|Wiesław Szymański, Anna Maria Rogalewska, Sabina Chyrek-Borowska, Irena Złotnik, Danuta Lenczewska |
Klinika Alergologii i Chorób Wewnętrznych Akademii Medycznej, ul. Skłodowskiej 24a, 15-276 Białystok
Guidelines of a joint IUIS/IAACI Allergen Standardization Committee influenced Polish manufactures to carry out standardization procedures of their allergenic extracts intended for both diagnostic and therapeutical goals. The aim of this study was to estimate the biological activity of allergenic pollen extracts (Intermediate product- IMP) and the collection of a pool of serum, used for further steps in in vitro standardization. Biological standardization based on determination of total allergenic potency of a given allergenic extract in comparison to histamine solution was conducted according to Nordic Guidelines. A selection of patients and individual steps of investigation were performed according to guidelines of the Dreborg's method. A concentration of allergen correlating with the activity of 10 000 BU/ml ( 10 HEP) was defined by the evaluation of geometric means of skin prick reactions from 23 patients by using a mathematical model of linear regression. Estimating by the statistical procedures median, reveals that the empirically investigated value of allergenic extracts was 12.25mg/ml. Therefore the estimated allergenic extract in a concentration of 12.25ľg/ml represents the same biological activity as is found in the solution of histamine in a concentration of 10 mg/ml relating to 10 000 BU/ml. Performed according to Nordic Guidelines, biological standardization is suitable for the evaluation of biological activity of allergenic extracts of pollen grains and it correlates with a previous clinical observations of these products.
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