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-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.

1. [Safety of work with microorganisms of the I-II groups of pathogenicity (hazard)]. SR 1.3.3118-13. M.: Federal Center of Hygiene and Epidemiology of the Rospotrebnadzor; 2014. 195 p.

2. Burdelov L.A., editor. [Atlas of Dissemination of Particularly Dangerous Infections in the Republic of Kazakhstan]. Amaty; 2012. 232 p.

3. Kutyrev V.V., Popova A.Yu., Ezhlova E.B., Demina Yu.V., Pakskina N.D., Shchuchinov L.V., Mikhailov E.P., Mishchenko A.I., Rozhdestvensky E.N., Bazarova G.Kh., Denisov A.V., Sharova I.N., Popov N.V., Kuznetsov A.A. [Infection of an individual with plague in the Gorno-Altaisk highmountain natural focus in 2014. Communication 1. Epidemiological and epizootiological peculiarities of plague manifestations in the Gorno-Altaisk high-mountain (Sailyugemsky) natural plague focus]. Probl. Osobo Opasn. Infek. 2014; 4:9–16.

4. Onishchenko G.G., Kutyrev V.V., editors. [Natural Plague Foci in the territory of the Caucasus, Caspian-Sea Region, Central Asia and Siberia]. M.: Meditsina; 2004. 192 p.

5. Onishchenko G.G., Kutyrev V.V., editors. [Laboratory Diagnostics of Dangerous Infectious Diseases]. M.: “Shiko”; 2013. 560 p.

6. Popov N.V., Bezsmertny V.E., Matrosov A.N., Knyazeva T.V., Kuznetsov A.A., Fedorov Yu.M., Popov V.P., Verzhutsky D.B., Korzun V.M., Chipanin E.V., Dubyansky V.M., Maletskaya O.V., Grigor’ev M.P., Balakhonov S.V., Kulichenko A.N., Kutyrev V.V. [Epizootic activity of natural plague foci in the territory of the Russian Federation in 2014 and prognosis for 2015]. Probl. Osobo Opasn. Infek. 2015; 1:10–7.

7. Tereshkina N.E., Terekhova I.V., Syrova N.A., Devdariani Z.L., Lyashova O.Yu., Grigor’eva G.V., Lobovikova O.A., Shul’gina I.V., Ivanenko I.L., Zakharova N.B., Bezrukova G.A., Spirin V.F. [Constructing and medical trials of a monoclonal dot- immuno-enzyme test-system “DIATul-M” for tularemia microbe detection]. Probl. Osobo Opasn. Infek. 2013; 2:42–5.

8. Frimel G., editor. [Immunological Methods]. M.: Meditsina; 1987. 472 p.

9. Abdul-Fattah A.M., Kalonia D.S., Pikal M.J. The Challenge of drying method selection for protein pharmaceuticals: product quality implication. J. Pharm. Sci. 2007; 96(8):1886–916. DOI: 10.1002/jps.20842.

10. Butler T. Plague into the 21st century. Clin. Infect. Dis. 2009; 49(5):736–42. DOI: 10.1086/604718.