Second rapid HIV test receives FDA approval
The Food and Drug Administration on Tuesday approved a rapid HIV testing kit manufactured by Dublin-based Trinity Biotech, The Wall Street Journal reports. The test, called the Uni-Gold Recombigen HIV Test, can detect HIV genetic material in blood serum, plasma, and whole blood samples in 10 minutes. In trials of more than 9,000 patients, the test detected 100% of HIV-positive blood samples and was 99.7% accurate on negative blood samples. The company plans to market the test to hospitals, physicians, and government programs, initially focusing on testing of health workers who accidentally expose themselves to HIV through needlestick injuries and pregnant women considered at risk for mother-to-child HIV transmissions. The tests cost $10 each. Trinity hopes to sell 500,000 kits in the United States in 2004.