Registration Number
0222U003417,
0121U114088
, R & D reports
Title
Development of a set of reagents for serological diagnosis of brucellosis
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Head
Moisa Larysa M., Кандидат біологічних наук
Registration Date
20-03-2022
Organization
Private Joint-Stock Company Scientific-Production Company "Diaprof-Med"
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The object of development is the process of manufacturing a set of reagents for serological diagnosis of brucellosis.
The aim of the work is to develop a set of reagents for the detection of IgG antibodies to the causative agent of brucellosis in human serum/plasma by ELISA and study its diagnostic characteristics in comparison with analogues of leading manufacturers and industrial test system "DIA®-Brucella-IgG".
Research methods - ELISA, immunological, biochemical, serological.
In the 2nd stage of work according to the schedule, the stability of the main diagnostic characteristics of the prototype candidate was investigated and confirmed, the volume of components was optimized, labels were finalized, instructions for use in accordance with Directive 98/79EC and Technological Regulations. After appropriate refinement, the candidate for the prototype "Brucella Ab Set of reagents for serological diagnosis of brucellosis" received the status of "prototype". A prototype experimental lot of 62 kits was produced and used to study its diagnostic characteristics using brucellosis-positive and brucellosis-negative sera and cross-reactive samples. Indicators of diagnostic characteristics of the prototype fully meet the Requirements for this project. Comparative studies of the diagnostic characteristics of the prototype with analogues of leading manufacturers, including EUROIMMUN, Germany and with the industrial test system "DIA®-Brucella-IgG" using a large sample of positive and negative for brucellosis sera, potentially cross-reactive samples for 11 infections. According to the obtained results, the diagnostic characteristics of the prototype correspond to the level of analogues of leading manufacturers and exceed the performance of the industrial test kit "DIA®-Brucella-IgG".
Product Description
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Vlasenko Ludmila V.
Herasymenko Halyna M.
Horlov Yurii Ivanovich
Didyk Tetiana V.
Kravtsova Hanna Yu.
Kravchenko Nataliia H.
Moisa Larysa M.
Serdiuk Volodymyr H.
Serdiuk Oleksii H.
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2022-03-21
