Standardization Of Allergenic Extracts

The need to standardize allergenic extracts has been recognized for many years. Variability in antigen composition and concentration is a major problem in both allergy testing and allergen immunotherapy regimens. Without standardization of extracts, there is no accurate system of quality control. The clinician often is forced to alter immunotherapy schedules with each new vial of extract because of lot-to-lot variability. Each allergen extract supplier uses its own assays and rarely compares specific antigen concentrations with competitors. The result of this disparity is that the clinician must bring more art than science to the field of allergen immunotherapy. Fortunately, this is changing, with the requirement for standardization of ragweed pollen, house dust mite, cat dander, and grass pollen extracts. The development of purified and even cloned allergens that can be expressed in bacteria or yeast hosts have allowed the production of vast quantities of allergen extract with little or no variance between batches (25,26,27,28,29 and 30). With investigators, clinicians, and government agencies that license extracts demanding improved standardization, it is expected that more progress in this area of allergy will be made in the near future.

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