Scientific platform, development and implementation of effective immunodiagnosis of tuberculosis infection in the Russian Federation

Cover Page

Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription Access

Abstract

The review presents scientific information about modern approaches to immunodiagnosis of tuberculosis infection in the Russian Federation, which allows to control the spread of infection and prevent the development of the disease in individuals infected with Mycobacterium tuberculosis (MTB). The results of Russian and foreign studies have shown a low total sensitivity of the Mantoux tuberculin skin test, which indicates a low predictive value of the test for the diagnosis of tuberculosis infection. The article presents the results of preclinical and clinical studies of a new diagnostic test for the detection of tuberculosis infection using Diaskintest. The results substantiate the purpose of Diaskintest for the diagnosis of tuberculosis infection, assessment of the process activity; differential diagnosis of tuberculosis; differential diagnosis of post-vaccination and infectious immune response (delayed-type hypersensitivity); monitoring the effectiveness of treatment. The article presents the results information on the screening of tuberculosis infection in the Russian Federation using Diaskintest, its significance, efficacy, and safety. The results of scientific studies carried out in recent years to assess the effectiveness of immunodiagnostics in the Russian Federation give reason to believe that the introduction of a modern screening method for diagnosing tuberculosis infection using Diaskintest can significantly improve the quality of doctors’ work on the early detection of various manifestations of tuberculosis infection and significantly reduce the state’s material costs for combating with tuberculosis.

About the authors

Dmitry A. Kudlay

NRC Institute of Immunology FMBA of Russia; Sechenov First Moscow State Medical University (Sechenov University)

Author for correspondence.
Email: D624254@gmail.com
ORCID iD: 0000-0003-1878-4467

MD, PhD, DSc (Medicine), Professor of the Pharmacology Department, Institute of Pharmacy, Leading Researcher at the Laboratory of Personalized Medicine and Molecular Immunology

Russian Federation, Moscow

References

  1. Vasilyeva IA, Belilovsky EM, Borisov SE, Sterlikov SA. WHO Global tuberculosis reports: compilation and interpretation. Tuberculosis and Lung Diseases. 2017;95(5):7–16. (In Russ.). doi: 10.21292/2075-1230-2017-95-5-7-16
  2. Global tuberculosis report 2016. Geneva: WHO, 2016. Available from: https://apps.who.int/iris/handle/10665/250441. Accessed: 12.03.2017.
  3. Russkikh OE. Latent tuberculosis infection: opportunities for diagnosis and treatment in Hiv-infected patients. Epidemiology and infectious diseases. Current issues. 2019;9(2):99–104. (In Russ.). doi: 10.18565/epidem.2019.9.2.99-104
  4. Latent tuberculosis infection: updated and consolidated guidelines for programmatic management. WHO, 2018.
  5. Gergert VYa, Yeremeev VV, Lyadova IV, et al. Problems of immunodiagnostics in tuberculosis. CTRI Bulletin. 2019;(1):5–14. (In Russ.). doi: 10.7868/S2587667819010011
  6. Aksenova VA, Baryshnikova LA, Klevno NI, Kudlai DA. Screening of children and adolescents for tuberculosis infection in Russia — past, present, future. Tuberculosis and lung diseases. 2019;97(9):59–67. (In Russ.). doi: 10.21292/2075-1230-2019-97-9-59-67
  7. Tuberculosis. Clinical diagnosis and management of tuberculosis, and measures for its prevention and control. The National Collaborating Centre for Chronic Conditions. London: Royal College of Physicians; 2006.
  8. Russkikh OE. Influence of social factors on the occurrence of tuberculosis at the institutions of confinement. Health care of the Russian Federation. 2007;(6):50–51. (In Russ.)
  9. HIV infection. Newsletter No. 40. Ed. by N.N. Ladnaya. Moscow: Federal Center for AIDS Prevention and Control, 2015. (In Russ.)
  10. Aksenova VA, Levi DT, Aleksandrova NV, et al. Pediatric TB: modern methods for prevention and early diagnostics. Doktor.Ru. 2017;15(144):9–15. (In Russ.)
  11. Kudlay DA. Biomarkers and immunological tests. experimental and clinical parallels of latent tuberculosis infection. Tuberculosis and lung disease. 2020;98(8):63–74. (In Russ.). doi: 10.21292/2075-1230-2020-98-8-63-74
  12. Yang H, Kruh-Garcia NA, Dobos KM. Purified protein derivatives of tuberculin — past, present, and future. FEMS Immunol Med Microbiol. 2012;66(3):273–280. doi: 10.1111/j.1574-695X.2012.01002.x
  13. Slogotskaya LV, Bogorodsakaya EM, Levi DT, et al. Comparison of efficacy of Diaskintest®, a skin test with a recombinant tuberculosis allergen, used for 10 years and Mantoux tuberculin sensitivity test used for 110 years. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;62(2):67–77. (In Russ.)
  14. Menzies D, Pai M, Comstock G. Meta-analysis: new tests for the diagnosis of latent tuberculosis infection: areas of uncertainty and recommendations for research. Ann Intern Med. 2007;146(5):340–354. doi: 10.7326/0003-4819-146-5-200703060-00006
  15. Rangaka MX, Wilkinson KA, Glynn JR, et al. Predictive value of interferon-γ release assays for incident active tuberculosis: a systematic review and meta-analysis. Lancet Infect Dis. 2012;12(1):45–55. doi: 10.1016/S1473-3099(11)70210-9
  16. Mack U, Migliori G, Sester M, et al. LTBI: latent tuberculosis infection or lasting immune responses to Mycobacterium tuberculosis? A TBNET consensus statement. Eur Respir J. 2009;33(5):956–73. doi: 10.1183/09031936.00120908
  17. Ferrara G, Losi M, D’Amico R, et al. Use in routine clinical practice of two commercial blood tests for diagnosis of infection with Mycobacterium tuberculosis: a prospective study. Lancet. 2006;367(9519):1328–1334. doi: 10.1016/S0140-6736(06)68579-6
  18. Vekemans J, Lienhardt C, Sillah JS, et al. Tuberculosis contacts but not patients have higher gamma interferon responses to ESAT-6 than do community controls in The Gambia. Infect Immun. 2001;69(10):6554–6557. doi: 10.1128/IAI.69.10.6554-6557.2001
  19. Weldingh K, Andersen P. ESAT-6/CFP10 skin test predicts disease in M. tuberculosis-infected guinea pigs. PLoS ONE. 2008;3(4):e1978. doi: 10.1371/journal.pone.0001978
  20. Higuchi K, Sekiya Y, Igari H, et al. Comparison of specificities between two interferon-gamma release assays in Japan. Int J Tuberc Lung Dis. 2012;16(9):1190–1192. doi: 10.5588/ijtld.11.0829
  21. Janssens J-P, Roux-Lombard P, Perneger T, et al. Quantitative scoring of an interferon — assay for differentiating active from latent tuberculosis. Eur Respir J. 2007;30(4):722–728. doi: 10.1183/09031936.00028507
  22. Lalvani A, Millington KA. T cell-based diagnosis of childhood tuberculosis infection. Curr Opin Infect Dis. 2007;20(3):264–271. doi: 10.1097/QCO.0b013e32813e3fd8
  23. Lalvani A. Diagnosing tuberculosis infection in the 21st century: new tools to tackle an old enemy. Chest. 2001;131(6):1898–1906. doi: 10.1378/chest.06-2471
  24. Mori T, Sakatani M, Yamagishi F, et al. Specific detection of tuberculosis infection: an interferon-c-based assay using new antigens. Am J Respir Crit Care Med. 2004;170(1):59–64. doi: 10.1164/rccm.200402-179OC
  25. Pai M, Kalantri S, Dheda K. New tools and emerging technologies for the diagnosis of tuberculosis: part I. Latent tuberculosis. Expert Rev Mol Diagn. 2006;6(3):413–422. doi: 10.1586/14737159.6.3.413
  26. Kozhnaya proba s preparatom “Diaskintest” — novye vozmozhnosti identifikatsiii tuberkuleznoy infektsii. Ed. by M.A. Paltsev. 2nd ed. Moscow: Shiko; 2011. P. 88–97. (In Russ.)
  27. Kiselev VI, Baranovsky PM, Rudykh IV, et al. Clinical trials of the new skin test diaskintest for the diagnosis of tuberculosis. Tuberculosis and Lung Diseases 2009;86(2):11–16. (In Russ.)
  28. Kozhnaya proba s preparatom “Diaskintest” — novye vozmozhnosti identifikatsiii tuberkuleznoy infektsii. Ed. by M.A. Paltsev. 2nd ed. Moscow: Shiko; 2011. P. 98–124. (In Russ.)
  29. Kiselev VI, Severin ES, Perelman MI, et al. New diagnostic solutions in the diagnosis and prevention of tuberculosis infection. Vestnik NII Molekulyarnoy meditsiny. 2005;(5):37–45. (In Russ.)
  30. Levi DT, Rukhamina ML. Preclinical studies of the drug “Diaskintest”. In: Kozhnaya proba s preparatom “Diaskintest” — novye vozmozhnosti identifikacii tuberkuleznoj infekcii. Ed by M.A. Pal’cev. 2nd ed. Moscow: Shiko; 2011. P. 98–113. (In Russ.)
  31. Bocharova IV, Mayorov KB, Demikhova OV, Kudlai DA. Stability of specific activity and specificity of the diagnostic preparation Diaskintest® during storage under stress conditions. Tuberculosis and socially significant diseases. 2013;(2):2–5. (In Russ.)
  32. Litvinov VI, Seltsovsky PP, Slogotskaya LV, et al. Clinical studies on the use of a skin sample with the drug “Diaskintest”. In: Kozhnaya proba s preparatom «Diaskintest» — novye vozmozhnosti identifikacii tuberkuleznoj infekcii. Ed by M.A. Pal’cev. 2nd ed. Moscow: Shiko; 2011. P. 14–125. (In Russ.)
  33. Kiselev VI, Baranovsky PM, Rudykh IV, et al. Clinical trials of the new skin test diaskintest for the diagnosis of tuberculosis. Tuberculosis and lung disease. 2009;86(2):11–16. (In Russ.)
  34. Ovsyankina ES, Gubkina MF, Ershova NG, Kobulashvili MG. Experience with the new skin test Diaskintest® used to diagnose respiratory tuberculosis in children and adolescents in a tuberculosis unit. Tuberculosis and lung disease. 2010;87(1):16–19. (In Russ.)
  35. Aksenova VA, Baryshnikova LA. Efficacy of the recombinant tuberculosis allergen for early identification of latent tuberculosis in children and adolescents in general healthcare settings. Current Pediatrics. 2015;14(3):358–362. (In Russ.) doi: 10.15690/vsp.v14i3.1371
  36. Slogotskaya LV, Senchikhina OYu, Bogorodskaya EM. Sensitivity of the test with a tuberculosis recombinant allergen containing ESAT6-CFP10 protein in the first identified patients with tuberculosis in the city of Moscow. Tuberculosis and socially significant diseases. 2013;(1):37–44. (In Russ.)
  37. Slogotskaya LV. Tuberkulinodiagnostics and new tests to detect infection. Meditsinskiy vestnik. 2013;629(16):16–17. (In Russ.)
  38. Aksenova VA, Baryshnikova LA, Klevno NI, et al. New possibilities of screening and diagnostics of various manifestations of tuberculosis infection in children and adolescents in Russia. Current Pediatrics. 2011;10(4):16–22. (In Russ.)
  39. Kudlay DA, Starshinova AA, Dovgalyuk IF. Recombinant tuberculosis allergen: 10-year of experience with the test in children and adolescents in the Russian Federation (meta-analysis data). Journal "Pediatria" named after G.N. Speransky. 2020;99(3):121–129. (In Russ.). doi: 10.24110/0031-403X-2020-99-3-121-129
  40. Litvinov VI, Slogotskaya LV, Seltsovsky PP, et al. A new skin test to diagnose tuberculosis infection. Russian Medical Journal. 2009;(1):52–55. (In Russ.)
  41. Pavlova MV, Starshinova AA, Sapozhnikova NV, et al. Diagnosis and clinical-radiological characterization of respiratory tuberculosis in adolescents. Tuberculosis and lung diseases. 2015;(1):10–14. (In Russ.)
  42. Slogotskaya LV, Senchikhina OYu, Nikitina GV, Bogorodskaya EM. Efficacy of a skin test with a tuberculosis allergen recombinant in detecting tuberculosis in children and adolescents of Moscow in 2013. Pediatric pharmacology. 2015;12(1):99–103. (In Russ.)
  43. Aksenova VA. New skin test Diaskintest as screening — a method for detecting tuberculosis. Doktor.Ru. 2011;65(6):35–39. (In Russ.)
  44. Barmina NA, Baryshnikova LA. Opportunities to increase the effectiveness of disease prevention in children in the foci of tuberculosis infection on the example of the Perm Territory. Tuberculosis and lung disease. 2018;96(9):50–56. (In Russ.). doi: 10.21292/2075-1230-2018-96-9-50-56
  45. Frolova KS, Borisov SE. Risk of developing active TB in IBD patients treated with anti TNF. Koloproktologiya. 2018;(1):49–56. doi: 10.33878/2073-7556-2018-0-1-49-56
  46. Russkikh OE, Sysoev PG, Romanova AI, et al. Modern immunological skin tests in diagnosis of tuberculosis. Teoriya i praktika sovremennoy nauki. 2018;36(6):814–817. (In Russ.)
  47. Barmina NA, Baryshnikova LA, Reichardt VV, et al. Criteria for the effectiveness of the treatment of tuberculosis in children in modern conditions. Tuberculosis and lung diseases. 2017;95(10):69–75. (In Russ.). doi: 10.21292/2075-1230-2017-95-10-69-74
  48. Lebedeva LV, Gracheva SG. Tuberculosis sensitivity and infection with children’s tuberculosis mycobacteria. Tuberculosis and lung diseases. 2007;84(1):5–9. (In Russ.)
  49. Aksenova VA, Levi DT, Alexandrova NV, Kudlai DA. Current tuberculosis incidence among children; medicines for prevention and diagnosis of tb. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(3):145–151. (In Russ.)
  50. Slogotskaya LV, Bogorodskaya EM. Comparative description of immunological tests for tuberculous infection detection. Mass screening opportunities. Tuberculosis and lung diseases. 2016;94(5):5–16. (In Russ.). doi: 10.21292/2075-1230-2016-94-5-5-16

Supplementary files

Supplementary Files
Action
1. JATS XML

Copyright (c) 2021 Kudlay D.A.

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Согласие на обработку персональных данных с помощью сервиса «Яндекс.Метрика»

1. Я (далее – «Пользователь» или «Субъект персональных данных»), осуществляя использование сайта https://journals.rcsi.science/ (далее – «Сайт»), подтверждая свою полную дееспособность даю согласие на обработку персональных данных с использованием средств автоматизации Оператору - федеральному государственному бюджетному учреждению «Российский центр научной информации» (РЦНИ), далее – «Оператор», расположенному по адресу: 119991, г. Москва, Ленинский просп., д.32А, со следующими условиями.

2. Категории обрабатываемых данных: файлы «cookies» (куки-файлы). Файлы «cookie» – это небольшой текстовый файл, который веб-сервер может хранить в браузере Пользователя. Данные файлы веб-сервер загружает на устройство Пользователя при посещении им Сайта. При каждом следующем посещении Пользователем Сайта «cookie» файлы отправляются на Сайт Оператора. Данные файлы позволяют Сайту распознавать устройство Пользователя. Содержимое такого файла может как относиться, так и не относиться к персональным данным, в зависимости от того, содержит ли такой файл персональные данные или содержит обезличенные технические данные.

3. Цель обработки персональных данных: анализ пользовательской активности с помощью сервиса «Яндекс.Метрика».

4. Категории субъектов персональных данных: все Пользователи Сайта, которые дали согласие на обработку файлов «cookie».

5. Способы обработки: сбор, запись, систематизация, накопление, хранение, уточнение (обновление, изменение), извлечение, использование, передача (доступ, предоставление), блокирование, удаление, уничтожение персональных данных.

6. Срок обработки и хранения: до получения от Субъекта персональных данных требования о прекращении обработки/отзыва согласия.

7. Способ отзыва: заявление об отзыве в письменном виде путём его направления на адрес электронной почты Оператора: info@rcsi.science или путем письменного обращения по юридическому адресу: 119991, г. Москва, Ленинский просп., д.32А

8. Субъект персональных данных вправе запретить своему оборудованию прием этих данных или ограничить прием этих данных. При отказе от получения таких данных или при ограничении приема данных некоторые функции Сайта могут работать некорректно. Субъект персональных данных обязуется сам настроить свое оборудование таким способом, чтобы оно обеспечивало адекватный его желаниям режим работы и уровень защиты данных файлов «cookie», Оператор не предоставляет технологических и правовых консультаций на темы подобного характера.

9. Порядок уничтожения персональных данных при достижении цели их обработки или при наступлении иных законных оснований определяется Оператором в соответствии с законодательством Российской Федерации.

10. Я согласен/согласна квалифицировать в качестве своей простой электронной подписи под настоящим Согласием и под Политикой обработки персональных данных выполнение мною следующего действия на сайте: https://journals.rcsi.science/ нажатие мною на интерфейсе с текстом: «Сайт использует сервис «Яндекс.Метрика» (который использует файлы «cookie») на элемент с текстом «Принять и продолжить».