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

Kevin P Delaney; Bernard M Branson; Apurva Uniyal; Peter R Kerndt; Patrick A Keenan; Krishna Jafa; Ann D Gardner; Denise J Jamieson; Marc Bulterys

doi:10.1097/01.aids.0000238412.75324.82

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

Journal article

Open access

Peer reviewed

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

Kevin P Delaney, Bernard M Branson, Apurva Uniyal, Peter R Kerndt, Patrick A Keenan, Krishna Jafa, Ann D Gardner, Denise J Jamieson and Marc Bulterys

AIDS (London), Vol.20(12), pp.1655-1660

08/01/2006

DOI: 10.1097/01.aids.0000238412.75324.82

PMID: 16868447

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Abstract

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. 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. 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. 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%). 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.

AIDS Serodiagnosis - methods

Blotting, Western - methods

Enzyme-Linked Immunosorbent Assay - methods

Female

HIV Antibodies - analysis

HIV Infections - diagnosis

HIV Infections - immunology

HIV-1 - immunology

HIV-2 - immunology

Humans

Predictive Value of Tests

Pregnancy

Reagent Kits, Diagnostic

Saliva - immunology

Saliva - virology

Sensitivity and Specificity

Details

Title: Subtitle: Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies
Creators: Kevin P Delaney - Centers for Disease Control and Prevention
Bernard M Branson - Centers for Disease Control and Prevention
Apurva Uniyal - Health Research Alliance
Peter R Kerndt - Los Angeles County Department of Public Health
Patrick A Keenan - University of Minnesota
Krishna Jafa - Centers for Disease Control and Prevention
Ann D Gardner - Arizona Department of Health Services
Denise J Jamieson - National Center for Chronic Disease Prevention and Health Promotion
Marc Bulterys - National HIV/AIDS/STI/TB Council
Resource Type: Journal article
Publication Details: AIDS (London), Vol.20(12), pp.1655-1660
DOI: 10.1097/01.aids.0000238412.75324.82
PMID: 16868447
ISSN: 0269-9370
eISSN: 1473-5571
Language: English
Date published: 08/01/2006
Academic Unit: Obstetrics and Gynecology; VPMA - Administration
Record Identifier: 9984446529502771

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