Trinity Biotech Gains CE Mark for 10-Minute COVID-19 Antigen Test
Trinity Biotech has received CE mark certification for its 10-minute COVID-19 antigen test for use by healthcare professionals and trained users.
The COVID-19 test was developed on the same platform as the company’s Trinscreen HIV test, which recently received World Health Organization approval.
The test uses anterior nasal swab samples rather than the more invasive nasopharangeal swabs. In clinical trials, it demonstrated 99 percent accuracy in identifying positive samples and 99 percent accuracy in identify negative samples, the company said.
Trinity said it plans to launch the test throughout the European Union as well as other countries that recognize the CE mark designation.