METHOD FOR PRODUCING POSITIVE CONTROL STANDARD SAMPLE OF HUMAN IMMUNOGLOBULIN TO DETERMINE ANTICOMPLEMENTARY ACTIVITY OF PREPARATIONS OF HUMAN IMMUNOGLOBULIN, AND STANDARD SAMPLE OF HUMAN IMMUNOGLOBULIN TO DETERMINE ANTICOMPLEMENTARY ACTIVITY OF PREPARATIONS OF HUMAN IMMUNOGLOBULIN Russian patent published in 2016 - IPC G01N33/48 

FIELD: biotechnology.

SUBSTANCE: group of inventions relates to biotechnology, specifically to human immunoglobulin standard samples used to determine anticomplementary activity of human immunoglobulins, and methods for their preparation. Group of inventions discloses a method of producing a positive control standard sample of human immunoglobulin comprising thermal treatment of sample in a water bath, cooling thermally treated sample at a temperature of (22±3) °C, anticomplementary activity determination of positive control sample; and a standard sample of human immunoglobulin containing a positive control, produced by disclosed method, and negative control with anticomplementary activity in range of 10-45 %.

EFFECT: group of inventions can be used to assess quality of human immunoglobulin preparations and enables to determine anticomplementary activity to improve reliability of results.

2 cl, 4 dwg, 11 ex