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

IF 2
Cole Schonhofer, Jennifer Bilawka, Scott Apperley, Christopher F Lowe, Michael Payne, Nancy Matic, Victor Leung, Marc G Romney, Patrick Tang, Aleksandra Stefanovic
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Abstract

Introduction. In cases where sputum is non-diagnostic or unavailable, bronchoscopy can yield high-value respiratory samples for tuberculosis (TB) diagnosis. Whilst Mycobacterium tuberculosis (MTB) complex culture remains the gold standard, molecular assays such as Xpert MTB/RIF Ultra (Xpert Ultra) are increasingly being used for rapid diagnosis.Gap Statement. 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.Aim. To retrospectively evaluate the performance of Xpert Ultra on bronchoscopy specimens in comparison to culture in a low-incidence, high-resource setting.Methodology. 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.Results. 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.Conclusion. 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.

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专家MTB/RIF Ultra支气管标本诊断肺结核在加拿大温哥华。
介绍。在无法诊断或无法获得痰液的情况下,支气管镜检查可获得用于结核病诊断的高价值呼吸道样本。虽然结核分枝杆菌(MTB)复体培养仍然是金标准,但Xpert MTB/RIF Ultra (Xpert Ultra)等分子检测越来越多地用于快速诊断。差距的声明。Xpert Ultra越来越多地用于结核病诊断,并已在痰标本上进行了广泛的评估,但对支气管镜检查样本的性能评估更为有限。回顾性评价Xpert Ultra在支气管镜检查标本上的表现,并与低发病率、高资源环境下的培养相比较。在2019年3月至2023年10月期间,临床怀疑患有结核病、痰不清或痰量有限并接受支气管镜检查的患者被纳入研究。支气管镜检查标本包括支气管肺泡灌洗、支气管清洗和支气管超声淋巴结组织活检。所有标本均行抗酸杆菌(AFB)涂片、分枝杆菌培养和Xpert Ultra检测。结核分枝杆菌培养阳性可作为结核诊断的参考标准。纳入126例患者的135例支气管镜检查样本。126例纳入的患者中有47例(37.3%)培养结核分枝杆菌阳性。总体而言,Xpert Ultra与MTB培养物的阳性率(PPA)和阴性阳性率(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阳性率为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15.2天(范围5-42天)后可获得阳性培养结果,而Xpert Ultra为24小时。Xpert Ultra PCR周期阈值与afb涂片分级和培养时间阳性密切相关。Xpert Ultra对通过支气管镜收集的标本进行检查,即使在涂片阴性的病例中,也与培养结果非常吻合。我们的研究结果支持在低发病率环境下使用Ultra对支气管镜标本进行准确和快速的结核病诊断。
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