TRIB - Trinity biotech receives European approval for rapid COVID-19 antigen test
Trinity Biotech (NASDAQ:TRIB) said on Friday it had achieved the European CE Mark or approval for its 10-minute Covid-19 antigen test. This CE mark allows for use by healthcare professionals and trained users. The test in clinical trails had demonstrated 99% sensitivity and 99% specificity. "The rapid Covid-19 antigen test has been developed by Trinity Biotech on the same lateral flow test platform as the recently World Health Organisation (WHO) approved Trinscreen HIV™ test and will be manufactured at the Company’s high volume automated lateral flow manufacturing site in Bray, Ireland," the company said. The Company expects to examine regulatory approval pathways in other countries as well.
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Trinity biotech receives European approval for rapid COVID-19 antigen test