Mycobacterial and Migrant Health Research Group, University of Basel Children's Hospital Basel and Department of Clinical Research, University of Basel, Basel, Switzerland.
Northern State Medical University, Arkhangelsk, Russia.
PLoS One. 2024 Aug 27;19(8):e0293272. doi: 10.1371/journal.pone.0293272. eCollection 2024.
A novel skin test-called Diaskintest (DT)-containing specific M. tuberculosis antigens is in clinical use in the Russian Federation (RF). This test may improve diagnosis of tuberculosis (TB) infection. The use and performance of the DT was described and compared to the tuberculin skin test (TST).
Data on children <18 years referred to a TB reference centre (Jan/2018- Dec/2019) with ≥1 DT and TST result available were analysed. An immune correlate of TB infection was defined as a positive TST (≥10 mm induration) or a positive DT (any induration).
Of 2710 included cases, the median age was 9.0 (IQR 5.7-13.1) years and 97.5% were BCG immunised. Overall, 1976 (79.9%) were TB uninfected, 724 (26.7%) had an immune correlate of TB infection and 10 (0.4%) TB disease. Reasons for referral were: positive or increasing skin test results in routine screening (992, 36.6%), screening before admission to a health care institution (501, 18.5%) and TB contact (457, 16.9%). DT was positive in 11.7% (308/2625) and TST in 63.1% (467/740) (Kappa 0.08, 95% CI:0.013-0.14). A positive DT was associated with older age (OR 1.16 (95% CI: 1.13-1.19) per year). Among TB contacts DT positivity was associated with contagiousness: highest proportion of positivity of 12.0% was observed when the index case was smear positive.
In a setting with universal BCG vaccination and regular screening with TST, DT was used to rule out TB infection as TST was commonly positive. We found an association of DT positivity and contagiousness of the index case in children contacts. These observations may suggest improved specificity and sensitivity of DT compared to TST.
一种新型皮肤测试——迪阿斯金特测试（DT），包含特定的结核分枝杆菌抗原，目前在俄罗斯联邦（RF）临床应用。该测试可能有助于诊断结核（TB）感染。本文描述并比较了 DT 与结核菌素皮肤试验（TST）的使用和性能。
分析了 2018 年 1 月至 2019 年 12 月期间，因至少有 1 次 DT 和 TST 检测结果，而转诊至结核病参考中心的<18 岁儿童的数据。将结核感染的免疫相关指标定义为 TST（硬结≥10 毫米）或 DT（任何硬结）阳性。
2710 例纳入病例的中位年龄为 9.0（IQR 5.7-13.1）岁，97.5% 接种过卡介苗。总体而言，1976 例（79.9%）未感染结核，724 例（26.7%）存在结核感染的免疫相关指标，10 例（0.4%）患有结核病。转诊原因包括：常规筛查中皮肤试验结果阳性或逐渐增加（992 例，36.6%）、入院前筛查（501 例，18.5%）和结核接触（457 例，16.9%）。DT 阳性率为 11.7%（308/2625），TST 阳性率为 63.1%（467/740）（Kappa 值为 0.08，95%CI：0.013-0.14）。DT 阳性与年龄较大有关（每增加 1 岁，OR 为 1.16（95%CI：1.13-1.19））。在结核接触者中，DT 阳性与传染性有关：当指示病例为痰涂片阳性时，DT 阳性率最高，为 12.0%。
在普遍接种卡介苗和常规 TST 筛查的背景下，DT 被用于排除 TB 感染，因为 TST 通常为阳性。我们发现，在儿童结核接触者中，DT 阳性与指示病例的传染性有关。这些观察结果可能表明 DT 与 TST 相比，具有更高的特异性和敏感性。
