title: Accuracy of a saliva test for HIV antibody.
abstract: The accuracy of a saliva collection and testing protocol for determination of HIV-1 antibody status was assessed under realistic field conditions. The 1,256 study participants came from two lower-prevalence settings--a self-referral testing clinic (478) and a street-based outreach program (431)--and two high-prevalence clinics--an HIV/AIDS treatment clinic (337) and a hemophilia clinic (10). Saliva was collected using the Omni-Sal collection device and was tested by technicians blind to serum status using a modified protocol that employed the Recombigen HIV-1 EIA. Serum was tested using standard methods. A single saliva enzyme immunoassay (EIA) correctly identified 358 of 368 seropositive individuals, for a sensitivity of 97.3% (95% CI: 95.1%-98.7), and 888 of 888 seronegative individuals, for a specificity of 100% (95% CI: 99.6-100). Confirmation of saliva EIA positives with a repeat saliva EIA and an in-house saliva radioimmunoprecipitation assay resulted in a substantial drop in sensitivity to 85.3% (95% CI: 81.0-89.0). We conclude that a single saliva EIA using the modified test protocol described is sufficiently accurate for surveillance purposes, but we do not recommend it for diagnostic purposes or screening.
authors.affiliation: B.C. Centre for Disease Control, Faculty of Medicine, University of British Columbia, Vancouver, Canada.
authors.forename: A
authors.initials: A
authors.lastname: King
authors.forename: S A
authors.initials: SA
authors.lastname: Marion
authors.forename: D
authors.initials: D
authors.lastname: Cook
authors.forename: M
authors.initials: M
authors.lastname: Rekart
authors.forename: P J
authors.initials: PJ
authors.lastname: Middleton
authors.forename: M V
authors.initials: MV
authors.lastname: O'Shaughnessy
authors.forename: J S
authors.initials: JS
authors.lastname: Montaner
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000175:diagnosis*; D000293:Adolescent; D000328:Adult; D000368:Aged; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D015483:HIV Antibodies / Q000032:analysis*; D015658:HIV Infections / Q000175:diagnosis*; D015528:HIV Seroprevalence; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D015203:Reproducibility of Results; D012463:Saliva / Q000276:immunology* / Q000382:microbiology; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies