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Trinity Biotech Gets CE Mark for Coronavirus Antibody Test

NEW YORK — Irish diagnostics firm Trinity Biotech said on Tuesday that it has received CE marking for its Captia SARS-CoV-2 IgG ELISA test.

The test uses a recombinant form of SARS-CoV-2 spike protein to detect immunoglobulin G against the virus. Trinity said that the test, which has demonstrated 100 percent specificity, will have applications in detecting past SARS-CoV-2 infection, monitoring individuals who have received SARS-CoV-2 vaccination, and screening individuals prior to vaccination.

Trinity said that it intends to launch the test in the US once it receives Emergency Use Authorization from the US Food and Drug Administration.