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FDA approves urine-only HIV test

Web posted June 3, 1998

Associated Press

WASHINGTON -- Calypte Biomedical Corp. says the Food and Drug Administration has approved its urine HIV Western blot test.

Calypte already had created a test that screened for antibodies to the AIDS virus in urine. But people who tested positive still needed a more accurate blood test called the Western blot to confirm infection. The new approval announced Monday allows confirmatory testing in urine, too, which Calypte says is safer and easier than traditional HIV blood tests because it doesn't require needles or specially trained health-care workers.

But the FDA cautioned that urine testing is not quite as accurate as blood testing.

In a study of 748 people who tested HIV-positive with blood tests, the urine test missed two infected people, the FDA said.

Special brochures that labs must give people about to be tested warn that blood tests are somewhat better at catching HIV infections, said Paul A. Mied, FDA's deputy director of transfusion-related diseases.

The brochures also say the urine test causes more false-positive results than the blood test in certain people at high risk for HIV or who have medical conditions like kidney or liver disease, he said.