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T-Detect COVID is now authorized for emergency use by the FDA.*

In studies, the T-Detect COVID test outperformed leading antibody tests.1, 2

In studies, the T-Detect COVID test outperformed leading antibody tests.1, 2

Special self-pay test price $150

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 the T-Detect COVID test and is subject to change. The T-Detect COVID test is FSA/HSA eligible.  

For Patients

The T-Detect COVID test can detect past COVID-19 infections for up to several months.

For Physicians

The T-Detect COVID test can capture past COVID-19 infections that may be missed by serology testing.

For Employers

The T-Detect COVID test can help your employees get the answers they need.

For Researchers

The T-Detect COVID test can support your research due to its high sensitivity and specificity.

Frequently asked questions

How does T-Detect COVID work?

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) 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 a 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.

What does the T-Detect COVID test measure?

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.

How accurate is the T-Detect test for COVID-19?

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.

What does the T-Detect COVID test mean in regard to immunity?

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.

Who should take this test?

The T-Detect COVID test can help you understand if you’ve had a recent or past COVID-19 infection.

The T-Detect COVID test can provide answers in these situations:

• You still have lingering symptoms and wonder if it was COVID-19
• You may have been exposed to COVID-19, but never got tested and you are concerned that you might have had COVID-19
• You were tested, but you are concerned it may have been a false negative

The test is also appropriate for those interested in supporting COVID-19 research.

The T-Detect COVID test is not meant to diagnose an active infection.

If I have a positive T-Detect COVID test, do I need to get a vaccine?

Please consult your doctor regarding whether you should be vaccinated against SARS-CoV-2. As of January 25, 2021, the CDC recommends vaccination for most people, even if they have had a natural infection with SARS-CoV-2.1

1. Frequently Asked Questions about COVID-19 Vaccination. Centers for Disease Control and Prevention website. Updated Jan. 25, 2020. Accessed Jan. 26, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html

Can a T cell test be used in place of, or in addition to, a PCR/antigen test?

T-Detect COVID is used to detect a recent or past COVID-19 infection. PCR/antigen tests are used to diagnose a current COVID-19 infection. Talk to your doctor about which test is right for you.

How long will it take to get results?

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.

What will results look like?

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.

If I got the COVID-19 vaccine, will it affect my T-Detect COVID results?

We do not currently have information on how the SARS-CoV-2 vaccine may affect the T cell response and the results of the T-Detect COVID test, but we are actively gathering data and will provide updates as information becomes available.

What does a negative T-Detect COVID test mean?

A recent study demonstrated 95% of patients tested positive for T cells up to five months after a confirmed positive PCR test.1 Clinically validated data for T-Detect COVID performance beyond five months is not available yet. Therefore, it is possible that individuals who received a positive PCR result for COVID-19 more than five months ago no longer have sufficient T cells to detect past infection.

1. Adaptive data on file.

What does “no result available” mean?

In some instances, we are not able to definitively determine a positive or negative result. If this happens, your result will say, “no result available.” Call our Clinical Services team at 833-T-DETECT (833-833-8328) to discuss redoing your test at no cost.

How much does this test cost?

The T-Detect COVID test 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 customary charge for the T-Detect COVID test and is subject to change. The T-Detect COVID test is FSA/HSA eligible.

Will insurance cover costs for the test?

The T-Detect COVID test is not currently covered by insurance. The patient is responsible for blood draw fees, copays for doctor visits, and any additional associated costs. The T-Detect COVID test is FSA/HSA eligible.

Eligible patients may qualify for discounted testing based on their income or medical expenses as part of Adaptive’s patient support program (Adaptive Assist). You can print an Adaptive Assist application and submit it to us at AdaptiveBiotech@mylabbill.com or fax to 440-788-2137. Alternatively, you can contact Adaptive at 855-236-9230 to find out if you might qualify for Adaptive Assist prior to placing your order.

If you have already purchased the test and your application for Adaptive Assist is approved to provide the test at a reduced cost, a refund will be processed to your credit card.

Is there financial assistance available?

Eligible patients may qualify for discounted testing based on their income or medical expenses as part of Adaptive’s patient support program (Adaptive Assist). You can print an Adaptive Assist application and submit it to us at AdaptiveBiotech@mylabbill.com or fax to 440-788-2137. Alternatively, you can contact Adaptive at 855-236-9230, to find out if you might qualify for Adaptive Assist prior to placing your order.

If you have already purchased the test and your application for Adaptive Assist is approved to provide the test at a reduced cost, a refund will be processed to your credit card.

What is the cancellation/refund policy?

Contact us at 833-T-DETECT (833-833-8328) within 24 hours if you wish to change or cancel your order. No refunds or cancellations can be made after 24 hours.

If we are unable to provide a laboratory report after you submit your blood sample, a refund will automatically be issued to the credit card you used and will be net of any costs for telehealth, phlebotomy, or other processing fees deducted. Contact us at 833-T-DETECT (833-833-8328) or email us at t-detectinquiries@adaptivebiotech.com.

What is mobile phlebotomy?

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

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

Labcorp is one of the largest clinical network laboratories in the U.S., with approximately 2,000 Patient Service Centers. If you select a Labcorp blood draw, a licensed phlebotomist (blood draw technician) will draw your blood at the Labcorp location you select after ordering the T-Detect COVID test.

PWNHealth is an independent healthcare provider network that provides oversight services to patients in connection with the laboratory testing they requested. PWNHealth and its services are independent from the laboratory and company from which patients request and register for the T-Detect COVID test.

Is this test available throughout the U.S.?

T-Detect COVID is available to be prescribed by healthcare professionals in all U.S. states.

Is this test available outside the U.S.?

The T-Detect COVID test is only available in the U.S. and is not available in U.S. Territories.

Where can I get more information about COVID-19 and other testing options?

You can visit CDC.gov and/or your county’s public health department website to learn more about COVID-19, testing options and vaccination schedules.

* 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.

References

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. 2020.
2. Adaptive data on file.

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