www.fdanews.com/articles/201719-oxford-immunotecs-covid-19-t-cell-test-gets-european-clearance
Oxford Immunotec’s COVID-19 T Cell Test Gets European Clearance
March 8, 2021
Oxford Immunotec has obtained CE Mark certification for its T-SPOT.COVID test, a diagnostic that detects T cell immune responses to SARS-CoV-2 using blood samples.
Antibodies are not always produced in response to SARS-CoV-2 infection, or they may wane quickly after infection. “In the absence of an antibody response, the T cell response may be protective from SARS-CoV-2 infection,” the company said.
According to a study that evaluated samples collected in the U.S., the test showed it could detect a SARS-CoV-2 T cell mediated immune response in patients who tested positive for coronavirus, even when they had negative serology test results for antibodies. The company has filed for an Emergency Use Authorization (EUA) from the FDA for its test.