Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies.
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.


METHODS
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.
Delaney
Kevin P
KP
Division 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
Branson
Bernard M
BM
Uniyal
Apurva
A
Kerndt
Peter R
PR
Keenan
Patrick A
PA
Jafa
Krishna
K
Gardner
Ann D
AD
Jamieson
Denise J
DJ
Bulterys
Marc
M
D015492:AIDS Serodiagnosis / Q000379:methods*; D015153:Blotting, Western / Q000379:methods; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D015483:HIV Antibodies / Q000032:analysis; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology; D015497:HIV-1 / Q000276:immunology; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D011237:Predictive Value of Tests; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic; D012463:Saliva / Q000276:immunology / Q000821:virology*; D012680:Sensitivity and Specificity
D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic