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Information × Registration Number 0218U001707, 0117U006625 , R & D reports Title Development of enzyme linked immunoassay of high sensitivity for hepatitis B early diagnostic. popup.stage_title Head Mandryk Sergij Yaroslavovich, Registration Date 26-06-2018 Organization Рrivate joint-stock company "Scientific production company "Diaproph-Med" popup.description2 Report on research work: 43 p., 4 drawing, 17 tables, add. 1, sources 6. Enzyme linked immunoassay, sensitivity, specificity, accuracy of the analysis results, stability upon storage. The object of the study is high sensitivity ELISA kit for hepatitis B early diagnostic. The purpose of the work was to create a new highly sensitive diagnostic immunoassay kit for hepatitis B HBsAg surface antigen detection in human blood serum or 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 - immunoassay analysis, monoclonal antibodies chromatography, microbiological, biochemical, methods of bioconjugation. At the reporting stage, work was carried out on the adaptation of the ELISA kit to experimental realization on a standart equipment for ELISA (thermoshakers, automatic reader etc.). It was done the investigation of the main kit's characteristics (sensitivity, specificity as well as precision of analysis results) using standart sera and control samples panels. Diagnostic ability of the kit to detect HBsAg using standart sera and control samples panels was estimated as 100%. Kit analytical sensitivity in detection of the second International HBsAg standart (NIBSC, Great Britain) as well as "ДС-СО-HBsAg" standart (Diagnostic systems, Russian Federation) was estimated as 0,01 IU/ml. In experiments without thermoshaker kit detects HBsAg standart of the ad and ay subtypes (Capricorn (USA) and Paul Erlich Institute) in concentration of 0,013 ng/ml. In experiments with thermoshaker - 0,0043 ng/ml. In experiments with nonselective donors sera kit's diagnostic specificity was detected as 99,8%. 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 С.Я. Мандрикc Ю.І. Горлов popup.nrat_date 2020-04-02 Close