Where to screen
AAb screening for those at risk of autoimmune T1D.
Where your patients can get screened
This may not be an exhaustive list of available screening options. The appropriateness of any AAb screening test and the validity of the test results are up to the requesting physician to determine.
| AVAILABLE SCREENING | WHERE | ELIGIBILITY |
|---|---|---|
Commercial labs1,2Blood draw |
|
|
Type 1 diabetes Screening CentralBlood draw or finger stick |
|
|
Online resources3Dried blood spot |
|
|
Autoimmunity Screening For Kids (ASK)4-6Blood draw or finger stick |
|
|
TrialNet1‡§II¶Blood draw or finger stick |
|
|
*
Quest Diagnostics also offers QuestHealth.com, which has its 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 2-45 years for first-degree relatives and 2-20 years for second-degree relatives.7
II
TrialNet will initially 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.8
¶
In screening, a 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 mIAA. IA-2A and ZnT8A will be measured in individuals positive for GADA.8
ADA Standards of Care recommendation: proactively screen at-risk patients for these 4 islet AAbs9#
GADA
Glutamic acid decarboxylase 65 AAb
GADA
Glutamic acid decarboxylase 65 AAb
IAA
Insulin AAb
IAA
Insulin AAb
IA-2A
Insulinoma-associated antigen 2 AAb
IA-2A
Insulinoma-associated antigen 2 AAb
ZnT8A
Zinc transporter-8 AAb
ZnT8A
Zinc transporter-8 AAb
According to the ADA Standards of Care, IA-2 AAb is an independent risk factor for T1D progression9
According to the ADA Standards of Care, IA-2 AAb is an independent risk factor for T1D progression.9
Varies depending on method of screening.
#Islet cell AAb (ICA) is also available for testing.10
AAb=autoantibody; ADA=American Diabetes Association; GADA=glutamic acid decarboxylase 65 autoantibody; IA-2A=insulinoma-associated antigen 2 autoantibody; ICA=islet cell autoantibody; mIAA=microinsulin autoantibody; T1D=type 1 diabetes; ZnT8A=zinc transporter-8 autoantibody.
Explore resources to support your patients
Find information on labs, screening options, and T1D research.
A comprehensive guide to early identification of patients at risk for T1D.
Research center dedicated to finding effective methods of prevention and treatment for diabetes.
An educational program for HCPs interested in T1D screening and monitoring programs.
Important Safety Information Anchor
IMPORTANT SAFETY INFORMATION
WARNING: Viral Reactivation
- Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia.
- Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD.
WARNINGS AND PRECAUTIONS
Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV have been reported with TZIELD. During and within 2 months of TZIELD treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV-associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk. The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia. Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., PCR testing). TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. During treatment with TZIELD, regularly monitor lymphocyte counts and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD and obtain viral load (e.g., PCR) promptly. If viral reactivation is confirmed, permanently discontinue TZIELD.
Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. CRS manifestations in TZIELD-treated patients included fever, nausea (with or without vomiting), fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment. 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. Obtain a CBC prior to starting TZIELD and monitor white blood cell counts during TZIELD treatment. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), permanently 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 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.
- Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
ADVERSE REACTIONS
Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea and headache.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm. To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy. Report pregnancies to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi
- 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 Boxed WARNING and patient selection criteria.
INDICATION
TZIELD (teplizumab-mzwv) is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 1 year of age and older with Stage 2 T1D.
REFERENCES
- Scheiner G, Weiner S, Kruger DF, et al. Screening for type 1 diabetes: role of the diabetes care and education specialist. ADCES Pract. 2022;10(5):20-25.
- ElSayed NA, Aleppo G, Aroda VR, et al. 2. Classification and diagnosis of diabetes: standards of care in diabetes—2023. Diabetes Care. 2023;46(supp 1):S19-S40.
- The role of autoantibodies in type 1 diabetes. Enable Biosciences. January 19, 2023. Accessed April 17, 2025. https://blog.enablebiosciences.com/2023/01/19/the-role-of-autoantibodies-in-type-1-diabetes/
- 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.
- Rewers M. ASK Study screening form. Autoimmunity Screening for Kids (ASK) Program. December 11, 2024. Accessed April 17, 2025. https://redcap.ucdenver.edu/surveys/?s=YLWCN8MT9R39
- Screening locations/options. Autoimmunity Screening for Kids (ASK) Program. Accessed April 17, 2025. https://www.askhealth.org/locations
- Participate. TrialNet. Accessed June 26, 2025. https://www.trialnet.org/participate
- Become a T1D detective. TrialNet. Accessed June 26, 2025. https://www.trialnet.org/hiddencodes
- American Diabetes Association Professional Practice Committee. Standards of care in diabetes—2026. Diabetes Care. 2026;49(suppl 1):S1-S371.
- 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.
- COMPASS Support START Form
- Call 1-844-778-2246 to speak with a TZIELD COMPASS representative
© 2026 Sanofi. All rights reserved. MAT-US-2503242-v3.0-04/2026
IMPORTANT SAFETY INFORMATION
INDICATION
IMPORTANT SAFETY INFORMATION
WARNING: Viral Reactivation
- Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia.
- Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD.
WARNINGS AND PRECAUTIONS
Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV have been reported with TZIELD. During and within 2 months of TZIELD treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV-associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk. The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia. Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., PCR testing). TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. During treatment with TZIELD, regularly monitor lymphocyte counts and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD and obtain viral load (e.g., PCR) promptly. If viral reactivation is confirmed, permanently discontinue TZIELD.
Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. CRS manifestations in TZIELD-treated patients included fever, nausea (with or without vomiting), fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment. 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. Obtain a CBC prior to starting TZIELD and monitor white blood cell counts during TZIELD treatment. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), permanently 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 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.
- Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
ADVERSE REACTIONS
Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea and headache.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm. To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy. Report pregnancies to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi
- 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 Boxed WARNING and patient selection criteria.
INDICATION
TZIELD (teplizumab-mzwv) is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 1 year of age and older with Stage 2 T1D.