A standardized quantitative skin-test assay of allergen potency and stability: studies on the allergen dose-response curve and effect of wheal, erythema, and patient selection on assay results

Allergic Rhinitis and its Impact on Asthma (ARIA) 2008*

“…Methods differ in Europe (1636) and in the USA (1637). Each manufacturer defines specific units and concentrations and a whole range of noninterrelated names for specific units currently appear on the labels of marketed products (1638).…”

Evaluation of allergen vaccine potency

“…Once reference vaccines are assigned potency units, subsequent production batches can be compared to the reference by a parallel-line skin test bioassay or a suitably validated in vitro potency assay [6,17]. For those allergen products for which a major allergenic component has been identified and shown to be predictive of relative potency by bioassay, the unit content of these major allergens may serve as the basis for standardization.…”

“…The procedures must follow precise protocols, including patient selection criteria, medications to be withheld prior to skin testing, use of the correct skin test device and technique, and use of appropriate statistical analyses [5][6][7][8][9][10][11]. An underlying assumption for using BAUs or BUs as potency units for allergen vaccines is that their efficacy and safety are related to their allergenic activity.…”

“…The ID 50 EAL method (Intradermal Dilution for 50 mm sum of erythema diameters determines bioequivalent allergy units) is used for assigning potency units to reference preparations in the United States [5,6]. At least 15 highly sensitive adult subjects with a history of allergic disease related to exposure to the allergen of interest are initially selected.…”

Allergens ofAlternaria

“…2. are minor and perhaps intermediate allergens as well. The definition of these categories has been based upon RAST or RAST inhibition, quantitative skin tests (Bjorkstkn et al 1984, Turkletaub et al 1982) quantitative immunoelectrophoresis (Aukrust 1979) or combinations of the above (Ingemann & Venov 1984). Alt-1 is a common and important allergen but it is by no means the only one (Lowenstein 1980, Bush et al 1983, Budd et al 1983a.…”