Frequently asked questions

T cells, which are a type of white blood cell, are the first responders of the adaptive immune system. When you’re exposed to a virus or bacteria, T cells jump into action by killing infected cells and stimulating antibody production. After your body fights off an infection or disease, a small number of T cells remain in the blood—often even after antibodies have waned—to remember how to ward off these invaders if they ever return.^1,2

1. Zou J., et al. “Robust SARS-CoV-2-specific T cell Immunity Is Maintained at 6 Months Following Primary Infection.” Nat Immunol. 2021.
2. 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.

T cells and antibodies are both important parts of the adaptive immune system; however, they perform different functions:

• T cells are the first responders of the adaptive immune system. When they encounter an invader (e.g., a virus or bacteria), they signal B cells to produce antibodies and the T cells kill infected cells.
• Antibodies are produced by B cells and bind to parts of invaders, preventing them from entering a cell or reproducing. Antibodies also mark harmful viruses and bacteria for killing by a different part of the immune system.
• Both antibodies and T cells remain in the body to help fight off the same virus or bacteria if it reappears in the future; however, some data show that T cells can remain long after antibodies wane.^1,2

1. Zou J., et al. “Robust SARS-CoV-2-specific T cell Immunity Is Maintained at 6 Months Following Primary Infection.” Nat Immunol. 2021.
2. 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.

COVID-19 (coronavirus disease 2019) is a contagious respiratory viral infection caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). It was first identified in late 2019, and is responsible for the pandemic.

Symptoms of COVID-19 include fever, cough, fatigue/malaise, shortness of breath, myalgias (muscle aches and pain), 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. For more information, visit CDC.gov.

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 a blood test that can help you understand your immune system’s response to SARS-CoV-2 (the virus that causes COVID-19). It is the first T-cell test to identify an adaptive T-cell immune response to SARS-CoV-2, indicating recent or past infection. It measures T cells instead of antibodies to detect recent or past SARS-CoV-2 infection.

T-Detect COVID is only available in the United States (not including United States Territories) to those age 18 or older.

T-Detect COVID can detect T cells in a blood sample that are specific to SARS-CoV-2 (the virus that causes COVID-19). T cells are the first responders of the adaptive immune system, and they help activate the antibody response. While antibodies to SARS-CoV-2 naturally wane and are detectable only in the shorter term, T cells may persist in the blood long after antibody responses decrease.^1-3 T-cell testing can detect past SARS-CoV-2 infection up to 10 months after symptoms appear (90% sensitivity*).⁴

* Sensitivity refers to a test’s ability to designate an individual with a disease as positive. A highly sensitive test means there are few false negative results, and thus fewer cases of disease are missed.⁵

1. Zou J., et al. “Robust SARS-CoV-2-specific T cell Immunity Is Maintained at 6 Months Following Primary Infection.” Nat Immunol. 2021.
2. 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.
3. Feng C., et al. “Protective humoral and cellular immune responses to SARS-CoV-2 persist up to 1 year after recovery.” Nat Comm. 2021.
4. Data on file. Adaptive Biotechnologies. 2021.
5. “Disease Screening – Statistics Teaching Tools.” New York State Department of Health website. Updated April 1999. Accessed December 9, 2021. https://www.health.ny.gov/diseases/chronic/discreen.htm

T-Detect COVID evaluates T cells in the blood to determine if there is evidence of a recent or past immune response to SARS-CoV-2, which would indicate a recent or past infection.

Early studies indicate that more than 35% of those who test positive for COVID-19 may be asymptomatic (do not have symptoms).¹ If you have had COVID-19, even if you did not experience symptoms, your immune system will still usually produce a T-cell response.

Additionally, in a clinical study, 75% of those who had a COVID-19 vaccination, but no history of natural infection, had a positive T-Detect COVID result.² A positive result should not be interpreted as an indication or degree of protection from infection.

1. Sah P., et al. “Asymptomatic SARS-CoV-2 infection: A systematic review and meta-analysis.” Proc Natl Acad Sci. 2021.
2. Snyder T., et al. “Magnitude and Dynamics of the T-Cell Response to SARS-CoV-2 Infection and Vaccination.” Oral presentation at: Infectious Disease (ID) Week. September 2021; virtual conference.

In clinical studies, T-Detect COVID showed specificity* of >99%.¹

When T-Detect COVID was compared with antibody (serology) testing:

• In one clinical study, T-Detect COVID was 95% sensitive^† 15 days^‡ post-symptom onset with PCR diagnosis, while leading antibody tests had a range of 88%-90%.¹
• In another clinical study, five months after symptom onset, T-cell testing correctly detected 95% of COVID-19-positive-patients, while leading antibody tests had a range of 50%-70%.²

* The specificity of a test is its ability to designate an individual who does not have a disease as negative. A highly specific test means there are few false positive results.³

† The sensitivity of a test is its ability to designate an individual with disease as positive. A highly sensitive test means there are few false negative results, and thus fewer cases of disease are missed.³

‡ Samples were tested out to a maximum of 106 days from symptom onset.

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. 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.
3. “Disease Screening – Statistics Teaching Tools.” New York State Department of Health website. Updated April 1999. Accessed December 9, 2021. https://www.health.ny.gov/diseases/chronic/discreen.htm

Sensitivity refers to a test’s ability to designate an individual with a disease as positive. A highly sensitive test means there are few false negative results, and thus fewer cases of disease are missed.¹

In one clinical study, T-Detect COVID was 95% sensitive 15 days* post-symptom onset with PCR diagnosis, while leading antibody tests had a range of 88%-90%.²

In another study five months after symptom onset, T-cell testing detected 95% of COVID-19-positive patients, while antibody tests had a range of 50%-70% in detecting COVID-19-positive patients.³

Another study demonstrated that up to 10 months after a previous positive PCR test, T-cell testing identified 90% of patients whom tested positive for SARS-CoV-2 (the virus that causes COVID-19) specific T cells.⁴

Performance data for T-cell testing greater than 10 months is not yet available. Therefore, it is possible that individuals who received a positive PCR result for SARS-CoV-2 more than 10 months ago may no longer have sufficient T cells to detect past infection.

* Samples were tested out to a maximum of 106 days from symptom onset.

1. “Disease Screening – Statistics Teaching Tools.” New York State Department of Health website. Updated April 1999. Accessed December 9, 2021. https://www.health.ny.gov/diseases/chronic/discreen.htm
2. 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.
3. 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.
4. Data on file. Adaptive Biotechnologies. 2021.

The specificity of a test is its ability to designate an individual who does not have a disease as negative. A highly specific test means there are few false positive results.¹

The specificity of T-Detect COVID is greater than 99%.²

1. “Disease Screening – Statistics Teaching Tools.” New York State Department of Health website. Updated April 1999. Accessed December 9, 2021. https://www.health.ny.gov/diseases/chronic/discreen.htm
2. 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.

Both T-Detect COVID and antibody tests can be used to detect the immune system’s response to SARS-CoV-2 (the virus that causes COVID-19), indicating a recent or past infection, and should not be used to determine current infection status.¹ T-Detect COVID can identify the immune system’s T-cell response, while antibody tests look for the presence of SARS-CoV-2-specific antibodies.

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.

T-Detect COVID and the nasal/throat swab tests for COVID-19 have different purposes.

Molecular tests, such as polymerase chain reaction (PCR) tests, and antigen tests are performed by taking a specimen from the nose or throat to determine the presence or absence of the virus’ genetic material or proteins, respectively. These tests are used to diagnose active infection with SARS-CoV-2 (the virus that causes COVID-19).

In contrast, T-Detect COVID evaluates T cells in the blood to determine if there is evidence of a recent or past immune response to SARS-CoV-2, which would indicate a recent or past SARS-CoV-2 infection.¹ T-Detect COVID is not intended to diagnose a current or active SARS-CoV-2 infection.

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.

T-Detect COVID can help you understand your immune system’s response to SARS-CoV-2 (the virus that causes COVID-19). It was developed to determine whether you had a recent or past infection from SARS-CoV-2. It is not designed to assess whether you currently have COVID-19.¹

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.

T-Detect COVID is used to detect a T-cell immune response to SARS-CoV-2 (the virus that causes COVID-19), which can indicate a recent or past infection. Molecular (PCR) and antigen tests are used to diagnose an active SARS-CoV-2 infection. Talk to your doctor about which test is right for you.

T-Detect COVID is used to detect a T-cell response to SARS-CoV-2 (the virus that causes COVID-19), which can indicate a recent or past infection. Antibody tests are also used to determine recent or past infection by SARS-CoV-2; however, they measure if B cells produced SARS-CoV-2-specific antibodies. Talk to your doctor about which test is right for you.

T-Detect COVID was developed and validated before SARS-CoV-2 (the virus that causes COVID-19) variants of concern were widespread. T-Detect COVID has not been validated with variants that have emerged since the original strain.

While T-Detect COVID may detect an immune response to SARS-CoV-2 even in the presence of variants, a positive result does not identify which SARS-CoV-2 variant an individual has an immune response to. The clinical performance of the test has not been established in all circulating variants, but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation.

A T-cell test and an antibody (serology) test measure different parts of the immune response to SARS-CoV-2 (the virus that causes COVID-19), so it’s possible to have a positive T cell test and a negative antibody test, or vice versa.

T cells may stay in the body longer than antibodies, so depending on how much time has passed since infection, T cells may be detectable while antibodies are not.¹

Talk with your doctor if you have questions about your T-Detect COVID test results.

1. Zou J., et al. “Robust SARS-CoV-2-specific T cell Immunity Is Maintained at 6 Months Following Primary Infection.” Nat Immunol. 2021.

Yes, it is possible to receive a positive COVID-19 PCR result in the past and not have SARS-CoV-2-specific T cells. There are a few possible explanations for this:

• Studies show that T cells may remain in the body long after antibodies wane, but it’s unclear exactly how long they remain after infection with SARS-CoV-2 (the virus that causes COVID-19).^1,2 Therefore, it is possible to have had COVID-19 and for T cells to have diminished by the time of testing to a number that is not detectable by laboratory tests.
• A molecular (PCR) or antigen test could have resulted in a false positive, meaning you did not have the disease and therefore would not have T cells.

The clinical performance of T-Detect COVID has not been established in 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.

Talk with your doctor if you previously tested positive for COVID-19 using a PCR or antigen test and then tested negative for T cells.

1. Zou J., et al. “Robust SARS-CoV-2-specific T cell Immunity Is Maintained at 6 Months Following Primary Infection.” Nat Immunol. 2021.
2. 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.

T-Detect COVID is a blood test that is analyzed by Adaptive Biotechnologies. The blood draw must be performed by a certified phlebotomist (blood draw technician). When ordering the test online, you can choose to have your blood drawn at one of Labcorp’s 2,000 Patient Service Centers or at home by a mobile phlebotomist (additional charges apply).

Some healthcare providers are now offering T-Detect in their clinics, and they can often perform a blood draw during your visit. Ask your doctor if their practice offers T-Detect COVID.

T-Detect COVID is intended for patients ages 18 and older. The test has not been validated for children under the age of 18; therefore, Adaptive Biotechnologies cannot accept or process orders for anyone under age 18. Adaptive is assessing the data required to include pediatric use, but no timeline has been established.

T-Detect COVID has been shown to detect a robust T-cell response to SARS-CoV-2 (the virus that causes COVID-19) starting 15 days after symptom onset, and is further supported by T-cell testing ranging up to 10 months.^1,2 Data beyond this time frame are not available. We will continue to update this information as new data become available.

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. Data on File. Adaptive Biotechnologies. 2021.

The impact of vaccination on T-Detect COVID results has not been established. The results from this test should not be interpreted as an indication or degree of protection from infection.

A recent study showed that 75% of 333 patients with no known history of natural infection had a positive T-cell test result after being vaccinated against SARS-CoV-2.¹ More research is needed to better understand these results. Adaptive Biotechnologies is actively gathering additional data and will provide updates as information becomes available.

1. Snyder T., et al. “Magnitude and Dynamics of the T-Cell Response to SARS-CoV-2 Infection and Vaccination.” Oral presentation at: Infectious Disease (ID) Week. September 2021; virtual conference.

As of January 11, 2022, the CDC recommends vaccination for most people, even if they have had a natural infection with SARS-CoV-2 (the virus that causes COVID-19).¹ Talk with your doctor about whether you should be vaccinated against SARS-CoV-2.

1. Frequently Asked Questions about COVID-19 Vaccination. Centers for Disease Control and Prevention website. Updated Jan. 11, 2022. Accessed Jan. 14, 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html.

The T-Detect COVID result is either positive or negative and does not differentiate a T-cell immune response to natural infection from COVID-19 vaccination.

The impact of vaccination on T-Detect COVID results has not been established and the results from this test should not be interpreted as an indication or degree of protection from infection. Adaptive Biotechnologies is actively gathering additional data and will provide updates as information becomes available.

T-Detect COVID is not a substitute for a vaccine passport. Check with the airline and/or country you are traveling to about COVID-19 testing and documentation requirements.

A T-Detect COVID result is not a substitute for a vaccine waiver or exemption. For more information about vaccine waivers and exemptions, visit the CDC.

T-Detect COVID was developed to determine whether you had a recent or past infection with SARS-CoV-2 (the virus that causes COVID-19). The performance of T-Detect COVID has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative result following COVID-19 vaccination has not been established and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination. Talk with your doctor about whether T-Detect COVID is right for you.

The T-Detect test is performed using a standard blood draw. You do not need to fast or prepare in any other way before the test is performed.

You may eat prior to your blood draw for T-Detect, and do not need to fast.

Approximately 6 mL (slightly more than a teaspoon) of blood will be drawn.

Most doctors’ offices don’t have T-Detect available at their clinics, so they cannot draw your blood for this test. A small number of healthcare providers offer T-Detect in their practices. Ask your doctor if they carry the test, or you can order it online.

During the ordering process, you can choose between a Labcorp in-office blood draw and ExamOne mobile phlebotomy. You can walk in or make an appointment online at any of Labcorp’s more than 2,000 Patient Service Centers. A test kit will not be shipped to those who select Labcorp for the blood draw. Labcorp will have the appropriate supplies to complete the blood draw.

There are no Labcorp locations in Hawaii, North Dakota or Vermont. ExamOne is the only blood draw option for residents of these states.

If you choose ExamOne, a test kit will be shipped to you and a mobile phlebotomist (blood draw technician) will come to your home or another location you choose, to draw your blood. Kits typically arrive three to five days after you receive the test authorization email.

Mobile phlebotomy is a traveling blood draw service in which a certified phlebotomist (blood draw technician) visits your home or another location you choose, to collect a blood sample.

If you select ExamOne mobile phlebotomy during the ordering process, an ExamOne representative will call you within two days of test authorization to schedule an appointment.

Most ExamOne mobile phlebotomists are available Monday through Friday from 8 a.m. to 5 p.m. In some areas, later appointments and Saturday appointment are available. When you speak to ExamOne, you can ask if they have extended or Saturday hours in your area.

The phlebotomist (blood draw technician) will follow all CDC guidelines, including wearing a face mask at all times and wearing gloves when making physical contact with you.

We partnered with a company called ExamOne to offer mobile blood draw services. All their phlebotomists (blood draw technicians) are certified according to state guidelines.

The person who will draw your blood will wear an identification badge with their name on it. If the person is not wearing a badge, ask to see it before your blood draw.

In some instances, ExamOne works with local certified phlebotomists who operate under different business names, to offer additional availability. The phlebotomist will still have identification to properly identify themself.

T-Detect is not currently covered by insurance. It is FSA/HSA eligible.

Eligible patients may qualify for discounted testing based on their income or medical expenses as part of the Adaptive Assist Patient Support Program. There are two ways to submit an Adaptive Assist application:

• Call Patient Support at 855-236-9230, Monday to Thursday between 9 a.m. and 7 p.m. or Fridays between 9 a.m. and 5 p.m. (Eastern Time).
• Print an application and mail it to:
  Adaptive Biotechnologies
  Dept LA 24084
  Pasadena, CA 91185-4084

T-Detect COVID costs $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 T-Detect COVID and is subject to change. T-Detect COVID is FSA/HSA eligible.

Eligible patients may qualify for discounted testing based on their income or medical expenses as part of the Adaptive Assist Patient Support Program. There are two ways to submit an Adaptive Assist application:

• Call Patient Support at 855-236-9230, Monday to Thursday between 9 a.m. and 7 p.m. or Fridays between 9 a.m. and 5 p.m. (Eastern Time).
• Print an application and mail it to:
  Adaptive Biotechnologies
  Dept LA 24084
  Pasadena, CA 91185-4084

Yes, T-Detect COVID is FSA/HSA eligible.

Eligible patients may qualify for discounted testing based on their income or medical expenses as part of the Adaptive Assist Patient Support Program. There are two ways to submit an Adaptive Assist application:

• Call Patient Support at 855-236-9230, Monday to Thursday between 9 a.m. and 7 p.m. or Fridays between 9 a.m. and 5 p.m. (Eastern Time).
• Print an application and mail it to:
  Adaptive Biotechnologies
  Dept LA 24084
  Pasadena, CA 91185-4084

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

If you select Labcorp for your blood draw, you can schedule an appointment online 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. Labcorp blood draw services are not available in Hawaii, North Dakota or Vermont.

If you choose mobile phlebotomy (an in-home blood draw) through ExamOne, Adaptive Biotechnologies will ship you a test kit and ExamOne will call you within two days of test authorization to schedule an appointment.

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

In the rare event that Adaptive Biotechnologies is unable to provide a laboratory report after receiving 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 and other processing fees. If you have questions, contact Clinical Services, Monday through Friday between 8:30 a.m. and 8 p.m. (Eastern Time) at 833-T-DETECT (833-833-8328) or T-DetectInquiries@adaptivebiotech.com.

T-Detect is a clinical test that requires a prescription. Once you answer the eligibility questions during the ordering process, an independent healthcare professional from PWNHealth will review your answers and authorize the prescription within 24 hours, if appropriate.

Contact Clinical Services, Monday through Friday between 8:30 a.m. and 8 p.m. (Eastern Time) at 833-T-DETECT (833-833-8328) or T-DetectInquiries@adaptivebiotech.com to start the onboarding process.

All healthcare providers are eligible to prescribe T-Detect.

Once a provider has completed the onboarding process to become a T-Detect provider, they can place test orders using the Adaptive Diagnostic Portal. Healthcare providers can contact Clinical Services, Monday through Friday between 8:30 a.m. and 8 p.m. (Eastern Time) at 833-T-DETECT (833-833-8328) or T-DetectInquiries@adaptivebiotech.com to start the onboarding process.

At this time, T-Detect ordering and results are not integrated into EHRs. Once a provider is onboarded, T-Detect can be ordered through the Adaptive Diagnostic Portal. Test results are available via the portal, by fax or by secure email. Providers can select a preferred delivery option during the onboarding process.

The estimated time for results is seven to 10 days from shipment of the blood sample.

The day and time a sample arrives at Adaptive Biotechnologies may impact turnaround time. Biological specimens are received and accessioned Monday through Saturday from 8 a.m. to 5 p.m. (Pacific Time). Samples cannot be received on Sundays or on the following holidays:

• New Year’s Day
• Memorial Day
• July 4 holiday
• Labor Day
• Thanksgiving Day
• Christmas Day

T-Detect COVID requires 6 mL of fresh peripheral blood drawn in a K2 EDTA tube. If the specimen will be shipped to Adaptive Biotechnologies the same day as collected, it should be stored at room temperature until shipment. If the specimen cannot be shipped the same day, it should be stored at 4°C until shipment.

Each T-Detect specimen collection kit includes a FedEx Priority Overnight pre-paid and pre-addressed shipping label. Package the specimen according to the directions included in the kit and place it in the FedEx Clinical Pak envelope. Bring the package to a FedEx location for same-day shipping, or arrange for a pickup by visiting FedEx.com or calling 800-463-3339.

Store T-Detect COVID kits at room temperature, and do not open until ready for use.

Specimens should be shipped within four days of being drawn, and can be shipped overnight to Adaptive Biotechnologies Monday through Saturday.

If you choose to get your blood drawn at Labcorp, they will have the appropriate materials to collect your blood sample. You will not be shipped a test kit.

A kit for sample collection will be sent directly to you if you choose to have an ExamOne mobile phlebotomist (blood draw technician) come to your home or another location you choose. You will need to give the test kit to the phlebotomist to use when collecting your blood sample.

If you selected Labcorp, they will have the appropriate materials to collect your blood sample, so you will not receive a test kit.

If you selected ExamOne mobile phlebotomy, your test kit should arrive within three to five days of receiving your test authorization email.

T-Detect COVID results are positive or negative. A positive test result with T-Detect COVID indicates that a T-cell immune response to SARS-CoV-2 (the virus that causes COVID-19) was detected. A positive result should not be interpreted as an indication or degree of protection from infection.

A negative result indicates that a T-cell immune response to SARS-CoV-2 was not detected.

T-Detect COVID has been shown to have high sensitivity. Sensitivity refers to a test’s ability to designate an individual with disease as positive. A highly sensitive test means there are few false negative results, and thus fewer cases of disease are missed.¹

A recent study demonstrated that 90% of patients tested positive for T cells up to 10 months after a confirmed positive PCR test.² Data for T-cell testing greater than 10 months are not yet available. Therefore, 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.

The clinical performance of T-Detect COVID has not been established in 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 performance of this test has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative result following COVID-19 vaccination has not been established, and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.

1. “Disease Screening – Statistics Teaching Tools.” New York State Department of Health website. Updated April 1999. Accessed December 9, 2021. https://www.health.ny.gov/diseases/chronic/discreen.htm
2. Data on file. Adaptive Biotechnologies. 2021.

A negative result indicates that a T-cell immune response to SARS-CoV-2 (the virus that causes COVID-19) was not detected.

T-Detect COVID has been shown to have high sensitivity.* A recent study demonstrated that 90% of patients tested positive for T cells up to 10 months after a confirmed positive PCR test.¹ Data for T-cell testing greater than 10 months are not yet available. Therefore, 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.

The clinical performance of T-Detect COVID has not been established in 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 performance of this test has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative result following COVID-19 vaccination has not been established, and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.

* Sensitivity refers to a test’s ability to designate an individual with disease as positive. A highly sensitive test means there are few false negative results, and thus fewer cases of disease are missed.²

1. Data on file. Adaptive Biotechnologies. 2021.
2. “Disease Screening – Statistics Teaching Tools.” New York State Department of Health website. Updated April 1999. Accessed December 9, 2021. https://www.health.ny.gov/diseases/chronic/discreen.htm

A positive result with T-Detect COVID indicates that a T-cell immune response to SARS-CoV-2 (the virus that causes COVID-19) was detected.

A positive test result should not be interpreted as protection from infection.

A recent study showed that 75% of 333 patients with no known history of natural infection had a positive T-cell test result after being vaccinated against SARS-CoV-2.¹ More research is needed to better understand these results. Adaptive Biotechnologies is actively gathering additional data, and will provide updates as information becomes available. 

1. Snyder T., et al. “Magnitude and Dynamics of the T-Cell Response to SARS-CoV-2 Infection and Vaccination.” Oral presentation at: Infectious Disease (ID) Week. September 2021; virtual conference.

In some instances, Adaptive Biotechnologies is not able to determine a positive or negative result for an immune response to SARS-CoV-2 (the virus that causes COVID-19).

If this happens, your result will say “no result available.” This may mean there was not enough T-cell DNA in your blood sample, which can sometimes be caused by underlying medical conditions; in that case a new blood sample would not be expected to give a different result. This may also mean there was a technical issue that prevented the blood sample from being tested properly, in which case a new blood sample may be useful.

Contact Clinical Services, Monday through Friday between 8:30 a.m. and 8 p.m. (Eastern Time) at 833-T-DETECT (833-833-8328) or T-DetectInquiries@adaptivebiotech.com.

Patients will receive an email when their results are available. The email will include a link to a secure website where results can be reviewed.

Healthcare providers will receive T-Detect COVID test results via one of three methods:

• Adaptive Biotechnologies Diagnostic Portal
• Fax
• Secure email

Providers can choose a preferred delivery method when registering to become a T-Detect COVID provider.

To speak with a provider about your test results, contact PWNHealth by calling 315-401-7865 or emailing covid19@pwnhealth.com.

PWNHealth is an independent healthcare provider network that offers oversight services to patients in connection with the laboratory testing that you have requested. PWNHealth and its services are independent from the laboratory and company from which you requested and registered for T-Detect COVID.

The result of a T-Detect COVID test is either positive or negative (and is not quantitative; i.e., numerical value). During the public health emergency, Adaptive Biotechnologies decided to make T-Detect COVID available for those who wanted to determine if they had an adaptive immune response to SARS-CoV-2 (the virus that causes COVID-19).

Each specimen (blood sample) is processed and tested to meet our rigorous laboratory requirements before a result is reported. If a specimen fails to meet any of these internal standards, it is re-processed. This does not necessarily mean there is a problem with the blood sample. Re-queuing will cause results to be delayed.

A T-cell response is typically detectable in blood as early as several days after initial infection or vaccination. How long this response lasts after infection or vaccination and the implications for immunity are not known.^1,2

The relationship between a demonstrable T-cell response and the risk of re-infection or a breakthrough infection is not well understood.

The performance of this test has not been established in individuals who have received a COVID-19 vaccine. The clinical significance of a positive or negative result following COVID-19 vaccination has not been established, and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.

Visit the CDC for further guidance on how to protect yourself from SARS-CoV-2.

1. Zou J., et al. “Robust SARS-CoV-2-specific T Cell Immunity Is Maintained at 6 Months Following Primary Infection.” Nat Immunol. 2021.
2. Snyder T., et al. “Magnitude and Dynamics of the T-Cell Response to SARS-CoV-2 Infection and Vaccination.” Oral presentation at: Infectious Disease (ID) Week. September 2021; virtual conference.

ExamOne is a national mobile phlebotomy service provider that Adaptive Biotechnologies has partnered with to 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.

Labcorp is one of the largest clinical network laboratories in the United States, with approximately 2,000 Patient Service Centers. You can walk in or schedule an appointment at any of its locations.

Labcorp facilities are not available in Hawaii, North Dakota or Vermont.

PWNHealth is an independent healthcare provider network that offers oversight services to patients in connection with the laboratory testing that you have requested. PWNHealth and its services are independent from the laboratory and company from which you requested and registered for T-Detect COVID. PWNHealth has independent clinicians who will determine whether or not to authorize your test.

You do not need to conduct a video visit. The independent clinician can authorize (or prescribe) the test based on your responses to the eligibility questionnaire, if appropriate.

Visit Labcorp to find a Patient Service Center near you.

For residents of Hawaii, North Dakota or Vermont: Labcorp does not have locations in these states; you must choose ExamOne mobile phlebotomy for your blood draw.

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.

Adaptive Biotechnologies follows all state and federal privacy rules, including the Health Insurance Portability and Accountability Act (HIPAA).

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, requires “every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19” to report the results from each such test to the Secretary of the Department of Health and Human Services (HHS). Additionally, the CDC states that the CARES Act requires laboratories to report all data to state or local public health departments using existing public health data reporting channels (in accordance with state law or policies).

T-Detect is only available to those 18 or older. The test has not been validated for children under the age of 18; therefore Adaptive Biotechnologies cannot accept or process orders for those under age 18.

T-Detect COVID has been granted Emergency Use Authorization by the FDA. For more information, visit the patient fact sheet or healthcare provider fact sheet.

T-Detect COVID is only available in the United States (not including United States Territories).

T-Detect COVID is available to be prescribed by healthcare professionals in all 50 states. It is not available in United States Territories.