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ORIGINAL RESEARCH article
Front. Cell. Infect. Microbiol.
Sec. Clinical Microbiology
Volume 14 - 2024 |
doi: 10.3389/fcimb.2024.1439099
Development and preliminary assessment of the iFIND TBR: All-in-One Molecular Diagnostic Assay for Rapid Detection of Mycobacterium tuberculosis and Rifampicin Resistance
Provisionally accepted- 1 Chinese Center For Disease Control and Prevention, Beijing, China
- 2 Department of Tuberculosis, Beijing Dongcheng District Center for Disease Control and Prevention, Beijing 100050, China, Beijing, China
- 3 Institute for Tuberculosis Control and Prevention, Gansu Provincial Center for Disease Control and Prevention, 730000, China, Lanzhou, China
- 4 Tuberculosis Dispensary of Changping District, Beijing, 102299, China, Beijing, China
- 5 National Institute for Public Health and the Environment (Netherlands), Bilthoven, Netherlands
Early and accurate diagnosis of tuberculosis (TB) is crucial for initiating timely treatment and preventing new infections. In this study, we introduced the iFIND TBR assay, an automated all-in-one tuberculosis detection approach that simultaneously detect Mycobacterium tuberculosis (MTB) and rifampicin (RIF) resistance. The limits of detection (LOD) of the iFIND TBR for MTB detection were 13.34 CFU/ml (95% CI, 11.71-16.47), and for RIF resistance was 109.79CFU/mL (95% CI, 95-138.19). The iFIND TBR assay accurately distinguish MTB strains from non-tuberculous mycobacteria (NTM) without any cross reactivity. Testing on 157 clinical sputum samples, compared with the bacteriologically TB standard, the overall sensitivity and specificity of the iFIND TBR was 100% (95%CI, 94.64, 100) and 85.29% (95% CI, 74.61, 92.72), respectively. When assessing RIF susceptibility, the iFIND TBR achieved a sensitivity of 98.15% (95% CI, 90.11-99.95) and a specificity of 85.71% (95% CI, 67.33-95.97), compared with phenotypic drug susceptibility testing.Discordant RIF susceptibility results were more frequently observed in samples exhibiting heteroresistance. These findings demonstrate that iFIND TBR assay performs well in detecting TB and RIF resistance, and shows promise as a point-of-care tool in resource-limited areas.
Keywords: Tuberculosis, Mycobacterium tuberculosis, iFIND TBR, Rifampicin resistance, detection
Received: 27 May 2024; Accepted: 07 Oct 2024.
Copyright: © 2024 Ou, Song, Xing, Zhao, Pei, Teng, Zhang, Sun, Liu, Xia, Zhou, Zheng, Song, Zhang, Wang, Anthony and Zhao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Yanlin Zhao, Chinese Center For Disease Control and Prevention, Beijing, China
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