Ko Sung Jun, Yoon Kui Hyun
Department of Internal Medicine, Wonkwang University Sanbon Hospital, Gunpo, Republic of Korea.
Department of Laboratory Medicine, Wonkwang University Sanbon Hospital, Gunpo, Republic of Korea.
Tuberc Respir Dis (Seoul). 2025 Jan;88(1):150-158. doi: 10.4046/trd.2024.0091. Epub 2024 Sep 23.
Several novel molecular platforms using nucleic acid amplification tests have been developed for the diagnosis of pulmonary tuberculosis (PTB) and rapid detection of isoniazid and rifampin resistance. Among them, the BD MAX MDR-TB assay (BD MAX) has shown high sensitivity and specificity; however, its diagnostic accuracy performed on bronchoscopy specimens has not been reported.
We retrospectively reviewed the medical records of patients with suspected PTB who underwent bronchoscopy. Patients who underwent BD MAX testing of bronchoscopy specimens were included in the final analysis. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for PTB diagnosis were calculated using a positive culture of Mycobacterium tuberculosis as the reference standard.
Of 114 patients, 34 had culture-confirmed PTB. The sensitivity, specificity, PPV, and NPV of BD MAX performed on bronchoscopy specimens for the diagnosis of PTB were 79.4%, 88.8%, 75.0%, and 91.0%, respectively. The sensitivity of BD MAX was superior to that of acid-fast bacillus smear (79.4% vs. 38.2%, p<0.001).
BD MAX performed on bronchoscopy specimens showed high accuracy for diagnosing PTB. BD MAX can be performed on bronchoscopy specimens in patients with suspected PTB.
已经开发了几种使用核酸扩增试验的新型分子平台用于肺结核（PTB）的诊断以及异烟肼和利福平耐药性的快速检测。其中，BD MAX耐多药结核病检测（BD MAX）已显示出高灵敏度和特异性；然而，其在支气管镜检查标本上的诊断准确性尚未见报道。
我们回顾性分析了接受支气管镜检查的疑似PTB患者的病历。对支气管镜检查标本进行BD MAX检测的患者纳入最终分析。以结核分枝杆菌培养阳性作为参考标准，计算PTB诊断的灵敏度、特异性、阳性预测值（PPV）和阴性预测值（NPV）。
114例患者中，34例经培养确诊为PTB。BD MAX在支气管镜检查标本上诊断PTB的灵敏度、特异性、PPV和NPV分别为79.4%、88.8%、75.0%和91.0%。BD MAX的灵敏度优于抗酸杆菌涂片（79.4%对38.2%，p<0.001）。
BD MAX在支气管镜检查标本上对PTB诊断显示出高准确性。BD MAX可用于疑似PTB患者的支气管镜检查标本检测。
