Application of Latex Agglutination and Immune Chromatography Methods for Rapid Identification of &lt;i&gt;Bacillus anthracis&lt;/i&gt; Cultures in the Epidemiological Investigation of Outbreaks

Кравец, Е. В.; Дугаржапова, З. Ф.; Родзиковский, А В; Khlyntseva, A. E.; Luneva, N. M.; Белова, Е. В.; Колосова, Н. В.; Рудницкий, С. Ю.; Соловьев, П. В.; Баранова, Е. В.; Biketov, S F

doi:10.21055/0370-1069-2011-1(107)-81-82

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“…ИХ-тесты также успешно применяются в лабораторной диагностике особо опасных инфекционных заболеваний, в том числе и сибирской язвы [14][15][16].…”

Section: результаты и обсуждениеunclassified

“…Это позволило нам показать возможность проведения испытания вакцины сибиреязвенной по показателю «Специфическая активность» методом подсчета общей концентрации спор по ОСО мутности бактериальных взвесей 10 МЕ, как это принято в испытаниях других бактериальных живых вакцин. На основании представленной в ОФС 1.7.2.0008.15 15 формулы подсчета бактериальной концентрации по ОСО мутности нами предложена формула (2) подсчета общей концентрации (ОК) спор в вакцине сибиреязвенной:…”

Section: результаты и обсуждениеunclassified

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Theoretical and Experimental Substantiation of Alternative Methods for Quality Control of Live Anthrax Vaccine

Алексеева¹,

Немировская²

2020

Biopreparaty. Profilaktika, diagnostika, lechenie

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Preventive immunisation against anthrax is carried out in accordance with the national Immunisation Schedule for Epidemic Settings. The vaccination is performed using a live vaccine—a freeze-dried suspension of Bacillus anthracis STI-1 vaccine strain spores in a stabilizing media. Improvement of the quality control of immunobiological medicines is a pressing issue and an integral part of the quality management system.The aim of study was to streamline quality control of live anthrax vaccine in terms of the following test parameters: identification and specific activity (total spore concentration).Materials and methods: identification and specific activity (total spore concentration) tests were performed for samples of live anthrax vaccine, batch 266, produced by the 48 Central Scientific Research Institute. The identification test was performed using the B. anthracis immunochromatography test kit for express detection and identification of anthrax pathogen spores produced by the State Research Center for Applied Microbiology and Biotechnology (Obolensk). The specific activity (total spore concentration) was assessed by the visual method and calculated in the Goryaev chamber using the industry reference standard of bacterial suspension turbidity equivalent to 10 IU—OSO 42-28-85 (by the Scientific Centre for Expert Evaluation of Medicinal Products). The number of live spores in live anthrax vaccine was determined by the microbiological method (by inoculating media). The statistical processing of the results was performed using Excel and Statistica 10.0.Results: the authors provided theoretical and experimental substantiation to support the feasibility of using immunochromatography as an alternative identification test method for live anthrax vaccine. Test samples dilutions of 108 microbial cells per millilitre and 109 microbial cells per millilitre are used in the test. The authors developed a test procedure for determination of the total spore concentration (specific activity) in live anthrax vaccine using an industry reference standard of turbidity equivalent to 10 IU, and proposed a formula for calculation of the total spore concentration.Conclusions: the developed test procedures could be recommended for inclusion in the live anthrax vaccine specification files as alternative methods of quality control.

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Section: результаты и обсуждениеunclassified

Theoretical and Experimental Substantiation of Alternative Methods for Quality Control of Live Anthrax Vaccine

Алексеева¹,

Немировская²

2020

Biopreparaty. Profilaktika, diagnostika, lechenie

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Domestically-Produced Monoclonal-Antibody-Based Means of Diagnosing Particularly Dangerous Infections

Кретенчук

2022

Problemy Osobo Opasnykh Infektsii

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Currently, great significance is attached to the preparation of diagnostic drugs based on specific immunoreagents, which include monoclonal antibodies produced by hybridomas. The use of monoclonal antibodies is one of the important approaches for the detection of pathogens of particularly dangerous infections – anthrax, brucellosis, tularemia, plague, cholera, glanders, and melioidosis. The review presents the main achievements of Russian scientists on obtaining such experimental drugs, and also pays attention to those sets of monoclonal reagents that are authorized in the Russian Federation. To date, three sets of reagents for detecting the causative agent of anthrax (latex agglutination, immunochromatographic method, multiplex immunofluorescence analysis) have been registered in our country on the basis of monoclonal antibodies; four sets of reagents for identifying the causative agent of tularemia (latex agglutination, immunochromatographic method, multiplex immunofluorescence analysis, dot-variant of enzyme immunoassay); three sets for the detection of plague microbe (enzyme immunoassay and immune chromatographic tests); five sets for cholera vibrios (slide agglutination, immunofluorescence, immune chromatographic method and enzyme immunoassay); two sets for the diagnosis of glanders and melioidosis (immunofluorescence); kits for detecting brucella have not been registered, there are only singular experimental designs. The involvement of modern drugs based on monoclonal antibodies in the diagnosis of particularly dangerous infections will improve the quality and reliability of laboratory analysis.

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Application of Latex Agglutination and Immune Chromatography Methods for Rapid Identification of <i>Bacillus anthracis</i> Cultures in the Epidemiological Investigation of Outbreaks

Cited by 2 publications

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Theoretical and Experimental Substantiation of Alternative Methods for Quality Control of Live Anthrax Vaccine

Theoretical and Experimental Substantiation of Alternative Methods for Quality Control of Live Anthrax Vaccine

Domestically-Produced Monoclonal-Antibody-Based Means of Diagnosing Particularly Dangerous Infections

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