Efficacy of the Recombinant Tuberculosis Allergen for Early Identification of Latent Tuberculosis in Children and Adolescents in General Healthcare Settings

Аксёнова, В. А.; Барышникова, Л. А.

doi:10.15690/vsp.v14i3.1371

Vopr. sovr. pediatr.

2015

DOI: 10.15690/vsp.v14i3.1371

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Efficacy of the Recombinant Tuberculosis Allergen for Early Identification of Latent Tuberculosis in Children and Adolescents in General Healthcare Settings

В. А. Аксёнова¹,

Л. А. Барышникова²

Abstract: ОБОСНОВАНИЕ В России массовая туберкулинодиагностика мно-гие десятилетия оставалась единственным методом скринингового обследования детей с целью ранне-го выявления туберкулезной инфекции. Измененный характер чувствительности к туберкулину вследствие инфицирования микобактериями туберкулеза (МБТ) был основанием для наблюдения и химиопрофилакти-ки туберкулеза у детей и подростков на участке фтизиа-тра в группах риска развития заболевания [1, 2].Однако остается нерешенным ряд вопросов. В частности, развитие пост… Show more

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ESAT-6 and CFP-10 antigens as a biotechnology molecule substrate. Applications in medicine

Kudlаy

2022

Russian Journal of Infection and Immunity

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Abstract. Recombinant technologies have been long widely used in medicine. This article presents a review on the application of medical technologies based on ESAT-6 and CFP-10 proteins in diagnostics and prevention of tuberculosis. ESAT-6 and CFP-10 are specific proteins whose genes are encoded in the RD-1 zone (region of difference) of M. tuberculosis. M. bovis BCG and in most nontuberculous mycobacteria lack the RD-1 genome fragment. The discovery of ESAT-6 and CFP-10 antigens allowed to make the first and so far, the only breakthrough in improving the diagnostics of latent tuberculosis infection after the first tuberculin skin test (TST) was implemented. The article describes the principle of action and the experience with diagnostic tools based on ESAT-6 and CFP-10 such as in vitro interferon-gamma release assays (IGRA) and in vivo recombinant tuberculosis allergen (RTA, Diaskintest). RTA is inoculated intradermally similar to TST followed by developing delayed-type immune reaction detected in the area closest to M. tuberculosis. Combined use of ESAT-6 and CFP-10 for early detection of tuberculosis infection allowed to ameliorate for many drawbacks related to TST thereby increasing afficacy in tuberculosis diagnostics. High sensitivity and specificity was confirmed for ESAT-6- and CFP-10-based tests, so that former BCG vaccination had no more effect on test results and lowered frequency of false positive results due to reaction to non-tuberculous mycobacteria. The results of a large-scale meta-analysis on studies with patients at high risk demonstrated that the risk of developing tuberculosis in subjects with positive vs. negative IGRA was increased by 9.35-fold (95% confidence interval (CI (6,48-13,49), whereas for TST – by 4.24-fold (95% CI (3.3-5.46)). 95.1%, (95% CI (95.06-95.1)). Analyzing available publications demonstrated sufficient evidence base regarding efficacy of using ESAT-6- CFP-10-based tests in tuberculosis diagnostics. Finally, there are also reviewed the diagnostic tests and vaccines based on using such proteins currently being under development.

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ESAT-6 and CFP-10 antigens as a biotechnology molecule substrate. Applications in medicine

Kudlаy

2022

Russian Journal of Infection and Immunity

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

Kudlаy

Анатольевич²

2021

Medical academic journal

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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 states material costs for combating with tuberculosis.

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Immunodiagnostic Tests in the Assessment of Specific Sensitization to <i>M. tuberculosis</i> in Children under the Current Epidemical Situation

Poddubnaya

Shilova

Kudlay³

et al. 2021

Tuberk. bolezni lëgk.

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The objective: to study the degree of specific sensitization according to the results of intradermal immunodiagnostic tests in children with different manifestations of tuberculosis infection under the current epidemic situation.Subjects and Methods. The degree of tuberculin sensitization was studied in 299 children from different age groups (0-14 years old) who were registered for dispensary follow-up in 2018-2019.Based on the results of a tuberculosis recombinant allergen test (TRA), the degree of specific sensitization was studied in children with tuberculin tests conversion (n = 102) and infected with Mycobacterium tuberculosis (MTB) for 2 years or more (n = 165) exposed to tuberculous infection in their families and from healthy environment, and 145 patients under 14 years old with local respiratory tuberculosis.Results. Moderate sensitization to tuberculin predominated in children with converted tuberculin test exposed to tuberculous infection in their families and those from healthy environments. According to the results of TRA test, a high degree of sensitization was observed 4.7 times more frequently in children with tuberculin test conversion exposed to tuberculosis in their families. In children from healthy environments, negative responses to TRA test were registered 2.4 times more frequently. In 73% of children infected with MTB, results of annual Mantoux tests didn’t differ much. Hyperergic reactions to TRA test in infected children exposed to tuberculous infection were 10 times more frequent than in those from healthy environments. A direct correlation was found between the high degree of sensitization to active M. tuberculosis and exposure to a tuberculosis case with a positive result of sputum test (χ2 < 0.001, p < 0.05). In the case of converted tuberculin test and infection with M. tuberculosis for 2 years or more, pronounced and hyperergic reactions to TRA test were registered with equal frequency and did not depend on the timing and duration of infection. A high risk factor and predictor of the disease development is high sensitization of the host to active M. tuberculosis which is found in patients with tuberculosis using TRA test six times more frequently versus Mantoux test (OR 5.951, 95% CI 3.548 and 9.981). The demonstrated results are important for the identification of children facing a high risk to develop active tuberculosis and preventive treatment prescription.

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Efficacy of the Recombinant Tuberculosis Allergen for Early Identification of Latent Tuberculosis in Children and Adolescents in General Healthcare Settings

Cited by 3 publications

References 0 publications

ESAT-6 and CFP-10 antigens as a biotechnology molecule substrate. Applications in medicine

ESAT-6 and CFP-10 antigens as a biotechnology molecule substrate. Applications in medicine

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

Immunodiagnostic Tests in the Assessment of Specific Sensitization to <i>M. tuberculosis</i> in Children under the Current Epidemical Situation

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