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Dana Gallo; J. Richard George, PhD; John H. Fitchen, MD; Andrew S. Goldstein, MS; Michael S. Hindahl, PhD

JAMA. 1997;277(3):254-258.

Abstract
Objective.
—To determine accuracy of a human immunodeficiency virus type 1 (HIV-1) antibody testing system using a device to collect and stabilize oral mucosal transudate (OMT), a fluid with increased levels of IgG; an enzyme immunoassay (EIA) screening test optimized for OMT; and a Western blot confirmatory test designed for use with OMT.

Design.
—The OMT specimens were tested by EIA and, if indicated, confirmatory Western blot according to a standard testing algorithm. The OMT results were compared with true HIV status as determined by serum testing and/or clinical diagnosis.

Patients.
—Specimens from 3570 subjects (2382 at low risk, 698 at high risk, 242 with acquired immunodeficiency syndrome [AIDS], and 248 "nonspecificity" [persons with diseases associated with an increased frequency of false-positive results in HIV testing]) were collected at 11 geographically diverse sites (including blood banks, public health clinics, general medical clinics, HIV clinics, sexually transmitted disease clinics, and a hemophilia center) in the United States.

Main Outcome Measures.
—Overall accuracy of testing OMT for HIV-1 antibodies compared with true HIV-1 antibody status; sensitivity and specificity of OMT EIA and Western blot.

Results.
—Sensitivity of OMT EIA testing in 673 true-positive subjects was 99.9% (672/673). The OMT Western blot results in the 673 true-positive subjects were positive in 665 and indeterminate in 8. The EIA followed by Western blot (if EIA was repeatedly reactive) yielded a negative result in 99.9% (2893/2897) of OMT samples from true negatives and an indeterminate result in 4. The OMT testing system provided the correct result or would trigger appropriate follow-up testing in 3569 (>99.9%) of 3570 cases.

Conclusion.
—HIV-1 antibody testing of OMT samples is a highly accurate alternative to serum testing.

Author Affiliations
for the OraSure HIV Clinical Trials Group

From the Viral and Rickettsial Disease Laboratory, California State Department of Health Services, Berkeley (Ms Gallo), and Epitope Inc, Beaverton, Ore (Drs George, Fitchen, and Hindahl and Mr Goldstein).

Footnotes
A complete list of the OraSure HIV Clinical Trials Group appears at the end of this article.

At the time of this research, Drs George, Fitchen, and Hindahl and Mr Goldstein had Epitope stock options and stock holdings. All own stock in the company and all, except Dr Hindahl, who is no longer with Epitope, currently have stock options.

Reprints: John H. Fitchen, MD, Epitope Inc, 8505 SW Creekside Place, Beaverton, OR 97008.

Toward Optimal Laboratory Use section editor: George D. Lundberg, MD, Editor, JAMA.

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