Screening for human immunodeficiency virus antibody in urine.

OBJECTIVE

To determine the diagnostic accuracy of an investigational test for human immunodeficiency virus (HIV) envelope antibodies in urine.

DESIGN

Matched blood and urine specimens were tested for HIV by two independent laboratories, both of which were blinded to all results at the other site. Duplicate positive enzyme-linked immunoassay (EIA) results were confirmed by immunofluorescent antibody or western blot.

SETTING

Six alcohol treatment centers in the San Francisco metropolitan area.

PATIENTS

Five hundred ninety-two recovering alcoholics.

MAIN OUTCOME MEASURES

Diagnosis of HIV infection by blood and urine EIA and western blot.

RESULTS

The experimental urine EIA, when confirmed by urine western blot, led to a correct diagnosis in all samples. One sample was negative by urine EIA screening, positive by blood EIA, and exhibited an indeterminate blood western blot pattern (p24 band only).

CONCLUSIONS

We encountered no false positive or false negative results using an investigational HIV antibody test for urine samples. There are several important advantages to HIV testing of urine versus serum or blood; however, there are also cogent reasons for limiting the use of alternative specimens for HIV testing.