Frequently asked questions

COVID-19

What is COVID-19?

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 the worldwide pandemic.

T cells

What are T cells?

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 rallies 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.

T-Detect COVID

What is T-Detect COVID?

T-Detect COVID is the first T cell test for COVID-19 available in the U.S. (not available in U.S. Territories) to those over age 18. It measures T cells instead of antibodies to detect recent or past SARS-CoV-2 infection (the virus that causes COVID-19).

Ordering

How can I order T-Detect COVID?

Patients can order T-Detect COVID by answering some eligibility questions and submitting payment through the T-Detect website. An independent healthcare provider will evaluate your responses and authorize your test order, if appropriate.

If you choose mobile phlebotomy through ExamOne, Adaptive will ship you a test kit and ExamOne will schedule blood draw services via mobile phlebotomy (an in-home blood draw).

If you select a blood draw at a Labcorp Patient Service Center, PWNHealth will place an order with Labcorp. You can schedule an appointment or walk into any of Labcorp’s Patient Service Centers for a blood draw. Labcorp will have the appropriate materials to collect the blood sample, so you will not receive a test kit.

Adaptive will process the blood sample and share results with you via a secure email from PWNHealth. The 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.

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.

Physicians can partner with Adaptive by signing a business agreement, establishing an account and prepaying for kits. Contact us to learn more.

Results

How long will it take to get results?

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

Payment

How much does this test cost?

T-Detect COVID is available to individuals at a special self-pay test price of $150, as part of our commitment to supporting testing options during the current public health emergency and to improve our understanding of the role of T cells in COVID-19.

Additional fees include test authorization ($9) and blood draw (on-site lab: $60 or in-home: $140).

The price does not represent the usual and customary charge for T-Detect COVID and is subject to change. T-Detect COVID is FSA/HSA eligible.

Partners

What is ExamOne?

ExamOne is a national mobile phlebotomy service provider that Adaptive Biotechnologies has partnered with to help provide blood draw services to patients.

Mobile phlebotomy is a mobile blood draw service in which a certified phlebotomist (someone trained to draw blood) visits your home or other location to collect a blood sample.

Privacy

Is my information kept private?

Adaptive Biotechnologies follows all state and federal privacy rules, including the Health Insurance Portability and Accountability Act (HIPAA). Under the CARES Act, we are required to report results to appropriate public authorities.

For physicians

How is T-Detect COVID different from antibody tests?

Individuals with mild or asymptomatic COVID-19 may not mount a detectable antibody response and may instead resolve infection through a cellular immune response.1,2

Traditional antibody (serology) tests measure IgM, IgG, and/or neutralizing antibodies to SARS-CoV-2 (the humoral component of the adaptive immune response). T-Detect COVID instead measures the cellular adaptive immune response to SARS-CoV-2 through T cell receptor sequencing.1,3

When T-Detect COVID was compared with serology testing:

  • In one study, 15 or more days after symptom onset with PCR-diagnosed COVID-19, T-Detect COVID identified 94.5% of patients, while leading serology (antibody) tests had a test range from 88.0–90.4% % at least 15 days post-diagnosis.3
  • In another study, five months after symptom onset, T cell testing detected 95% of COVID positive patients, while the serology (antibody) test had a range of 50-70% in detection of COVID-19 positive patients.4
  • In one study, T-Detect COVID showed a specificity of >99%.3
  1. Long Q., et al. “Clinical and Immunological Assessment of Asymptomatic SARS-CoV-2 Infections.” Nat Med. 2020.
  2.  Shields A.M., et al. “SARS-CoV-2 Seroconversion in Health Care Workers.” medRxiv. 2020.
  3. 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.
  4. 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.

For employers

How can employers order the test?

Contact us or call Clinical Services at 833-833-8328 to be connected to the team that handles contract pricing and to discuss an ordering process that works best for you and your employees.

For researchers

Can I use both T-Detect COVID and the immunoSEQ Assay for my research?

The immunoSEQ® Assay sequences the full repertoire in your samples and you will receive the immune receptor sequencing data on your samples where you can apply the immunoSEQ® T-MAP™ COVID Tool to identify SARS-CoV-2-specific TCRs in your samples.

T-Detect COVID should be applied where a positive/negative result will suffice for your research.

If you’d like to learn more about how you can use immunoSEQ or T-Detect in your research or clinical trials, please contact us.

* 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.

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