Clinical Research, Scientific and Clinical Antituberculosis Center of Moscow Government Department of Clinical Research, Scientific and Clinical Antituberculosis Center of Moscow Government Health Department, Moscow, Russian Federation.
PLoS One. 2018 Dec 21;13(12):e0208705. doi: 10.1371/journal.pone.0208705. eCollection 2018.
A 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).
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 active tuberculosis during mass screening in the primary medical service in Moscow.
The 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.
From 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.
In 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.
一组俄罗斯科学家开发了 Diaskintest，它由结核分枝杆菌特异性重组蛋白 CFP10-ESAT6 组成，用于皮肤测试（0.2 μg/0.1 ml）。
评估 TST 与 2 TU PPD-L 以及包含 ESAT6-CFP10 蛋白的结核重组过敏原（Diaskintest）在莫斯科初级医疗服务中进行大规模筛查时新诊断为活动性肺结核的儿童和青少年中的比较敏感性。
该试验是对 2013 年至 2016 年在莫斯科诊断为活动性肺结核的儿童和青少年进行的综合回顾性群组研究，年龄在 0 至 17 岁之间。
从 441 名被选中进行分析的患者中，有 408 名患者同时进行了 TST 与 2 TU PPD-L 和 Diaskintest 两种检测，其中 193 名患者同时进行了两种检测，其中 162 名患者接受了卡介苗接种。408 例肺结核患者两种检测的比较结果：在截断值≥5 mm 时，两种检测的敏感性相似：Diaskintest 98.3%（95%CI 97.0-99.6%），TST 98.0%（95%CI 96.7-99.4%），在截断值≥10 mm 时，两种检测的敏感性均降低：Diaskintest 90.0%（95%CI 87.0-93.0%），TST 88.7%（95%CI 85.6-91.9%），但在截断值≥15 mm 时，敏感性的降低具有统计学意义：对于 Diaskintest 为 61.5%（95%CI 56.7-66.3%），对于 TST 为 46.3%（95%CI 41.4-51.3%），p<0.0001。在 193 名患者（包括 162 名卡介苗接种者）同时在不同手上进行检测的结果与 408 名患者的结果没有差异。在所有组中，Diaskintest 与 TST 的结果之间均存在显著相关性。
在患有活动性肺结核的儿童和青少年中，Diaskintest 为 0.2 μg/ml 和 2 TU PPD-L 的 Mantoux 试验在截断值为 5 mm 时具有高敏感性（98%）；然而，在截断值≥15 mm 时，敏感性显著降低，并且在 Mantoux 试验中降低更为明显。Diaskintest 的优点是，与 Mantoux 试验不同，在大规模卡介苗接种的情况下，它具有高特异性。该试验操作简单，可用于大规模筛查。
