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 other T cells to kill infected cells.
• Antibodies are produced by B cells and bind to parts of the 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 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.

Lyme disease, the most common tick-borne illness that occurs throughout the United States, is an infectious disease caused by the bacterium Borrelia burgdorferi and spread from the bite of an Ixodes tick (also called a deer tick or black-legged tick).

Patients with untreated Lyme disease can develop a wide range of symptoms, depending on the stage of infection:¹

• Presence of an Erythema migrans (EM) rash, also known as a bulls-eye rash
• Early signs and symptoms (three to 30 days after a tick bite) may include fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes and can occur in the absence of a rash.
• Later signs and symptoms (days to months after a tick bite) may include severe headaches and neck stiffness, additional EM rashes on other areas of the body, facial palsy (loss of muscle tone or droop on one or both sides of the face), and/or arthritis with severe joint pain and swelling (particularly in the knees and other large joints).

1. Signs and Symptoms of Untreated Lyme Disease. Center for Disease Control and Prevention website. Updated January 15, 2021/ Accessed May 23, 2022. https://www.cdc.gov/lyme/signs_symptoms/index.html

T-Detect Lyme is a blood test that can help you understand your immune system’s response to Borrelia burgdorferi, the bacterium that causes Lyme disease, aiding in the diagnosis of early Lyme disease. It is the first T-cell based test to identify an adaptive T-cell immune response to Borrelia burgdorferi, indicating prior exposure to the bacterium.

T-Detect Lyme evaluates T cells in the blood to determine if there is evidence of an adaptive immune response to Borrelia burgdorferi, the bacterium that causes Lyme disease, by identifying signals in the form of T-cell receptor (TCR) sequences associated with Lyme disease.

In clinical studies, T-Detect Lyme showed specificity of 99%.²

When T-Detect Lyme was compared with standard two-tiered testing (STTT):

• In the clinical validation study, T-Detect Lyme was 54% sensitive in subjects who presented with an EM rash living in Lyme-endemic regions (or living in areas where Lyme disease is most common) compared to 30% for STTT in the same population.²
• In another clinical study, T-Detect Lyme had nearly two times greater sensitivity than STTT in patients with early Lyme disease (56% vs. 30%).¹
• In the same study, T-Detect Lyme showed three times greater sensitivity than STTT in the first four days after symptoms appeared (44% vs. 14%).¹

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.

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.

1. Greissl J, et al. Immunosequencing of the T-cell receptor repertoire reveals signatures specific for diagnosis and characterization of early Lyme disease. medRxiv. 2 Aug. 2021. Doi:10.1101/2021.07.30.21281353
2. Data on file. Adaptive Biotechnologies. 2022.

T-Detect Lyme and STTT for Lyme disease evaluate two different components of the immune response to Borrelia burgdorferi, the bacterium that causes Lyme disease.

T-Detect Lyme is a single blood test that can help you understand your immune system’s response to Borrelia burgdorferi, aiding in the diagnosis of early Lyme disease, by looking at your T cells.

STTT identifies an immune response to Borrelia burgdorferi using an enzyme immunoassay (EIA) or immunofluorescent assay (IFA) followed by a Western immunoblot, to detect IgM and IgG antibodies against Borrelia burgdorferi. There are specific criteria that must be met after the initial reading in order to proceed to the Western immunoblot testing.

T-Detect Lyme is for patients presenting with suspected early Lyme disease. This would include presenting with signs and symptoms consistent with Lyme disease and suspected exposure to an Ixodes tick (also called a deer ticks or black-legged tick).

The impact of antibiotic treatment on the performance of T-Detect Lyme is unknown. In a clinical study, the performance of T-Detect Lyme was measured in patients who received less than 72 hours of appropriate antibiotic treatment for early Lyme disease. The sensitivity of T-Detect Lyme was 56% compared to 30% for standard two-tiered testing (STTT).¹

Talk with your doctor if you are currently on antibiotics or other medications to determine if T-Detect Lyme is right for you.

1. Greissl J, et al. Immunosequencing of the T-cell receptor repertoire reveals signatures specific for diagnosis and characterization of early Lyme disease. medRxiv. 2 Aug. 2021. Doi:10.1101/2021.07.30.21281353

T-Detect Lyme is not intended to be used to detect PTLDS.

T-Detect Lyme is a blood test that can help you understand your immune system’s response to Borrelia burgdorferi, the bacterium that causes Lyme disease, aiding in the diagnosis of early Lyme disease.

In the United States, Lyme disease is rarely caused by Borrelia mayonii, the only species besides Borrelia burgdorferi shown to cause Lyme disease in North America.

T-Detect Lyme has not been evaluated or tested on other species of bacteria. In a clinical study, the performance of T-Detect Lyme was measured in patients who lived within the United States and presented with an EM rash.¹

1. Greissl J, et al. Immunosequencing of the T-cell receptor repertoire reveals signatures specific for diagnosis and characterization of early Lyme disease. medRxiv. 2 Aug. 2021. Doi:10.1101/2021.07.30.21281353

T-Detect Lyme results are either positive or negative (not quantitative, i.e., numerical value). A positive test result with T-Detect Lyme indicates that an adaptive T-cell immune response to Borrelia burgdorferi (the bacterium that causes Lyme disease) was detected. A negative test result indicates that a T-cell immune response to Borrelia burgdorferi was not detected. T-Detect Lyme has been shown to have greater sensitivity than current Lyme disease diagnostics in early stages of the disease; however, in certain circumstances, including but not limited to duration of time since infection, the test may be negative despite a prior Borrelia burgdorferi infection.

A positive result with T-Detect Lyme indicates that a T-cell immune response to Borrelia burgdorferi, the bacterium that causes Lyme disease, was detected.

A negative result with T-Detect Lyme indicates that a T-cell immune response to Borrelia burgdorferi, the bacterium that causes Lyme disease, was not detected.

A T-cell test and antibody (serology) test measure different parts of the immune response to Borrelia burgdorferi (the bacterium that causes Lyme disease), so it is possible to have a positive T-cell test and a negative antibody test, or vice versa.

In a clinical study, the sensitivity of T-Detect Lyme was 44% in patients who presented with early Lyme disease less than or equal to four days from the start of symptoms, compared to 14% with standard two-tiered testing (STTT).¹ The antibody response (specifically, IgM response) usually peaks during the first several weeks of disease, which may limit the ability to detect an immune response during the early stages of Lyme disease.²

Talk to your doctor if you have questions about the result of your T-Detect Lyme test.

1. Greissl J, et al. Immunosequencing of the T-cell receptor repertoire reveals signatures specific for diagnosis and characterization of early Lyme disease. medRxiv. 2 Aug. 2021. Doi:10.1101/2021.07.30.21281353
2. Kalish R, et al. Persistence of Immunoglobulin M or Immunoglobulin G Antibody Responses to Borrelia burgdorferi 10–20 Years after Active Lyme Disease. Clin Infect Dis. 2021. doi.org/10.1086/322669

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 COVID-19 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.

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 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 if you currently have COVID-19.

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 (the virus that causes COVID-19), which would indicate a recent or past infection.

In clinical studies, T-Detect COVID showed specificity greater than 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 Samples were tested out to a maximum of 106 days from symptom onset.
• 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

Specificity based on negative percent agreement (NPA) in confirmed RT-PCR negative subjects.

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.

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.

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.” Clin Infect Dis. 2022. doi:10.1093/cid/ciac353
2. Elyanow R., et al. “T cell Receptor Sequencing Identifies Prior SARS-CoV-2 Infection and Correlates with Neutralizing Antibody Titers and Disease Severity.” JCI Insight. 2022. doi:10.1172/jci.insight.150070

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.

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.

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 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.

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

A recent study demonstrated that 86% of patients tested positive for T cells up to 15 months after a confirmed positive PCR test.¹ Data for T-cell testing greater than 15 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. Gittelman RM., et al. “Longitudinal analysis of T cell receptor repertoires reveals shared patterns of antigen-specific response to SARS-CoV-2 infection.” JCI Insight. 2022. doi:10.1172/jci.insight.151849

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 86% of patients tested positive for T cells up to 15 months after a confirmed positive PCR test.¹ Data for T-cell testing greater than 15 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.

1. Gittelman RM., et al. “Longitudinal analysis of T cell receptor repertoires reveals shared patterns of antigen-specific response to SARS-CoV-2 infection.” JCI Insight. 2022. doi:10.1172/jci.insight.151849

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. 

As of May 20, 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 May 20, 2022. Accessed May 23, 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html.

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.

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 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.  

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.” Clin Infect Dis. 2022. doi:10.1093/cid/ciac353

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.” Clin Infect Dis. 2022. doi:10.1093/cid/ciac353

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.

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 result.

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 test result in the past and not have SARS-CoV-2-specific T cells. Possible explanations for this may include, but are not limited to:

• Studies show that T cells may remain in the body 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.” Clin Infect Dis. 2022. doi:10.1093/cid/ciac353

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.

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.

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.

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.

T-Detect Lyme is only available from a healthcare provider. Your blood must be drawn in their clinic. Share this doctor discussion guide and instructions for ordering T-Detect with your doctor.

T-Detect COVID is available from healthcare providers that offer the test. If your provider orders the test, your blood must be drawn in their clinic. If you order T-Detect COVID online, you must have your blood drawn at a Labcorp Patient Service Center or by an ExamOne mobile phlebotomist.

T-Detect Lyme is only available from a healthcare provider. Your blood must be drawn in their clinic.

For T-Detect COVID, you can order the test online and choose a Labcorp in-office blood draw or mobile phlebotomy (additional fees apply) conducted by ExamOne. Once you receive prescription authorization, your prescription will expire six months from that date.

You can walk in or make an appointment online at any of Labcorp’s more than 2,000 Patient Service Centers. A test collection kit will not be shipped to those who select Labcorp for their blood draw. Labcorp will have the appropriate supplies to complete the blood draw.

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

If you choose mobile phlebotomy, a test collection 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. Test collection kits typically arrive three to five days after you receive the test authorization email.

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 collection kit.

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

If you selected mobile phlebotomy, your test collection kit should arrive within three to five days of receiving your 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. Mobile phlebotomy for T-Detect COVID is available through ExamOne.

If you select ExamOne mobile phlebotomy during the online 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.

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 through 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

The T-Detect COVID list price is $219. For an additional $80, patients can choose mobile phlebotomy instead of going to a Labcorp Patient Service Center for a blood draw. The price does not represent the usual and customary charge for T-Detect COVID and is subject to change.

The list price for T-Detect Lyme, currently only available through your healthcare provider, is $399.

T-Detect 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 through 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 tests are 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 through 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 Lyme is only available from your healthcare provider. Share this doctor discussion guide and instructions for ordering T-Detect with your doctor.

For T-Detect COVID, you can order the test 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 collection 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 collection 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.

For T-Detect COVID, once you answer the eligibility questions during the online ordering process, an independent healthcare professional from PWNHealth will review your answers and authorize the prescription within 24 hours, if appropriate.

At this time, T-Detect Lyme can only be ordered by your healthcare provider.

T-Detect is a blood test that is analyzed by Adaptive Biotechnologies. The blood draw must be performed by a certified phlebotomist (blood draw technician) or other appropriately qualified healthcare professional. T-Detect Lyme is only available from your healthcare provider. They can often perform a blood draw during your visit.

T-Detect COVID can be ordered by your healthcare provider or online and 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).

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, 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.

At this time, separate test requisition forms (TRFs) must be completed and two blood samples must be drawn.

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 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 test collection kit includes a FedEx Priority Overnight pre-paid and pre-addressed shipping label. Package the specimen according to the directions included in the test collection 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 test collection 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.

Healthcare providers who order the test will receive T-Detect test results via one of three methods:

• Adaptive Biotechnologies Diagnostic Portal
• Fax
• Secure email

Providers can choose a preferred delivery method during onboarding.

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

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.

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

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.

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

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

Adaptive has developed clinical tests intended to identify an immune response to a given disease. The goal of this study is to provide real-world data to evaluate and improve clinically available T-Detect tests based on your health information, as well as to provide data for future T-Detect tests.

You may be asked to participate in this study if you ordered a T-Detect test and opted-in to contribute to Adaptive’s ongoing T cell-based research. Review the consent form and decide whether you want to participate in the study.

Your participation includes:

1. Electronic questionnaire
   You’ll be asked to complete an electronic questionnaire during the study to collect information about your medical history, as well as symptoms and diagnostic tests performed relating to your suspected condition. All information provided will be de-identified in accordance with Health Insurance Portability and Accountability Act (HIPAA) standards. You’ll receive a $50 gift card for completing the questionnaire (if all questions are answered).
2. Optional portion
   You have the option to complete additional questionnaires, over an indefinite period or as long as the study remains open. You’ll receive a $50 gift card for completing each additional questionnaire (if all questions are answered). Longitudinal questionnaires are adapted to the study’s needs and will only be sent to participants as applicable.

Adaptive will store, use and share your identifiable information and/or identifiable biospecimens for purposes of this research study, as well as for other medical and scientific research that may be conducted by Adaptive or other researchers, including other biotechnology companies, academic and medical institutions, or drug and device companies, for the indefinite future.

By consenting to participate in this study, you’re agreeing to both the use and sharing of your identifiable information and identifiable biospecimens for research conducted in the T-Detect Real-World Data Study, as well as to the use and sharing of your identifiable information and identifiable biospecimens for other future medical and scientific research, the details of which are not known at this time.

The main risk is that your privacy could be violated. We will do our best to protect your information from going to people who should not have it. This includes removing information that could be used to easily identify you. The risk that your identifiable information or identifiable biospecimen will go to someone who should not get it is very small.

You will not receive any direct benefits for being part of this study.

However, research using your identifiable information and identifiable biospecimens may help others by improving our understanding of health and disease, improving healthcare, making safer or more effective diagnostics, and developing new scientific knowledge.

Neither you nor your insurance company will be billed for your participation in the T-Detect Real-World Data Study.

You’ll be given a $50 gift card for your participation in the T-Detect Real-World Data Study. You must complete the online questionnaire (if all questions are answered) in order to qualify for the gift card.

If you choose to participate in the optional portion of the study after your initial study participation, you’ll be given an additional $50 gift card for completing each additional online questionnaire (if all questions are answered). Longitudinal questionnaires are adapted to the study’s needs and will only be sent to participants as applicable.

Yes, you may withdraw (revoke) your permission to use and disclose your health information at any time. You can do this by sending written notice to the study doctor at clinicaloperations@adaptivebiotech.com. However, if you withdraw your permission for use and disclosure of your health information, you won’t be able to remain a part of this study. Also, although withdrawing your permission will prevent further uses and disclosures of your health information, it will not invalidate uses and disclosures that have already been made at the time the permission is withdrawn. Your original permission will be good until December 31, 2060 if it’s not revoked.

Every effort will be made to ensure confidentiality of Protected Health Information (PHI), in accordance with Health Insurance Portability and Accountability Act (HIPAA). There’s a small risk that your information will be given to others without your permission.

Total confidentiality cannot be guaranteed, but we will limit disclosures of your health information, as described in the above question and answer. If the results of this research study are presented at meetings or in publications, your identity will not be included in the information that is disclosed. Government agencies or staff sometimes review studies such as this one to make sure they’re being conducted safely and legally. If a review of this study takes place, your records may be examined. The reviewers will protect your privacy, and the study records will not be used to put you at legal risk.

Your participation in the real-world data study is voluntary. If you change your mind, notify the study staff in writing at clinicaloperations@adaptivebiotech.com. If you withdraw permission to use your samples, no new testing will be done; however, the results of any tests already performed will remain in the study data. Your participation in this study may also be stopped at any time by the study doctor or the sponsor, without requiring your consent, for the following reasons:

• They deem that it is in your best interests; or
• You do not consent to continue in the study after being told of changes in the research that may affect you.

You will be told about any new information that might change your decision to be in the real-world data study. You may be asked to sign a new consent form if this occurs.

Please email the study staff at clinicaloperations@adaptivebiotech.com or Ctaromino@adaptivebiotech.com.

Phone: 206-600-6737 (24 hours)

For any of the following reasons:

• If you have any questions about the study or your part in it;
• If you feel you have had a research-related injury; or
• If you have questions, concerns or complaints about the research.

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

T-Detect is only available to those age 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 Lyme is a CLIA laboratory-developed test (LDT) and has not been cleared or approved by the U.S. Food and Drug Administration (FDA) for this intended use.

At this time, T-Detect is only available in the United States (not including United States Territories). T-Detect Lyme is not yet available in New York.

T-Detect COVID is available to be prescribed by healthcare professionals in all 50 states. 

T-Detect Lyme is available to be prescribed by healthcare professionals in all states except New York state; however, we are working to obtain New York regulatory approval. Sign up here to be notified when T-Detect Lyme is available in New York.

T-Detect is not available in United States Territories.

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 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 via online ordering. PWNHealth and its services are independent from the laboratory and company from which you requested and registered for T-Detect.