ROCKVILLE, MARYLAND--On August 6, 1996

ROCKVILLE, MARYLAND--On August 6, 1996, the Food and Drug Administration approved the first HIV test that uses urine samples. All previously approved HIV tests use either blood or oral fluid samples.

The new urine-based test detects the presence of antibodies to HIV-1, the virus that causes the vast majority of U.S. AIDS cases, using an enzyme linked immunosorbent assay (ELISA) method.

The test is approved to screen for HIV-1 infection and may be useful for medical purposes when the collection of blood samples is impractical.

The test is manufactured by the Calypte Biomedical Corporation of Berkeley, Calif., and will be marketed as the Calypte HIV-1 Urine EIA. It will also be marketed by Seradyn Inc. of Indianapolis, Indiana as the Seradyn Sentinel HIV-1 Urine EIA.

The test can be ordered only by a physician. Samples will be analyzed in certified medical laboratories. Any initially reactive sample will be retested twice. If even one of the second tests is reactive, the screening test will be considered positive, although this positive result does not always indicate HIV infection.

For confirming a positive screening test, anyone testing positive with the Calypte test must be retested with a more accurate test using a blood sample.