Evaluation of Trace calls by Xpert MTB/RIF Ultra for clinical management in low TB burden settings

Fifty-nine patients with presumptive TB and at least one Xpert MTB/RIF Ultra trace call result during diagnostic workup before treatment initiation in the period November 2017-December 2020 at the Policlinico di S. Orsola in Bologna (Italy), were included in the study.<br>The aim of the study was to evaluate the frequency and epidemiology of trace readouts in routine clinical practice in a low TB prevalence setting and to propose a guidance on how to manage patients with trace result according to available data (i.e. clinical, radiological, bacteriological and others). <br>Database reports epidemiological data, sample localization, smear microscopy, mycobacterial culture, Xpert Ultra and IGRA results, histology, imaging and clinical data, start therapy date, outcome.

本研究纳入了2017年11月至2020年12月期间，在意大利博洛尼亚圣奥尔索拉综合医院（Policlinico di S. Orsola）启动治疗前的诊断评估阶段，临床疑似肺结核（Tuberculosis, TB）且至少出现1次Xpert MTB/RIF Ultra（Xpert MTB/RIF Ultra）痕量检测结果的59例患者。
本研究旨在评估肺结核低流行地区常规临床诊疗工作中，痕量检测结果的发生频率与流行病学特征，并基于现有临床、影像学、细菌学及其他相关数据，为痕量结果患者的管理提出指导性方案。
本研究数据库涵盖流行病学资料、标本采集部位、涂片显微镜检查、分枝杆菌培养、Xpert MTB/RIF Ultra检测结果、干扰素γ释放试验（Interferon-Gamma Release Assay, IGRA）结果、组织病理学资料、影像学资料、临床信息、治疗启动日期及转归结局。