MONOCLONAL ANTIBODY IMMUNOREACTIVE WITH NUCLEOCAPSID (CORE) PROTEIN OF C-4G5 HEPATITIS VIRUS, METHOD OF DIAGNOSTICS OF HEPATITIS C VIRAL (HCV) INFECTION, AND COMBINATION OF MONOCLONAL ANTIBODIES FOR ITS IMPLEMENTATION Russian patent published in 2008 - IPC C12P21/08 C07K16/08 G01N33/569 

FIELD: biotechnologies.

SUBSTANCE: obtaining monoclonal antibodies immunoreactive with the nucleocapsid protein of the hepatitis virus C-4G5, and the development of a method of diagnostics based on the double layer version of immunoenzymometric assay for the detection of the nucleocapsid (core protein) of the hepatitis C virus using a combination of linear and conformational core protein epitope monoclonal antibodies 27, 1F9, and 4G5: MCA 1F9: linear epitope with amino-acid residues (AAR) 81-85, MCA 27, and 4G5: conformational epitopes at site 1-150 of the core protein AAR. The combination of monoclonal antibodies 27, 1F9, and 4G5, immunoreactive with the hepatitis C virus nucleocapsid protein may be used both for the capture (capture antibodies) and for the detection (detection antibodies) of the core protein. The double layer variant of the immunoenzymometric assay developed for the detection of the nucleocapsid of the hepatitis C virus using a combination of monoclonal antibodies including MCA 4G5 has high sensitivity and allows to detect core proteins in blood of both asymptomatic HCV-infected donors and patients suffering from acute and chronic hepatitis C. The advantages of the immunoenzymometric assay of the core protein may be useful for determining the viral load during IF therapy.

EFFECT: allows to diagnose hepatitis C with high probability at early stages of disease and is efficient for detection of HCV of at least three genotypes most actual for Russia.

3 cl, 3 tbl, 4 ex