Uni-Gold Recombigen® HIV is simple to use, provides rapid results and is 100 percent sensitive and 99.7 percent specific. The product has previously received CLIA waiver for use in detecting HIV 1 antibodies in venous whole blood samples and Trinity has already applied for CLIA waiver for finger stick whole blood.
Trinity Biotech is a leading supplier of Rapid HIV tests in the
Commenting on the FDA approval, Ronan OCaoimh, CEO, said While we were extremely pleased last year to get serum, plasma and whole blood approval for Uni-Gold HIV, todays finger stick whole blood approval is of significantly greater importance as it opens up for Trinity a much larger public health market including CDC funded programs. In addition, this finger-stick approval provides full access to a new doctors office market for Trinity Biotech. We have already applied for CLIA waiver for the finger stick whole blood claim and confidently expect to receive it in the next month. This latest approval means that our Uni-Gold HIV test can now be used in all significant segments of the
Uni-Gold Recombigen® HIV Test continues to enjoy competitive advantages particularly in the areas of speed to test result and sensitivity. These advantages are now further enhanced by the approval to use multiple sample types with our product. With the increase in worldwide funding to fight HIV/AIDS through programs such as PEPFAR (Presidents Emergency Program for AIDS Relief) and the WHO 3x5 program, there will be a significant increase in the use of rapid HIV tests over the coming years and Trinity Biotech is very well positioned to take advantage of this growth in the marketplace.
Trinity Biotech develops, acquires, manufactures and markets more than 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The broad line of test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases. Trinity Biotech sells worldwide in more than 80 countries through its own sales force and a network of international distributors and strategic partners.
SOURCE: Trinity Biotech plc