Trinity Biotech Receives FDA Clearance for Strep A Test

Trinity Biotech plc (Dublin, Ireland) today announced that Trinity's Uni-Gold Strep A test has been cleared by FDA.

Uni-Gold Strep A test is a rapid, qualitative assay for Strep A antigen which can be carried out directly on throat swabs giving results in minutes. The assay is a membrane-format test that provides visually-read color results to detect Streptococcal A. The test facilitates differential diagnosis of bacterial versus viral infections, resulting in more appropriate and cost-effective use of antibiotic therapy. It is intended for use in hospital laboratories, physicians' offices, and other point-of-care settings.

The worldwide market for Strep A antigen rapid tests was $90 million in 1998, of which $40 million was in the United States.

Two further Uni-Gold tests for infectious diseases, Uni-Gold HIV and Uni-Gold H.Pylori, are currently under consideration by the FDA. Trinity now has a portfolio of seven Uni-Gold rapid assays, three of which are FDA cleared.

Trinity Biotech manufactures over 100 diagnostic products for the point-of-care, self-testing, and clinical laboratory segments of the diagnostic market.