重组结核变应原皮内试验（迪氏皮肤试验）与其他免疫学检测方法在结核病感染诊断中的比较。
A comparison of intradermal test with recombinant tuberculosis allergen (diaskintest) with other immunologic tests in the diagnosis of tuberculosis infection.
作者信息
Starshinova Anna, Zhuravlev Viacheslav, Dovgaluk Irina, Panteleev Alexandr, Manina Vera, Zinchenko Ulia, Istomina Evgenia, Pavlova Maria, Yablonskiy Piotr
机构信息
Federal State Saint Petersburg Research Institute of Phthisiopulmonology of Ministry of Health Russian Federation, Federal State Institution of Higher Education Saint Petersburg State University, Petersburg, Russia.
Federal State Saint Petersburg Research Institute of Phthisiopulmonology of Ministry of Health Russian Federation, Petersburg, Russia.
出版信息
Int J Mycobacteriol. 2018 Jan-Mar;7(1):32-39. doi: 10.4103/ijmy.ijmy_17_18.
BACKGROUND
The WHO strategy for eradication of tuberculosis (TB) by 2035 (The End TB Strategy) is aimed at an early and precise diagnosis and subsequent effective treatment of TB patients. Currently, there is no gold standard for the diagnosis of latent TB infection. This study evaluated the diagnostic capabilities of a new intradermal test using recombinant TB allergen (Diaskintest) compared with tuberculin skin test (TST) and commercial TB interferon-gamma release assays (IGRAs).
METHODS
A post-hoc data analysis that involved examining 860 HIV-negative, bacillus Calmette-Guérin (BCG)-vaccinated persons aged 1-65 years who visited the TB health-care institutions of Saint Petersburg to rule out or confirm an active TB was conducted from 2011 to 2016.
RESULTS
A high degree of consistency of the Diaskintest results with the enzyme-linked immunospot and QuantiFERON-TB Gold In-Tube test (ELISPOT and QFT) results was observed in the examined pediatric population (n = 696), with a Diaskintest cutoff ≥5 mm: the kappa consistency indices were 1.000 and 0.937, for ELISPOT and QFT, respectively. A high sensitivity of Diaskintest, comparable with the IGRA tests, was observed in patients with a confirmed TB diagnosis in all age groups. The sensitivity of Diaskintest in patients of the TB/MTB + group aged 18 years and older was 88.7%; of ELISPOT, 90.6%; of QFT, 87.0%. The conducted analysis has shown a high concordance of results of the commercial TB tests in adult HIV-negative patients (n = 164) with a Diaskintest cutoff ≥5 mm: the kappa indices were 0.805 and 0.636 (Diaskintest vs. ELISPOT and QFT, respectively) among BCG-vaccinated people.
CONCLUSION
According to the WHO recommendations, replacing the TST by IGRAs is not recommended as a public health intervention in resource-constrained settings because the IGRA tests are more costly and technically complex to conduct than the TST. Diaskintest has comparable complexity to the TST and its performance is close to that of IGRA in a BCG-vaccinated population. Thus, our study demonstrates that replacing the TST by Diaskintest can be recommended as a public health intervention in resource-constrained and universal BCG vaccination settings.
背景
世界卫生组织到2035年消除结核病的战略（终止结核病战略）旨在对结核病患者进行早期精确诊断并随后进行有效治疗。目前，潜伏性结核感染的诊断尚无金标准。本研究评估了一种使用重组结核变应原的新型皮内试验（Diaskintest）与结核菌素皮肤试验（TST）和商用结核干扰素-γ释放试验（IGRAs）相比的诊断能力。
方法
进行了一项事后数据分析，该分析涉及对2011年至2016年期间860名年龄在1至65岁、HIV阴性、接种过卡介苗（BCG）的人进行检查，这些人前往圣彼得堡的结核病医疗机构以排除或确诊活动性结核病。
结果
在接受检查的儿科人群（n = 696）中，观察到Diaskintest结果与酶联免疫斑点试验和全血γ干扰素释放检测（QuantiFERON-TB Gold In-Tube test，ELISPOT和QFT）结果高度一致，Diaskintest临界值≥5 mm：ELISPOT和QFT的kappa一致性指数分别为1.000和0.937。在所有年龄组确诊为结核病的患者中，观察到Diaskintest具有与IGRA试验相当的高敏感性。在18岁及以上的结核病/结核分枝杆菌阳性（TB/MTB +）组患者中，Diaskintest的敏感性为88.7%；ELISPOT为90.6%；QFT为87.0%。所进行的分析表明，在临界值≥5 mm的成年HIV阴性患者（n = 164）中，商用结核病检测结果与Diaskintest高度一致：在接种卡介苗的人群中，kappa指数分别为0.805和0.636（分别为Diaskintest与ELISPOT和QFT相比）。
结论
根据世界卫生组织的建议，不建议在资源有限的环境中将IGRAs替代TST作为公共卫生干预措施，因为IGRA试验比TST成本更高且技术操作更复杂。Diaskintest与TST的操作复杂性相当，并且在接种卡介苗的人群中其性能接近IGRA。因此，我们的研究表明，在资源有限且普遍接种卡介苗的环境中，可建议用Diaskintest替代TST作为公共卫生干预措施。
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