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Abstract：
OBJECTIVE: In this prospective study, the diagnosis accuracy of nanopore sequencing-based Mycobacterium tuberculosis (MTB) detection was determined through examining bronchoalveolar lavage fluid (BALF) samples from pulmonary tuberculosis (PTB) -suspected patients. Compared the diagnostic performance of nanopore sequencing, mycobacterial growth indicator tube (MGIT) culture and Xpert MTB/rifampin resistance (MTB/RIF) assays.
METHODS: Specimens collected from suspected PTB cases across China from September 2021 to April 2022 were tested then assay diagnostic accuracy rates were compared.
RESULTS: Among the 111 suspected PTB cases that were ultimately diagnosed as PTB, the diagnostic rate of nanopore sequencing was statistically significant different from other assays (P < 0.05). Fleiss\' kappa values of 0.219 and 0.303 indicated fair consistency levels between MTB detection results obtained using nanopore sequencing versus other assays, respectively. Respective PTB diagnostic sensitivity rates of MGIT culture, Xpert MTB/RIF and nanopore sequencing of 36.11%, 40.28% and 83.33% indicated superior sensitivity of nanopore sequencing. Analysis of area under the curve (AUC), Youden\'s index and accuracy values and the negative predictive value (NPV) indicated superior MTB detection performance for nanopore sequencing (with Xpert MTB/RIF ranking second), while the PTB diagnostic accuracy rate of nanopore sequencing exceeded corresponding rates of the other methods.
CONCLUSIONS: In comparison with MGIT culture and Xpert MTB/RIF assays, BALF\'s nanopore sequencing provided superior MTB detection sensitivity and thus is suitable for testing of sputum-scarce suspected PTB cases. However, negative results obtained using these assays should be confirmed based on additional evidence before ruling out a PTB diagnosis.
METHODS: Specimens collected from suspected PTB cases across China from September 2021 to April 2022 were tested then assay diagnostic accuracy rates were compared.
RESULTS: Among the 111 suspected PTB cases that were ultimately diagnosed as PTB, the diagnostic rate of nanopore sequencing was statistically significant different from other assays (P < 0.05). Fleiss\' kappa values of 0.219 and 0.303 indicated fair consistency levels between MTB detection results obtained using nanopore sequencing versus other assays, respectively. Respective PTB diagnostic sensitivity rates of MGIT culture, Xpert MTB/RIF and nanopore sequencing of 36.11%, 40.28% and 83.33% indicated superior sensitivity of nanopore sequencing. Analysis of area under the curve (AUC), Youden\'s index and accuracy values and the negative predictive value (NPV) indicated superior MTB detection performance for nanopore sequencing (with Xpert MTB/RIF ranking second), while the PTB diagnostic accuracy rate of nanopore sequencing exceeded corresponding rates of the other methods.
CONCLUSIONS: In comparison with MGIT culture and Xpert MTB/RIF assays, BALF\'s nanopore sequencing provided superior MTB detection sensitivity and thus is suitable for testing of sputum-scarce suspected PTB cases. However, negative results obtained using these assays should be confirmed based on additional evidence before ruling out a PTB diagnosis.
摘要：
目的：在这项前瞻性研究中，通过检查肺结核(PTB)疑似患者的支气管肺泡灌洗液(BALF)样本,确定了基于纳米孔测序的结核分枝杆菌(MTB)检测的诊断准确性.比较了纳米孔测序的诊断性能，分枝杆菌生长指示管（MGIT）培养和XpertMTB/利福平抗性（MTB/RIF）测定。
方法：对2021年9月至2022年4月在中国各地收集的疑似PTB病例的样本进行测试，然后比较分析诊断准确率。
结果：在最终诊断为PTB的111例疑似PTB病例中，纳米孔测序的诊断率与其他检测方法差异有统计学意义(P<0.05)。Fleiss\'kappa值为0.219和0.303表明使用纳米孔测序与其他测定获得的MTB检测结果之间的一致性水平相当。分别。MGIT培养的相应PTB诊断灵敏度，XpertMTB/RIF和纳米孔测序的36.11%，40.28%和83.33%表明纳米孔测序的灵敏度较高。曲线下面积（AUC）分析，Youden的指标和准确度值以及阴性预测值（NPV）表明纳米孔测序的MTB检测性能优越（XpertMTB/RIF排名第二），而纳米孔测序的PTB诊断准确率超过了其他方法的相应准确率。
结论：与MGIT培养和XpertMTB/RIF测定相比，BALF的纳米孔测序提供了优越的MTB检测灵敏度，因此适用于痰液稀缺的可疑PTB病例的检测。然而,在排除PTB诊断之前,应根据其他证据确认使用这些检测方法获得的阴性结果.
方法：对2021年9月至2022年4月在中国各地收集的疑似PTB病例的样本进行测试，然后比较分析诊断准确率。
结果：在最终诊断为PTB的111例疑似PTB病例中，纳米孔测序的诊断率与其他检测方法差异有统计学意义(P<0.05)。Fleiss\'kappa值为0.219和0.303表明使用纳米孔测序与其他测定获得的MTB检测结果之间的一致性水平相当。分别。MGIT培养的相应PTB诊断灵敏度，XpertMTB/RIF和纳米孔测序的36.11%，40.28%和83.33%表明纳米孔测序的灵敏度较高。曲线下面积（AUC）分析，Youden的指标和准确度值以及阴性预测值（NPV）表明纳米孔测序的MTB检测性能优越（XpertMTB/RIF排名第二），而纳米孔测序的PTB诊断准确率超过了其他方法的相应准确率。
结论：与MGIT培养和XpertMTB/RIF测定相比，BALF的纳米孔测序提供了优越的MTB检测灵敏度，因此适用于痰液稀缺的可疑PTB病例的检测。然而,在排除PTB诊断之前,应根据其他证据确认使用这些检测方法获得的阴性结果.
