COMPOSITIONS AND METHODS FOR TREATING GAUCHER DISEASE Russian patent published in 2020 - IPC G01N33/53 G01N33/543 C12Q1/25 

FIELD: medicine.

SUBSTANCE: group of inventions relates to determining the production of neutralizing antibodies in subjects undergoing Gaucher's disease treatment. Disclosed is a method of detecting a neutralizing anti-glucocerebrosidase antibody in a sample from a subject, comprising immobilising glucocerebrosidase on the surface; bringing sample into contact with immobilized glucocerebrosidase; washing step; adding labeled glucocerebrosidase; a washing step for removing labeled glucocerebrosidase, which is not bound to the anti-glucocerebrosidase antibody; detection and quantification of the mark; assessing the presence of a specific isotype of the anti-glucocerebrosidase antibody, where the isotype is selected from a group, consisting of IgG, IgM, IgA and IgE, and determining whether the anti-glucocerebrosidase antibody neutralises glucocerebrosidase activity using cells which express human macrophage receptors against mannose (MMR). Also disclosed is a method for identifying an individual for which treating Gaucher's disease with an alternative replacement therapy with a glucocerebrosidase enzyme will be effective, and a kit for carrying out said method of detecting antibodies.

EFFECT: group of inventions provides detecting neutralizing anti-glucocerebrosidase antibodies in a sample in a subject who receives or previously received a glucocerebrosidase enzyme replacement therapy.

16 cl, 26 dwg, 40 tbl, 9 ex