Oxford Immunotec has submitted an emergency use authorization (EUA) request to the U.S. Food and Drug Administration (FDA) for its T-SPOT.COVID test to detect T cell immune response to COVID-19, according to a company news release.
In a clinical study using samples collected in the United States, the T-SPOT.COVID test had a positive agreement with PCR-results of 96.6% (84/87) in SARS-CoV-2 infected individuals more than 60 days after first PCR positive result. At more than 60 days (with the furthest time point after first positive PCR test result being >240 days) positive agreement remained high at 83.3% (40/48). The T-SPOT.COVID test detected substantially more people with previous positive PCR results than serology in the cohort, whose positivity rate was lower and declined faster over time, according to the company.
In an endemic cohort of U.S. individuals selected to be at a relative lower risk of SARS-CoV-2 infection (based on the absence of self-reported symptoms, negative serology results and no prior history of a positive PCR test result for SARS-CoV-2) the T-SPOT.COVID test had a negative agreement of 98.0% (96/98).
The company developed the T-SPOT.COVID test as an evolution of its T-SPOT Discovery SARS-CoV-2 assay, a research-use only test used to gain insights about the immune response to SARS-CoV-2.
