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Information × Registration Number 0222U003096, 0121U114087 , R & D reports Title Development of a diagnostic test system for the detection of IgM antibodies to measles virus by enzyme-linked immunosorbent assay (ELISA) popup.stage_title Head Kyselova Olena K., Кандидат біологічних наук Registration Date 18-02-2022 Organization Private Joint-Stock Company Scientific-Production Company "Diaprof-Med" popup.description2 Objective is to develop a diagnostic ELISA test kit for detection of anti-measles IgM with sensitivity and specificity comparable to that of CE-marked commercial counterparts and whose use will diagnose measles in the early stages of infection. During the reporting stage, work was performed to obtain research and production lots of biological components and made a research and production lots of test kits. The study of diagnostic characteristics (sensitivity, specificity, accuracy, cross-reactivity) of the prototype and comparison of diagnostic characteristics of the prototype and analogues of leading manufacturers using standard panels of positive and negative serum samples containing antibodies to measles virus. Technical documentation for a lot of test kit prototype has been prepared. The obtained results showed the ability of the test kit to detect measles infection at all stages of its development with high susceptibility, which is not inferior to its foreign counterparts with CE marking. The specificity parameters of the developed prototype of the test kit "Measles IgM" using serum samples of commercial standard panels of negative sera and panels containing cross-reactive markers is - 100%. The sensitivity of the developed test kit using commercial panels for measles IgM and reliably confirmed positive sera for measles IgM is - 100%. The test kit has high rates of convergence and reproducibility of results - coefficient of variation (CV) for convergence - INTER - 7.47% for reproducibility between three different laboratories - INTER - 1.6%. The predicted term of stability of the diagnosticum, calculated mathematically using calculation methods at accelerated storage and elevated temperature, is 15.5 months. The developed test system is adapted to the reaction on standard ELISA equipment, on a thermoshaker and an open-type ELISA automatic analyzer. Product Description popup.authors Besarabenko Kateryna Yevhenivna Varzanova Iryna Serhiivna Horlov Andrii Yu. Kyselova Olena K. Makarets Olena M. Oleshko Hanna Mykolaivna Petryk Olha Anatoliivna Polishchuk Daryna Volodymyrivna Serdiuk Volodymyr H. Shevchuk Anzhelika Oleksandrivna popup.nrat_date 2022-03-09 Close