Related Experiment Video
Updated: Aug 6, 2026
The α-test: Rapid Cell-free CD4 Enumeration Using Whole Saliva
Published on: May 16, 2012
Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies
Kevin P Delaney1, Bernard M Branson, Apurva Uniyal
1Division of HIV/AIDS Prevention--Surveillance and Epidemiology, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. Kdelaney@cdc.gov
Objective:
To evaluate the performance of a rapid HIV antibody test used with whole blood and oral fluid in settings where the test is likely to be used.
Design:
In four separate studies, we compared the accuracy of the rapid test performed on whole blood and oral fluid specimens with the results of conventional HIV tests.
Methods:
Oral fluid and whole blood from persons of unknown HIV status recruited from clinics, labor and delivery units, and outreach venues were tested with the OraQuick Advance rapid HIV-1/2 antibody test. Sensitivity and specificity were compared with results of the enzyme immunoassay (EIA) and Western blot algorithm used by the study sites.
Results:
OraQuick sensitivity was 99.7% with whole blood and 99.1% with oral fluid from 327 persons who were HIV antibody positive by the conventional algorithm. OraQuick specificity was 99.9% with whole blood and 99.6% with oral fluid from 12 010 HIV-negative persons; EIA specificity was 99.7%. A cluster of 16 false-positive oral fluid tests occurred in one study, in which specificity was lower (99.0%) than in the other three studies (99.6-99.8%).
Conclusions:
In diverse settings in four studies, the OraQuick test showed high sensitivity and specificity for HIV antibody in whole blood and oral fluid specimens. Slightly more false-positive and false-negative results occurred with oral fluid than with whole blood, but performance with both specimen types was similar to, or better than, that of conventional EIAs.
