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Information × Registration Number 0218U001706, 0117U006625 , R & D reports Title Development of enzyme linked immunoassay of high sensitivity for hepatitis B early diagnostic. popup.stage_title Head Valentin Dmitrievich Dymanskij, Registration Date 26-06-2018 Organization Рrivate joint-stock company "Scientific production company "Diaproph-Med" popup.description2 Report on research work: 77 pp., 2 tabl., 8 pic., 3 ad., 5 sources. IMMUNOENZYME ANALYSIS, MONOCLONAL ANTIBODIES, RECOMBINANT RAWS, SENSITIVITY, SPECIFICITY. The object of the study is a high sensitivity enzyme-linked immunoassay test-system for the early determination of hepatitis B virus infection. The purpose of the work is to create a highly sensitive diagnostic immunoassay test system for the hepatitis B HBsAg surface antigen determination in serum or human plasma, it to sensitivity and specificity will not yield to foreign CE-marked commercial analogues and the using of it will allow to detect hepatitis B at different stages of the infectious process and will increase the safety of donor blood and reduce the rate of spread of hepatitis B infection. Methods of investigation - immuno-enzymatic analysis, biochemical, immunological. As a result of the project, technologies for obtaining biological components and the production of experimental test systems. At the reporting stage, work was carried out on the development and acquisition of biological components for the production of experimental test system samples: highly specific anti-HBsAg monoclonal antibodies using hybridoma technology and affinity chromatography, as well as conjugated anti- HBsAg antibodies synthesis. Experimental samples of the test kit are designed in the "sandwich" format of the solid-phase immunoassay analysis. According to the results of primary studies, experimental samples of test systems on diagnostic characteristics have a sensitivity and specificity of 100% in the study of human serum samples that have been characterized. Key words: immunoassay, monoclonal antibodies, recombinant proteins. Product Description popup.authors В.Д. Думанский Л.О. Ганова О.А. Петрик О.К. Кисельова О.М. Чумак С.В. Степанюк С.О. Бандуренко Т.В. Жиліховська Ю.І. Горлов popup.nrat_date 2020-04-02 Close