STANDARD SAMPLE OF THE CONTENT OF ANTI-D ANTIBODIES IN PREPARATIONS OF HUMAN IMMUNOGLOBULINS Russian patent published in 2019 - IPC A61K39/395 

FIELD: medicine.

SUBSTANCE: invention relates to medicine, in particular to immunology, and can be used to determine the content of anti-D antibodies in human immunoglobulin preparations in the hemagglutination reaction. For this, the kit contains two components that are solutions of human immunoglobulins: a positive component with a certified anti-D antibody content in the range from 1:4 to 1:8, anti-rhesus activity of not more than 0.7 IU/ml and certified protein content of not less than 25 mg/ml, obtained from blood plasma Rh(-) of donors of IV(AB) blood group; a negative component with a certified content of anti-D antibodies in an amount corresponding to a dilution of less than 1:2, undetectable anti-rhesus activity and a certified protein content of at least 25 mg/ml, obtained from blood plasma Rh(+) of donors of IV(AB) blood group.

EFFECT: use of this invention allows to evaluate the quality of human immunoglobulin preparations and allows to determine the content of anti-D antibodies by hemagglutination.

1 cl, 17 ex, 4 tbl