Trinity Biotech has received FDA approval to market its Uni-Gold® Recombigen™ HIV test in the United States. The product is approved for detection of antibodies to HIV in human serum, plasma, or whole blood. It is the first and only device to be approved for use with all three sample types. In clinical trials involving more than 9,000 patient specimens, Uni-Gold Recombigen HIV demonstrated a test sensitivity of 100% and specificity greater than 99.7%.
The single-reagent Uni-Gold Recombigen HIV test requires only one step and produces a result within 10 minutes. In contrast, conventional laboratory tests for HIV may not produce results for hours or even days.
Uni-Gold Recombigen HIV has been used outside the United States since 1995.
Trinity Biotech
(800) 325-3424; www.trinitybiotech.com
