METHOD FOR DETERMINATION OF APOLIPOPROTEIN E4 Russian patent published in 2022 - IPC G01N33/543 A61P25/28 

FIELD: medicine.

SUBSTANCE: group of inventions relates to a method for detection of apolipoprotein E isotype 4 (hereinafter – ApoE4) or its fragments in a patient’s blood sample and its use. The method for in vitro detection of apolipoprotein E isotype 4 (ApoE4) or its fragments in a subject’s blood sample includes stages of: contact of the specified sample with a solid phase, where the solid phase is not covered with any binding agent or capturing molecule; contact of the specified sample simultaneously or sequentially with at least one binding agent, which specifically binds to ApoE4 to form, thereby, an ApoE4-binding agent complex, where the specified binding agent is an antibody, or a functional fragment of the antibody, or frame protein other than IgG, where ApoE4 or its fragments are immobilized on the specified solid phase, and the binding agent binds to ApoE4, and where binding of ApoE4 or the ApoE4-binding agent complex with the specified solid phase occurs in the presence of a detergent, and detection of the ApoE4-binding agent complex, where ApoE4 fragments contain at least 6 amino acids in length, provided that amino acid 158, which is arginine, is included in the specified fragment, where a sequence including amino acid 158 relates to SEQ ID NO:1. A kit for detection of ApoE4 in vitro in a subject’s blood sample is described. The use of the kit is described. The use of a method is also described for stratification of the risk or stratification of the use of therapeutic measures for a treatment or a pathological condition associated with increased levels of ApoE4 and for detection of the risk of development of Alzheimer’s disease, where the increased level of ApoE4 above the determined threshold value is prognostic for an increased risk of development of Alzheimer’s disease.

EFFECT: above-mentioned group of solutions allows for simple and reliable specific detection of apolipoprotein E isotype 4 or its fragment in a subject’s blood sample.

22 cl, 4 tbl, 8 ex, 7 dwg