T-Detect COVID received the Health Innovation of the Year award by Geekwire and was honored as a finalist in Fast Company’s 2021 World Changing Ideas award in the Pandemic Response category.
T cells know if you had COVID-19.*
In studies, T-cell testing outperformed antibody tests.1, 2
T cells know if you had COVID-19.*
In studies, T-cell testing outperformed antibody tests.1, 2
Be the first to know about T-Detect news, offers and updates.
Sign UpT-Detect COVID is a T-cell test that may confirm a recent or past COVID-19 infection.
Knowing whether you had COVID-19 can help you and your doctor manage your health. While antibody tests have been widely used to look for evidence of a SARS-CoV-2 infection (the virus that causes COVID-19), a recent study showed that T-Detect COVID outperformed leading antibody tests in determining recent or past infection.1 T-Detect COVID is the first test to look for T-cell responses to SARS-CoV-2.
For Patients
T-cell testing can detect past COVID-19 up to ten months after infection with 90% sensitivity.3
For Physicians
T-Detect COVID can capture past COVID-19 infections that may be missed by serology testing.
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—up to 10 months after infection (90% sensitivity).3 Learn more about the role of T cells in fighting COVID-19.
References
- Dalai, S, et al. Clinical Validation of a Novel T-Cell Receptor Sequencing Assay for Identification of Recent or Prior SARS-CoV-2 Infection. medRxiv. 2021.
- Elyanow R., et al. T-cell receptor sequencing identifies prior SARS-CoV-2 infection and correlates with neutralizing antibody titers and disease severity. medRxiv. 2021.
- Data on File. Adaptive Biotechnologies. 2021.
*The performance of this test has not been established in individuals that have received a COVID-19 vaccine.
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™ COVID is not indicated for use in patients under age 18.