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Determination of the stability of diluted allergen extracts using a concentration step prior to EAST inhibition

机译:Determination of the stability of diluted allergen extracts using a concentration step prior to EAST inhibition

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SummaryBackgroundGenerally the stability of diluted allergen extracts, as used for skin testing, provocation testing und immunotherapy can not be tneasured using a normal enzyme allergosorbent test (EAST) inhibition method.ObjectiveThe aim of this study was to determine the stability of diluted allergen extracts using an ultrafiltration step prior to the standard EAST inhibition procedure, in which the allergen extract was concentrated 100‐fold.MethodsThis eoncentration procedure was validated forDermatophagoides pteronyssinus, timothy pollen, birch pollen and cat dander extraets and used in a stability study in which three batches were stored for 1 year al 6° C and 25° C.ResultsThere was no difference in relative potency before and after concentration of birch and timothy pollen extracts.D. pteronyssinusand cat dander extracts showed a significant decrease of 25 and 35 of the relative potency after concentration. The mean coeffieient of variation of 12 determinations of the stability study was 11.8.ConclusionFor all allergens the 30BU/mL or approximately 0.00025 mg/mL solution was stable for 12 months at both temperatures, except for D.pteronyssinuswhich declined rapidly at 2

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