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ASK: free autoimmunity screening for US children and adults

What this study tests

A free US research screening program for children aged 1–17 and adults, with or without a family history of T1D or celiac disease. Colorado appointments, mailed Labcorp collection kits and an at-home option are described by the program.

Editorial review: .

Source dates appear in the references where available; this record has no dated citation metadata.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
US children aged 1–17 and adults can use the free research screening program, with or without a family history of T1D or celiac disease. Positive tests require confirmation and follow-up; consult the program for current instructions.Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
In the original celiac report, 242 of the first 9,973 children screened were positive for tissue-transglutaminase autoantibodies by either assay. Of those, 185 returned for confirmation and 149 were positive by the radiobinding assay; these are autoantibody results, not 149 confirmed clinical celiac diagnoses. A separate 6-Plex assay study used 880 samples from 828 children. Its abstract reports agreement in 35/37 children who later developed T1D, but its full Results reports 37/39. Both report 105/119 in a high-risk subgroup, while defining that subgroup differently. These unresolved discrepancies and selected samples prevent treating those ratios as current population screening yield or a randomized DKA benefit.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Published celiac screening study: initial tissue-transglutaminase autoantibody positivity and confirmation by radiobinding assay
  • Published 6-Plex validation study: antibody-assay agreement in selected samples, including children who subsequently developed T1D

The full picture

Program and access

ASK is a research screening program run by the Barbara Davis Center at the University of Colorado Anschutz Medical Campus. Its current website offers free T1D and celiac screening to US children aged 1–17 and adults, with or without a family history. It lists COMIRB approval 14-0553; ethics approval and trial registration are separate matters.5

The program describes Colorado appointments, a mailed collection kit for a Labcorp draw for people more than 30 miles from screening sites, and an at-home option. Families should follow the operator’s current instructions.2

What the published studies show

The first celiac screening report included 9,973 children: 242 initially had tissue-transglutaminase autoantibodies, 185 returned for confirmation, and 149 were confirmed positive by the radiobinding assay. A positive antibody test is not by itself a confirmed clinical diagnosis of celiac disease.3

The 6-Plex assay validation analyzed 880 serum samples from 828 children aged 1–17. Its abstract reports assay agreement in 35/37 children who later developed T1D, whereas the full Results reports 37/39. Both report agreement in 105/119 high-risk children, but the abstract describes multiple-autoantibody children while the full Results includes children with multiple antibodies or later T1D. These internal discrepancies remain unresolved. The selected validation samples do not establish general-population prevalence or the current program’s screening yield.4

ASK combines screening with education and follow-up. The program aims to identify disease early and help families prepare. The two reports summarized here do not provide a randomized estimate of DKA reduction, and no such numerical benefit is inferred from them.534

Sources

  1. [1]
    ASK Research Program: eligibility and screening · Open-source community — Program operator; current access checked 16 September 2026.
  2. [2]
    ASK: screening locations and at-home options · Open-source community

    ASK Research Program. Screening locations and options.

  3. [3]
    Mass Screening for Celiac Disease: The Autoimmunity Screening for Kids Study · Peer-reviewed study

    Stahl MG, et al. Mass Screening for Celiac Disease: The Autoimmunity Screening for Kids Study. American Journal of Gastroenterology (2021).

  4. [4]
    High-Throughput Multiplex Electrochemiluminescence Assay Applicable to General Population Screening for Type 1 Diabetes and Celiac Disease · Peer-reviewed study

    He L, et al. High-Throughput Multiplex Electrochemiluminescence Assay Applicable to General Population Screening for Type 1 Diabetes and Celiac Disease. Diabetes Technology & Therapeutics (2022).

  5. [5]

    ASK Research Program. About us: eligibility, operator, study group, funding and COMIRB approval. https://www.askhealth.org/about-us