Quality Management System in Stavropol Research Anti-Plague Institute

The analysis of the structure of quality management system and the areas of its activity is presented. Trends for its further improvement are defined

Construction and Approval of the Test-System for the Detection of Antibodies to Anthrax Agent Using Indirect Fluorescent Immunoassay

Constructed and validated has been the test-system for the detection of antibodies to anthrax agent using indirect fluorescent immunoassay. The panel consists of antigen preparation, positive control sample, negative control, and FITS-labeled rabbit antibodies. Studied have been 10 acapsular B. anthracis strains with different plasmid content and colony morphology. B. anthracis vaccine strain STI-1 is demonstrated to be the optimal one as antigen preparation. Sensitivity of this test-system is not less than 1:40, the working dilution of FITC-conjugate being 1:16. Specificity of the panel has been studied using 100 sera of healthy donors. Approved is 100 % reproducibility of the technique at different time intervals, as well as when carried by different specialists. The test-system allows for confirmation of anthrax diagnosis in humans

Validation of Technological Process of Production of Liquid Brucellosis Diagnosticum for Agglutination Reaction, Suspension for Diagnostic Purposes

Presented are the results of validation of technological process of production of brucellosis diagnosticu

Научно-методические разработки биотехнологий производства иммунобиологических препаратов для экспресс-диагностики инфекционных заболеваний и детекции их возбудителе

The present article describes the scientific and methodological development of biotechnological manufacture of test-system components (diagnostic preparations) for instant diagnosis of plague, brucellosis, tularemia, anthrax, cholera. In this regard, in the first place the effective methods for obtaining complete antigenic complexes used for immunizing animals for the purpose of developing highly potent immune sera have been established. These antisera were used in determining optimum parameters of manufacture on the basis of their diagnosticums. Methodical basis of developing magnetic immunosorbents for selective concentration of infectious agents and their instant diagnosis methods has been mentioned. Moreover, the article describes the development of piezoelectric quartz crystal biosensors to detect plague, brucellosis and tularemia pathogens by gravimetric flow injection analysis, allowing to quickly implement the process of reliable identification of a test pathogen in antigen-antibody complex.Представлены научно-методические разработки биотехнологий производства компонентов тест-систем (диагностических препаратов) для экспресс-диагностики чумы, бруцеллеза, туляремии, сибирской язвы, холеры. Для этого, прежде всего, были отработаны эффективные методики получения полноценных антигенных комплексов, применяемых для иммунизации животных в целях получения высокоактивных иммунных сывороток. Полученные иммунные сыворотки были использованы при определении оптимальных параметров производства на их основе диагностикумов. Приведены методические основы конструирования магноиммуносорбентов для селективного концентрирования возбудителей инфекционных заболеваний и их индикации экспресс-методами. Кроме того, приведена разработка пьезокварцевых биосенсорных устройств для выявления возбудителей чумы, бруцеллеза, туляремии в гравиметрическом проточно-инжекционном анализе, позволяющих быстро реализовать процесс достоверного распознавания исследуемого патогена в образовавшемся комплексе антиген-антител

Development of New Approaches of Obtaining the Hyperimmune Sera for Production of Medical Immunobiological Preparations

Developed were the new immunization schedules of obtaining plague, brucellar, anthrax, tularemia, cholera, leptospirosis, legionellosis and campilobacteriosis hyperimmune sera based on optimal combinations of specific protein antigenic complexes with immunomodulators, providing high specific immune response in 100 % of animals, significant reduction of immunization terms, material and labor input. Immune sera obtained are high quality biological material to be used for production of different diagnostic immunobiological preparations

Scientific and methodical development of biotechnological production of immunobiological preparations for instant diagnosis of infectious diseases and detection of pathogens

The present article describes the scientific and methodological development of biotechnological manufacture of test-system components (diagnostic preparations) for instant diagnosis of plague, brucellosis, tularemia, anthrax, cholera. In this regard, in the first place the effective methods for obtaining complete antigenic complexes used for immunizing animals for the purpose of developing highly potent immune sera have been established. These antisera were used in determining optimum parameters of manufacture on the basis of their diagnosticums. Methodical basis of developing magnetic immunosorbents for selective concentration of infectious agents and their instant diagnosis methods has been mentioned. Moreover, the article describes the development of piezoelectric quartz crystal biosensors to detect plague, brucellosis and tularemia pathogens by gravimetric flow injection analysis, allowing to quickly implement the process of reliable identification of a test pathogen in antigen-antibody complex

FEATURES OF MASS-SPECTROMETRIC PROTEIN PROFILES OF STRAINS OF BRUCELLOSIS CAUSATIVE AGENT DURING PREPARATION OF CULTURE ON VARIOUS NUTRIENT MEDIA

Aim. Carry out comparative analysis using time-of-flight mass-spectrometry with matrix laser desorption/ionization (MALDI-TOF MS) of protein profiles of brucellosis causative agents (Brucella melitensis Rev-1 and Brucella abortus 19BA), cultivated in various nutrient media: Albimi agar, brucellagar and erythrit-agar. Materials and methods. Vaccine strains: Brucella melitensis Rev-1 and Brucella abortus 19BA. Protein profiling in linear mode on Microflex «Bruker Daltonics» MALDI-TOF mass-spectrometer. Results. A number of characteristic features of brucella mass-spectra was detected: in particular, preservation of the total qualitative composition of protein profiles of cultures and significant differences in the intensity of separate peaks depending on the nutrient medium used. Conclusion. Based on the analysis of the data obtained, use of Albimi agar as the nutrient medium for preparation of brucella culture samples for mass-spectrometric analysis was shown to be optimal

Mastering of Technology of Production of Brucellosis Diagnostic Bacteriophages

Presented are technologies of production of brucellosis diagnostic bacteriophages developed on the basis of determination of optimal conditions of the phages reproduction. Stability of the finished product was evaluated using Shuhard control charts

Immune-Magnetic Absorbents Used for Express Diagnosis of Dangerous Infectious Diseases: Biotechnology Aspects and Experience of Application

Compositional micro-grained immune-magnetic absorbents (IMA) were obtained on the basis of silica - aluminocilicate, modified by polyglucin and sodium secondary alkylsulphate. IMA were shown to possess high adsorption activity due to their developed surface and implanted specific ligand, standard structural features, mechanical reliability, chemical and microbiological stability. The existence of magnetic material provided facilitation and convenience of operations with absorbents in analysis performance. Applying of IMA allowed to release of any mixtures with their adverse effect on reaction during samples preparing by means of rinsing the absorbent with fixed infected agent on it; concentrating the unknown pathogen to the extent possible increased the specificity and sensitivity of express-analysis methods (EIA and PCR), the time spending for analysis reduced substantially (up to 1-3hours)