Evaluation of a system using oral mucosal transudate for HIV-1 antibody screening and confirmatory testing. OraSure HIV Clinical Trials Group.
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.


METHODS
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
HIV-1 antibody testing of OMT samples is a highly accurate alternative to serum testing.
Gallo
D
D
Viral and Rickettsial Disease Laboratory, California State Department of Health Services, Berkeley, USA.
George
J R
JR
Fitchen
J H
JH
Goldstein
A S
AS
Hindahl
M S
MS
D000465:Algorithms; D015153:Blotting, Western; D005122:Exudates and Transudates / Q000276:immunology / Q000821:virology; D005260:Female; D015483:HIV Antibodies / Q000032:analysis*; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology / Q000517:prevention & control; D015497:HIV-1 / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D007124:Immunoenzyme Techniques; D007074:Immunoglobulin G / Q000032:analysis; D008297:Male; D008403:Mass Screening; D009061:Mouth Mucosa / Q000276:immunology / Q000821:virology*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D013048:Specimen Handling
D015483:HIV Antibodies; D007074:Immunoglobulin G