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Screening options

Autoantibody (AAb) screening for those at risk of autoimmune T1D.

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A young girl wrapping her hand around her dad's arm and smiling

Where your patients can get screened

This may not be an exhaustive list of available screening options. The appropriateness af any AAb screening test and the validity of the test results are up to the requesting physician to determine.

AVAILABLE SCREENING WHERE ELIGIBILITY

Commercial Labs1,2

Blood draw
  • Commercial lab (eg, Labcorp, Quest Diagnostics)* or HCP’s office
  • Patients and providers receive results
  • Any individual with a valid script from a licensed HCP
  • Cost based on insurance coverage
  • Most insurance plans cover some or all of the patient cost

Type 1 diabetes Screening Central

Blood draw or finger stick

Visit bit.ly/4cBt3E1
  • Home screening kits to be sent to patients from Screening Central telemed practitioner; if appropriate, labs can also be ordered
  • Telehealth appointments available (optional)
  • Commercially insured patients only
  • Costs are variable based on service

Visit bit.ly/4cBt3E1

Online ordering3,4

Dried blood spot
  • Testing kits from vendors (eg, Enable Biosciences†: clinical@enablebiosciences.com)
  • Patients and providers received results
  • Individuals regardless of family history of T1D
  • May be processed and covered by insurance

Autoimmunity Screening For Kids (ASK)5-7

Blood draw or finger stick

Visit Autoimmunity Screening for Kids
  • At Barbara Davis Center for Diabetes or other Colorado locations
  • Home screening kits
  • Patients and/or providers receive results
  • Individuals aged 1 or older, regardless of family history of TID
  • No out-of-pocket costs

Visit Autoimmunity Screening for Kids

Quest health8,9

Blood draw

Visit Quest Health
  • In-person at Quest patient service centers
  • You must be 18 years of age or older to purchase a test on QuestHealth.com. This test requires specimen collection at a Quest Diagnostics location.
  • Collection not available in AK, AZ, or HI.

Visit Quest Health

TrialNet1द

Blood draw or finger stick

Visit Type 1 Diabetes TrialNet
  • TrialNet location, event, or health fair
  • Patient may also administer a kit at home or bring it to Labcorp or Quest Diagnostics
  • Only patients receive results
  • Only for those individuals with a family history of T1D with certain age restrictions or those who already tested positive through another program
  • No out-of-pocket costs

Visit Type 1 Diabetes TrialNet

*

Quest Diagnostics also offers QuestHealth.com, which has it's own eligibility criteria and testing protocol (see website for more information).

†

Enable Biosciences is not available in the state of New York.

‡

TrialNet has an age limit of 2.5-45 years for first-degree relatives and 2.0-20 years for second-degree relatives.

§

TrialNet will intially test for 2 AAbs. If 1 or more AAbs are found with the first test, additional testing may be done to screen for other AAbs.

In screening, a simple blood test is done for the presence of diabetes-related biochemical AAbs (GADA and mIAA). Additional AAbs ICA, IA-2A, and ZnT8A will also be measured in individuals positive for microinsulin autoantibody (mIAA), ICA, IA-2A, and ZnT8A will be measured in individuals positive for GADA.

Download AAb screening options

The American Diabetes Association (ADA) recommends screening at-risk patients for 4 islet AAbs2,11*

GADA

Glutamic acid decarboxylase 65 AAb

IAA

Insulin AAb

IA-2A

Insulinoma-associated antigen 2 AAb

ZnT8A

Zinc transporter-8 AAb

Varies depending on method of screening.

*Islet cell AAb (ICA) is also available for testing.11,12

How to screenWho to screen

Screening resources

The following handbook and 3rd party websites have more information about screening and how to get screened. This is not an exhaustive list.

A droplet with a checkmark on it
Type 1 Diabetes Screening Handbook

A comprehensive guide to early identification of patients at risk for T1D.

Download handbook
A care center
Barbara Davis Center for Diabetes

Research center dedicated to finding effective methods of prevention and treatment for diabetes.

Barbara Davis Center for Diabetes
A droplet with a no symbol over it
Stop T1D Program

An educational program for HCPs interested in T1D screening and monitoring programs.

Stop T1D Program

Important Safety Information Anchor

INDICATION

TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
  • Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
  • Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
  • Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
  • Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.
    • Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
    • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.

ADVERSE REACTIONS

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm.
  • Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Please see full Prescribing Information, including patient selection criteria, and Medication Guide. View Important Safety Information page.

REFERENCES

  1. Scheiner G, Weiner S, Kruger DF, Pettus J. Screening for type 1 diabetes: Role of the diabetes care and education specialist. ADCES Pract. 2022;10(5):20-25.
  2. American Diabetes Association Professional Practice Committee. Diagnosis and classification of diabetes: standards of care in diabetes—2025. Diabetes Care. 2025;(48)(Suppl 1):S27-S49.
  3. Screening Central. Frequently asked questions. Accessed March 31, 2025. https://type1test.labpass.com/en/faq
  4. Enable Biosciences. The role of autoantibodies in type 1 diabetes. Published January 2023. Accessed July 17, 2024. https://blog.enablebiosciences.com/2023/01/19/the-role-of-autoantibodies-in-type-1-diabetes/
  5. Enable Biosciences. Type 1 testing. Accessed July 17, 2024. https://type1testing.enablebiosciences.com/
  6. McQueen RB, Geno Rasmussen C, Waugh K, et al. Cost and cost-effectiveness of large-scale screening for type 1 diabetes in Colorado. Diabetes Care. 2020;43(7):1496-1503.
  7. ASK. Study screening form. Accessed July 17, 2024. https://redcap.ucdenver.edu/surveys/?s=YLWCN8MT9R39
  8. ASK. Screening locations. Accessed July 17, 2024. https://www.askhealth.org/locations
  9. Quest Diagnostics. In-home sample collection. Accessed March 31, 2025. https://www.questhealth.com/product/quest-mobile-in-home-sample-collection-12043M.html
  10. Quest Diagnostics. Prepare for a test. Accessed March 31, 2025. https://www.questdiagnostics.com/patients/get-tested/prepare
  11. TZIELD Prescribing Information. Provention Bio, Inc; 2023.
  12. Phillip M, Achenbach P, Addala A, et al. Consensus guidance for monitoring individuals with islet autoantibody‑positive pre‑stage 3 type 1 diabetes. Diabetes Care. 2024;47(8):1276-1298.
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© 2025 Sanofi. All rights reserved. MAT-US-2503242-v1.0-04/2025

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
  • Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
  • Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
  • Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
  • Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.
    • Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
    • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.

ADVERSE REACTIONS

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm.
  • Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Please see full Prescribing Information, including patient selection criteria, and Medication Guide. View Important Safety Information page.