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Information × Registration Number 0218U001106, 0116U008724 , R & D reports Title Development of enzyme linked immunoassay of high sensitivity for p24 HIV1 and HIV2 specific antibodies detection popup.stage_title Head Ganova Larisa Alexandrovna, Registration Date 19-01-2018 Organization Рrivate joint-stock company "Scientific production company "Diaproph-Med" popup.description2 Report on research work: 254 pp., 44 p., 29 pp., 3 pp., 10 sources.IMMUNOENZYME ANALYSIS, MONOCLONAL ANTIBODIES, RECOMBINANT RAWS, SENSITIVITY, SPECIFICITY. The object of the study is an enzyme-linked immunoassay test system for the determination of anti-HIV p24/p26 HIV and total antibodies against HIV-1/2 of high sensitivity.The purpose of the work is to create a highly sensitive diagnostic immunoassay test system for the simultaneous determination of anti-HIV p24/p26 HIV and IgG, IgM, IgA antibodies to HIV-1/2 in serum or human plasma.Methods of investigation - immuno-enzymatic analysis, biochemical, immunological.As a result of the project, technologies for obtaining biological components and the production of test systems based on them for the simultaneous determination of anti-HIV p24 / p26 HIV and specific antibodies to HIV 1/2 of high sensitivity were developed. Five experimental prototypes and a test series (124 sets) of the test system were manufactured in conditions of industrial production.The diagnostic ability of the test system to detect antibodies to HIV-1/2 in the study of samples of standard panel of sera was 100%. The analytical sensitivity of the test system according to the international standard of antigen p24 HIV-1 is 1 IU / ml, the standard p24 HIV-1 (ABI, USA) - 2.5 pg / ml, standard p24 HIV-1 (MBA, RF) - 20 pg / ml The test system detects HIV infection at all stages of its development with high sensitivity, which is not inferior to its foreign counterparts, which have CE-marking.Specificity of the test system in the study of standard panels of negative serums was 100%, diagnostic specificity in the analysis of 5 210 serum nonselective donors - 99.94%.The predicted stability period of the test system, calculated on the basis of its accelerated storage at elevated temperature, is 2.1 years.The developed test system is adapted to the reaction on standard equipment for ELISA, on a thermosheet and an open enzyme immunoassay analyzer. Product Description popup.authors В.Д.Думанський Л.М.Мойса Л.О.Ганова Н.О.Дмітрієва О.А.Петрик О.К.Кисельова О.М.Чумак Т.Ю.Трохимчук Ю.І.Горлов popup.nrat_date 2020-04-02 Close