The new Covid-19 ELISA Antibody test is designed to identify the individuals who have been exposed to the SARS-CoV-2 virus within the population
Trinity Biotech, a developer and manufacturer of diagnostic products, has applied with the US FDA for an Emergency Use Authorization (EUA) for its Covid-19 IgG ELISA antibody test.
The new Covid-19 diagnostic test is designed to identify the individuals who have been exposed to the SARS-CoV-2 virus within the population.
Trinity Biotech chief executive offer Ronan O’Caoimh said: “We are very pleased to announce the submission of our Covid-19 ELISA antibody test for FDA Emergency Use Authorization (EUA).
“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.”
Covid-19 IgG ELISA antibody test has more than 98% specificity and 95% sensitivity
The new Covid-19 antibody test is said to show more than 98% specificity and 95% sensitivity, in samples collected 14 days or longer from the onset of symptom. The FDA EUA submission is said to enable the company start marketing the antibody test immediately.
In addition to the ELISA antibody test, the company is developing a new rapid point-of-care Covid-19 antibodies test that needs only one drop of blood through a finger prick, to give results in 12 minutes. The test is being developed to have utility similar to the ELISA antibody test.
Trinity is also planning to secure the FDA EUA pathway to speed up the approval for sale in the US, following the completion of development and transfer to manufacturing of the rapid test.
The company claimed that its pipeline of new Covid-19 products adds to its existing Viral Transport Media (VTM) product, which is used in the Covid-19 sample collection process for PCR molecular testing.
It has also increased the manufacture of VTM to meet the demand growth over the past months.