T-Detect: A powerful T cell-based clinical test
Adaptive Biotechnologies’ T-Detect is a revolutionary clinical test that provides insight into a person’s immune response to a current or past infection. T-Detect builds on how our bodies naturally detect diseases, using nature’s most finely tuned diagnostic: the adaptive immune system. Using T cells, which contain information specific to a particular disease like COVID-19 or Lyme disease, T-Detect can see what’s going on inside our cells.
Why T cells?
T cells, which are a type of white blood cell, are the first responders of the adaptive immune system. They kickstart antibody production, as well as target and destroy harmful viruses and bacteria. T cells persist in the blood after antibody responses wane. Learn more about how T cells work.
- Data on file. Adaptive Biotechnologies. 2022.
T-Detect COVID is not FDA cleared or approved. It is authorized for emergency use under an Emergency Use Authorization (EUA).
Testing of venous whole blood using K2 EDTA specimens is limited to laboratories designated by Adaptive Biotechnologies Corporation that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets the requirements to perform high complexity tests as described in the T-Detect COVID Test Standard Operating Procedure that was reviewed by the FDA under this EUA.
This test has been authorized only for detecting and identifying the presence of an adaptive T-cell immune response to SARS-CoV-2, not for any other viruses or pathogens.
The performance of this test was established based on the evaluation of a limited number of clinical specimens. Clinical performance has not been established with all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
T-Detect Lyme is for prescription use only. For in vitro diagnostic use only. The CLIA laboratory-developed test (LDT) service has not been cleared or approved by the U.S. Food and Drug Administration (FDA) for this intended use.
T-Detect is not indicated for use in patients under age 18.