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.
Adaptive has partnered with Microsoft to use the company’s artificial intelligence and machine learning technology, to read that information and develop a map of the body’s immune response to many different diseases. We’re using this map to generate a pipeline of T cell-based tests – including a test for COVID-19.
When the COVID-19 pandemic began, Adaptive had already been working on T-Detect for years. With our existing knowledge and expertise in the adaptive immune system, we extended our work to COVID-19 to develop T-Detect COVID, the first-ever T cell-based clinical test to receive FDA emergency use authorization (EUA). T-Detect COVID can detect an adaptive immune response to recent or past SARS-CoV-2 infection (the virus that causes COVID-19).*
A revolutionary clinical test
T-Detect COVID is the first-ever T cell-based clinical test to receive an FDA EUA, giving healthcare providers a new clinical resource to evaluate a person’s immune response when it may be otherwise challenging to access this information.
By using T cells to detect the presence of infection, T-Detect may fill important gaps that can be left by standard antibody screenings. Compared to antibodies, T cells can offer a faster and more accurate picture of the immune system’s response to a disease, through:
• A longer diagnostic window: T cells kick off the immune response before antibodies do – three to five days after a new infection, sometimes even before symptoms appear – and they also stay in the body longer, while antibodies tend to wane more quickly.1
• A holistic picture: T cells develop highly targeted responses to various parts of a virus, playing a more specific role in the overall immune response. Their specialized receptors are extraordinarily diverse, able to recognize and differentiate between the millions of antigens our bodies are continuously exposed to.
The science behind T-Detect
T cells are the first responders of the adaptive immune system, and they activate the antibody response (learn more about T cells). These cells have specialized receptors that must be extraordinarily diverse to recognize one or a small number of the millions of antigens – foreign substances in the body that trigger an immune response – we’re continuously exposed to.
Adaptive is translating the diverse genetic code of these receptors into data, so it can be analyzed both at the individual level and across entire populations – helping us understand how the immune system responds to disease. This is no easy task, and it’s why we’re collaborating with Microsoft. Ultimately, we’ve translated the complex biology of the adaptive immune system into a machine-learning problem that is massive – but solvable.
Why choose T-Detect?
• It was developed by the world’s foremost immune medicine experts: Since 2009, Adaptive Biotechnologies has been on the cutting edge of immune medicine. Our mission is to detect and treat disease the way the immune system does naturally – which we believe has the potential to transform modern medicine, improving human health and quality of life. With state-of-the-art labs and emerging technology, Adaptive continues to grow our team and our expertise in immune medicine.
• It’s award-winning: 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.
• It’s evolving by the minute: COVID-19 is the first of many potential diseases we hope to detect by looking at T-cell response. It’s our goal to use future versions of T-Detect to help diagnose many different illnesses using the immune system’s natural abilities.
The T-Detect approach
Development of the first T cell-based clinical test for COVID-19
Watch the video to learn how Adaptive developed the first T cell-based clinical test for COVID-19: Using a set of identified “shared” T-cell receptors (TCRs) that are seen across multiple infected individuals, we identified a T-cell signature that can be used to develop a clinical test.
- T Cells vs. B Cells Fact Sheet, Adaptive Biotechnologies, accessed Dec. 14, 2021.
*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.