Department of Clinical Laboratory, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
Department of Laboratory Medicine, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Int J Infect Dis. 2019 Apr;81:91-96. doi: 10.1016/j.ijid.2019.01.050. Epub 2019 Feb 7.
To evaluate the diagnostic performance of Xpert MTB/RIF Ultra for EPTB (Extrapulmonary Tuberculosis) patients on different types of extrapulmonary specimens from different anatomic sites.
Patients with suspected EPTB were prospectively included, extrapulmonary specimens were collected and subjected to culture, Xpert and Xpert Ultra assays in accordance with relevant guidelines.
A total of 225 cases were included which contained 200 EPTB cases (43 culture-positive EPTB, 157 culture-negative EPTB which were diagnosed based on pathological results and a satisfied response to anti-TB treatment) and 25 non-EPTB cases. Sensitivities of Xpert Ultra and Xpert for culture-positive cases were 83.7% (95%CI, 68.7-92.7) and 67.4% (95% CI, 51.3-80.5) respectively. Specificities of Xpert Ultra and Xpert were 92.0% (95% CI, 72.5-98.6) and 96.0% (95% CI, 77.7-99.8) respectively. The sensitivities of Xpert Ultra, Xpert and culture for 200 EPTB cases were 52.5% (105/200, 95% CI, 45.4-59.6), 34.0% (68/200, 95% CI, 27.6-41.1) and 21.5% (43/200, 95% CI, 16.2-28.0) respectively. By comparison among different types of specimens, Xpert Ultra can detect 78.9% (56/71) of EPTB on fine-needle aspiration (FNA) tissues which was higher than that on pleural fluid (43.7% (45/103), p<0.05.
Xpert Ultra assay had a higher sensitivity than those of Xpert and culture on extrapulmonary specimens, which could be a promising approach for rapid EPTB diagnosis.
评估 Xpert MTB/RIF Ultra 检测不同部位不同类型的肺外标本中肺外结核（EPTB）的诊断性能。
前瞻性纳入疑似 EPTB 患者，按照相关指南收集肺外标本并进行培养、Xpert 和 Xpert Ultra 检测。
共纳入 225 例患者，其中包括 200 例 EPTB 患者（43 例培养阳性 EPTB，157 例培养阴性 EPTB，基于病理结果和对抗结核治疗的满意反应进行诊断）和 25 例非 EPTB 患者。Xpert Ultra 和 Xpert 对培养阳性病例的灵敏度分别为 83.7%（95%CI，68.7-92.7）和 67.4%（95%CI，51.3-80.5）。Xpert Ultra 和 Xpert 的特异性分别为 92.0%（95%CI，72.5-98.6）和 96.0%（95%CI，77.7-99.8）。200 例 EPTB 患者中，Xpert Ultra、Xpert 和培养的灵敏度分别为 52.5%（105/200，95%CI，45.4-59.6）、34.0%（68/200，95%CI，27.6-41.1）和 21.5%（43/200，95%CI，16.2-28.0）。通过比较不同类型的标本，Xpert Ultra 可检测到 78.9%（56/71）的经细针抽吸（FNA）组织中的 EPTB，高于胸腔积液中的 43.7%（45/103）（p<0.05）。
Xpert Ultra 检测在肺外标本中对 EPTB 的检测灵敏度高于 Xpert 和培养，可能是一种快速诊断 EPTB 的有前景的方法。
