mesЭкстремальная биомедицинаExtreme Medicine3033-89643033-8972Centre for Strategic Planning of the Federal Medical and Biological Agency10.47183/mes.2022.046mes-201Research ArticleОБЗОРREVIEWТехнические средства на основе иммунохроматографии для индикации патогенных микроорганизмов и токсиновImmunochromatography-based portable equipment for indication of pathogenic microorganisms and toxinsЯрковС. П.YarkovS. P.

Сергей Петрович Ярков

Волоколамское шоссе, д. 75, корпус 1, 125424, г. Москва

Sergei P. Yarkov

Volokolamskoye, 75, str. 1, 125424, Moscow

diasol@dol.ruШиленкоИ. В.ShilenkoI. V.

Москва

Moscow

ТретьяковС. И.TretyakovS. I.

Москва

Moscow

ИшковЮ. Н.IshkovY. N.

Москва

Moscow

СтяжкинК. К.StyazhkinK. K.

Москва

Moscow

Federal State Unitary Enterprise "State Scientific Research Institute of Biological Engineering" FMBA of Russia (FSUE “SSRIBE”)Russian FederationГосударственный научно-исследовательский институт биологического приборостроения Федерального медико-биологического агентстваРоссияFederal State Unitary Enterprise "State Scientific Research Institute of Biological Engineering" FMBA of Russia (FSUE “SSRIBE”)Russian Federation2022281020242441422Copyright © Ярков С.П., Шиленко И.В., Третьяков С.И., Ишков Ю.Н., Стяжкин К.К., 20242024Ярков С.П., Шиленко И.В., Третьяков С.И., Ишков Ю.Н., Стяжкин К.К.Yarkov S.P., Shilenko I.V., Tretyakov S.I., Ishkov Y.N., Styazhkin K.K.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.extrememedicine.ru/jour/article/view/201

В обзоре рассмотрены аналитические возможности и состав технических средств на основе иммунохроматографии для экспрессной индикации патогенных для человека бактерий, вирусов и токсинов, разработанных в Государственном научно-исследовательском институте биологического приборостроения ФМБА России. Рассмотрены технические характеристики и состав серийных укладок УИХЭ-1, предназначенных для осуществления моноаналитного и мультианалитного иммунохроматографического анализа патогенных микроорганизмов и токсинов в смывах с поверхностей объектов окружающей среды, в культуральных средах, комплектов ЭкБ и ЭкБ-01 для анализа содержимого пробоотборников биологического аэрозоля. Приведены сведения об аналитических свойствах укладки для люминесцентного иммунохроматографического анализа УЛИ-1, экспериментальном образце флуориметра-рефлектометра «Зондаж». Проведено сравнение технических характеристик индикационных укладок и комплектов с зарубежными аналогами, указаны направления совершенствования технических средств на основе иммунохроматографии.

This review looks at analytical capabilities and composition of portable equipment based on lateral flow immunoassay for rapid indication of human pathogenic bacteria, viruses and toxins which was developed by the State Research Institute of Biological Instrumentation under the auspices of the Federal Medical and Biological Agency of Russia. The review presents technical characteristics and composition of portable test kits UIHE-1 designed for taking monoanalytical and multi-analytical lateral flow immunoassay on pathogenic microorganisms and toxins in washes from environmental objects surfaces and in culture media; it also describes kits EkB and EkB-01 for analysis of biological aerosol samplers contents. Information is given on the analytical properties of luminescence lateral flow immunoassay kit ULI-1, an on the experimental prototype of fluorimeter-reflectometer "Zondazh". The technical characteristics of indication kits were compared with those of foreign origin, areas for improvement of portable equipment based on lateral flow immunoassay were indicated.

патогенные бактериивирусытоксиныиммунохроматографияидентификацияукладки и комплектыpathogenic bacteriavirusestoxinsimmunochromatographyidentificationsets and kitsисследования проводили в рамках государственных заказов Федерального медико-биологического агентства России (№ 42.128.11.6, № 42.133.12.6) и Министерства здравоохранения России (№ К-27-ФЦП/82-1).the studies were carried out under government contracts with the Russian Federal Medical and Biological Agency (№ 42.128.11.6, № 42.133.12.6) and the Russian Ministry of Health (№ K-27-FTP/82-1).ReferencesLeavitt SA. A Thin Blue Line: The History of the Pregnancy Test Kits. 2003 (cited 2022, Nov. 14); Available from: https://www.history.nih.gov/exhibits/thinblueline/introduction.html.Leavitt SA. A Thin Blue Line: The History of the Pregnancy Test Kits. 2003 (cited 2022, Nov. 14); Available from: https://www.history.nih.gov/exhibits/thinblueline/introduction.html.de Puig H, Bosch I, Gehrke L, Hamad-Schifferli K. Challenges of the nano-bio interface in lateral flow and dipstick immunoassays. Trends in Biotechnology. 2017; 35 (12):1169–80.de Puig H, Bosch I, Gehrke L, Hamad-Schifferli K. Challenges of the nano-bio interface in lateral flow and dipstick immunoassays. Trends in Biotechnology. 2017; 35 (12):1169–80.Li J, Macdonald J. Multiplexed lateral flow biosensors: Technological advances for radically improving point-of-care diagnoses. Biosensors and Bioelectronics. 2016; 83: 177–92.Li J, Macdonald J. Multiplexed lateral flow biosensors: Technological advances for radically improving point-of-care diagnoses. Biosensors and Bioelectronics. 2016; 83: 177–92.Posthuma-Trumpie GA, Korf J, van Amerongen A. Lateral flow (immuno) assay: Its strengths, weaknesses, opportunities and threats. A literature survey. Analytical and Bioanalytical Chemistry. 2009; 393 (2): 569–82.Posthuma-Trumpie GA, Korf J, van Amerongen A. Lateral flow (immuno) assay: Its strengths, weaknesses, opportunities and threats. A literature survey. Analytical and Bioanalytical Chemistry. 2009; 393 (2): 569–82.Dzantiev BB, Byzova NA, Urusov AE, Zherdev AV. Immunochromatographic methods in food analysis. TrAC Trends in Analytical Chemistry. 2014; 55: 81–93.Dzantiev BB, Byzova NA, Urusov AE, Zherdev AV. Immunochromatographic methods in food analysis. TrAC Trends in Analytical Chemistry. 2014; 55: 81–93.Bahadır EB, Sezgintürk MK. Lateral flow assays: Principles, designs and labels. TrAC Trends in Analytical Chemistry. 2016; 82: 286–306.Bahadır EB, Sezgintürk MK. Lateral flow assays: Principles, designs and labels. TrAC Trends in Analytical Chemistry. 2016; 82: 286–306.Quesada-González D, Merkoçi A. Nanoparticle-based lateral flow biosensors. Biosensors and Bioelectronics. 2015; 73: 47–63.Quesada-González D, Merkoçi A. Nanoparticle-based lateral flow biosensors. Biosensors and Bioelectronics. 2015; 73: 47–63.Zherdev AV, Dzantiev BB. Ways to Reach Lower Detection Limits of Lateral Flow Immunoassays. Rapid Test - Advances in Design, Format and Diagnostic Applications, 2018. DOI: 10.5772/intechopen.76926.Zherdev AV, Dzantiev BB. Ways to Reach Lower Detection Limits of Lateral Flow Immunoassays. Rapid Test - Advances in Design, Format and Diagnostic Applications, 2018. DOI: 10.5772/intechopen.76926.Каримова Т. В., Прядкина Е. Н., Якунина О. Ю., Иванова Л. К., Дубень Л. Г., Кузубов В. И., и др. Использование иммунохроматографического анализа для индикации патогенных биологических агентов. В сборнике: Материалы IX Межгосударственной научно-практической конференции «Современные технологии в реализации глобальной стратегии борьбы с инфекционными болезнями на территории государств-участников Содружества Независимых Государств»; 2 октября 2008 г. Российская Федерация, г. Волгоград. 87–88.Karimova TV, Pryadkina EN, Yakunina OYu, Ivanova LK, Duben LG, Kuzubov VI, i dr. Ispol'zovanie immunoxromatograficheskogo analiza dlya indikacii patogennyx biologicheskix agentov. V sbornike: Materialy IX Mezhgosudarstvennoj nauchno-prakticheskoj konferencii «Sovremennye texnologii v realizacii global'noj strategii bor'by s infekcionnymi boleznyami na territorii gosudarstvuchastnikov Sodruzhestva Nezavisimyx Gosudarstv»; 2 oktyabrya 2008 g. Rossijskaya Federaciya, g. Volgograd. 87–88. Russian.Ярков С. П., Башарова Л. А., Третьяков С. И., Злобин В. Н. Создание индикаторных иммунохроматографических элементов для выявления риккетсий Бернета. Проблемы особо опасных инфекций. 2013; 4: 79–81.Yarkov SP, Basharova LA, Tret'yakov SI, Zlobin VN. Sozdanie indikatornyx immunoxromatograficheskix ehlementov dlya vyyavleniya rikketsij Berneta. Problemy osobo opasnyx infekcij. 2013; 4: 79–81. Russian.Шиленко И. В., Ярков С. П., Артемов А. В., Смирнов А. М., Кононенко А. Б. Отечественный иммунохроматографический тест для выявления сальмонелл различных серогрупп. Ветеринария и кормление. 2011; 4: 12–13.Shilenko IV, Yarkov SP, Artemov AV, Smirnov AM, Kononenko AB. Otechestvennyj immunoxromatograficheskij test dlya vyyavleniya sal'monell razlichnyx serogrupp. Veterinariya i kormlenie. 2011; 4: 12–13. Russian.Ярков С. П., Шиленко И. В., Титов А. А., Бровкина А. Н., Третьяков С. И., Храмов Е. Н. Разработка мультианалитного иммунохроматографического теста для индикации токсинов. Проблемы особо опасных инфекций. 2015; 4: 103–08.Yarkov SP, Shilenko IV, Titov AA, Brovkina AN, Tret'yakov SI, Xramov EN. Razrabotka mul'tianalitnogo immunoxromatograficheskogo testa dlya indikacii toksinov. Problemy osobo opasnyx infekcij. 2015; 4: 103–08. Russian.Ярков С. П., Шиленко И. В., Третьяков С. И., Наумов П. В. Носимый комплект биологического контроля для специфической индикации биологических поражающих агентов в объектах окружающей среды ЭкБ-01. В cборнике: II Всероссийская научно-практическая конференция «Исследование вопросов радиационной, химической и биологической защиты в мирное и военное время». 14–15 сентября 2021 г. Кострома; с. 301–306.Yarkov SP, Shilenko IV, Tretyakov SI, Naumov PV. Nosimyj komplekt biologicheskogo kontrolya dlya specificheskoj indikacii biologicheskix porazhayushhix agentov v ob"ektax okruzhayushhej sredy EhkB-01. V cbornike: II Vserossijskaya nauchno-prakticheskaya konferenciya «Issledovanie voprosov radiacionnoj, ximicheskoj i biologicheskoj zashhity v mirnoe i voennoe vremya». 14–15 sentyabrya 2021 g. Kostroma; s. 301– 306. Russian.Шиленко И. В., Ярков С. П., Злобин В. Н. Носимый комплект для выявления возбудителей особо опасных инфекций на принципе люминесцентной иммунохроматографии. Журнал инфекционной патологии. 2009; 16 (3): 222–23.Shilenko IV, Yarkov SP, Zlobin VN. Nosimyj komplekt dlya vyyavleniya vozbuditelej osobo opasnyx infekcij na principe lyuminescentnoj immunoxromatografii. Zhurnal infekcionnoj patologii. 2009; 16 (3): 222–23. Russian.Li Q, Zhang S, Cai Y, Yang Y, Hu F, Liu X, et al. Rapid detection of Listeria monocytogenes using fluorescence immunochromatographic assay combined with immunomagnetic separation technique. International Journal of Food Science & Technology. 2017; 52 (7): 1559–66.Li Q, Zhang S, Cai Y, Yang Y, Hu F, Liu X, et al. Rapid detection of Listeria monocytogenes using fluorescence immunochromatographic assay combined with immunomagnetic separation technique. International Journal of Food Science & Technology. 2017; 52 (7): 1559–66.Razo SC, Panferov VG, Safenkova IV, Varitsev YA, Zherdev AV, Dzantiev BB. Double enhanced lateral flow immunoassay for potato virus X based on a combination of magnetic and gold nanoparticles. Analytica Chimica Acta. 2018; 1007: 50–60.Razo SC, Panferov VG, Safenkova IV, Varitsev YA, Zherdev AV, Dzantiev BB. Double enhanced lateral flow immunoassay for potato virus X based on a combination of magnetic and gold nanoparticles. Analytica Chimica Acta. 2018; 1007: 50–60.Kim H-Y, Stojadinovic A, Izadjoo MJ. Affinity maturation of monoclonal antibodies by multi-site-directed mutagenesis. In: Monoclonal Antibodies. Totowa, NJ, USA: Springer, Humana Press, 2014; p. 407–20. Available from: https://link.springer.com/book/10.1007%2F978-1-62703-992-5#about.Kim H-Y, Stojadinovic A, Izadjoo MJ. Affinity maturation of monoclonal antibodies by multi-site-directed mutagenesis. In: Monoclonal Antibodies. Totowa, NJ, USA: Springer, Humana Press, 2014; p. 407–20. Available from: https://link.springer.com/book/10.1007%2F978-1-62703-992-5#about.Dias AM, Roque AC. The future of protein scaffolds as affinity reagents for purification. Biotechnology and Bioengineering. 2017; 114 (3): 481–91.Dias AM, Roque AC. The future of protein scaffolds as affinity reagents for purification. Biotechnology and Bioengineering. 2017; 114 (3): 481–91.Jauset-Rubio M, El-Shahawi MS, Bashammakh AS, Alyoubi AO. Advances in aptamersbased lateral flow assays. TrAC Trends in Analytical Chemistry. 2017; 97: 385–98.Jauset-Rubio M, El-Shahawi MS, Bashammakh AS, Alyoubi AO. Advances in aptamersbased lateral flow assays. TrAC Trends in Analytical Chemistry. 2017; 97: 385–98.Chen A, Yang S. Replacing antibodies with aptamers in lateral flow immunoassay. Biosensors and Bioelectronics. 2015; 71: 230–42.Chen A, Yang S. Replacing antibodies with aptamers in lateral flow immunoassay. Biosensors and Bioelectronics. 2015; 71: 230–42.Leow CH, Fischer K, Leow CY, Cheng Q, Chuah C, McCarthy J. Sigle domain antibodies as new biomarker detectors. Diagnostics. 2017; 7 (4): 52.Leow CH, Fischer K, Leow CY, Cheng Q, Chuah C, McCarthy J. Sigle domain antibodies as new biomarker detectors. Diagnostics. 2017; 7 (4): 52.Welch NG, Scoble JA, Muir BW, Pigram PJ. Orientation and characterization of immobilized antibodies for improved immunoassays. Biointerphases. 2017; 12 (2): 02D301.Welch NG, Scoble JA, Muir BW, Pigram PJ. Orientation and characterization of immobilized antibodies for improved immunoassays. Biointerphases. 2017; 12 (2): 02D301.Shen M, Rusling JF, Dixit CK. Site-selective orientated immobilization of antibodies and conjugates for immunodiagnostics development. Methods. 2017; 116: 95–111.Shen M, Rusling JF, Dixit CK. Site-selective orientated immobilization of antibodies and conjugates for immunodiagnostics development. Methods. 2017; 116: 95–111.Iijima M, Si K. Scaffolds for oriented and close-packed immobilization of immunoglobulins. Biosensors and Bioelectronics. 2017; 89: 810–21.Iijima M, Si K. Scaffolds for oriented and close-packed immobilization of immunoglobulins. Biosensors and Bioelectronics. 2017; 89: 810–21.Kruljec N, Bratkovič T. Alternative affinity ligands for immunoglobulins. Bioconjugate Chemistry. 2017; 28 (8): 2009–30.Kruljec N, Bratkovič T. Alternative affinity ligands for immunoglobulins. Bioconjugate Chemistry. 2017; 28 (8): 2009–30.Serebrennikova KV, Samsonova JV, Osipov AP, Senapati D, Kuznetsov DV. Gold nanoflowers and gold nanospheres as labels in lateral flow immunoassay of procalcitonin. Nano Hybrids and Composites. 2017; 13: 47–53.Serebrennikova KV, Samsonova JV, Osipov AP, Senapati D, Kuznetsov DV. Gold nanoflowers and gold nanospheres as labels in lateral flow immunoassay of procalcitonin. Nano Hybrids and Composites. 2017; 13: 47–53.Xu P, Li J, Huang X, Duan H, Ji Y, Xiong Y. Effect of the tip length of multi-branched AuNFs on the detection performance of immunochromatographic assays. Analytical Methods. 2016; 8 (16): 3316–24.Xu P, Li J, Huang X, Duan H, Ji Y, Xiong Y. Effect of the tip length of multi-branched AuNFs on the detection performance of immunochromatographic assays. Analytical Methods. 2016; 8 (16): 3316–24.van Amerongen A, Besselink G, Blazkova M, PosthumaTrumpie GA, Koets M, Beelen- Thomissen M. Chapter 19: Carbon nanoparticles as detection label for diagnostic antibody microarrays. In: Abuelzein E, Editor. Trends in Immunolabelled and Related Techniques. Rijeka, Croatia: InTech, 2012; p. 311–330.van Amerongen A, Besselink G, Blazkova M, PosthumaTrumpie GA, Koets M, Beelen- Thomissen M. Chapter 19: Carbon nanoparticles as detection label for diagnostic antibody microarrays. In: Abuelzein E, Editor. Trends in Immunolabelled and Related Techniques. Rijeka, Croatia: InTech, 2012; p. 311–330.Suárez-Pantaleón C, Wichers J, Abad-Somovilla A, van Amerongen A, Abad-Fuentes A. Development of an immunochromatographic assay based on carbon nanoparticles for the determination of the phytoregulator forchlorfenuron. Biosensors and Bioelectronics. 2013; 42: 170–6.Suárez-Pantaleón C, Wichers J, Abad-Somovilla A, van Amerongen A, Abad-Fuentes A. Development of an immunochromatographic assay based on carbon nanoparticles for the determination of the phytoregulator forchlorfenuron. Biosensors and Bioelectronics. 2013; 42: 170–6.Liu B, Wang L, Tong B, Zhang Y, Sheng W, Pan M, et al. Development and comparison of immunochromatographic strips with three nanomaterial labels: Colloidal gold, nanogoldpolyaniline-nanogold microspheres (GPGs) and colloidal carbon for visual detection of salbutamol. Biosensors and Bioelectronics. 2016; 85: 337–42.Liu B, Wang L, Tong B, Zhang Y, Sheng W, Pan M, et al. Development and comparison of immunochromatographic strips with three nanomaterial labels: Colloidal gold, nanogoldpolyaniline-nanogold microspheres (GPGs) and colloidal carbon for visual detection of salbutamol. Biosensors and Bioelectronics. 2016; 85: 337–42.Yu L, Li P, Ding X, Zhang Q. Graphene oxide and carboxylated graphene oxide: Viable two-dimensional nanolabels for lateral flow immunoassays. Talanta. 2017; 165: 167–75.Yu L, Li P, Ding X, Zhang Q. Graphene oxide and carboxylated graphene oxide: Viable two-dimensional nanolabels for lateral flow immunoassays. Talanta. 2017; 165: 167–75.Wang Y, Qin Z, Boulware DR, Pritt BS, Sloan LM, González IJ, et al. Thermal contrast amplification reader yielding 8-fold analytical improvement for disease detection with lateral flow assays. Analytical Chemistry. 2016; 88 (23): 11774–82.Wang Y, Qin Z, Boulware DR, Pritt BS, Sloan LM, González IJ, et al. Thermal contrast amplification reader yielding 8-fold analytical improvement for disease detection with lateral flow assays. Analytical Chemistry. 2016; 88 (23): 11774–82.Barnett JM, Wraith P, Kiely J, Persad R, Hurley K, Hawkins P, et al. An inexpensive, fast and sensitive quantitative lateral flow magneto-immunoassay for total prostate specific antigen. Biosensors. 2014; 4 (3): 204–20.Barnett JM, Wraith P, Kiely J, Persad R, Hurley K, Hawkins P, et al. An inexpensive, fast and sensitive quantitative lateral flow magneto-immunoassay for total prostate specific antigen. Biosensors. 2014; 4 (3): 204–20.Chen Y, Wang K, Liu Z, Sun R, Cui D, He J. Rapid detection and quantification of tumor marker carbohydrate antigen 72–4 (CA72– 4) using a superparamagnetic immunochromatographic strip. Analytical and Bioanalytical Chemistry. 2016; 408 (9): 2319–27.Chen Y, Wang K, Liu Z, Sun R, Cui D, He J. Rapid detection and quantification of tumor marker carbohydrate antigen 72–4 (CA72– 4) using a superparamagnetic immunochromatographic strip. Analytical and Bioanalytical Chemistry. 2016; 408 (9): 2319–27.Lago-Cachón D, Oliveira-Rodríguez M, Rivas M, Blanco-López MC, Martínez-García JC, Moyano A, et al. Scanning magnetoinductive sensor for quantitative assay of prostate- specific antigen. IEEE Magnetics Letters. 2017; 8: 1–5.Lago-Cachón D, Oliveira-Rodríguez M, Rivas M, Blanco-López MC, Martínez-García JC, Moyano A, et al. Scanning magnetoinductive sensor for quantitative assay of prostate- specific antigen. IEEE Magnetics Letters. 2017; 8: 1–5.Zhao Y, Chen X, Lin S, Du D, Lin Y. Integrated immunochromatographic strip with glucometer readout for rapid quantification of phosphorylated proteins. Analytica Chimica Acta. 2017; 964: 1–6.Zhao Y, Chen X, Lin S, Du D, Lin Y. Integrated immunochromatographic strip with glucometer readout for rapid quantification of phosphorylated proteins. Analytica Chimica Acta. 2017; 964: 1–6.Mak WC, Beni V, Turner AP. Lateral-flow technology: From visual to instrumental. TrAC Trends in Analytical Chemistry. 2016; 79: 297–305.Mak WC, Beni V, Turner AP. Lateral-flow technology: From visual to instrumental. TrAC Trends in Analytical Chemistry. 2016; 79: 297–305.Quesada-González D, Merkoçi A. Mobile phone-based biosensing: An emerging “diagnostic and communication” technology. Biosensors and Bioelectronics. 2017; 92: 549–62.Quesada-González D, Merkoçi A. Mobile phone-based biosensing: An emerging “diagnostic and communication” technology. Biosensors and Bioelectronics. 2017; 92: 549–62.Zarei M. Portable biosensing devices for point-of-care diagnostics: Recent developments and applications. TrAC Trends in Analytical Chemistry. 2017; 91: 26–41.Zarei M. Portable biosensing devices for point-of-care diagnostics: Recent developments and applications. TrAC Trends in Analytical Chemistry. 2017; 91: 26–41.Yarkov SР, Tretyakov SI, Shilenko IV, Titov AA, Basharova LA, Khramov EN. Experience of pathogens identification tools development in the environment using immunochromatography. The 13th CBRNe Protection Symposium. Science for Safety&Security. September 24th–26th Malmö, Sweden, 2019; р. 118.Yarkov SР, Tretyakov SI, Shilenko IV, Titov AA, Basharova LA, Khramov EN. Experience of pathogens identification tools development in the environment using immunochromatography. The 13th CBRNe Protection Symposium. Science for Safety&Security. September 24th–26th Malmö, Sweden, 2019; р. 118.

The authors declare that there are no conflicts of interest present.