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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">izmertech</journal-id><journal-title-group><journal-title xml:lang="ru">Измерительная техника</journal-title><trans-title-group xml:lang="en"><trans-title>Izmeritel`naya Tekhnika</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">0368-1025</issn><issn pub-type="epub">2949-5237</issn><publisher><publisher-name>ФГУП "ВНИИФТРИ"</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.32446/0368-1025it.2025-5-88-97</article-id><article-id custom-type="elpub" pub-id-type="custom">izmertech-2435</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>МЕДИЦИНСКИЕ И БИОЛОГИЧЕСКИЕ ИЗМЕРЕНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>MEDICAL AND BIOLOGICAL MEASUREMENTS</subject></subj-group></article-categories><title-group><article-title>Особенности измерений в лабораторной медицине и пути совершенствования внешней оценки качества</article-title><trans-title-group xml:lang="en"><trans-title>Measurements in laboratory medicine and external quality assessment</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0482-0802</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ковязина</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kovyazina</surname><given-names>N. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Надежда Алексеевна Ковязина</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Kovyazina Nadezhda Alekseevn</p><p>Saint Peter</p></bio><email xlink:type="simple">nakovzn@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6268-8969</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Алхутова</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Alkhutova</surname><given-names>N. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Наталья Александровна Алхутова</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Alkhutova Natalia Alexandrovna</p><p>Saint Petersburg</p></bio><email xlink:type="simple">nalhutova@yandex.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/0000-0003-4061-7411</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Вонский</surname><given-names>М. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Vonsky</surname><given-names>M. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Максим Сергеевич Вонский</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Vonsky Maxim Sergeevich</p><p>V. A. Almazov National Medical Research Center</p></bio><email xlink:type="simple">m.s.vonsky@vniim.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/0000-0002-6222-5884</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Чуновкина</surname><given-names>А. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Chunovkina</surname><given-names>A. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Анна Гурьевна Чуновкина</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Chunovkina Anna Guryevna</p><p>Saint Petersburg</p></bio><email xlink:type="simple">A.G.Chunovkina@vniim.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2079-0439</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Эмануэль</surname><given-names>В. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Leonidovich</surname><given-names>V. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Владимир Леонидович Эмануэль</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Emanuel Vladimir Leonidovich</p><p>Saint Petersburg</p></bio><email xlink:type="simple">vladimirem1@gmail.com</email><xref ref-type="aff" rid="aff-4"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Всероссийский центр экстренной и радиационной медицины им. А. М. Никифорова МЧС России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>The Nikiforov Russian Center of Emergency and Radiation Medicine, EMERCOM of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Всероссийский научно-исследовательский институт метрологии им. Д. И. Менделеева</institution><country>Россия</country></aff><aff xml:lang="en"><institution>V. A. Almazov National Medical Research Center; D. I. Mendeleyev Institute for Metrology</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Всероссийский научно-исследовательский институт метрологии им. Д. И. Менделеева</institution><country>Россия</country></aff><aff xml:lang="en"><institution>V. A. Almazov National Medical Research Center</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>Первый Санкт-Петербургский государственный медицинский университет им. И. П. Павлова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Pavlov First State Medical University of St. Petersburg</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>14</day><month>11</month><year>2025</year></pub-date><volume>74</volume><issue>5</issue><fpage>88</fpage><lpage>97</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; ФГУП "ВНИИФТРИ", 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">ФГУП "ВНИИФТРИ"</copyright-holder><copyright-holder xml:lang="en">ФГУП "ВНИИФТРИ"</copyright-holder><license xlink:href="https://www.izmt.ru/jour/about/submissions#copyrightNotice" xlink:type="simple"><license-p>https://www.izmt.ru/jour/about/submissions#copyrightNotice</license-p></license></permissions><self-uri xlink:href="https://www.izmt.ru/jour/article/view/2435">https://www.izmt.ru/jour/article/view/2435</self-uri><abstract><p>Рассмотрен такой инструмент проверки квалификации лаборатории, подтверждения требуемого или заявляемого лабораториями уровня точности измерений, как внешняя оценка качества в форме межлабораторных сличений. Выделены отраслевые особенности измерений в лабораторной медицине и проанализированы результаты многолетнего участия в системе внешней оценки качества. На основании проведённого анализа сделан вывод, что в отсутствие соответствующих эталонов, сертифицированных стандартных образцов и референтных методик для многих аналитов система внешней оценки качества медицинских лабораторий приобретает иное значение: становится незаменимым инструментом получения объективных данных о воспроизводимости/согласованности полученных в разных лабораториях результатов, выявления смещений результатов измерений лабораторий-участниц. В таких условиях внешняя оценка качества подтверждает квалификацию медицинской лаборатории в использовании конкретной аналитической методики в совокупности с референтными клиническими сведениями, соответствующими конкретной методике. Полученные результаты будут полезны специалистам, работающим на стыке метрологии и клинической лабораторной диагностики, а также производителям медицинских изделий для диагностики in vitro и провайдерам внешней оценки качества.</p></abstract><trans-abstract xml:lang="en"><p>External quality assessment, conducted in the form of interlaboratory comparisons, is traditionally a tool for verifying laboratory qualifications and confirming the level of measurement accuracy required or claimed by laboratories. The authors identified industry-specific measurement features in laboratory medicine and analyzed long-term participation in the external quality assessment system. Based on these data, the authors concluded that in the absence of appropriate standards, certified reference materials and reference methods for many analytes, the external quality assessment system for medical laboratories acquires a different meaning and becomes an indispensable tool for obtaining objective data on the reproducibility/ consistency of the results obtained in different laboratories, identifying biases in the measurement results of participating laboratories. In such circumstances, an external quality assessment confirms the qualification of a medical laboratory in using a specific analytical technique in combination with reference clinical information corresponding to this particular technique. The results obtained may be of interest to specialists working at the interface of metrology and clinical laboratory diagnostics, as well as manufacturers of medical devices for in vitro diagnostics and external quality assessment providers.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>клинико-лабораторное исследование</kwd><kwd>диагностика in vitro</kwd><kwd>неопределённость измерения</kwd><kwd>метрологическая прослеживаемость</kwd><kwd>калибратор</kwd><kwd>референтный материал</kwd><kwd>стандартный образец</kwd><kwd>внешняя оценка качества</kwd></kwd-group><kwd-group xml:lang="en"><kwd>clinical laboratory study</kwd><kwd>in vitro diagnostic</kwd><kwd>measurement uncertainty</kwd><kwd>metrological traceability</kwd><kwd>calibrator</kwd><kwd>reference material</kwd><kwd>external quality assessment</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Kovyazina N. 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