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Biotech / Medical : Trinity Biotech (TRIBY) -- Ignore unavailable to you. Want to Upgrade?


To: PAR who wrote (9408)6/2/1998 9:47:00 AM
From: Bucky Katt  Respond to of 14328
 
Of interest>>>FDA approves urine-only HIV test
4.24 a.m. ET (825 GMT) June 2, 1998

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.