FDA Approves Trinity Biotech Rapid HIV Test for Use With Blood Serum, Plasma, Whole Blood
The FDA has approved Dublin, Ireland-based Trinity Biotech PLC's Uni-Gold Recombigen rapid HIV test, the first rapid-test product approved for use in detecting HIV in blood serum, plasma and whole blood, according to Trinity, Dow Jones/Wall Street Journal reports. The test, which offers results within 10 minutes and will cost doctors and hospitals $10 per test, detected 100% of HIV-positive specimens and returned 99.7% accurate results for HIV-negative specimens in Trinity-sponsored trials involving more than 9,000 patient samples, according to Dow Jones/Journal. Trinity President Brendan Farrell said that the Uni-Gold test is "every bit as accurate as lab-based tests," which can take days or weeks to return results, Dow Jones/Journal reports. Trinity plans to market the test to government programs, physicians and hospitals for testing patients and health care workers who may be exposed to HIV through accidental needle sticks, Dow Jones/Journal reports. Farrell said that the hospital market is "not being met at the moment," adding, "There are over 800,000 needlestick injuries per year in U.S. hospitals. They need to know urgently if that patient was infected with HIV." Trinity hopes to sell 400,000 to 500,000 tests in the United States in 2004. The company plans to target CDC programs, which could be a potential $30 million market for the company, and the approximately 200,000 pregnant women who are considered at "high risk" for mother-to-child HIV transmission, Dow Jones/Journal reports. Farrell said the test is already sold in Africa and Asia and is approved for use in the World Health Organization's HIV testing program in Africa.
Competition for OraQuick Test
Trinity's test is expected to "compete directly" with Bethlehem, Pa.-based OraSure Technologies' OraQuick rapid HIV test, according to Dow Jones/Journal (Middleton, Dow Jones/Wall Street Journal, 12/30/03). OraSure in October 2003 announced that it is seeking pre-market FDA approval for its test for use in detecting HIV in saliva or plasma. In September, the agency approved the OraQuick HIV test for expanded use in hospitals using blood drawn intravenously and stored in a tube. The test previously could be used only with blood obtained from a finger prick (Kaiser Daily HIV/AIDS Report, 10/1/03). In February 2003, President Bush announced a plan to expand the availability of the OraQuick rapid test, which offers results that are 99.6% accurate within 20 minutes, to more than 100,000 doctors' offices and public health clinics nationwide (Kaiser Daily HIV/AIDS Report, 10/30/03).