The FDA recently announced that it issued an emergency use authorization for the Adaptive Biotechnologies T-Detect COVID test.
The T-Detect COVID-19 test is a sequencing-based test that identifies people with an adaptive T cell immune response to SARS-CoV-2, which can indicate recent or past infection with the coronavirus.
“Today’s authorization further underscores the FDA’s commitment to innovation in test development,” Jeff Shuren, director of the FDA center for devices and radiological health, said in a news release. “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 test works by analyzing DNA sequences from T cells to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2. A positive result indicates a recent or prior infection and a negative test indicates that they’re unlikely to have been infected with the virus. However, negative results do not preclude acute or current SARS-CoV-2 infection.
T cell response can be detected in blood several days after initial infection, but it is unknown how long the T cell immune response remains after infection and what level of protection may be provided by a T cell immune response.
Adaptive Biotechnologies said test results should be used in combination with a clinical examination, patient medical history and other findings. It should not be used to diagnose current SARS-CoV-2 infection.
The test is indicated for use by qualified healthcare professionals on samples from individuals who are 15 days or more post-symptom onset. Testing is also limited to labs that are designated by Adaptive Biotechnologies and are certified under the clinical laboratory improvement amendments of 1988 and meet the requirements to perform high complexity tests.
Antibodies start to develop in the body within one to three weeks after infection with the SARS-CoV-2 virus. However, the FDA has said that the antibody tests are not 100% accurate because of the chances of false positives and negatives. For example, if someone tests positive for SARS-CoV-2 antibodies but does not have those specific antibodies, the result is considered a false positive. If someone tests negative but does have those specific antibodies, the result is considered a false negative.
