Vasilyeva Irina A, Aksenova Valentina A, Kazakov Alexey V, Kiseleva Yulia Y, Maryandyshev Andrey O, Dolzhenko Elena N, Abramchenko Anna V, Klevno Nadejda I, Glebov Konstantin A, Panova Anna E, Petrova Larisa Y, Sheikis Elena G, Seregina Inna V, Nikishova Elena I, Doktorova Natalia P, Samoilova Anastasia G
FSBI National Medical Research Center for Phthisiopulmonology and Infectious Diseases, Ministry of Health of the Russian Federation, Moscow, Russia.
Department of Phthisiology, Pirogov Russian National Research Medical University, Ministry of Health of the Russian Federation, Moscow, Russia.
Front Med (Lausanne). 2023 Mar 1;10:1042461. doi: 10.3389/fmed.2023.1042461. eCollection 2023.
The tuberculin skin test has significant limitations for use in individuals vaccinated with BCG. The presence in the genome of of the RDI region, which is absent in the genome of Mycobacterium bovis BCG and most non-tuberculous mycobacteria, made it possible to develop new skin tests, which include a skin test with a recombinant tuberculosis allergen [RTA (Diaskintest®, JSC Generium, Russia)]. Diaskintest has shown high diagnostic performance in clinical trials and in conditions of high prevalence of tuberculosis infection. In 2021, the Russia was excluded from the WHO list of high TB burden countries, which makes relevant an assessment of the specificity of the RTA test under conditions of low epidemiologic risk for tuberculosis to confirm the high specificity of the test.
To assess the specificity of Diaskintest in the regions of the Russian Federation with low epidemiologic risk for tuberculosis.
A multicenter, open-label, prospective study was conducted, which included 150 healthy volunteers aged 18-30 years old, vaccinated with BCG, who were not at risk of tuberculosis, from regions with low epidemiologic risk (Oryol region, Ryazan region, and Arkhangelsk region). During the study, 4 visits were scheduled for each participant: [Visit 0 (screening), Visit 1, Visit 2 (in 72 h) and Visit 3 (in 28 days)]. All participants, who excluded active and latent tuberculosis infection, underwent a test with RTA. To assess the safety of RTA tests, all systemic and local adverse events that occurred during 28 days were recorded. The trial was filed in the NIH clinical trials database ClinicalTrials.gov (NCT05203068).
In individuals with a negative T-SPOT.TB test, the specificity of the RTA test was 97% (95% CI: 92-99%) with a cut-off of >0 mm. The study findings confirm data 2009: 100.00 (95% CI: 94-100). When evaluating the safety of the RTA test during 28 days of follow-up, the participants did not report local and systemic adverse reactions that had a causal relationship with the RTA test.
Diaskintest is highly specific and safe, therefore it is a valuable tool as a screening test for early detection of tuberculosis.
结核菌素皮肤试验在接种卡介苗的个体中使用存在显著局限性。牛分枝杆菌卡介苗和大多数非结核分枝杆菌基因组中不存在的RDI区域存在于结核分枝杆菌基因组中，这使得开发新的皮肤试验成为可能，其中包括使用重组结核变应原的皮肤试验[RTA（Diaskintest®，俄罗斯Generium公司）]。Diaskintest在临床试验和结核感染高流行情况下已显示出高诊断性能。2021年，俄罗斯被排除在世卫组织高结核病负担国家名单之外，这使得在结核病流行病学风险较低的情况下评估RTA试验特异性以确认该试验的高特异性变得很有必要。
评估Diaskintest在俄罗斯联邦结核病流行病学风险较低地区的特异性。
开展了一项多中心、开放标签的前瞻性研究，纳入了150名年龄在18至30岁之间、接种过卡介苗、无结核病风险且来自流行病学风险较低地区（奥廖尔地区、梁赞地区和阿尔汉格尔斯克地区）的健康志愿者。在研究期间，为每位参与者安排了4次访视：[访视0（筛查）、访视1、访视2（72小时后）和访视3（28天后）]。所有排除活动性和潜伏性结核感染的参与者均接受了RTA检测。为评估RTA检测的安全性，记录了28天内发生的所有全身和局部不良事件。该试验已提交至美国国立卫生研究院临床试验数据库ClinicalTrials.gov（NCT05203068）。
在T-SPOT.TB检测为阴性的个体中，RTA检测的特异性为97%（95%置信区间：92-99%），临界值>0毫米。研究结果证实了2009年的数据：100.00（95%置信区间：94-100）。在随访的28天内评估RTA检测的安全性时，参与者未报告与RTA检测有因果关系的局部和全身不良反应。
Diaskintest具有高度特异性且安全，因此作为早期检测结核病的筛查试验是一种有价值的工具。
