Chronic Spontaneous Urticaria Serum

Human Chronic Spontaneous Urticaria Serum for Mast Cell Research

Our Chronic Spontaneous Urticaria (CSU) Serum is sourced from IRB-consented donors clinically diagnosed with chronic spontaneous urticaria. Each sample is processed and frozen within 24 hours of collection to preserve labile mediators and keep handling consistent from lot to lot. Serum is acellular, and it holds a particular importance in CSU research because donor serum itself carries the factors that activate mast cells and basophils in functional bioassays.

Why CSU Serum for Mast Cell Research

Chronic spontaneous urticaria is fundamentally a mast cell-driven disease. Cutaneous mast cells degranulate without an identifiable external trigger, releasing histamine and other preformed and newly generated mediators that produce the characteristic weals, flare and pruritus, with angioedema in a substantial proportion of patients. Understanding what drives that degranulation is the central question in the field, and serum is where the candidate drivers circulate.

  • Histamine and mast cell mediators — histamine release is the proximate cause of the weal and itch, and the therapeutic dominance of H1-antihistamines follows directly from this.
  • Tryptase and mast cell burden — serum tryptase reflects mast cell mass and activation and is a standard readout in mast cell disorders.
  • Recognised endotypes — a type I autoallergic endotype involves IgE directed against autoantigens such as IgE anti-thyroid peroxidase, while a type IIb autoimmune endotype involves IgG autoantibodies against FcεRI or IgE; both are recognised subtypes rather than the single mechanism of the disease.
  • Functional serum bioassays — because the activating factors are soluble, donor serum can be applied to indicator basophils or mast cells in basophil histamine release and basophil activation test formats, an application unique to this specimen.
  • Coagulation and complement crosstalk — activation of the extrinsic coagulation pathway and complement products including C5a have been implicated in amplifying mast cell activation and are measurable in the acellular compartment.
  • Type 2 and inflammatory mediators — IL-4, IL-5, IL-13, IL-31 and related mediators support biologic programmes targeting IgE, FcεRI signalling and the type 2 axis.

Donor Stratification Available

  • Endotype markers — donors with IgG anti-FcεRI or anti-IgE reactivity (type IIb autoimmune) and donors with IgE anti-TPO reactivity (type I autoallergic), subject to documentation
  • Clinical features — weals alone versus weals with angioedema; disease duration and reported severity scores where captured
  • Total IgE status — high, normal and low total IgE donors, relevant to anti-IgE biologic response research
  • Associated serology — donors with concurrent thyroid autoantibody positivity or documented autoimmune thyroid disease
  • Treatment status — antihistamine-responsive, antihistamine-refractory, anti-IgE biologic-treated, and immunosuppressant-treated donors; inducible urticaria comparator donors on request
  • Matched healthy controls available, drawn on the same protocol and matched for age, sex and ethnicity

Product Features

  • Collected from clinically confirmed chronic spontaneous urticaria donors
  • Research Use Only (RUO)
  • Processed and frozen within 24 hours of collection
  • IRB-approved protocols with documented consent
  • Standard and custom aliquot volumes; volumes reported per lot

De-identified Donor Data

  • Diagnosis confirmation
  • Age, sex assigned at birth, and ethnicity
  • Donor-reported medical history and comorbidities
  • Treatment response and angioedema history reported per lot where captured
  • Additional CSU-specific clinical fields available on request

Applications

  • Basophil activation test and basophil histamine release assay development using donor serum
  • Mast cell degranulation and mediator release assays with serum as the activating input
  • Tryptase and histamine metabolite quantification
  • Anti-FcεRI and anti-IgE autoantibody detection and endotype classification
  • IgE anti-TPO and total IgE serology development
  • Complement and coagulation pathway crosstalk studies
  • Multiplex cytokine and chemokine profiling in mast cell-driven disease
  • Pharmacodynamic and target engagement readouts for anti-IgE, FcεRI-signalling and mast cell-directed therapeutics

Other Chronic Spontaneous Urticaria 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 & Customization

Chronic spontaneous urticaria 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. To compare collection formats or check wider availability, visit our human serum page.

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?

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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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