Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter study

Background: Posterior oropharyngeal saliva (POS) is increasingly recognized as an alternative specimen for detecting respiratory pathogens. The accuracy of Xpert® MTB/RIF Ultra (X-Ultra), when performed on POS obtained from patients with paucibacillary pulmonary tuberculosis (TB) is unclear. Methods...

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Main Authors: Peijun Tang, Rongmei Liu, Lin Qin, Ping Xu, Yu Xiong, Yunfeng Deng, Zizheng Lv, Yuanyuan Shang, Xinghui Gao, Lin Yao, Ruoyu Zhang, Yanjun Feng, Caihong Ding, Hui Jing, Liang Li, Yi-Wei Tang, Yu Pang
Format: Article
Language:English
Published: Taylor & Francis Group 2023-12-01
Series:Emerging Microbes and Infections
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Online Access:https://www.tandfonline.com/doi/10.1080/22221751.2022.2148564
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author Peijun Tang
Rongmei Liu
Lin Qin
Ping Xu
Yu Xiong
Yunfeng Deng
Zizheng Lv
Yuanyuan Shang
Xinghui Gao
Lin Yao
Ruoyu Zhang
Yanjun Feng
Caihong Ding
Hui Jing
Liang Li
Yi-Wei Tang
Yu Pang
author_facet Peijun Tang
Rongmei Liu
Lin Qin
Ping Xu
Yu Xiong
Yunfeng Deng
Zizheng Lv
Yuanyuan Shang
Xinghui Gao
Lin Yao
Ruoyu Zhang
Yanjun Feng
Caihong Ding
Hui Jing
Liang Li
Yi-Wei Tang
Yu Pang
author_sort Peijun Tang
collection DOAJ
description Background: Posterior oropharyngeal saliva (POS) is increasingly recognized as an alternative specimen for detecting respiratory pathogens. The accuracy of Xpert® MTB/RIF Ultra (X-Ultra), when performed on POS obtained from patients with paucibacillary pulmonary tuberculosis (TB) is unclear. Methods: We consecutively recruited adults with symptoms suggestive of pulmonary TB who were negative by both smear microscopy and Xpert MTB/RIF (X-Classic). Each participant was required to provide one bronchoalveolar lavage fluid (BALF) and one POS specimen, respectively. Diagnostic performances of X-Ultra and X-Classic on POS were compared against clinical and mycobacterial reference standards. Findings: 686 participants meeting inclusion criteria were consecutively enrolled into the study. The overall diagnostic sensitivities of X-Ultra and X-Classic on POS samples were 78.9% [95% confidence interval (CI): 72.8–83.8] and 56.4% (95% CI: 49.7–62.9), respectively; the specificities were 96.6% (95% CI: 94.3–98.1) for X-Ultra and 97.6 (95CI: 95.5–98.8) for X-Classic in POS specimens. Notably, the sensitivity of X-Ultra on POS was as sensitive as X-Classic on BALF against microbiological reference standard (78.9% VS 73.1%). Against clinical diagnosis as a reference standard, the sensitivities of X-Ultra and X-Classic on POS were 55.9% (95% CI: 50.5–61.2; 193/345) and 40.0% (95% CI: 34.8–45.4; 138/345), respectively. The risk of negative results with POS was dramatically increased with decreasing bacterial loads. Conclusions: The testing of POS using X-Ultra shows promise as a tool to identify patients with paucibacillary TB. Considering that bronchoscopy is a semi-invasive procedure, POS testing ahead of bronchoscopy, may decrease the need for bronchoscopic procedures, and the cost of care.
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spelling doaj-art-55ecfdc1b2d84edf82e26fbb40100b292025-08-20T01:49:27ZengTaylor & Francis GroupEmerging Microbes and Infections2222-17512023-12-0112110.1080/22221751.2022.2148564Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter studyPeijun Tang0Rongmei Liu1Lin Qin2Ping Xu3Yu Xiong4Yunfeng Deng5Zizheng Lv6Yuanyuan Shang7Xinghui Gao8Lin Yao9Ruoyu Zhang10Yanjun Feng11Caihong Ding12Hui Jing13Liang Li14Yi-Wei Tang15Yu Pang16Department of Tuberculosis, The Fifth People's Hospital of Suzhou, The Affiliated Infectious Diseases Hospital, Suzhou Medical College of Soochow University, Suzhou, People’s Republic of ChinaDepartment of Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaDepartment of Endoscopic Diagnosis & Treatment, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaDepartment of Clinical Laboratory, The Fifth People’s Hospital of Suzhou, Infectious Disease Hospital Affiliated to Soochow University, Suzhou, People’s Republic of ChinaDepartment of Tuberculosis, Shandong Public Health Clinical Center, Jinan, People’s Republic of ChinaKatharine Hsu International Research Center of Human Infectious Diseases, Shandong Public Health Clinical Center Affiliated to Shandong University, Jinan, People’s Republic of ChinaDepartment of Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaDepartment of Bacteriology and Immunology, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaCepheid, Danaher Diagnostic Platform, Shanghai, People’s Republic of ChinaDepartment of Tuberculosis, The Fifth People's Hospital of Suzhou, The Affiliated Infectious Diseases Hospital, Suzhou Medical College of Soochow University, Suzhou, People’s Republic of ChinaDepartment of Tuberculosis, The Fifth People's Hospital of Suzhou, The Affiliated Infectious Diseases Hospital, Suzhou Medical College of Soochow University, Suzhou, People’s Republic of ChinaDepartment of Tuberculosis, The Fifth People's Hospital of Suzhou, The Affiliated Infectious Diseases Hospital, Suzhou Medical College of Soochow University, Suzhou, People’s Republic of ChinaDepartment of Tuberculosis, Shandong Public Health Clinical Center, Jinan, People’s Republic of ChinaKatharine Hsu International Research Center of Human Infectious Diseases, Shandong Public Health Clinical Center Affiliated to Shandong University, Jinan, People’s Republic of ChinaDepartment of Bacteriology and Immunology, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaCepheid, Danaher Diagnostic Platform, Shanghai, People’s Republic of ChinaDepartment of Bacteriology and Immunology, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaBackground: Posterior oropharyngeal saliva (POS) is increasingly recognized as an alternative specimen for detecting respiratory pathogens. The accuracy of Xpert® MTB/RIF Ultra (X-Ultra), when performed on POS obtained from patients with paucibacillary pulmonary tuberculosis (TB) is unclear. Methods: We consecutively recruited adults with symptoms suggestive of pulmonary TB who were negative by both smear microscopy and Xpert MTB/RIF (X-Classic). Each participant was required to provide one bronchoalveolar lavage fluid (BALF) and one POS specimen, respectively. Diagnostic performances of X-Ultra and X-Classic on POS were compared against clinical and mycobacterial reference standards. Findings: 686 participants meeting inclusion criteria were consecutively enrolled into the study. The overall diagnostic sensitivities of X-Ultra and X-Classic on POS samples were 78.9% [95% confidence interval (CI): 72.8–83.8] and 56.4% (95% CI: 49.7–62.9), respectively; the specificities were 96.6% (95% CI: 94.3–98.1) for X-Ultra and 97.6 (95CI: 95.5–98.8) for X-Classic in POS specimens. Notably, the sensitivity of X-Ultra on POS was as sensitive as X-Classic on BALF against microbiological reference standard (78.9% VS 73.1%). Against clinical diagnosis as a reference standard, the sensitivities of X-Ultra and X-Classic on POS were 55.9% (95% CI: 50.5–61.2; 193/345) and 40.0% (95% CI: 34.8–45.4; 138/345), respectively. The risk of negative results with POS was dramatically increased with decreasing bacterial loads. Conclusions: The testing of POS using X-Ultra shows promise as a tool to identify patients with paucibacillary TB. Considering that bronchoscopy is a semi-invasive procedure, POS testing ahead of bronchoscopy, may decrease the need for bronchoscopic procedures, and the cost of care.https://www.tandfonline.com/doi/10.1080/22221751.2022.2148564TuberculosisMTB/RIF Ultraaccuracydiagnosisposterior oropharyngeal saliva
spellingShingle Peijun Tang
Rongmei Liu
Lin Qin
Ping Xu
Yu Xiong
Yunfeng Deng
Zizheng Lv
Yuanyuan Shang
Xinghui Gao
Lin Yao
Ruoyu Zhang
Yanjun Feng
Caihong Ding
Hui Jing
Liang Li
Yi-Wei Tang
Yu Pang
Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter study
Emerging Microbes and Infections
Tuberculosis
MTB/RIF Ultra
accuracy
diagnosis
posterior oropharyngeal saliva
title Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter study
title_full Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter study
title_fullStr Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter study
title_full_unstemmed Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter study
title_short Accuracy of Xpert® MTB/RIF Ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis: a prospective multicenter study
title_sort accuracy of xpert r mtb rif ultra test for posterior oropharyngeal saliva for the diagnosis of paucibacillary pulmonary tuberculosis a prospective multicenter study
topic Tuberculosis
MTB/RIF Ultra
accuracy
diagnosis
posterior oropharyngeal saliva
url https://www.tandfonline.com/doi/10.1080/22221751.2022.2148564
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