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

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.