ACCURACY OF A SALIVA TEST FOR HIV ANTIBODY

The accuracy of a saliva collection and testing protocol for determina tion of HIV-1 antibody status was assessed under realistic field condi tions. The 1,256 study participants came from two lower-prevalence set tings-a self-referral testing clinic (478) and a street-based outreach program (431)-and two high-prevalence clinics-an HIV/AIDS treatment c linic (337) and a hemophilia clinic (10). Saliva was collected using t he Omni-Sal collection device and was tested by technicians blind to s erum status using a modified protocol that employed the Recombigen HIV -1 EIA. Serum was tested using standard methods. A single saliva enzym e immunoassay (EIA) correctly identified 358 of 368 seropositive indiv iduals, 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 a n in-house saliva radioimmunoprecipitation assay resulted in a substan tial drop in sensitivity to 85.3% (95% CI: 81.0-89.0). We conclude tha t a single saliva EIA using the modified test protocol described is su fficiently accurate for surveillance purposes, but we do not recommend it for diagnostic purposes or screening.