T cell responses arise earlier than antibodies, and last through clearance into convalescence.1
T-Detect COVID is the first clinical test that detects T cells to confirm recent or past SARS-CoV-2 infections. T-Detect COVID test results are a binary positive/negative result. A positive result indicates an adaptive T cell immune response to SARS-CoV-2 (the virus that causes COVID-19) was detected. A negative result indicates that past exposure to SARS-CoV-2 probably did not occur.**
Much of what we are learning about T cells is consistent with what we see in the immune response to other viruses, but the combination of global scientific focus and the number of people infected with the virus in such a short period of time has led to an understanding of the variability of individual responses on a greater scale. In the setting of COVID-19, we are seeing:
Time since infection
* Based on prior research on coronavirus T cell responses2,3
- T cell responses arise earlier than antibodies and last through clearance into convalescence.1
- T cells play a critical role in supporting the development of antibodies by B cells, and can serve as the first signs of an immune response to SARS-CoV-2 infection.2
- The majority of individuals with COVID-19 generate a T cell response composed of both CD8+ T cells, or “killer” T cells, which destroy virus-infected cells, and CD4+ “helper” T cells, which help other immune cells, including B cells that produce antibodies.3
- SARS-CoV-2 specific CD8+ and CD4+ T cells were observed in convalescent patients with mild and severe COVID-19.4
- Zuo J, et al. Robust SARS-CoV-2-specific T-cell immunity is maintained at 6 months following primary infection. bioRxiv. 2020.
- Channappanavar R, et al. Virus-specific memory CD8 T cells provide substantial protection from lethal Severe Acute Respiratory Syndrome Coronavirus infection. J Virol. 2014;88(19):11034-11044.
- Ng O, et al. Memory T cell responses targeting the SARS coronavirus persist up to 11 years post-infection. Vaccine. 2016;34(17):2008-2014.
- Gittelman RM, et al. Diagnosis and tracking of past SARS-CoV-2 infection in a large study of Vo’, Italy through T-cell receptor sequencing. medRxiv. 2020.
- Data on file. Adaptive Biotechnologies. 2021.
T cell testing can detect past COVID-19 up to ten months after infection with 90% sensitivity.5
T-Detect COVID can capture past COVID-19 infections that may be missed by serology testing.
T-Detect COVID may help your employees get the answers they need.
* T-Detect COVID is not FDA cleared or approved. It is authorized for emergency use under an Emergency Use Authorization.
This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an 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 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. **The clinical performance has not been established in 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.
T-Detect™ COVID is not indicated for use in patients under age 18.