Modification of Determination Method for Staphylococcus Alpha Antitoxin in Human Plasma for Fractionation, II + III Precipitate and Immunoglobulin Preparations

Complex treatment of staphylococcal infection is carried out using normal immunoglobulins, antistaphylococcal immunoglobulin, and immunospecific plasma. Their effectiveness depends on the concentration of staphylococcus alpha antitoxin. This indicator is determined in immunoglobulin preparations and in the plasma used for their production. During the production process, the potency of the intermediate – II+III precipitate – should be precisely evaluated. The existing method for determining staphylococcus alpha antitoxin is intended for monitoring the quality of plasma for fractionation, determination of normal and specific human immunoglobulins. The information about the possibility of its use for testing II+III precipitate is currently lacking. The task of increasing the accuracy and extending the application scope of the existing method for determining staphylococcus alpha antitoxin for testing II + III precipitate appears highly relevant. In this study, we aimed to modify the method for determining staphylococcus alpha antitoxin in plasma for fractionation, II+III precipitate and immunoglobulin preparations. The assessment of the potency was carried out in accordance with Pharmacopoeia. The method of quantitative determination of staphylococcus alpha antitoxinin human plasma for fractionation, II+III precipitate and readymade immunoglobulin preparations was modified. The range of optical density values at the stage of setting the limit of the hemolytic effect of the toxin was determined. The conditions for testing II+III precipitate were selected. A dilution scheme of the samples with a discreteness of 1 IU/ml was proposed. The specificity of antibody detection in samples was confirmed. The convergence linearity and correctness of the modified method was established. The implemented modification of the method extended the scope of its application due to the possibility of testing II+III precipitate. The accuracy of assessing the content of staphylococcus alpha antitoxin was increased by reducing the discreteness of determination and eliminating the subjectivity of visual assessment of the limit of the hemolytic action of the toxin. The result of determination of metrological characteristics showed the suitability of the modified method for quality control of raw materials and finished products.

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