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

• Published in: Emerging microbes & infections 2023-12, Vol.12 (1), p.2148564-2148564
• Main Authors: Tang, Peijun, Liu, Rongmei, Qin, Lin, Xu, Ping, Xiong, Yu, Deng, Yunfeng, Lv, Zizheng, Shang, Yuanyuan, Gao, Xinghui, Yao, Lin, Zhang, Ruoyu, Feng, Yanjun, Ding, Caihong, Jing, Hui, Li, Liang, Tang, Yi-Wei, Pang, Yu
• Format: Article
• Language: English
• Subjects: accuracy; Adult; Antibiotics, Antitubercular - therapeutic use; Bronchoscopy; diagnosis; Humans; MTB/RIF Ultra; Mycobacterium tuberculosis - genetics; posterior oropharyngeal saliva; Prospective Studies; Rifampin; Sensitivity and Specificity; Tuberculosis; Tuberculosis, Pulmonary - diagnosis; Tuberculosis, Pulmonary - microbiology
• ISSN: 2222-1751; 2222-1751
• DOI: 10.1080/22221751.2022.2148564

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.