The study carried out assessed the sensitivities of current, FDA-approved and CLIA-waived, rapid HIV tests and found significant variability with respect to early HIV detection capability in recently infected individuals. In this study, Uni-Gold demonstrated far superior performance than all currently available FDA-approved, CLIA-waived rapid HIV tests and outperformed even an FDA-approved, "moderately complex" rapid HIV test available.
Brendan Farrell, Chief Executive Officer of Trinity Biotech, commented, "Accurately diagnosing HIV infections is central to stemming the spread of the disease. The Uni-Gold Recombigen Rapid HIV test is the only FDA-approved, CLIA-waived rapid HIV test available with 100 percent sensitivity, or the ability to determine a patient's HIV positive status. As was noted in this important study, of all the FDA-approved rapid HIV tests available today, only the Uni-Gold Recombigen HIV test could potentially detect both IgG and IgM, using a patented, third generation, sandwich-based capture and detection system. This is why we firmly believe Uni-Gold is ideally suited as the screening test for acute care settings, such as hospital emergency rooms, labor and delivery settings, or stat labs where blood is being taken from the patient and 100 percent sensitivity and earlier detection is critical. Trinity wishes to commend researchers at the University of California, San Francisco and the San Francisco Department of Health for their important work assessing rapid HIV test performance in recently infected individuals."
For further information, please see: http://www.unigoldhiv.com/ or call 800.325.3424.
Forward-looking statements in this release are made pursuant to the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialization and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.
Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and blood coagulation disorders, and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information please see the Company's website: www.trinitybiotech.com.
Contact:
Contact : Trinity Biotech plc Brendan Farrell (353)-1-2769800 E-mail: Email Contact
Source: Trinity Biotech
