Irish-founded medical diagnostics company Trinity Biotech has filed a fast-track submission for its Covid-19 antibody test with the Food and Drugs Administration (FDA) in the US.
The Nasdaq-listed company is seeking emergency use authorisation (EUA) for its Covid-19 IgG Elisa antibody test, which will determine which individuals have been exposed to the SARS-CoV-2 virus.
In a statement, Trinity said the product demonstrates specificity in excess of 98 per cent and sensitivity in excess of 95 per cent, in samples of 14 days or more from symptom onset.
EUA submission allows the company to begin marketing its product immediately.
“The test demonstrates both impressive specificity and sensitivity. Meanwhile, the Elisa testing platform with its excellent reputation for quality and widespread adoption makes it an ideal format for large scale antibody testing,” said chief executive Ronan O’Caoimh.
Trinity Biotech is also working on a rapid point-of-care Covid-19 test to detect antibodies to the virus that can be run in 12 minutes using one drop of blood procured by finger prick. It also intends to submit for EUA approval for this product shortly.
The Irish company develops, manufactures and markets diagnostic systems for the point-of-care and clinical laboratory segments of the diagnostic market. Its products are sold in more than 110 countries, and it employs more than 500 people.
