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FDA authorizes first T cell-based test to detect prior SARS-CoV-2

FDA authorizes first T cell-based test to detect prior SARS-CoV-2

(HealthDay)—The T-Detect COVID Test, a T cell-based test that helps to identify individuals with recent or prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, was granted emergency use authorization, the U.S. Food and Drug Administration announced Friday.

The next-generation sequencing-based test analyzes DNA sequences to identify those with an adaptive T cell immune response to SARS-CoV-2. As opposed to antibody tests, which have been the primary detection method to determine prior SARS-CoV-2 infection, T cell responses appear earlier and last longer in the blood, according to a company press release. The FDA notes that the test will be especially useful for people who may have had symptoms of SARS-CoV-2 or who believe they were exposed but did not test positive with a molecular or antigen diagnostic test.

A positive test result signaling that an individual has recently or previously been infected with SARS-CoV-2 could help to address potential long-term effects of the virus. The FDA notes that negative results do not preclude acute or current SARS-CoV-2 infection, and the test results should be used in combination with clinical examination, patient medical history, and other findings.

The T-Detect COVID Test is indicated for use at least 15 days after symptom onset. Patients can order the test online after answering eligibility questions through a secure portal. Virtual providers authorize the prescription, and patients can have their blood drawn by a mobile phlebotomist or at a Labcorp patient service center.

It is currently unknown how long the T cell immune response remains in individuals after infection and what level of protection a T cell immune response provides. “Information and scientific data that deepen our understanding of SARS-CoV-2 remain important keys to get ahead of this global pandemic,” Jeff Shuren, M.D., J.D., director of the FDA Center for Devices and Radiological Health, said in an agency news release.

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