New FDA authorization allows for T cell immunity testing for COVID-19
The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a new COVID-19-related test that is a first of its kind. This EUA was issued March 5, 2021, for Adaptive Biotechnologies’ T-Detect COVID Test.
The T-Detect COVID Test uses next-generation sequencing (NGS) to determine if an individual’s T cells have formed an immune response. Until now, many of the clinical tests used to assess immune response have focused on the presence of antibodies, not the T cells that produce them. This area of COVID-19 testing could potentially hold the key to.
“Today’s authorization further underscores the FDA’s commitment to innovation in test development,” said Jeffrey Shuren, MD, JD, Director of FDA’s Center for Devices and Radiological Health. “The T-Detect COVID Test is a novel technology that assesses the T cell immune response to COVID-19. Information and scientific data that deepen our understanding of SARS-CoV-2 remain important keys to get ahead of this global pandemic.”
The ability to test for T-cell response can be used to indicate a recent or a prior SARS-CoV-2 infection while a negative test means this is unlikely. The FDA points out that this test should not be used for the diagnosis of an acute SARS-CoV-2 infection. The FDA also clearly states, “it is unknown how long the T cell immune response remains following infection and what level of protection may be provided by the presence of a T-cell immune response.”
While T-cell immunity is still a very active field of COVID-19 study, this new test now allows clinicians to offer T-cell COVID-19 testing for their patients.