Construction and Medical Trials of Monoclonal Immuno-Enzyme Test-System for the Detection of Encapsulated Plague Agent Strains, “EIAPESTF1-M”
Objective of the study was to develop and then conduct medical trials of the “Monoclonal immune-enzyme test-system for the detection of plague agent (“EIAPESTF1-M”).Materials and methods. Utilized were materials for carrying out sandwich EIA. MCA 1B3 to Y. pestis F1 served as diagnostic immune-reage...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Federal Government Health Institution, Russian Research Anti-Plague Institute “Microbe”
2016-09-01
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| Series: | Проблемы особо опасных инфекций |
| Subjects: | |
| Online Access: | https://journal.microbe.ru/jour/article/view/333 |
| Summary: | Objective of the study was to develop and then conduct medical trials of the “Monoclonal immune-enzyme test-system for the detection of plague agent (“EIAPESTF1-M”).Materials and methods. Utilized were materials for carrying out sandwich EIA. MCA 1B3 to Y. pestis F1 served as diagnostic immune-reagent. To determine sensitivity and specificity of the designed immune-enzyme test-system, investigated were samples of 24 natural and genetically modified pFra+ and pFra– Y. pestis strains and 56 strains of heterologous bacteria Enterobacteriaceae family.Results and conclusions. Based on monoclonal antibodies to Yersinia pestis capsular antigen, constructed was “Monoclonal immune-enzyme test-system for the detection of plague agent (“EIAPESTF1-M”), which is characterized by high specificity and allows for the detection of encapsulated plague agent strains in biological samples and for identification of pure cultures with sensitivity of 5·105 – 1·106 mc/ml. It is highly competitive with comparator drug – “Diagnostic fluorescent absorbed equine plague immunoglobulins”, lyophilizate for diagnostic purposes, by RusRAPI “Microbe”. It possesses such advantages as objective result recording and capability of result documentation. “EIAPESTF1-M” is registered in the RF Federal Service for Surveillance in the Sphere of Healthcare and Social Development, reference No 2013/711, dated 31.05.2013 and approved for use in the territory of the Russian Federation. |
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| ISSN: | 0370-1069 2658-719X |