BackgroundA group of Russian scientists has developed Diaskintest, which comprises Mycobacterium tuberculosis-specific recombinant proteins CFP10-ESAT6, for skin testing (0.2 μg/0.1 ml).Study purposeTo evaluate the comparative sensitivity of TST with 2 TU PPD-L and a skin test with tuberculous recombinant allergen (Diaskintest) containing the ESAT6-CFP10 protein in children and adolescents with newly diagnosed active tuberculosis during mass screening in the primary medical service in Moscow.Materials and methodsThe trial was a comprehensive retrospective group study of children and adolescents diagnosed in Moscow with active tuberculosis in 2013–2016, aged 0 to 17 years inclusive.ResultsFrom 441 patients selected for analysis 408 patients had both tests (TST with 2 TU PPD-L and Diaskintest) performed, in 193 patients both tests were given simultaneously, of them 162 patients were BCG-vaccinated. Comparative results of both tests in 408 patients with tuberculosis: at cut-off ≥ 5 mm, both tests has similar sensitivity: Diaskintest 98.3% (95% CI 97.0–99.6%), TST 98.0% (95% CI 96.7–99.4%), at cut-off ≥10 mm, the sensitivity decreases for both tests: Diaskintest 90.0% (95% CI 87.0–93.0%), TST 88.7% (95% CI 85.6–91.9%), but at cut-off ≥ 15 mm, the decrease in sensitivity is statistically significant: for Diaskintest 61.5% (95% CI 56.7–66.3%), and for TST 46.3% (95% CI 41.4–51.3%), p <0.0001.The results of simultaneous setting of tests on different hands in 193 people (including 162 BCG-vaccinated), do not differ from the results for 408 people.The correlation between the results of Diaskintest and TST was significant in all groups.ConclusionIn children and adolescents with active tuberculosis, Diaskintest of 0.2 μg/ml and the Mantoux test with 2 TU PPD-L have high sensitivity (98%) at a cut-off of 5 mm; however, at cut-off ≥ 15 mm sensitivity is significantly reduced, and the decrease is more pronounced in the Mantoux test. The advantage of Diaskintest is that, unlike the Mantoux test, it has high specificity under the conditions of mass BCG vaccination. The test is simple to carry out, and can be used in mass screening.

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Background. A group of Russian scientists has developed Diaskintest, which comprisesMycobacterium tuberculosis-specific recombinant proteins CFP10-ESAT6, for skin testing (0.2 µg/0.1 ml).Study purpose: to evaluate the comparative sensitivity of TST with 2 TU PPD-L and a skin test with tuberculous recombinant allergen (Diaskintest) containing the ESAT6-CFP10 protein in children and adolescents with newly diagnosed respiratory tuberculosis during mass screening in the primary medical service in Moscow, 2013Moscow, -2016 Materials and methods. The trial was a comprehensive retrospective group study of children and adolescents diagnosed in Moscow with respiratory tuberculosis in 2013-2016, aged 0 to 17 years inclusive. From 441 patients selected for analysis 408 patients had both tests (TST 2 with 2 TU PPD-L and Diaskintest) performed, in 193 patients both tests were given simultaneously, of them 162 patients were BCG-vaccinated. Results. Comparative results of both tests in 408 patients with tuberculosis: at cut-off ≥ 5 mm, both tests has similar sensitivity: Diaskintest 98.3 % (95 % CI 97.0-99.6 %), TST 98.0 % (95 % CI 96.7-99.4 %), at cut-off ≥ 10 mm, the sensitivity decreases for both tests: Diaskintest 90.0 % (95 % CI 87.0-93.0 %), TST 88.7 % (95 % CI 85.6-91.9 %), but at cut-off ≥ 15 mm, the decrease in sensitivity is statistically significant: for Diaskintest 61.5 % (95 % CI 56.7-66.3 %), and for TST 46.3 % (95 % CI 41.4-51.3 %), p <0.0001. The results of simultaneous setting of tests on different hands in 193 people (including 162 BCG-vaccinated), do not differ from the results for 408 people. The correlation between the results of Diaskintest and TST was significant in all groups. Conclusion. In children and adolescents with respiratory tuberculosis, Diaskintest of 0.2 µg/ml and the Mantoux test with 2 TU PPD-L have high sensitivity (98%) at a cut-off of 5 mm; however, at cut-off ≥ 15 mm sensitivity is significantly reduced, and the decrease is more pronounced in the Mantoux test. The advantage of Diaskintest is that, unlike the Mantoux test, it has high specificity under the conditions of mass BCG vaccination. The test is cost-effective, simple to carry out, and can be used in mass screening. ≥ 100 per 100,000 population [2,3]. Due to the low specificity of 3the Mantoux test, the high frequency of false positives due to cross-sensitization with the BCG vaccine strain (Mycobacterium bovis BCG) -difficulties arise in interpreting it. [4,5].An important stage in improving the methods of diagnosis of tuberculosis was the possibility of studying and deciphering the genome of tuberculosis mycobacteria, which allowed to identify the differences between M. bovis BCG vaccine strain and Mycobacterium tuberculosis virulent strains. In particular, in M. tuberculosis genome, a region of difference (RDI) was discovered, which contains genes that code for the secretion of CFP10 and ESAT6 proteins.These proteins are expressed on the surface of the mycobacterial cell upon its multiplication and determine the virulent prope...

1 ГБУЗ «Московский городской научно-практический центр борьбы с туберкулезом ДЗМ», Москва, РФ 2 ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» МЗ РФ, Москва, РФ 3 ФГБУ «Государственный научный центр «Институт иммунологии» Федерального медико-биологического агентства», Москва, РФ Дана оценка существующих иммунологических тестов для выявления туберкулезной инфекции (ТКП, лабораторных тестов IGRA, кожного теста с аллергеном туберкулезным рекомбинантным). Проведен анализ последних разработок по созданию иммунологических тестов, способных дифференцировать латентную туберкулезную инфекцию и активный туберкулез. Показаны трудности создания такого теста и проведения клинических испытаний. Приведен опыт Московской противотуберкулезной службы по использованию кожного теста с аллергеном туберкулезным рекомбинантным в качестве скринингового метода выявления туберкулезной инфекции, его способности выявлять инфекцию в стадии ее развития, когда превентивная терапия оказывается наиболее эффективной, поскольку противотуберкулезные препараты действуют на микобактерии, находящиеся в стадии репликации, а не в дормантном (спящем) состоянии. Такая тактика способствовала снижению заболеваемости как в группах повышенного риска заболевания, так и в целом среди населения. Ключевые слова: иммунодиагностика, туберкулезная инфекция, выявлениеДля цитирования: Слогоцкая Л. В., Синицын М. В., Кудлай Д. А. Возможности иммунологических тестов в диагностике латентной туберкулезной инфекции и туберкулеза // Туберкулёз и болезни лёгких.The article assesses existing immunological tests aimed to detect tuberculosis infection (tuberculin skin test, IGRA, skin test with a recombinant tuberculosis allergen). The latest inventions in the development of immunological tests that can differentiate latent tuberculosis infection and active tuberculosis have been analyzed. The difficulties encountered when developing such a test and conducting clinical trials have been demonstrated. The article presents the experience of the Moscow TB service in using the skin test with recombinant tuberculosis allergen as a screening method for tuberculosis infection, its ability to detect the infection at the stage of its development when preventive therapy is most effective since anti-tuberculosis drugs kill mycobacteria that are replicating but not dormant. Such tactics contributed to the incidence rate decrease both in high-risk groups and among the general population. For citations: Slogotskaya L.V., Sinitsyn M.V., Kudlay D.А. Potentialities of immunological tests in the diagnosis of latent tuberculosis infection and tuberculosis.