FDA Approves Trinity Biotech's Uni-Gold Recombigen HIV Test for Use in Doctors' Offices, Clinics
July 2, 2004
FDA has approved Ireland-based Trinity Biotech's Uni-Gold Recombigen HIV test for use in almost 200,000 clinics and doctors' offices in the United States, the company on Wednesday announced, the Associated Press reports. FDA first approved the test -- which can detect HIV antibodies in blood, serum and plasma within 10 minutes -- for use in hospitals in December 2003, according to the Associated Press (Associated Press, 6/30). According to a Trinity release, the test has received a waiver under the Clinical Laboratory Improvements Amendments of 1988 for use in detecting HIV antibodies in whole blood samples. "We are very excited to receive CLIA waiver for our Uni-Gold Recombigen HIV test," Trinity President Brendan Farrell said, adding, "This waiver enhances the competitive advantages" of the product (Trinity release, 6/30). The company said it manufactures a large number of its tests for sale in African countries, according to the Associated Press (Associated Press, 6/30).
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