Development of an algorithm for formation of a plasma donor base for producing a standard sample of anti-D antibody

Relevance. The potency of raw materials, intermediate products and the finished preparation of human anti-D immunoglobulin must be determined in international units. The application of the international standard for anti-D immunoglobulin in the Russian Federation has difficulties associated with the duration of delivery and the need to comply with increased requirements for the conditions of transportation of biological thermolabile substances. In this regard, there is a need for the development of a domestic standard sample for the content of anti-D antibodies and its certification in international units. An integral step in obtaining this standard is the creation of a raw material base, taking into account the requirements for the content of anti-D antibodies in the immune blood plasma of donors. The aim of the study. To develop an algorithm for the selection of plasma donors for the production of a domestic standard sample for the anti-D antibodies content. Material and methods. The data of the information system of transfusiology for the period from january 2015 to december 2020 were analyzed about 510 donors with identified anti-erythrocyte antibodies. Immunohematological tests were performed by gel centrifugation using reagents and a set of equipment manufactured by Bio-Rad Laboratories (Switzerland). The concentration of anti-D antibodies in the blood plasma of donors was calculated in relation to the 2nd WHO international standard for anti-D immunoglobulin, NIBSC 01/572 (Great Britain). Results. It is proposed to use blood plasma of persons naturally immunized to the D-antigen as a substance for the production of a standard sample. As a result of the analysis of the requirements for the analytical range of methods for determining the potency of human anti-D immunoglobulin, it was established that the content of anti-D antibodies in the production pool of plasma for obtaining a standard sample should be at least 3.75 IU/ml. The selection of donors begins with the formation from the transfusion information system of list person with Rh-negative affiliation and identified anti-erythrocyte antibodies based on the results of a medical examination. Potential donors of anti-D plasma sent for immunohematological examination for determine the specificity of antierythrocyte antibodies and the content of anti-D antibodies. The presence of specific antibodies to the D-antigen is the basis for including information about the donor in the forming database. Conclusions. The necessity of creating a domestic standard sample for the content of anti-D antibodies has been proved. An algorithm for the formation of a raw material base for the production of a domestic standard sample has been developed. Using the formulated selection principles, a donor base was created, including 22 women (as of December 2020), in whose plasma the anti-D antibodies content is in the range from 0.1 to 28.5 IU/ml.

donor base, anti-D antibodies, standard sample, human anti-D immunoglobulin, anti-D plasma