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Related Experiment Video

Updated: Sep 5, 2025

Symptom Assessment of Patients with Allergic Rhinitis Using an Allergen Exposure Chamber
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Standardized allergen extracts for allergen immunotherapy.

Harold S Nelson

    Allergy and Asthma Proceedings
    |July 12, 2022
    PubMed
    Summary

    Nineteen U.S. allergen extracts were standardized by the FDA, improving consistency and safety. Standardized allergen immunotherapy extracts ensure reliable potency and efficacy for allergy treatment.

    Area of Science:

    • Allergen immunotherapy
    • Pharmacology
    • Immunology

    Background:

    • Allergen extracts are crucial for allergy diagnosis and treatment.
    • Lack of standardization previously led to variability in potency and efficacy.

    Purpose of the Study:

    • To describe the standardization process for U.S. allergen extracts by the FDA.
    • To outline the methods used to ensure lot-to-lot consistency and comparability.

    Main Methods:

    • Established "representative" extracts for 19 different allergens.
    • Determined extract potency using total protein, radial diffusion, or intradermal dilution (ID50EAL) assays.
    • Developed in vitro tests (radial immunodiffusion, ELISA, isoelectric focusing) for lot release.

    Main Results:

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    • Standardized extracts ensure consistent potency across different batches and manufacturers.
    • Standardization guarantees the presence of significant allergens within extracts.
    • Developed validated in vitro assays for quality control.

    Conclusions:

    • Standardized allergen extracts offer improved safety and efficacy compared to non-standardized ones.
    • This standardization facilitates more reliable allergen immunotherapy.
    • Ensures consistent quality for U.S. allergen extracts.