Registration Number
0222U003275,
0121U114089
, R & D reports
Title
Development of enzyme-linked immunosorbent assays for the detection of IgG antibodies to Borrelia burgdorferi in human serum or plasma
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Head
Trokhymchuk Tetiana Yu., Кандидат біологічних наук
Registration Date
22-02-2022
Organization
Private Joint-Stock Company Scientific-Production Company "Diaprof-Med"
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The object of development is enzyme-linked immunosorbent assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum or plasma.
The aim of the work is to develop enzyme-linked immunosorbent assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum or plasma.
Research methods - enzyme-linked immunosorbent assay, protein chromatography, microbiological, biochemical, bioconjugation methods.
During the reporting stage, work was performed to obtain production lots of biocomponents and production of lot of the kit prototype . 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 positive and negative for Borrelia burgdorferi sera. A package of technical documentation for the produced lot of the prototype has been issued.
The obtained results testified to the high sensitivity of the prototype to the detection of IgG antibodies to B. burgdorferi, which is not inferior to its foreign counterparts with CE marking.
The parameter of the specificity of the test system in the study of panels of negative sera (155 samples) was 99.3%, the specificity in the study of 354 sera with cross-reactive factors - 98.8%.
The kit has a high rate of reproducibility of results: the average coefficient of variation (CV) in the study of the convergence of the results of the analysis between 3 different samples was 6.3%, between three different laboratories - 12.4%.
The quality of the kit did not deteriorate during storage at 2-8 ° C for 1 month (observation period). The estimated stability of the test system, calculated for accelerated storage at elevated temperatures is 15 months.
The developed kit is adapted to the reaction on standard ELISA equipment, on a thermoshaker and an open-type ELISA analyzer.
Product Description
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Holubovska Anastasiia O.
Horlov Andrii Yu.
Zhylikhovska Tetiana V.
Makarets Olena M.
Pavlenko Kateryna V.
Serdiuk Oleksii H.
Trokhymchuk Tetiana Yu.
Tsybulska Lidiia I.
Shapovalova Svitlana M
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2022-03-09
