / Q000276:immunology; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012463:Saliva / Q000276:immunology*; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic