Objectives. To evaluate the performance of Xpert MTB/RIF for lymph node tuberculosis (LNTB). Methods. We searched databases for published reports. We reviewed the studies and identified the performance of Xpert MTB/RIF with respect to a composite reference standard (CRS) and culture. We used a bivariate random-effects model to perform meta-analyses and used metaregression to analyze sources of heterogeneity. Results. 15 independent studies compared Xpert MTB/RIF with CRS while 21 comparing it with culture were included. The pooled sensitivity and specificity of Xpert MTB/RIF were 79% and 98% compared to that of CRS, respectively, and 84% and 91% compared to that of culture, respectively. The pooled sensitivity and specificity using fine needle aspiration (FNA) samples versus CRS were 80% and 96%, whereas those against culture were 90% and 89%, respectively. The percentages while working with tissue samples versus CRS were 76% and 100%, respectively, whereas those against culture were 76% and 92%, respectively. There was no significant difference in diagnostic efficiency among the types of specimen. Conclusions. Xpert MTB/RIF demonstrates good diagnostic efficiency for LNTB and is not related to the type of specimen, obtained via different routes.

To evaluate the accuracy of the CapitalBioMycobacterium real-time polymerase chain reaction (PCR) detection test for pulmonary Mycobacterium tuberculosis (MTB) and nontuberculous mycobacterial (NTM) infection. We analyzed 2460 samples from patients with suspected pulmonary mycobacterial infection collected between June 1, 2018, and July 31, 2019, to determine the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of the CapitalBio Mycobacterium detection test for MTB and NTM infections and to evaluate its diagnostic accuracy compared with mycobacterial culture. The sensitivity, specificity, PPV, NPV, and AUC of the CapitalBio Mycobacterium detection test for MTB was 83.0%, 79.9%, 80.8%, 82.2%, and 0.81, respectively. This was similar to the diagnostic accuracy of Xpert MTB/RIF for MTB and was significantly higher than that of smear. For pulmonary NTM infection, the sensitivity, specificity, PPV, NPV, and AUC of the test was 82.0%, 99.6%, 94.1%, 98.5%, and 0.91, respectively. The diagnostic accuracy of the CapitalBio Mycobacterium detection test was also significantly higher than that of smear for NTM. The CapitalBio Mycobacterium detection test has good diagnostic accuracy for MTB and NTM infections. It is of great significance in the differential diagnosis of early pulmonary mycobacterial infection.

Purpose: This study aimed to evaluate the efficacy of nanopore sequencing for diagnosing pulmonary tuberculosis (PTB) using smear-negative clinical specimens. Methods: We conducted a retrospective study based on a review of patient medical records to assess the accuracy of nanopore sequencing as a diagnostic tool for smear-negative PTB. Compared with clinical diagnosis, we determined the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of nanopore sequencing. Results: A total of 647 patients were evaluated. Nanopore sequencing demonstrated an overall sensitivity of 91.7%, specificity of 85.3%, PPV of 95.1%, NPV of 76.4%, and AUC of 0.88. Notably, the overall diagnostic accuracy of nanopore sequencing was significantly higher than that of Mycobacterium tuberculosis (MTB) culture technique. Conclusion: Nanopore sequencing exhibited satisfactory overall diagnostic accuracy for smear-negative PTB, regardless of MTB culture status. Therefore, if conditions permit, nanopore sequencing is recommended as a diagnostic method for smear-negative PTB.

Purpose: We evaluated CapitalBio Mycobacterium RT-PCR assay diagnosing tuberculous pericarditis (TBP), performed a head-to-head comparison with Xpert MTB/RIF, and assessed the impact of a parallel test (positive result for either of these two tests). Methods: We reviewed suspected TBP patients with Xpert MTB/RIF, CapitalBio Mycobacterium RT-PCR assay, and Mycobacterium tuberculosis (MTB) culture. We analyzed sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC). Results: Seventy-four patients were included. Overall sensitivity, specificity, PPV, NPV, and AUC of CapitalBio Mycobacterium RT-PCR assay compared with culture were 50%, 91.1%, 64.3%, 85%, and 0.71, respectively. Overall sensitivity, specificity, PPV, NPV, and AUC of Xpert MTB/RIF for TBP were 61.1%, 91.1%, 68.8%, 87.9%, and 0.76. Parallel test values were 72.2%, 91.1%, 72.2%, 91.1%, and 0.82. The diagnostic accuracy of Xpert MTB/RIF was higher than CapitalBio Mycobacterium RT-PCR assay but was not significant (P > 0.05). The parallel test could improve diagnostic accuracy, but it was not significant compared to single tests (P > 0.05). Conclusion: CapitalBio Mycobacterium RT-PCR assay had a moderate diagnostic accuracy, similar to Xpert MTB/RIF. The parallel test maximized diagnostic efficacy, but differences were not significant. CapitalBio Mycobacterium RT-PCR assay and Xpert MTB/RIF for TBP could be an initial option for early diagnosis.

Objective: Early and precise diagnosis of tuberculous serous effusions is a huge challenge. Nanopore sequencing is a potentially efficient assay. The objective of the current study was to evaluate the diagnostic accuracy of nanopore sequencing for tuberculous serous effusions using clinical specimens directly, and to provide a new pathway for the early and precise diagnosis of tuberculous serous effusions. Methods: This was a retrospective analysis of the effectiveness of nanopore sequencing as a diagnostic method for tuberculous serous effusions using clinical specimens (pleural fluid, pericardial effusion, and ascitic fluid). Using clinical diagnosis as reference standard, the diagnostic accuracy indicators such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) for the tests in question were evaluated. Results: In total, 132 patients were eligible for inclusion. Nanopore sequencing showed sensitivity of 93.3%, specificity of 85.2%, PPV of 96.1%, NPV of 76.7%, and AUC of 0.89 for tuberculous serous effusions. The diagnostic accuracy of nanopore sequencing was significantly superior than that of Xpert MTB/RIF and culture. Similar results were observed in different types of tuberculous serous effusions (pleural tuberculosis, pericardial tuberculosis, and peritoneal tuberculosis). Conclusion: Nanopore sequencing was efficient for the rapid diagnosis of tuberculous serous effusions and had a very positive effect. For paucibacillary tuberculous serous effusions, nanopore sequencing might become an effective method for detecting pathogenic bacteria.