Translational Research Unit, Department of Epidemiology and Preclinical Research National Institute for Infectious Diseases L. Spallanzani-IRCCS, Rome, Italy.
Expert Rev Mol Diagn. 2023 Jul-Dec;23(9):783-795. doi: 10.1080/14737159.2023.2240230. Epub 2023 Aug 10.
Despite huge efforts, tuberculosis (TB) is still a major public health threat worldwide, it is estimated that a quarter of the global population is infected by Mycobacterium tuberculosis (Mtb). For controlling TB and reducing Mtb transmission it is fundamental to diagnose TB infection (TBI) as well as the progressors from TBI to disease to identify those requiring preventive therapy. At present, there is no gold standard test for TBI diagnosis although several new methodologies have been attempted.
This review provides an update on the most recent approaches to develop reliable tests to diagnose TBI and progressors from infection to disease. Experimental tests are based on either the direct identification of Mtb (i.e., Mtb DNA upon host cells isolation; Mtb proteins or peptides) or host response (i.e., levels and quality of specific anti-Mtb antibodies; host blood transcriptome signatures).
The experimental tests described are very interesting. However, further investigation and randomized clinical trials are needed to improve the sensitivity and specificity of these new research-based tests. More reliable proofs-of-concept and simplification of technical procedures are necessary to develop new diagnostic tools for identifying TBI patients and those that will progress from infection to TB disease.
尽管付出了巨大努力,结核病(TB)仍然是全球主要的公共卫生威胁,据估计,全球四分之一的人口感染了结核分枝杆菌(Mtb)。为了控制结核病并减少 Mtb 的传播,对结核感染(TBI)以及从 TBI 进展为疾病的进展者进行诊断以确定需要预防性治疗的人群至关重要。目前,虽然已经尝试了几种新方法,但 TBI 诊断尚无金标准测试。
本文综述了最近开发可靠的 TBI 诊断和从感染到疾病进展者的检测方法的最新进展。实验性检测基于 Mtb 的直接鉴定(即宿主细胞分离后的 Mtb DNA;Mtb 蛋白或肽)或宿主反应(即特异性抗 Mtb 抗体的水平和质量;宿主血液转录组特征)。
所描述的实验性检测非常有趣。然而,需要进一步的调查和随机临床试验来提高这些基于新研究的检测方法的灵敏度和特异性。需要更可靠的概念验证和简化技术程序,以开发用于识别 TBI 患者和从感染进展为结核病的患者的新诊断工具。