Abstract
Relevance. Tuberculosis immunodiagnostics is based on the ESAT-6 and CFP-10 antigens (RD1 region of Mycobacterium tuberculosis), which are absent from BCG strains and form the antigenic basis of IGRA and TBST. Their clinical use requires consideration of several interpretation-related features arising from the biology of the antigen-specific immune response.
The aim of the review was to analyze the molecular and pathogenetic mechanisms underlying the diagnostic use of ESAT-6 and CFP-10, to systematize the key features and limitations of interpreting IGRA/TBST results in relation to the stage of the tuberculosis process, and to propose a multilevel algorithm for personalized interpretation.
Material and methods. A narrative review of literature indexed in PubMed, Scopus, Web of Science, eLibrary, as well as WHO documents for 1995 – 2026 was conducted; 213 publications were analyzed, and 42 sources were included in the review (37 in English, 5 in Russian).
Main findings. ESAT-6 and CFP-10 are immunodominant proteins of the M. tuberculosis complex, associated with the ESX-1 secretion system and mycobacterial virulence. Interpretation of ESAT-6/CFP-10-based tests has important limitations: a positive IGRA or TBST result cannot independently differentiate eliminated, latent, and active infection; discordance between IGRA and TBST results in the same patient may reflect differences in the biological substrates assessed (in vitro versus in vivo); and cross-reactivity with certain nontuberculous mycobacteria is possible.
Conclusion. ESAT-6 and CFP-10-based tests should be considered not as absolute indicators of active tuberculosis, but as markers of immunological memory. A transition to a multilevel interpretation model integrating epidemiological, clinical, radiological, and microbiological data is clinically justified. Particular caution should be exercised in patients with immunodeficiencies, those receiving immunosuppressive therapy, and those with chronic bronchopulmonary diseases.
Keywords
Authors and affiliations
https://elibrary.ru/vsvqdd E.A. Borodulina(1), D.A. Kudlay(2–4), E.A. Amosova(1), B.E. Borodulin(1)
1Federal State Budgetary Educational Institution of Higher Education “Samara State Medical University” of the Ministry of Healthcare
of the Russian Federation, Russian Federation, Samara, 443099, Chapaevskaya, 99; 2Federal State Autonomous Educational Institution
of Higher Education I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation
(Sechenov University), Russian Federation, 119991, Moscow, Trubetskaya str., 8, build. 2; 3Federal State Budget Educational Institution
of Higher Education M.V. Lomonosov Moscow State University, Leninskie Gory, 1, Moscow, 119991, Russian Federation;
4The Federal Scientific “State Research Center Institute of Immunology” of the Federal Medical and Biological Agency
of Russia, Kashirskoye Shosse, 24, 115522, Moscow, Russian Federation;
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