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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">biopreparat</journal-id><journal-title-group><journal-title xml:lang="ru">БИОпрепараты. Профилактика, диагностика, лечение</journal-title><trans-title-group xml:lang="en"><trans-title>Biological Products. Prevention, Diagnosis, Treatment</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2221-996X</issn><issn pub-type="epub">2619-1156</issn><publisher><publisher-name>Scientific Centre for Expert Evaluation of Medicinal Products</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30895/2221-996X-2020-20-3-146-158</article-id><article-id custom-type="elpub" pub-id-type="custom">biopreparat-297</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group></article-categories><title-group><article-title>Перспективы использования технологической платформы ELISPOT в системе противоэпидемических мероприятий против новой коронавирусной инфекции COVID-19</article-title><trans-title-group xml:lang="en"><trans-title>Prospects for Using the ELISPOT Technological Platform as Part of Anti-Epidemic Measures Against the New Coronavirus Infection COVID-19</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2695-8869</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Потеряев</surname><given-names>Д. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Poteryaev</surname><given-names>D. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Потеряев Дмитрий Александрович, канд. биол. наук.</p><p>ул. Владимирская, д. 14, пос. Вольгинский, Петушинский район, Владимирская область, 601125</p></bio><bio xml:lang="en"><p>Dmitry A. Poteryaev, Cand. Sci. (Biol.).</p><p>14 Vladimirskaya St., Volginsky town, Petushinskiy District, Vladimir Oblast 601125</p></bio><email xlink:type="simple">poteryaev@ibcgenerium.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1314-894X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хамитов</surname><given-names>Р. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Khamitov</surname><given-names>R. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Хамитов Равиль Авгатович, д-р мед. наук, проф.</p><p>ул. Владимирская, д. 14, пос. Вольгинский, Петушинский район, Владимирская область, 601125</p></bio><bio xml:lang="en"><p>Ravil A. Khamitov, Dr. Sci. (Med.), Professor.</p><p>14 Vladimirskaya St., Volginsky town, Petushinskiy District, Vladimir Oblast 601125</p></bio><email xlink:type="simple">khamitov@ibcgenerium.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7129-6062</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ефимов</surname><given-names>Г. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Efimov</surname><given-names>G. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Ефимов Григорий Александрович, канд. биол. наук.</p><p>Новый Зыковский проезд, д. 4, Москва, 125167</p></bio><bio xml:lang="en"><p>Grigory A. Efimov, Cand. Sci. (Biol.).</p><p>4 Novy Zykovsky proezd, Moscow 125167</p></bio><email xlink:type="simple">efimov@blood.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6980-7190</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шустер</surname><given-names>А. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Shuster</surname><given-names>A. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Шустер Александр Михайлович, канд. биол. наук.</p><p>ул. Владимирская, д. 14, пос. Вольгинский, Петушинский район, Владимирская область, 601125</p></bio><bio xml:lang="en"><p>Aleksandr M. Shuster, Cand. Sci. (Biol.).</p><p>14 Vladimirskaya St., Volginsky town, Petushinskiy District, Vladimir Oblast 601125</p></bio><email xlink:type="simple">shuster@ibcgenerium.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Общество с ограниченной ответственностью «Международный биотехнологический центр «ГЕНЕРИУМ»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>International Biotechnology Center “GENERIUM”</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Национальный медицинский исследовательский центр гематологии» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>National Research Center for Hematology</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2020</year></pub-date><pub-date pub-type="epub"><day>14</day><month>08</month><year>2020</year></pub-date><volume>20</volume><issue>3</issue><fpage>146</fpage><lpage>158</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Потеряев Д.А., Хамитов Р.А., Ефимов Г.А., Шустер А.М., 2020</copyright-statement><copyright-year>2020</copyright-year><copyright-holder xml:lang="ru">Потеряев Д.А., Хамитов Р.А., Ефимов Г.А., Шустер А.М.</copyright-holder><copyright-holder xml:lang="en">Poteryaev D.A., Khamitov R.A., Efimov G.A., Shuster A.M.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.biopreparations.ru/jour/article/view/297">https://www.biopreparations.ru/jour/article/view/297</self-uri><abstract><p>Определение наличия Т-клеточного иммунного ответа к вирусу SARS-CoV-2 актуально как для диагностики заболевания у пациентов с наличием симптомов, так и для определения общего количества людей, перенесших данное заболевание, в том числе бессимптомно. Кроме того, данные тесты эффективны для оценки иммунного ответа после проведения вакцинации, а также оценки напряженности специфического иммунитета в группах риска и ранее переболевших. При этом среди методов оценки Т-клеточного иммунного ответа наиболее перспективным является тест ELISPOT на выброс интерферона гамма (IGRA) под действием специфических вирусных антигенов. В обзоре рассмотрены перспективы использования технологической платформы ELISPOT в клинико-лабораторной практике при работе с новой коронавирусной инфекцией COVID-19 с учетом особенностей иммунного ответа при данном заболевании. В качестве источников литературы использовались статьи, опубликованные в реферируемых журналах, препринты статей, размещенные на ресурсах arXiv, кроме того, использовались личные коммуникации авторов с ведущими иммунологами. Показано, что внедрение В- и Т-клеточного ELISPOT-тестов позволит осуществлять мониторинг иммунологического статуса пациентов и выбор тактики лечения, выявлять наиболее уязвимые группы населения, осуществлять комплексную оценку вакцинных препаратов на этапах разработки, клинических исследований и внедрения в практику. Обсуждаются вопросы сохранения Т-клеточного иммунитета в крови переболевших коронавирусными инфекциями HCoV, SARS, MERS, COVID-19 и преимущества Т-клеточного ELISPOT-теста перед серологическими тестами для эпидемиологической оценки распространенности новой коронавирусной инфекции и в клинических исследованиях вакцин против COVID-19. Биотехнологические компании имеют готовую технологическую платформу, легко адаптируемую под конкретный вид анализа и патогена, для разработки и промышленного производства наборов ELISPOT. Подтверждена необходимость разработки вакцин, стимулирующих как клеточный, так и гуморальный иммунные ответы, поднят вопрос о защитном потенциале перекрестного иммунитета, приобретенного до пандемии COVID-19.</p></abstract><trans-abstract xml:lang="en"><p>Determination of T-cell immune response to SARS-CoV-2 is important both for diagnosis of the disease in symptomatic patients, and for determination of the total number of people who have had the disease, including its asymptomatic form. In addition, these assays are efficient for assessing the immune response after vaccination, as well as immunity levels in risk groups and in convalescent patients. The most promising method of T-cell immune response assessment is an ELISPOT-based assay measuring the release of interferon-gamma (IGRA) after stimulation with coronavirus-specific antigens. The present review analyses the prospects for using the ELISPOT technological platform in the clinical laboratory setting when dealing with the new coronavirus infection COVID-19, given specific aspects of the immune response. The review summarises data from articles published in peer-reviewed journals, preprints of articles available at arXiv resources, and information that some leading immunologists shared with the authors during private discussions. It has been shown that the introduction of B- and T-cell ELISPOT assays will make it possible to monitor the immunological status of patients, select a treatment strategy, identify the most vulnerable populations, carry out comprehensive assessment of vaccines during the development, clinical trials and implementation stages. The paper discusses the issues of maintaining T-cell immunity in the blood of people who have had HCoV, SARS, MERS, and COVID-19 coronavirus infections. It also discusses the advantages of the T-cell ELISPOT assay over serological tests as regards epidemiological assessment of the prevalence of the new coronavirus infection, and clinical trials of COVID-19 vaccines. Biotechnology companies have a ready-made technological platform for the development and industrial-scale production of ELISPOT kits, and this platform is easily adaptable to specific types of assays and pathogens. The paper supports the need to develop vaccines that would stimulate both cellular and humoral immune responses, and raises the question of the protective potential of cross-immunity acquired before the COVID-19 pandemic.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>ELISPOT</kwd><kwd>SARS-CoV-2</kwd><kwd>COVID-19</kwd><kwd>Т-лимфоциты</kwd><kwd>В-клетки</kwd><kwd>антитела</kwd><kwd>вакцина</kwd><kwd>иммунитет</kwd></kwd-group><kwd-group xml:lang="en"><kwd>ELISPOT</kwd><kwd>SARS-CoV-2</kwd><kwd>COVID-19</kwd><kwd>T-cells</kwd><kwd>B-cells</kwd><kwd>antibodies</kwd><kwd>vaccine</kwd><kwd>immunity</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Авторы благодарны Markus Maeurer (Fundação Champalimaud, Португалия) и Chiara Agrati (Istituto Nazionale Malattie Infettive Lazzaro Spallanzani, Италия) за обсуждение методов исследования иммунитета к SARS-CoV-2.</funding-statement><funding-statement xml:lang="en">The authors are grateful to Markus Maeurer (Fundação Champalimaud, Portugal) and Chiara Agrati (Istituto Nazionale Malattie Infettive Lazzaro Spallanzani, Italy) for discussions of methods used in SARS-CoV-2 immunity studies.</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, et al. 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