Celiac Disease Serum

Celiac Disease Serum for Autoimmune Enteropathy Research

Our Celiac Disease Serum is sourced from IRB-consented donors clinically diagnosed with celiac disease. Each sample is processed and frozen within 24 hours of collection to preserve autoantibodies, cytokines, and other circulating analytes. Serum is acellular, and is the standard matrix for celiac serology.

Celiac Disease Autoimmunity and Why Serum

Celiac disease is an autoimmune enteropathy triggered by dietary gluten in genetically susceptible individuals. It is unusual among autoimmune diseases in having a known environmental trigger and a well-characterised antigen:

  • HLA restriction is near-absolute. Essentially all patients carry HLA-DQ2 or HLA-DQ8, which present deamidated gluten peptides to CD4+ T cells; HLA typing therefore has strong negative predictive value
  • Transglutaminase 2 is both enzyme and autoantigen. It deamidates gliadin peptides to increase their DQ2/DQ8 affinity, and is itself the target of the disease-defining autoantibody response
  • Serum autoantibodies are the diagnostic backbone: IgA anti-transglutaminase 2, IgA anti-endomysial antibodies, and antibodies to deamidated gliadin peptides
  • Selective IgA deficiency is an important caveat — it is over-represented in celiac disease and causes false-negative IgA-based serology, so total IgA and IgG-class assays matter for cohort design
  • Small-intestinal pathology is villous atrophy with crypt hyperplasia and intraepithelial lymphocytosis, graded on the Marsh classification; intraepithelial lymphocyte activation is IL-15 dependent
  • Serology normalises on a gluten-free diet, which makes diet adherence and treatment status decisive variables when selecting donors for antibody-positive cohorts

Donor Stratification Available

  • Diet status: gluten-containing diet versus established gluten-free diet
  • Anti-transglutaminase 2 antibody status and titre category where clinically tested
  • HLA-DQ2 and HLA-DQ8 genotype where available
  • Biopsy-confirmed versus serology-based diagnosis, with Marsh grade where documented
  • Symptom pattern, including classical gastrointestinal, extraintestinal, or asymptomatic presentation
  • Coexisting autoimmune conditions such as type 1 diabetes or autoimmune thyroid disease
  • Age at diagnosis, sex assigned at birth, and race/ethnicity
  • Matched healthy controls available

Product Features

  • Collected from clinically confirmed celiac disease donors
  • Processed and frozen within 24 hours of collection
  • Research Use Only (RUO)
  • Standard and custom aliquot volumes available
  • IRB-approved protocols with documented consent

De-identified Donor Data

  • Diagnosis confirmation, including method of diagnosis where documented
  • Age, sex assigned at birth, and ethnicity
  • Donor-reported allergy and infectious disease history
  • Diet adherence, serology results, and comorbidities available on request

Applications

  • Anti-transglutaminase 2, anti-endomysial, and deamidated gliadin peptide antibody assay development
  • Diagnostic immunoassay validation, calibration, and reference panel construction
  • IgA-deficient and IgG-class serology method development
  • Autoantibody titre and diet-response longitudinal studies
  • Cytokine and inflammatory mediator profiling
  • Intestinal permeability and barrier marker research
  • Proteomic and metabolomic biomarker discovery
  • Therapeutic candidate screening and gluten-challenge study support

Other Celiac Disease Specimen Types

Compliance and Quality Assurance

  • IRB-approved and HIPAA-compliant protocols
  • Electronic informed consent with 21 CFR Part 11-compliant e-signatures
  • Documentation support available for regulatory review

Ordering and Customization

Celiac disease serum is available in standard and custom volumes. For pricing, international orders, or documentation requirements, please email learnmore@sanguinebio.com to ensure compatibility with your country’s regulations. For healthy-donor controls and the full specimen range, see our human serum collection.

Protocols & Documentation

  • Serum Isolation

    Protocol for serum preparation from whole blood, including collection handling, clarification, and quality documentation.

    Download
  • Informed Consent Form (ICF)

    Available upon request — confirms donor consent for research use and downstream commercialization.

Serum

Frequently Asked Questions

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Are samples IRB approved?

1 Answer

YES – All collections are conducted under IRB-approved protocols and electronic informed consent. Sanguine utilizes Advarra and WCG IRB for oversight.

YES – all our products are research use only (RUO).

Storage depends on sample type but often cryopreserved samples stored in liquid nitrogen can be stored for years.

Extensive customization is available. To discuss your project request a quote or email us at learnmore@sanguinebio.com.

Sanguine offers flexible prospective collection services tailored to fit your research. For more information and to request a quote, please see: our prospective biospecimen collection services page.

Timelines depend on condition, sample type, and I/E criteria but we often start collection within 2 weeks of signed agreement.

YES – we have in-stock inventory. You can also email us at learnmore@sanguinebio.com as we continually get new samples in our inventory.

Each sample from a different individual – Unique donor means each sample comes from a different person, ensuring biological diversity in your study.

YES – Unique donors can be specified and guaranteed based on your requirements.

For information about sample quality, please see: Quality and Compliance

YES – “IRB-approved collection protocols” and IRB approval documentation available upon request. Sanguine utilizes two internationally-recognized IRBs (Advarra and WCG IRB) for review and approval.

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Need a custom Serum cohort?

Our scientific team can scope prospective collections with donor-specific I/E criteria, typically starting within 2 weeks of agreement.

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