Skin test based on Mycobacterium tuberculosis antigens (ESAT-6 and CFP-10) for the detection of tuberculosis infection in world practice

Q4 Medicine

Pulmonologiya Pub Date : 2023-07-13 DOI:10.18093/0869-0189-2023-33-4-559-567

О.Е.Русских, Е.В.Савинцева, Д.А.Кудлай, Н.П.Докторова, П.Г.Сысоев, O. E. Russkikh, E. V. Savintseva, D. Kudlay, N. Doktorova, P. Sysoev

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引用次数: 0

Abstract

According to experts, 2 billion people in the world are infected with the causative agent of tuberculosis. A priority task in the diagnosis of tuberculosis infection is the use of accurate, accessible and scalable tools. The tuberculin skin test (TST), or Mantoux test, and the interferon gamma release assay (IGRA) are currently used to diagnose tuberculosis infection. In 2022, the World Health Organization (WHO) identified a fundamentally new class of skin tests for the early detection of tuberculosis infection, the so-called Mycobacterium tuberculosis antigen-based skin tests (TBST). These tests include Diaskintest (Russia), C-Tb (India), and C-TST (China) and pose an alternative to the tuberculin skin test and the IGRA. The aim of this work was to conduct a systematic review of domestic and foreign literature sources on the use of a new skin test based on M. tuberculosis antigens (ESAT-6 and CFP-10) to detect tuberculosis infection (Diaskintest) in world practice. Conclusion. According to the literature data, including the published results of meta-analyzes on the use of skin tests, it has been shown that recombinant tuberculous allergen test, as a new skin test based on M. tuberculosis antigens (ESAT-6 and CFP-10), or TBST, has high sensitivity and specificity for the detection of tuberculosis infection. Its sensitivity and specificity are significantly higher than those of the tuberculin test. TBST skin test results are comparable to those of IGRA, have a favorable safety profile, combined with high laboratory test specificity and ease of performance and assessment of the result in one cut (cut-off > 0 mm – any size papule is considered positive). Thus, TBST is a valuable tool for early detection of TB infection. Taking into account the volume of scientific clinical studies on recombinant tuberculous allergen test in the world practice, more than 10 years of experience in clinical practice in Russia and the CIS countries, it can be concluded that recombinant tuberculous allergen test is currently the leading test for mass diagnosis of tuberculosis infection not only in Russia, but also in the world.

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基于结核分枝杆菌抗原(ESAT-6和CFP-10)的皮肤试验检测结核感染的世界惯例

据专家称，世界上有20亿人感染了肺结核。诊断结核感染的一项优先任务是使用准确、可获得和可扩展的工具。结核菌素皮肤试验(TST)或Mantoux试验和干扰素γ释放试验(IGRA)目前用于诊断结核感染。2022年，世界卫生组织(世卫组织)确定了一种全新的用于结核病感染早期检测的皮肤试验，即所谓的结核分枝杆菌抗原皮肤试验(TBST)。这些试验包括Diaskintest(俄罗斯)、C-Tb(印度)和C-TST(中国)，是结核菌素皮肤试验和IGRA的替代方法。本研究的目的是对国内外文献资料进行系统综述，介绍一种基于结核分枝杆菌抗原(ESAT-6和CFP-10)的新型皮肤试验(Diaskintest)在世界范围内检测结核感染的应用情况。结论。根据文献资料，包括已发表的皮试使用meta分析结果显示，重组结核过敏原试验作为一种基于M. tuberculosis抗原(ESAT-6和CFP-10)或TBST的新型皮试，对结核感染的检测具有较高的敏感性和特异性。其敏感性和特异性均明显高于结核菌素试验。TBST皮肤试验结果与IGRA相当，具有良好的安全性，结合高实验室测试特异性和易于执行和评估一次切割结果(截止> 0 mm -任何大小的丘疹都被认为是阳性的)。因此，TBST是早期发现结核感染的宝贵工具。考虑到世界各国实践中对重组结核过敏原试验的科学临床研究量，结合俄罗斯及独联体国家10多年的临床实践经验，可以得出结论:重组结核过敏原试验不仅在俄罗斯，而且在世界范围内都是目前大规模诊断结核感染的领先试验。

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来源期刊

Pulmonologiya Medicine-Pulmonary and Respiratory Medicine

CiteScore

1.40

自引率

0.00%

发文量

期刊介绍： The aim of this journal is to state a scientific position of the Russian Respiratory Society (RRS) on diagnosis and treatment of respiratory diseases based on recent evidence-based clinical trial publications and international consensuses. The most important tasks of the journal are: -improvement proficiency qualifications of respiratory specialists; -education in pulmonology; -prompt publication of original studies on diagnosis and treatment of respiratory diseases; -sharing clinical experience and information about pulmonology service organization in different regions of Russia; -information on current protocols, standards and recommendations of international respiratory societies; -discussion and consequent publication Russian consensus documents and announcement of RRS activities; -publication and comments of regulatory documents of Russian Ministry of Health; -historical review of Russian pulmonology development. The scientific concept of the journal includes publication of current evidence-based studies on respiratory medicine and their discussion with the participation of Russian and foreign experts and development of national consensus documents on respiratory medicine. Russian and foreign respiratory specialists including pneumologists, TB specialists, thoracic surgeons, allergists, clinical immunologists, pediatricians, oncologists, physiologists, and therapeutists are invited to publish article in the journal.