FDA issues emergency use approval for T-Detect COVID Test
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- Source: U.S. Food and Drug Administration
- Date: 07 Mar,2021
Now, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for its T-Detect COVID Exam developed by Adaptive Biotechnologies. The T-Detect COVID Evaluation is a next generation sequencing established (NGS) test to assist in identifying people with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.
Today’s authorization further underscores the FDA’s commitment to innovation in test development. 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.”
Jeff Shuren, M.D., J.D., Director, FDA’s Center for Devices and Radiological Health
The test assesses DNA (deoxyribonucleic acid) sequences from T cells (white blood cells) to assist in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 disease. A positive test result indicates prior or recent infection with SARS-CoV-2, while a negative test result suggests that a patient is unlikely to have been infected with SARS-CoV-2. Negative results do not preclude severe or present SARS-CoV-2 infection. All results from the test should be used together with a clinical examination, patient medical history and other findings. The T-Detect COVID Test should not be used to diagnose current SARS-CoV-2 infection.
A T cell response might be detected in blood many days after initial infection; however, it is unknown how long the T cell immune response remains following infection and what degree of protection may be provided by the presence of a T cell immune response. The T-Detect COVID test will be a practical tool to help determine if a person previously had COVID-19. This is particularly important for men and women that may have exhibited symptoms previously or believe they’ve been exposed but have not tested positive for COVID-19 using a molecular or antigen diagnostic test.
The test is suggested for use by qualified healthcare professionals on samples from those who are 15 times or more post-symptom onset.