Xpert MTB/RIF Ultra在加拿大温哥华支气管标本诊断肺结核中的性能

Xpert MTB/RIF Ultra performance on bronchial specimens in diagnosing pulmonary tuberculosis in Vancouver, Canada.

作者信息

Schonhofer Cole, Bilawka Jennifer, Apperley Scott, Lowe Christopher F, Payne Michael, Matic Nancy, Leung Victor, Romney Marc G, Tang Patrick, Stefanovic Aleksandra

机构信息

Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, Canada.

Division of Medical Microbiology and Virology, St. Paul's Hospital, Providence Health Care, Vancouver, Canada.

出版信息

J Med Microbiol. 2025 Jun;74(6). doi: 10.1099/jmm.0.002022.

Abstract

In cases where sputum is non-diagnostic or unavailable, bronchoscopy can yield high-value respiratory samples for tuberculosis (TB) diagnosis. Whilst (MTB) culture remains the gold standard, molecular assays such as Xpert MTB/RIF Ultra (Xpert Ultra) are increasingly being used for rapid diagnosis. Xpert Ultra is increasingly used for TB diagnosis and has been extensively evaluated on sputum specimens, but assessment of performance on bronchoscopy samples is more limited. To retrospectively evaluate the performance of Xpert Ultra on bronchoscopy specimens in comparison to culture in a low-incidence, high-resource setting. Patients with a clinical suspicion of TB, who had non-diagnostic sputum or limited sputum production and underwent bronchoscopy between March 2019 and October 2023, were included in the study. Bronchoscopy specimens comprised bronchoalveolar lavages, bronchial washings and endobronchial ultrasound lymph node tissue biopsies. All included specimens underwent acid-fast bacilli (AFB) smear, mycobacterial culture and Xpert Ultra. Positive MTB culture was considered the reference standard for TB diagnosis. One hundred thirty-five bronchoscopy samples from 126 patients were included. Cultures were positive for MTB in 47 out of 126 (37.3%) of included patients. Overall, positive percent agreement (PPA) and negative percent agreement (NPA) of Xpert Ultra to MTB culture were 93.6% and 98.7%, respectively. In 19 AFB smear-positive cases, Xpert Ultra had 100% PPA and NPA, whilst in 28 smear-negative cases, PPA and NPA were 89.3% and 98.6%, respectively. On average, positive culture results were available after 15.2 days of incubation (range, 5-42 days) versus 24 h for Xpert Ultra. Xpert Ultra PCR cycle threshold values correlated strongly with AFB-smear grade and time-to-culture positivity. Xpert Ultra performed on specimens collected via bronchoscopy demonstrated excellent agreement with culture, even in smear-negative cases. Our results support the use of the Ultra on bronchoscopy specimens for accurate and rapid TB diagnosis in a low-incidence setting.

摘要

在痰液检查无法确诊或无法获取痰液的情况下,支气管镜检查可为结核病(TB)诊断提供高价值的呼吸道样本。虽然结核分枝杆菌(MTB)培养仍是金标准,但诸如Xpert MTB/RIF Ultra(Xpert Ultra)等分子检测方法正越来越多地用于快速诊断。Xpert Ultra越来越多地用于结核病诊断,并且已在痰液标本上进行了广泛评估,但对支气管镜检查样本性能的评估则较为有限。为了在低发病率、高资源环境中,回顾性评估Xpert Ultra在支气管镜检查标本上相对于培养的性能。本研究纳入了2019年3月至2023年10月期间临床怀疑患有结核病、痰液检查无法确诊或痰液分泌有限且接受了支气管镜检查的患者。支气管镜检查标本包括支气管肺泡灌洗、支气管冲洗和支气管内超声引导下淋巴结组织活检。所有纳入的标本均进行了抗酸杆菌(AFB)涂片、分枝杆菌培养和Xpert Ultra检测。MTB培养阳性被视为结核病诊断的参考标准。纳入了126例患者的135份支气管镜检查样本。126例纳入患者中有47例(37.3%)的培养结果显示MTB阳性。总体而言,Xpert Ultra与MTB培养的阳性百分比一致性(PPA)和阴性百分比一致性(NPA)分别为93.6%和98.7%。在19例AFB涂片阳性病例中,Xpert Ultra的PPA和NPA均为100%,而在28例涂片阴性病例中,PPA和NPA分别为89.3%和98.6%。平均而言,培养阳性结果在孵育15.2天(范围为5 - 42天)后可得,而Xpert Ultra检测24小时即可出结果。Xpert Ultra的PCR循环阈值与AFB涂片分级和培养阳性时间密切相关。即使在涂片阴性的病例中,通过支气管镜检查采集的标本上进行的Xpert Ultra检测与培养结果也显示出极好的一致性。我们的结果支持在低发病率环境中,将Xpert Ultra用于支气管镜检查标本以进行准确、快速的结核病诊断。

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