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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">cardiovascular</journal-id><journal-title-group><journal-title xml:lang="ru">Кардиоваскулярная терапия и профилактика</journal-title><trans-title-group xml:lang="en"><trans-title>Cardiovascular Therapy and Prevention</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1728-8800</issn><issn pub-type="epub">2619-0125</issn><publisher><publisher-name>«SILICEA-POLIGRAF» LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.15829/1728-8800-2023-3709</article-id><article-id custom-type="elpub" pub-id-type="custom">cardiovascular-3709</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>БИОБАНКИРОВАНИЕ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>BIOBANKING</subject></subj-group></article-categories><title-group><article-title>Оценка надежности результатов серологического мониторинга по материалам биобанка</article-title><trans-title-group xml:lang="en"><trans-title>Assessment of the reliability of serological monitoring results based on biobank materials</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-8521-1741</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ноздрачева</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Nozdracheva</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Анна Валерьевна Ноздрачева — кандидат медицинских наук, заведующий лабораторией неспецифической профилактики инфекционных заболеваний отдела эпидемиологии.</p><p>Москва</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">nozdracheva0506@mail.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/0000-0002-6686-9011</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Семененко</surname><given-names>Т. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Semenenko</surname><given-names>T. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Татьяна Анатольевна Семененко — доктор медицинских наук, профессор, руководитель отдела эпидемиологии.</p><p>Москва</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">semenenko@gamaleya.org</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБУ "Национальный исследовательский центр эпидемиологии и микробиологии им. Н.Ф. Гамалеи" Минздрава России</institution></aff><aff xml:lang="en"><institution>National Center of Epidemiology and Microbiology</institution></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>10</day><month>12</month><year>2023</year></pub-date><volume>22</volume><issue>11</issue><issue-title>Биобанкирование</issue-title><fpage>3709</fpage><lpage>3709</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Ноздрачева А.В., Семененко Т.А., 2023</copyright-statement><copyright-year>2023</copyright-year><copyright-holder xml:lang="ru">Ноздрачева А.В., Семененко Т.А.</copyright-holder><copyright-holder xml:lang="en">Nozdracheva A.V., Semenenko T.A.</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://cardiovascular.elpub.ru/jour/article/view/3709">https://cardiovascular.elpub.ru/jour/article/view/3709</self-uri><abstract><sec><title>Цель</title><p>Цель. Оценить сохранность иммуноглобулинов (Ig) разных классов (IgА, IgМ, IgG, IgЕ) в условиях продолжительного низкотемпературного хранения образцов сыворотки крови.</p></sec><sec><title>Материал и методы</title><p>Материал и методы. В работе использованы образцы сывороток крови из коллекции отдела эпидемиологии, исследованные методом иммуноферментного анализа на наличие антител классов IgА, IgМ, IgG, IgЕ двукратно: сразу по поступлению в лабораторию и после хранения при температуре -70о C в течение 8 лет.</p></sec><sec><title>Результаты</title><p>Результаты. По истечении периода хранения серопозитивных сывороток уровень антител класса IgA статистически значимо не изменился (р=0,7). В отношении остальных классов иммуноглобулинов (IgM, IgG, IgE) наблюдалось небольшое (не &gt;15%), однако статистически значимое снижение их уровня в сыворотке крови (р&lt;0,05), наиболее выраженное для Ig E. Показано, что чем выше был уровень антител в образцах при первом исследовании, тем более он снизился после долгосрочного хранения (корреляционная связь при р&lt;0,05). Это не привело к появлению ложноотрицательных результатов, что связано с выявленной нами большей "точностью" измерения именно небольших значений.</p></sec><sec><title>Заключение</title><p>Заключение. Длительное низкотемпературное хранение образцов сывороток крови в условиях биобанка обеспечивает сохранность антител разных классов и является основой достоверности результатов будущих исследований.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Aim</title><p>Aim. To evaluate the safety of immunoglobulins (Ig) of different classes (IgA, IgM, IgG, IgE) under conditions of long-term low-temperature storage of blood serum samples.</p></sec><sec><title>Material and methods</title><p>Material and methods. The work used samples of blood serum from the collection of the Department of Epidemiology, examined by enzyme immunoassay for antibodies of classes IgA, IgM, IgG, IgE twice as follows: immediately upon receipt in the laboratory and after storage at a temperature of -70о C for 8 years.</p></sec><sec><title>Results</title><p>Results. After the storage of seropositive sera, the level of IgA antibodies did not change significantly (p=0,7). For the remaining classes of immunoglobulins (IgM, IgG, IgE), a small (not &gt;15%) but significant decrease (p&lt;0,05), most pronounced for IgE, was observed. It was shown that the higher the antibody level in the samples during the first study, the more it decreased after long-term storage (correlation at p&lt;0,05). This did not lead to false negative results, which is due to the greater accuracy in measuring small values.</p></sec><sec><title>Conclusion</title><p>Conclusion. Long-term low-temperature storage of serum samples in biobank conditions ensures the safety of antibodies of different classes and is the basis for the reliability of future studies.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>биобанкирование</kwd><kwd>хранение образцов</kwd><kwd>иммуноглобулины</kwd><kwd>сыворотка крови</kwd><kwd>сохранность антител</kwd></kwd-group><kwd-group xml:lang="en"><kwd>biobanking</kwd><kwd>sample storage</kwd><kwd>immunoglobulins</kwd><kwd>blood serum</kwd><kwd>preservation of antibodies</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена при поддержке Государственного задания Минобрнауки РФ № FZWN-2020-0017 (дизайн, анализ и интерпретация данных)</funding-statement><funding-statement xml:lang="en">The work was supported by the State assignment of the Ministry of Education and Science of the Russian Federation № FZWN-2020-0017 (design, analysis and interpretation of data)</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">Ma H, Ó'Fágáin C, O'Kennedy R. Antibody stability: A key to performance — Analysis, influences and improvement. Biochimie. 2020;177:213­25. doi:10.1016/j.biochi.2020.08.019.</mixed-citation><mixed-citation xml:lang="en">Ma H, Ó'Fágáin C, O'Kennedy R. Antibody stability: A key to performance — Analysis, influences and improvement. Biochimie. 2020;177:213­25. doi:10.1016/j.biochi.2020.08.019.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Семененко Т. А., Акимкин В. Г. Сероэпидемиологические исследования в системе надзора за вакциноуправляемыми инфекциями. Журнал микробиологии, эпидемиологии и иммунобиологии. 2018;95(2):87­94. doi:10.36233/0372­93112018­2­87­94.</mixed-citation><mixed-citation xml:lang="en">Semenenko TA, Akimkin VG. Seroepidemiology in the surveillance of vaccine­ preventable diseases. Journal of microbiology, epidemiology and immunobiology. 2018;95(2):87­94. (In Russ.) doi:10.36233/0372­93112018­2­87­94.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Анисимов С. В., Ахмеров Т. М., Балановский О. П. и др. Биобанкирование. Национальное руководство. Москва: ООО "Издательство ТРИУМФ", 2022. 308 с. ISBN: 978­5­93673­322­2.</mixed-citation><mixed-citation xml:lang="en">Anisimov SV, Akhmerov TM, Balanovsky OP, et al. Biobanking. National Manual. Moscow: TRIUMPH Publishing House LLC, 2022. 308 p. (In Russ.) ISBN: 978­5­93673­322­2.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Семененко Т. А., Ананьина Ю. В., Боев Б. В. и др. Банки биологических ресурсов в системе фундаментальных эпидемиологических и клинических исследований. Вестник Российской академии медицинских наук. 2011;10:5­9.</mixed-citation><mixed-citation xml:lang="en">Semenenko TA, Anan'ina YV, Boev BV, et al. Banks of biological resources in the system of basic epidemiological and clinical studies. Annals of the Russian academy of medical sciences. 2011;10:59. (In Russ.)</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Долудин Ю. В., Борисова А. Л., Покровская М. С. и др. Современные передовые практики и рекомендации по биобанкированию Клиническая лабораторная диагностика. 2019;64(12):769­76. doi:10.18821/08692084­2019­64­12­769­776.</mixed-citation><mixed-citation xml:lang="en">Doludin YV, Borisova AL, Pokrovskaya MS, et al. Current best practices and biobanking recomedations. Russian Clinical Laboratory Diagnostics. 2019;64(12):769­76. (In Russ.)doi:10.18821/08692084­2019­64­12­769­776.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Покровская М. С., Борисова А. Л., Сивакова О. В. и др. Управление качеством в биобанке. мировые тенденции и опыт биобанка ФГБУ "НМИЦ профилактической медицины" Минздрава России. Клиническая лабораторная диагностика. 2019;64(6):380­4. doi:10.18821/0869­2084­2019­64­6­380­384.</mixed-citation><mixed-citation xml:lang="en">Pokrovskaya MS, Borisova AL, Sivakova OV, et al. Quality management in biobank. World tendencies and experience of biobank of FSI "NMRC for preventive medicine" of the Ministry of healthcare of Russia. Russian Clinical Laboratory Diagnostics. 2019;64(6):380­4. (In Russ.) doi:10.18821/0869­2084­2019­64­6­380­384.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Anisimov SV, Granstrem OK, Meshkov AN, et al. National association of biobanks and biobanking specialists: new community for promoting biobanking ideas and projects in Russia. Biopreserv Biobank. 2021;19(1):73­82. doi:10.1089/bio.2020.0049.</mixed-citation><mixed-citation xml:lang="en">Anisimov SV, Granstrem OK, Meshkov AN, et al. National association of biobanks and biobanking specialists: new community for promoting biobanking ideas and projects in Russia. Biopreserv Biobank. 2021;19(1):73­82. doi:10.1089/bio.2020.0049.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Castro AR, Jost HA. Effect of multiple freeze and thaw cycles on the sensitivity of IgG and IgM immunoglobulins in the sera of patients with syphilis. Sex Transm Dis. 2013;40(11):870­1. doi:10.1097/OLQ.0000000000000036.</mixed-citation><mixed-citation xml:lang="en">Castro AR, Jost HA. Effect of multiple freeze and thaw cycles on the sensitivity of IgG and IgM immunoglobulins in the sera of patients with syphilis. Sex Transm Dis. 2013;40(11):870­1. doi:10.1097/OLQ.0000000000000036.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Козлова В. А., Метельская В. А., Покровская М. С. и др. Изучение стабильности биохимических маркеров при непрерывном длительном хранении сыворотки крови и при однократном размораживании. Кардиоваскулярная терапия и профилактика. 2020;19(6):2736. doi:10.15829/1728­8800­2020­2736.</mixed-citation><mixed-citation xml:lang="en">Kozlova VA, Metelskaya VA, Pokrovskaya MS, et al. Stability of serum biochemical markers during standard long­term storage and with a single thawing. Cardiovascular Therapy and Prevention. 2020;19(6):2736. (In Russ.) doi:10.15829/1728­8800­2020­2736.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Vignoli A, Tenori L, Morsiani C, et al. Serum or Plasma (and Which Plasma), That Is the Question. J Proteome Res. 2022;21(4):106172. doi:10.1021/acs.jproteome.1c00935.</mixed-citation><mixed-citation xml:lang="en">Vignoli A, Tenori L, Morsiani C, et al. Serum or Plasma (and Which Plasma), That Is the Question. J Proteome Res. 2022;21(4):106172. doi:10.1021/acs.jproteome.1c00935.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Rouet R, Lowe D, Christ D. Stability engineering of the human antibody repertoire. FEBS Lett. 2014;588(2):269­77. doi:10. 1016/j.febslet.2013.11.029.</mixed-citation><mixed-citation xml:lang="en">Rouet R, Lowe D, Christ D. Stability engineering of the human antibody repertoire. FEBS Lett. 2014;588(2):269­77. doi:10. 1016/j.febslet.2013.11.029.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Correia IR. Stability of IgG isotypes in serum. MAbs. 2010;2(3):221­32. doi:10.4161/mabs.2.3.11788.</mixed-citation><mixed-citation xml:lang="en">Correia IR. Stability of IgG isotypes in serum. MAbs. 2010;2(3):221­32. doi:10.4161/mabs.2.3.11788.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Moggridge J, Biggar K, Dawson N, et al. Sensitive Detection of Immunoglobulin G Stability Using in Real­ Time Isothermal Differential Scanning Fluorimetry: Determinants of Protein Stability for Antibody­ Based Therapeutics. Technol Cancer Res Treat. 2017;16(6):997­1005. doi:10.1177/1533034617714149.</mixed-citation><mixed-citation xml:lang="en">Moggridge J, Biggar K, Dawson N, et al. Sensitive Detection of Immunoglobulin G Stability Using in Real­ Time Isothermal Differential Scanning Fluorimetry: Determinants of Protein Stability for Antibody­ Based Therapeutics. Technol Cancer Res Treat. 2017;16(6):997­1005. doi:10.1177/1533034617714149.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Xiang H, Chan D, Bates R. Minimization of freeze/thaw­induced protein aggregation and optimization of a drug substance formulation matrix. BioPharm Int. 2015;28(8):30­7.</mixed-citation><mixed-citation xml:lang="en">Xiang H, Chan D, Bates R. Minimization of freeze/thaw­induced protein aggregation and optimization of a drug substance formulation matrix. BioPharm Int. 2015;28(8):30­7.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Martin P, Colandene J, Pruett WA, et al. Impact of manufacturing­ scale freeze­thaw conditions on a mAb solution. BioPharm Int. 2017;30(2):30­6.</mixed-citation><mixed-citation xml:lang="en">Martin P, Colandene J, Pruett WA, et al. Impact of manufacturing­ scale freeze­thaw conditions on a mAb solution. BioPharm Int. 2017;30(2):30­6.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Manikwar P, Majumdar R, Hickey JM, et al. Correlating excipient effects on conformational and storage stability of an IgG1 monoclonal antibody with local dynamics as measured by hydrogen/deuterium­exchange mass spectrometry. J Pharm Sci. 2013;102(7):2136­51. doi:10.1002/jps.23543.</mixed-citation><mixed-citation xml:lang="en">Manikwar P, Majumdar R, Hickey JM, et al. Correlating excipient effects on conformational and storage stability of an IgG1 monoclonal antibody with local dynamics as measured by hydrogen/deuterium­exchange mass spectrometry. J Pharm Sci. 2013;102(7):2136­51. doi:10.1002/jps.23543.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Ma H, O'Kennedy R. Generation and optimization of antibodies for use in biosensors/ In: Nanobiosensors for personalized in situ biomedical diagnostics (ed Pranjal Chandra and Esther Sehgal) Institute of Engineering and Technology (IET) Publishing. 2016;209­30. ISBN: 9781849199506; e­ ISBN: 9781849199513. 638 p. doi:10.1049/PBHE001E.</mixed-citation><mixed-citation xml:lang="en">Ma H, O'Kennedy R. Generation and optimization of antibodies for use in biosensors/ In: Nanobiosensors for personalized in situ biomedical diagnostics (ed Pranjal Chandra and Esther Sehgal) Institute of Engineering and Technology (IET) Publishing. 2016;209­30. ISBN: 9781849199506; e­ ISBN: 9781849199513. 638 p. doi:10.1049/PBHE001E.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Ноздрачева А. В., Семененко Т. А. Влияние длительного хранения образцов сывороток крови в условиях биобанка для проведения популяционных сероэпидемиологических исследований. Кардиоваскулярная терапия и профилактика. 2022;21(11):3407. doi:10.15829/1728­8800­2022­3407.</mixed-citation><mixed-citation xml:lang="en">Nozdracheva AV, Semenenko ТA. Influence of long­term storage of blood serum samples in a biobank for population­ based seroepidemiologic studies. Cardiovascular Therapy and Prevention. 2022;21(11):3407. (In Russ.) doi:10.15829/1728­8800­2022­3407.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Волошкин А. А., Рыбак Л. А., Ноздрачева А. В. и др. Роботизированная система на базе дельта манипулятора для аликвотирования в закрытых камерах и боксах. Экстремальная робототехника. 2022;1(1):436­44.</mixed-citation><mixed-citation xml:lang="en">Voloshkin AA, Rybak LA, Nozdracheva AV, et al. Robotic system based on a delta manipulator for aliquation in closed chambers and boxes. Extreme Robotics. 2022;1(1):436­44. (In Russ.)</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Khalapyan S, Rybak L, Nebolsin V, et al. Robotic System for Blood Serum Aliquoting Based on a Neural Network Model of Machine Vision. Machines. 2023;11(3):349. doi:10.3390/machines11030349.</mixed-citation><mixed-citation xml:lang="en">Khalapyan S, Rybak L, Nebolsin V, et al. Robotic System for Blood Serum Aliquoting Based on a Neural Network Model of Machine Vision. Machines. 2023;11(3):349. doi:10.3390/machines11030349.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
