Diagnostic accuracy of Xpert MTB/RIF Ultra for detecting pulmonary tuberculosis and rifampicin resistance: a systematic review and meta-analysis.

Yan Chen, Man-Qing Wang, Ya-Fang Zheng, Yu-Qi Hu, Jin-Xia Huang, Zi-Xin Yuan, Zu-Yan Wu, Lu-Fang Huang, Chu-Ting Tang, Feng-Yi Zhang, Jin-Ke He, Xu-Guang Guo, Bao-Mei Yan

Journal: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology 2025;44(3):681-702

PMID: 39754613

Abstract

BACKGROUND

Public health issues related to tuberculosis still exist. Because Xpert MTB/RIF Ultra is more effective than conventional TB diagnostic techniques are, it is now regarded as an emerging technology. The diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculosis was assessed in this systematic study.

METHODS

We searched the PubMed, Cochrane, EMBASE, and Web of Science databases for pertinent literature published before January 18, 2024. The quality of the collected literature was assessed via Review Manager 5.3 software, which applies the quality assessment of diagnostic accuracy studies criteria. Using Metadisc 1.40 software, the sensitivity, specificity, and summary receiver operating characteristic curves were plotted and examined. Stata 12.0 was the program we utilized to assess publication bias in this investigation. The Prospero prospective register of systematic reviews included this study (reference number CRD42024569674).

RESULTS

Analysis of 187 fourfold tables from 72 studies revealed that Xpert MTB/RIF Ultra demonstrated an overall pooled sensitivity of 76% and specificity of 95% for detecting pulmonary tuberculosis. The positive likelihood ratio (PLR) was 14.91, and the negative likelihood ratio (NLR) was 0.23, with an area under the curve (AUC) of 0.9351 and a diagnostic odds ratio (DOR) of 73.39. For detecting rifampin resistance, the combined sensitivity and specificity were 94% and 97%, respectively. The pooled PLR was 24.94, the NLR was 0.07, and the DOR was 429.05. The area under the summary receiver operating characteristic (SROC) curve was 0.9868.

CONCLUSION

In conclusion, developing effective laboratory diagnostic tools for identifying Mycobacterium tuberculosis is essential for epidemiological research. This study demonstrated that Xpert MTB/RIF Ultra effectively diagnosed Mycobacterium tuberculosis infection, including pulmonary tuberculosis, as well as rifampin resistance, highlighting its potential as a valuable tool for both diagnosis and resistance detection.

© 2025. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

Address: Department of Ultrasound Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, 510150, China.; Department of Clinical Medicine, The First School of Clinical Medicine, Guangzhou Medical University, Guangzhou, 511436, China.; Department of Ultrasound Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, 510150, China.; Department of Clinical Medicine, The Third School of Clinical Medicine, Guangzhou Medical University, Guangzhou, 511436, China.; Department of Ultrasound Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, 510150, China.; Department of Cardiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, 510080, China.; Department of Ultrasound Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, 510150, China.; Department of Nutrition and Food Hygiene, School of Public Health, Guangzhou Medical University, Guangzhou, 511436, China.; Department of Ultrasound Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, 510150, China.; Department of Clinical Medicine, The Sixth School of Clinical Medicine, Guangzhou Medical University, Guangzhou, 511436, China.; Department of Ultrasound Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, 510150, China. [email protected].; Department of Clinical Laboratory Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, 510150, China. [email protected].; Department of Clinical Medicine, The Third School of Clinical Medicine, Guangzhou Medical University, Guangzhou, 511436, China. [email protected].; Guangzhou Key Laboratory for Clinical Rapid Diagnosis and Early Warning of Infectious Diseases, King Med School of Laboratory Medicine, Guangzhou Medical University, Guangzhou, 510000, China. [email protected].; Department of Ultrasound Medicine, Guangdong Provincial Key Laboratory of Major Obstetric Diseases, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, 510150, China. [email protected].

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