FDA approves widespread use of HIV test
July 07 2004 11:00 PM ET
The Food and Drug Administration last week approved the use of Trinity Biotech's Uni-Gold Recombigen HIV test for use in about 200,000 clinics and doctors' offices in the United States. The FDA approved the test for use in hospitals in December 2003. The test can detect HIV antibodies in whole blood, serum, or plasma in about 10 minutes. The FDA issued a Clinical Laboratory Improvements Amendments waiver allowing its use in nonhospital settings for whole blood samples, including finger-stick samples.
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