COVID-19 is a communicable respiratory viral infection caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). It was first identified in Wuhan, China, in late 2019 and is responsible for an ongoing worldwide pandemic.

Symptoms of COVID-19 include fever, cough, fatigue/malaise, shortness of breath, myalgias, loss of taste, and loss of smell, among others. Severe COVID-19 illness may progress to respiratory and/or cardiovascular failure, blood clots and death.

T cells are the first responders of the adaptive immune system and activate the antibody response. While antibodies to SARS-CoV-2 (the virus that causes COVID-19 infection) naturally wane and are detectable in the shorter term, T cell responses can persist in the blood long after antibody responses wane.^1,2,4

The T-Detect COVID test can detect T cells in the blood sample that can remain for up to several months after symptoms appear.^{1,2, 3}

1. Zuo J, et al. Robust SARS-CoV-2-specific T-cell immunity is maintained at six months following primary infection. bioRxiv. 2020.
2. Adaptive data on file.
3. Ng, O, et al. Memory T cell responses targeting the SARS coronavirus persist up to 11 years post-infection. Vaccine. 2016.
4. 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. 2020.

The T-Detect COVID test can detect an immune response to SARS-CoV-2, the virus that causes COVID-19 disease, to assess recent or past infection. It is not intended for the diagnosis of active/current SARS-CoV-2 infection.

T cells are key players in the adaptive immune system. When the body is invaded by a foreign substance like a virus or bacteria, the immune system begins to rally one of its earliest lines of defense, helper T cells, to join the fight.

Helper T cells may call on their allies to kickstart antibody production to support the fight against the disease. Helper T cells also alert other types of T cells to the presence of foreign invaders to be targeted and destroyed.

After the body has fought off an infection or disease, a small number of T cells remain in the blood. They are called memory T cells and their job is to remember how to ward off these invaders if they ever return.

When the T-Detect COVID test was compared with serology testing:

• In one study, 15 or more days after symptom onset with PCR-diagnosed COVID-19, the T-Detect COVID test identified 94.5% of patients, while leading serology (antibody) tests had a test range from 88.0 -90.4%.¹
• In another study, 5+ months after PCR diagnosis, the T-Detect COVID test detected 95% of COVID-19 positive patients, while the serology (antibody) test had a range of 52-71% in detection of COVID-19 positive patients.²
• In studies, the T-Detect COVID test showed a specificity of >99%.¹

1. 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.
2. Adaptive data on file.

A T cell response is typically detectable in blood several days after initial infection. How long this response lasts post-infection and the implications for immunity are not known. In one study, T cells were shown to persist in the blood for more than six months after initial infection and studies of other coronaviruses show T cell responses can persist for several years.^1,2,3

To protect yourself and others, the CDC recommends you wear a mask, stay at least six feet from others whom you don’t live with, avoid crowds and wash your hands often with soap and water for at least 20 seconds (especially after you have been in a public place or after blowing your nose, coughing, or sneezing).

1. Zuo J, et al. Robust SARS-CoV-2-specific T-cell immunity is maintained at six months following primary infection. bioRxiv. 2020.
2. Channappanavar R, et al. Virus-specific memory CD8 T cells provide substantial protection from the lethal Severe Acute Respiratory Syndrome Coronavirus infection. J Virol. 2014.
3. Ng, O, et al. Memory T cell responses targeting the SARS coronavirus persist up to 11 years post-infection. Vaccine. 2016.

Estimated time for results is 7-10 days from shipment of blood sample (including 5-7 days for lab processing). Lab processing begins once all required provider and patient information is validated.

The T-Detect COVID test results are a positive or negative result. A positive result means there was a recent or past exposure to SARS-CoV-2, the virus that causes COVID-19. A negative result indicates that past exposure to SARS-CoV-2 probably did not occur.

T-Detect COVID has been shown to have high sensitivity. However, in certain circumstances, including but not limited to the number of days since infection, the test may be negative despite a prior SARS-CoV-2 infection.

Contact us at t-detect@adaptivebiotech.com or call Clinical Services at 888-552-8988, option 1 to be connected to the team that handles contract pricing and to discuss an ordering process that works best for you and your employees.

We have several options. Adaptive will work with you to determine the ordering process that works best for you and your employees.

T-Detect COVID is not indicated for use in patients under age 18.

Adaptive does not share individual protected health information (PHI) with employers.

Results will be made available to the prescribing physician, who will then share the results with the patient.

Employers can access aggregated results that have been de-identified.

Employers can ask employees to consent to testing. Employer COVID-19 testing and screening protocols and policies should adhere to relevant state and local guidelines, which vary greatly by jurisdiction. Furthermore, general fundamental privacy law principles of transparency, notice, choice, and fairness should guide your practices.

The T-Detect COVID test is a T cell test, which determines recent or past exposure to SARS-CoV-2, the virus that causes COVID-19. It should not be used to determine active COVID-19 infection.

An employer may choose to administer COVID-19 RT-PCR testing to employees before initially permitting them to enter the workplace and/or periodically to determine if their presence in the workplace poses a direct threat to others.

The ADA does not interfere with employers following recommendations by the CDC or other public health authorities regarding whether, when, and for whom testing or other screening is appropriate. Federal and state guidelines should be consulted when determining back to work criteria and appropriateness of testing.

T-Detect COVID has been authorized for emergency use by the FDA under an Emergency Use Authorization. For more information, visit the patient fact sheet.