T1D associated autoantibody screening assay information
This assay provides a qualitative assessment of four (4) T1D-associated autoantibodies, (GAD65, IA2, IAA and ZnT8). The samples are analyzed using the enzyme-linked immunosorbent assay (ELISA) technique.
Clinical utility of the T1D associated autoantibody screening assay:
- The screening test is performed using a small sample of capillary blood
- Results can facilitate detection of early-stage autoimmune T1D, enabling proactive monitoring and management by HCPs
For performance data and specifications, contact genomics@revvity.com to speak with the lab director.
About autoimmune type 1 diabetes (aT1D)
Autoimmune T1D is a condition characterized by the immune system's progressive destruction of insulin-producing beta cells in the pancreas, resulting in lifelong exogenous insulin-dependance.5,8,9 Autoantibodies associated with the development of aT1D include:1
- Insulin autoantibody (IAA)
- GAD autoantibody (GADA)
- Insulinoma antigen-2 autoantibody (IA-2A)
- Zinc transporter type 8 autoantibody (ZnT8A)
Detection of one or more of these autoantibodies prior to the clinical diagnosis of aT1D can indicate an increased risk of the development of aT1D, as well as early stages of the disease.8
Staging autoimmune T1D
Autoimmune T1D begins months or years before the onset of symptoms and hyperglycemia, and is classified by three distinct stages.2,8 Stage 1 and Stage 2 represent early-stage presymptomatic aT1D. In these stages, individuals have two or more aT1D-associated islet autoantibodies. In stage 1, glucose levels are within normal range, however, individuals in stage 2 experience dysglycemia. Stage 3 is when symptoms appear, hyperglycemia is observed and a clinical diagnosis typically takes place.8
Proactive screening in early aT1D helps to identify individuals who may be at risk.3,4
Who should be screened for early-stage aT1D?
Certain groups of people may be at increased risk for aT1D and should be considered a priority for screening:
- First-degree relatives (FDR) and second-degree relatives (SDRs) of someone with aT1D, such as a parent, sibling, child, grandparent, cousin10,11
- Patients diagnosed with any autoimmune condition, particularly celiac disease and thyroid disease9
- Those with a family history of autoimmune diseases9
- Patients who may have been previously diagnosed with type 2 diabetes or pre-diabetes, but their clinical features or response to treatment could suggest autoimmune T1D9
- Screening in the general population, especially children, will help identify people with presymptomatic disease but no family history of aT1D or autoimmune disease. This is important, given that 90% of autoimmune T1D cases are in individuals without a family history of diabetes.12,13
Benefits and considerations of early detection
Benefits
Early screening can identify individuals at risk before severe symptoms appear, allowing for earlier planning and monitoring. This proactive approach may help prevent critical illness and manage the condition more effectively from the outset.11 It also reduces the trauma of an acute diagnosis for patients and families.14,15
aT1D frequently presents with preventable life-threatening complications, such as diabetic ketoacidosis (DKA), which can lead to hospitalization, severe psychological impact, serious health consequences and may lead to poorer cognitive development, especially when it occurs in childhood.16 Early detection can reduce the rate of DKA from approximately 50% among patients who don’t undergo screening to less than 5% in screened populations.12,16,17 This is particularly important given that DKA at the onset of T1D is associated with increased mortality risk, longer hospitalizations, higher insulin requirements, shorter remission period, and worse glycemic control over time.8
Early diagnosis of aT1D positively affects longevity and decreases morbidity, all while having a significant positive impact on the quality of life and mental health of patients and their families.4,18
Other potential benefits of earlier diagnosis include:
- Lower risk of DKA at diagnosis as well as ongoing monitoring to allow healthcare professionals to intervene prior to development of DKA14,19
- Reduced emotional burden related to diagnosis through counselling and education to help improve quality of life and address potential feelings of stress, anxiety, and other psychological issues15,19,20
- Opportunity for parents and caregivers time to prepare for disease progression19
- Fewer long-term complications, including hypoglycemia, retinopathy, nephropathy, and neuropathy8
- Improve access to care, including opportunity to participate in future intervention trials4
Considerations
Some individuals and families may experience anxiety when considering screening, especially when waiting for or receiving results. This can be mitigated with education and counselling. Studies have shown that early identification of aT1D in children in conjunction with education may reduce parenting stress at diagnosis compared to a sudden aT1D diagnosis at stage 3.18
References
- Kawasaki E. Anti-Islet Autoantibodies in Type 1 Diabetes. Int J Mol Sci 2023;24(12):10012.
- Couper JJ, et al. ISPAD clinical practice consensus guidelines 2018: Stages of type 1 diabetes in children and adolescents. Pediatr Diabetes 2018;19(Suppl 27):20–7.
- Barker JM, et al. Clinical characteristics of children diagnosed with type 1 diabetes through intensive screening and follow-up. Diabetes Care 2004;27(6):1399–404.
- Elding Larsson H, et al. Reduced prevalence of diabetic ketoacidosis at diagnosis of type 1 diabetes in young children participating in longitudinal follow-up. Diabetes Care 2011;34(11):2347–52.
- Besser REJ, et al. ISPAD Clinical Practice Consensus Guidelines 2022: Stages of type 1 diabetes in children and adolescents. Pediatr Diabetes 2022;23(8):1175–87.
- Mastronardi CA, et al. The use of dried blood spot sampling for the measurement of HbA1c: a cross-sectional study. BMC Clin Pathol 2015;15:3.
- Mathew TK, et al. Blood Glucose Monitoring. [Updated 2023 Apr 23]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available at: ncbi.nlm.nih.gov/books/NBK555976. Accessed February 27, 2025.
- Insel RA, et al. Staging Presymptomatic Type 1 Diabetes: A Scientific Statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care 2015;38(10):1964–74.
- Holt RIG, et al. The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2021;44(11):2589–625.
- Ekoe J-M, et al. Screening for Diabetes in Adults. Can J Diabetes 2018; 42:S16–9.
- TrialNet. TrialNet Recommendations for Clinicians. Available at: trialnet.org/healthcare-providers. Accessed July 12, 2024.
- Sims EK, et al. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes 2022;71:610–23.
- Karges B, et al. A comparison of familial and sporadic type 1 diabetes among young patients. Diabetes Care 2021;44(5):1116–24.
- Muñoz C, et al. Misdiagnosis and diabetic ketoacidosis at diagnosis of type 1 diabetes: Patient and caregiver perspectives. Clin Diabetes 2019;37(3):276–81.
- Juvenile Diabetes Research Foundation. Modeling the total economic value of novel type 1 diabetes (T1D) therapeutic concepts. January 2020. Available at: t1dfund.org/wp-content/uploads/2020/02/Health-Advances-T1D-Concept-Value-White-Paper-2020.pdf. Accessed February 2024.
- Simmons KM, Sims EK. Screening and prevention of type 1 diabetes: Where are we? J Clin Endocrinol Metab 2023;108:3067–79.
- Alonso GT, et al. Diabetic ketoacidosis at diagnosis of type 1 diabetes in Colorado children, 2010–2017. Diabetes Care 2020;43:117–21.
- Smith LB, et al. Family adjustment to diabetes diagnosis in children: Can participation in a study on type 1 diabetes genetic risk be helpful? Pediatr Diabetes 2018;19(5):1025–33.
- Scheiner G, et al. Screening for type 1 diabetes: Role of the diabetes care and education specialist. ADCES in Practice 2022;10(5):20–5.
- Moore DJ, et al. Recommendations for Screening and Monitoring the Stages of Type 1 Diabetes in the Immune Therapy Era. Int J Gen Med 2024;17:3003–14.
How to order
Step 1
Test selection and place order
Step 2
Specimen collection and shipment
Step 3
Get results
How to order
1. Test Selection and Place order with Revvity
- Complete the Revvity Test Requisition Form.
- Please make sure that all sections are completed and that the patient has signed the informed consent form
2. Specimen collection and Shipment
Sample collection options:
Collection by the health care provider
- Familiarize yourself and the patient with the DBS sample collection card. Step-by-step instructions for collecting a DBS sample can be found here.
- If you do not have a kit available in your office, please contact us here and we can have one or more sent out to your office at no cost. You should receive the kit(s) within 72 hours.
- Obtain a sample for testing from the patient using one of the provided Revvity Omics test packs.
- Ensure that the patient sample is labelled with the patient’s name and date of birth.
- Package the patient sample, informed consent form, and test requisition form back into the test kit.
Sample Collection coordinated by Revvity Omics
- On the requisition form you can request Revvity Omics coordinate sample collection via patient service centre local lab or mobile phlebotomy.
- Revvity Omics will arrange for sample collection through a Canadian lab partner. The lab partner will reach out to your patient to schedule an appointment for phlebotomy. For lab collection or mobile phlebotomy, a DBS kit is mailed to the patient ahead of their appointment, or you can provide the patient with a kit if you have one in stock.
- The sample will be shipped to Revvity Omics by the lab partner facilitating the sample collection. Utilize the shipping instructions included in the kit to create a shipping label and ready the package for shipping.
3. Get Results
Results will be emailed or faxed to you by Revvity within 10 business days after the sample and completed test requisition form and informed consent form have been received by Revvity Omics.
Results can also be accessed through your Revvity Omics Portal account.
To request access to the Revvity results portal, click here.
- What sample collection types are available through mobile phlebotomy?
Dried Blood Spot (DBS) sample collection is available through mobile phlebotomy. At the time-of-service request by the provider, a DBS sample pack will be sent to the patient ahead of the mobile phlebotomy appointment, or you can provide the patient with a pack if you have one in stock.
- Is there any cost for in-lab or mobile phlebotomy to the patient?
No, there are no costs to you or your patients for any sample collection or shipping.
- What are the days/hours of availability for appointments, and are there any regions in Canada that are excluded?
Appointments can be scheduled Monday-Friday. Hours will depend on the type and location of sample collection. Please call Revvity Omics Customer Support for more information: 1 866-354-2910. Phlebotomists are available throughout Canada, but some rural areas may need additional time for scheduling.
- What if the lab partner is unable to get in touch with the patient to schedule the appointment?
The lab partner will make 3 attempts to reach the patient. If they are unable to get in touch with the patient to schedule an appointment, they will contact the provider requesting the service to discuss further steps.
- What does the patient need to provide at the time of appointment?
The patient will be asked to provide identification to the examiner and will need to have on-hand the DBS collection pack that was mailed or given to them in advance.
- Can the appointment be rescheduled?
Yes, once an appointment is scheduled, the lab partner will provide a scheduling coordinator’s number to use for any scheduling needs before the appointment. If any issues arise during the appointment that the lab partner is unable to immediately resolve, they will notify Revvity Omics of the unsuccessful collection and determine how to move forward. The appointment can be re-scheduled if necessary.
The UncoverT1D Early Detection Program is sponsored by sanofi aventis Canada Inc., with testing services provided by Revvity Omics, Inc. in Pittsburgh, PA. Testing can be ordered at no-cost for eligible individuals by health care providers. This program is sponsored to address unmet testing needs in the autoimmune T1D early detection space in Canada.
The UncoverT1D Early Detection Program is not intended to and should not interfere in any way with a healthcare professional's or patient's independent judgment and freedom of choice. Healthcare professionals and patients should always consider the full range of testing and treatment options and select those most appropriate for the individual patient.
Any requests or questions regarding the testing services offered through the UncoverT1D Early Detection Program should be directed to Revvity by email at genomics@revvity.com or by phone at 1-866-354-2910.
The content provided is for informational purposes only and is not a substitute for professional medical advice, diagnosis or treatment.
This testing service has not been cleared or approved by the U.S. Food and Drug Administration. Testing services may not be licensed in accordance with the laws in all countries. The availability of specific test offerings is dependent upon laboratory location. The content on this page is provided for informational purposes only, not as medical advice. It is not intended to substitute the consultation, diagnosis, and/or treatment provided by a qualified licensed physician or other medical professionals.