Subscribe to our Newsletters !!
In molecular biology, the LAMP (Loop-Mediated Isot
Pharmaceutical laboratories have been adopting imm
Relevant codes should be used when coding fibromya
Alembic Pharmaceuticals Limited appoints Mr. Manis
The importance of comparing the treatment of asthm
It is important to understand that natural remedie
In a world constantly in motion, Microbioz India r
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.
U.S. Food and Drug Administration