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


N. R. Niemeijer, ALK Benelux, PO Box 1518, 9701 BM Groningen. The Netherlands.


Background Generally 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.

Objective The 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.

Methods This eoncentration procedure was validated for Dermatophagoides 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.

Results There was no difference in relative potency before and after concentration of birch and timothy pollen extracts. D. pteronyssinus and 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%.

Conclusion For all allergens the 30BU/mL or approximately 0.00025 mg/mL solution was stable for 12 months at both temperatures, except for D. pteronyssinus which declined rapidly at 25°C.