Construction and Medical Trials of Monoclonal Immuno-Enzyme Test-System for the Detection of Encapsulated Plague Agent Strains, “EIAPESTF1-M”

Abstract

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.

Keywords

• yersinia pestis
• capsular antigen f1
• monoclonal antibodies
• diagnostic test-system
• enzyme immune-assay
• immunodiagnostics