NEW YORK ─ Oxford Immunotec on Thursday announced that it has obtained CE marking for its T-Spot.COVID test, which provides qualitative detection of the T-cell mediated immune response to SARS-CoV-2 in whole blood.
It has also applied for Emergency Use Authorization from the US Food and Drug Administration for the test.
Oxford Immunotec's T-Spot.COVID test evolved from its T-Spot Discovery SARS-CoV-2 assay, a research test used to gain insights into the immune response to SARS-CoV-2.
"The T-Spot technology platform is a standardized way of measuring T cells," Oxford Immunotec CEO Peter Wrighton-Smith said in a statement. "It has been proven in clinical use for over 18 years with another major infectious disease, tuberculosis, which kills around 1.5 million people every year."
The T-Spot.COVID test complements results obtained by serology testing to give a more comprehensive view of a person's adaptive immune response to SARS-CoV-2 infection, and it could be used alongside serology to support the clinical assessment of people who present with a suspected SARS-CoV-2 infection but are PCR negative, the firm said.
In a clinical study using samples collected in the US, the test detected a SARS-CoV-2 cell-mediated immune response in people who tested positive by PCR, even with negative serology test results, the firm said. T-Spot.COVID had a positive agreement with PCR-results of 96.6 percent in SARS-CoV-2-infected people less than 60 days after the first PCR positive result, Oxford Immunotec said. At greater than 60 days, the positive agreement was 83.3 percent, the firm added.
The announcement of regulatory progress for T-Spot.COVID comes as Oxford Immunotec is being acquired by Waltham, Massachusetts-based PerkinElmer for about $591 million.