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Development of analytical biotechnologies for the needs of immunological diagnostics


Work number - M 22 FILED

Presented National Technical University of Ukraine "Igor Sikorsky Kyiv Polytechnic Institute

Authors:
Galkin O.Yu., D.Sc., Lutsenko T.M., Ph.D., Krynina O.I.

The work reflects the results of complex studies on the development of molecular bases and biotechnology of highly informative means for immunological diagnostics (on the example of enzyme-linked immunosorbent assay, ELISA) and parameters of bioanalytical standardization and validation of diagnostic devices. The work allowed to develop highly sensitive and specific ELISA kits for diagnosis of a number of infectious human diseases (urogenital chlamydia, tuberculosis, diphtheria), determination of the state of humoral immunity, including assessment of the level of allergy.

The socio-economic effect of the work is addressed to two circumstances. First, the authors have developed ELISA diagnostic, which by their bioanalytical characteristics are not inferior to better foreign analogues or exceed them. And it makes possible to diagnose a number of infectious diseases more effectively, as well as human immunity diagnosis. Secondly, the established scientific and methodological approaches to the quality assessment of ELISA kits is an element of ensuring a modern level of evaluation of diagnostic preparations by the national conformity assessment bodies in accordance with the requirements of the Technical Regulation on Medical Devices for in vitro Diagnosis.

Number of publications: 82 works, including 1 monograph, 38 scientific articles (including 8 articles in international scientific publications and 6 articles in journals indexed in Scopus and/or Web of Science), 16 patents of Ukraine for utility models (declarative patents), 3 educational and methodical developments. Total number of links to the publications of the authors’ team (according to Google Scholar): 77. Total index of citations of authors of the work: Galkin O.Yu. - h-index (Scopus) = 3, h-index (Google Scholar) = 6; Lutsenko T.M. - h-index (Scopus) = 2, h-index (Google Scholar) = 3; Krynina OI - h-index (Scopus) = 1, h-index (Google Scholar) = 1.

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