METHOD FOR QUANTITATIVE DETERMINATION OF ANTI-D-ANTIBODIES IGG IN PREPARATIONS OF HUMAN IMMUNOGLOBULIN ANTI-RHESUS RH0(D) Russian patent published in 2022 - IPC G01N33/15 G01N33/48 A61B10/00 

FIELD: healthcare, pharmacy, biotechnology and immunology.

SUBSTANCE: present invention relates to the field of healthcare, pharmacy, biotechnology and immunology and can be used to quantify anti-D IgG antibodies in anti-Rhesus Rh₀(D) human immunoglobulin drugs for quality control. The method includes preparing an immunosorbent by immobilizing washed papainized erythrocytes of the phenotype of Rh-positive erythrocytes (Rh(+))I(0) of the human blood group (hereinafter referred to as R1R1 phenotype erythrocytes) on the solid phase. Then the immobilized papainized erythrocytes are distributed in the immunosorbent and their distribution is evaluated. Then a competitive enzyme immunoassay (ELISA) is performed. At the same time, the distribution of the aggregated layer of immobilized papainized erythrocytes of the R1R1 phenotype in the immunosorbent is not less than 88%, with the distribution coefficient of erythrocytes of the R1R1 phenotype not more than 0.22; where the linear range of anti-D-IgG antibodies is from 1.88 IU/ml to 30 IU/ml.

EFFECT: method has efficiency, specificity, sensitivity, linearity of the analytical range (dose-response), precision, correctness of the results.

9 cl, 7 dwg, 14 tbl, 8 ex