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The aim was to present the experience of using mobile laboratory for monitoring and diagnostics (MLMD) during the epizootiological monitoring of the northern provinces of Vietnam. MLMD was transferred by Federal Service for Surveillance in the Sphere of Consumers Rights Protection and Human Welfare to the Socialist Republic of Vietnam as part of implementation of cooperation programs on combating infectious diseases. The use of MLMD made it possible to obtain new information on the circulation of pathogens of natural-focal infectious diseases on the territory of Vietnam. It also provided the necessary conditions for conducting research using methods of express diagnostics, bacteriological analysis, performing a full cycle of work – from the receipt of samples to the disinfection and destruction of infected material in compliance with the requirements of biological safety in the field. The effectiveness of using mobile laboratories in response to the emergencies of sanitary and epidemiological nature, both to strengthen stationary laboratory bases and to organize diagnostic studies in remote regions, has been shown. The use of MLMD for the diagnosis of COVID‑19 has been an effective component of countering the new coronavirus infection in Vietnam and significantly increased the volume of testing in the country.

The aim of the study: to analyze the pathogenetic structure of ventriculitis, their relationship with age, risk factors, study the etiological characteristics, clinical and diagnostic features, evaluate outcomes of ventriculitis and features of mortality.Materials and methods: a retrospective analysis of inpatient medical charts of 72 children with ventriculitis received treatment in the neurosurgery department of Filatov Children hospital №5, St-Petersburg, from January 2008 to December 2017 was carried out.Results: Most cases of ventriculitis occurred in infants (up to 1 year) and young children (1-3 years old). The largest group among pathogenetic variants of ventriculitis was shunt infection – 50 (69.44%) cases. Other groups were: ventriculostomy-associated ventriculitis – 12 (16,67%) cases; ventriculitis following a neurosurgical procedure without external ventricular drainage – 6 (8,33%) cases; ventriculitis complicated meningitis in patients without prior neurosurgery – 4 (5,56%) cases. The presence of such risk factors for ventriculitis as cerebrospinal fluid leakage (18,06%), intraventricular blood prior to the development of ventriculitis (22,22%), and other systemic infections (59,72%) were noted. The crucial role in the diagnosis of ventriculitis is played by the inflammatory changes in the ventricular cerebrospinal fluid on the background of specific clinical findings and indicative anamnesis. The commonest organism causing ventriculitis in the study was Staphylococcus epidermidis – 24 (33,33%) patients. Ventriculitis mortality rate was 8,33% (6 cases). Analysis of adverse outcomes revealed that aggressive health-care-associated multidrug resistant organisms are more dangerous for life, especially in patients with severe central nervous system pathology prior to ventriculitis.

Objective of the study was to select the criteria and methodological approaches to reclassify avirulent strains of plague agent from pathogenicity (hazard) group I into pathogenicity group III. Materials and methods. We have reviewed domestic and foreign normative, methodological documents, scientific publications in the field of laboratory diagnostics of plague and biosafety provision while working with pathogenic biological agents.Results and discussion. A complex of criteria for reclassification of Y. pestis strains from hazard group I into hazard group III has been substantiated; the methods for their assessment identified. Validation has revealed the grounds for reassignment of a number of avirulent Y. pestis strains included into the training kit which is compiled for mastering the training module “Microbiology and laboratory diagnostics of plague” into pathogenicity group III. We have demonstrated the feasibility of combining the structured methods of assessment of pathogenic properties in plague microbe with additional informative ones; in particular, evaluation of cytotoxicity of Y. pestis strains in relation to leucocytes of whole human blood in vitro. Analysis of a strain virulence should be built on complex characterization of major pathogenicity factors using advanced molecular-genetic research methods, the data on phenotypic manifestations of their functioning, as well as the level of pathogenicity for sensitive laboratory animals. The review of the utilized quantitative indicators for differentiation of plague microbe strains by virulence taking into account LD50 values for Y. pestis EV NIIEG strain is a relevant task. It is practical to supplement the complex approach with informative research methods, notably, characterization of strain cytotoxicity which shows high correlation with virulence criterion LD50.

Objective of the investigation was to assess epidemiological and epizootiological conditions in natural plague foci of the Russian Federation, neighboring states and foreign countries in 2019. Negative effect of the current climate warming on the state of parasitic systems of natural foci with circulation of plague microbe of the main subspecies, medieval biovar, phylogenetic branch 2.MED1 is emphasized. In 2019, local plague epizooties were registered in the territory of two (Gorno-Altai high-mountain and Tuva mountain) out of 11 natural plague foci of the Russian Federation. The total area of epizooty covered 2248.5 km2 . All in all, 31 cultures of Y. pestis of the main subspecies, antique biovar, phylogenetic branch 4.ANT and 5 cultures of Altai biovar, central-asian subspecies, phylogenetic branch 0.PE4a were isolated. The forecast for continuing tense epidemiological situation, both for 2020 and for 2021–2025, has been substantiated for natural foci with circulation of the main subspecies of antique biovar, phyologenetic branch 4.ANT: Gorno-Altai high-mountain and Tuva mountain ones. In the remaining nine natural foci in the territory of the Russian Federation epizootic manifestations of plague in 2020 are highly improbable. This prognosis is an indication to optimize the deployment of human and logistical resources of plague control institutions through concentrated preventive activities in the territories of epizootically active natural plague foci. Otlined is the necessity to put a new enhanced classification of Y. pestis into practice.

Objective of the study was to review the current normative-methodological documentation on the matters of safe handling of pathogenic biological agents (PBA) of the III–IV pathogenicity groups. Materials and methods. We used analytical method for the study. We carried out comparative analysis of the provisions contained in the current regulations approved at different times for different agencies on the matters of air filtering system equipping, usage of microbiological safety cabinets, ensuring hand washing station provision for laboratories, inspection of disinfectants entering a lab, and waste decontamination procedures. Results and discussion. We have considered the provisions of the current documentation that require further refinement and clarification for the future editions of sanitary regulations. Two aspects draw increasing attention: the problem of regulating the inlet and exhaust ventilation system setup in the laboratories of microbiological specialization for work with PBA and the need to devise a consistent coordinated regulatory framework. Examples provided in the paper demonstrate the necessity of adhering to the integrated unified approach to the requirements for biosafety provision in the documents of various agencies; clear wording; harmonized system of normative and technical specifications for laboratory equipment, stating the basic characteristics of microbiological safety cabinets and ventilation systems. The documents should be in compliance with the requirements of various agencies. The maintenance of technical-engineering systems should be performed by the specialists with an appropriate qualification on a regular basis.

Diversity of currently available on the market means of respiratory organs protection (MROP) dictates the necessity to assess the specimens in regard to the possibility of using them for work with dangerous biological agents. The review presents the analysis of modern personal protection equipment for respiratory organs. National and inter-state standards, national legislative and normative documents, foreign recommendations, materials from periodicals, related to the matters of selection and usage of MROP, as well as information on the MROP models provided by manufacturers have been studied. Considered are different types and modifications of filtering MROP and applicable to them requirements. Peculiarities of MROP usage when working with agents of infectious diseases are also analyzed. Based on the conducted research, recommendations on the selection and exploitation of MROP for work with infectious diseases agents have been put forward, problematic aspects that require complex scientific-technical and regulatory solutions in order to ensure the safety of the personnel involved in handling infectious disease agents have been identified. The following conclusions are drawn: to protect the staff performing operations with harmful and dangerous biological agents, it is necessary to use MROP with anti-aerosol barriers; the choice of modification for specific situations and working conditions should be based on the results of assessment of biological hazard and associated risks. Peculiarities of the options, exploitation, and decontamination of MROP, actions in case of an accident related to the breaching of MROP integrity must be covered in the regulatory document at the institutional level, according to which an officer is obliged to receive introductory and recurring instructions. Enhancement of regulatory procedures in the sphere of biological safety provision should aim at clarification of legitimacy of using specific MROP for work with harmful and dangerous biological agents. Preferences in the choice of MROP for work with PBA have been pointed out.

Nowadays infectious diseases of brain, despite the great possibilities of modern medicine, remain an important and still unsolved, problem, in neurosurgery. Among such diseases, ventriculitis takes a specific place due to appearance of a life-threatening condition that requires emergency, intensive and long-term treatment, as well as resistance to therapy, high frequency of generalization of infectious process and. relapsing course.Objective: to evaluate the results of treatment of children with ventriculitis, depending on age, pathogenetic type of ventriculitis and applied approaches in treatment, to develop an optimal management for patients with ventriculitis.Methods. The results of examination and. treatment of all patients with ventriculitis admitted, to “N.F. Filatov Children hospital N5", St. Petersburg, from January 2008 to December 2017 were analyzed. A total of 72 patients with ventriculitis aged, from 1 month, to 17 years were treated, during the study period.Results. All patients with ventriculitis received, combined, systemic antibiotic therapy. The intraventricular route of antibiotic administration, was additionally used, in 81.9% of cases. In most cases, patients underwent external ventricular drainage to relieve acute hydrocephalus. In management of children with shunt infection, complete or partial removal of infected, shunt system, was performed, along with external drainage. In some cases, neuroendoscopic surgery were required, such, as endoscopic examination of the ventricular system, with removing pus and. debris, followed, by external drainage, septostomy, fenestration of cysts, removal of the lateral ventricle foreign body, endoscopic third, ventriculostomy.Conclusions. Presently the main tools in the treatment of children with ventriculitis are antibacterial therapy and. external ventricular drainage. Given the problem, of low ability of antibiotics to penetrate the blood-brain barrier, even those recommended, for use in cerebral infections, it is necessary to consider the issue of addition intravenous antibiotic therapy with intraventricular administration, promptly. In case of ventriculitis appearance the implanted, devices (valve shunting systems, external ventricular drains) shall be removed, early and. completely with further placing a new external ventricular drainage, which is necessary. Neuroendoscopic surgery in treatment of children with ventriculitis can be used, depending on specific causes and objectives, and. can be indispensable in cases of protracted, ventriculitis.

For a reliable assessment of the presense of the immune layer to cholera agent, it is necessary to determine the level of specific antibodies in human blood serum. To detect specific anticholera antibodies serological methods are used, aimed to identify agglutinating, vibriocidal and toxin neutralizing antibodies. At the same time, the stated methods have several drawbacks which can be eliminated when using biological microarrays to detect specific antibodies. Object of work. Assessment of the level of the immune layer to cholera agent in individuals residing in the territory of the Republic of Guinea, using a biological microchip. Materials and methods. 190 blood serum samples of people living on the territory of three provinces of the Republic of Guinea, collected over the period of May-October 2016 were studied. The detection of specific antibodies to antigens of V. cholerae was performed using the immunochip for serodiagnosis in the indirect analysis. V. cholerae O-antigens and cholera toxin were used as specific antigens for sensibilization of the immunochip surface. Results and discussion. As a result of the analysis, using immunochip, specific antibodies to O1 and O139-antigens of V. cholerae at the titer of 1:100 were not detected in any of the cases. At the same time, antibodies to cholera toxin were found in 66 samples (34.7 %); titers varied from 1:100 to 1:1600, being 1:100 in 59 samples, 1:400 - in 1 sample, 1:800 - in 2 samples, 1:1600 - in 4 samples. The absence of statistically significant differences depending on the gender of the examined people and the territory of their residence was noted. The obtained results can be explained by the fact that antibodies to cholera toxin are more resistant and circulate longer in human serum than antibodies to O-antigens. Studies have demonstrated the presence of IgG antibodies complementary to cholera toxin in sera, which may indicate both the contact of the population with the cholera pathogen and the formation of post-vaccinal immunity.

Considered have been possible variants of emergencies, which may arise while working in BSC with pathogenic microorganisms. Put forward have been the algorithms for localization and control of the incident when working in BSC Safety Class II without spills; with spills within the working chamber; with spills and release of infectious material beyond the BSC working chamber; and incidents with compromised personal protection equipment.

Demonstrated is the structural and functional interrelation between sanitary protection of the territories, epidemiological monitoring, and the state sanitary-epidemiological surveillance. Sanitary protection of the territories (SPT) of the Russian Federation is a separate focus area authorizing sanitary prophylactic (anti-epidemic) activities, with a self-sustained sub-goal. It combines individual roles appertained to epidemiological monitoring and to federal sanitary-epidemiological surveillance, only in reference to a particular item - emergency situation in the sphere of sanitary-epidemiological welfare of the population. Specificity of the SPT is a balance between functionality and capacity of the monitoring, surveillance and control. Legislative and regulatory legal acts, which concern sanitary protection of the territory, provide the means for defining its basic organizational principles: country-wide activities, self-sufficiency and self-support of the Rospotrebnadzor, three-level hierarchical system, and information exchange.

A set of documents concerning biological safety at the institutional level is prepared and put in to practice. Three levels of specialists` admission for works with pathogenic biological agents of the I-IV groups have been developed, substantiated and introduced. Considered are the variants of execution of coupled (simultaneous) work with PBA of different groups. The statement on control of disinfectants received by the institution defines the order of control execution as regards newly received disinfectants and correspondence of disinfectants` working solutions in the laboratories to the requirements of sanitary regulations. Demonstrated is practicability of the assessment of protective efficacy of air-cleaning filters in the exhaust ventilation systems of “contaminated” area rooms in the laboratories carrying out the works with PBA using bacterial aerosol and physical method.

Carried out is a range of investigations aimed at the improvement of the anti-epidemic procedures for works with infectious disease agents (herein biological safety provision) in mobile laboratories of specialized anti-epidemic teams (SAET). Evaluation of the operational experience of stationary and field laboratories, as well as comparative analysis of the national safety requirements for works with pathogenic biological agents and WHO international regulations in the sphere of biological safety provision in laboratories, has made it possible to outline common for all types of microbiological laboratories principles for biosafety provision. With due consideration of these principles formulated are the core requirements for the provision of biological safety of SAET activities. Based on the results of biorisk and biohazard assessment which have to do with innovative mobile laboratories, worked out is a system of anti-epidemic procedures aimed towards establishment of the conditions that offer as low as practically achievable level of risk for personnel of SAET mobile laboratories, for population and human environment too. These practices, designed for biological safety provision among the personnel of mobile laboratories (ML), have been played back in a number of standard operational procedures. With a view to establishing of the environment with acceptable level of biorisk for the personnel and population when ML are used for various purposes and in various contingencies (in full force, single unit or several modules), worked out are the algorithms of decision-making support as regards selection of modules and optional accessories. However, there is a need for emergency response plans and training programs for the personnel on the provision of biosafety in ML to ensure and maintain acceptable level of biorisk connected with ML functioning.

Presented are the results of assessment of the national regulatory framework in the field of pathogenic biological agents handling in comparison with the same foreign one and WHO recommendations. Shown is the necessity of timely introduction of amendments or revision of the national regulatory documents. The topical issues requiring decision are specified. The proposals on improvement of normative legal regulations are submitted. The development of the common regulatory document integrating the issues of biological safety provision seems to be advisable.

Analyzed is the performance of works with the strains of fixed rabies virus under the conditions of anti-rabies immunoglobulin manufacturing. Evaluated is the effectiveness of the established system for the provision of biological safety, which has allowed for safe manufacturing of anti-rabies immunoglobulin within the period of 12 years.

The analysis of current regulatory requirements and applicable guidelines, as well as scientific papers, confirmed the existence of the subsystem of the control over epidemiological situation at the potentially hazardous biological facility. This subsystem is an element of the facility biosafety support system. Developed is the set of models which contain schemes of epidemiological situation management in case a sick facility officer is detected whose disease is suspected to be caused by the microorganisms of I-II pathogenicity groups.

Presented is the algorithm of assessment of the level of professional qualification of the personnel authorized for work with pathogenic biological agents of I-II groups, developed for the first time. Determined are the essence, requirements for organization and order of assessment of the indices that predict the presence of occupational knowledge and skills necessary for safe, high-quality and effective execution of professional duties.

A set of risk assessment methods was used for substantiation of safe functioning of mobile laboratories (ML) of specialized anti-epidemic teams (SAET). The utilized methods were borrowed from diverse spheres of activity and recommended for evaluation of biological hazard and risk associated with work with pathogenic biological agents. The obtained data represent the basis for biorisk management in SAET` ML functioning.

At present, in compliance with sanitary and epidemiologic regulations in force, equipping of microbiological laboratory with modern engineering and technical systems and equipment is considered to be the important condition ensuring adherence with the biological safety requirements. The abovementioned systems and equipment, together with the rules and techniques of the safe work with pathogenic microorganisms, should provide the set of biological safety measures for the laboratory personnel. Biological safety cabinets of the second and the third classes serve as additional protection means. Considered are peculiarities of the design and benefits of different biosafety cabinets used in BSL 2-3 laboratories, and some of their shortcomings are determined.

Analyzed were normative and methodical documents which were in force at different stages determined as regards current tasks, staff schedule and the equipment table of the specialized anti-epidemic teams (SAET). Substantiated was the necessity to develop the new regulatory document, comprising requirements of biosafety provision of the specialized anti-epidemic teams functioning. Determined was the way of further improvement of normative and methodical provision of biosafety under conditions of practical realization of the conception of SAET modernization. It included the development of the set of regulatory documents specifying the fulfillment of the main provisions of the Standing Оrder and elaboration of management system based on risk analysis.

Within the frames of an analytical review, modern approaches are described whose development is considered to be very important in order to rationally operate secure working procedures at the facilities of medical and biological profile. Peculiarities of formulating the methods to assess biological hazards are analyzed together with the ways of their objectivization. The place and the role of biological safety as a scientific trend are discussed in relation with the problem of availability of practical application of the "risk theory" elements with the aim of making governing decisions based on complex, well established estimations. The architecture of the system of modeling and estimation of potential danger associated with handling pathogenic biological agents is enunciated.

The results of the second phase of the experiments are presented in the paper, where β-propiolactone was used to decontaminate materials from Yersinia pestis. Both slurries and suspensions of the internal organs were decontaminated of Y. pestis 231 with 0.1 % concentrations of the preparation after 18 to 24 hours' exposition in the refrigerator, as well as at 37 °C for as long as 6 hours or more. Optimal schedules for immunologic examination are offered to prepare the samples taken in the combined foci of plague and arboviral infections.