Trinity Biotech Earns CE Mark for COVID-19 ELISA Test

Trinity Biotech has been granted CE mark certification for its Captia SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) antibody test.

The test detects IgG antibodies in patients, revealing if they have been previously exposed to the virus or if a vaccination has generated an immune response.

Trinity said it has significant capacity that will enable it to scale up production of the test for sale in Europe and other regions. The company previously launched the product in the U.S. using the FDA’s Emergency Use Authorization pathway.