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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
Xichao Ou Xichao Ou 1Zexuan Song Zexuan Song 1Ruida Xing Ruida Xing 1Bing Zhao Bing Zhao 1Shaojun Pei Shaojun Pei 1Chong Teng Chong Teng 2Lincai Zhang Lincai Zhang 3Qian Sun Qian Sun 4Fang Liu Fang Liu 3Hui Xia Hui Xia 1Yang Zhou Yang Zhou 1Yang Zheng Yang Zheng 1Yuanyuan Song Yuanyuan Song 1Zhiguo Zhang Zhiguo Zhang 4Shengfen Wang Shengfen Wang 1Richard Anthony Richard Anthony 5Yanlin Zhao Yanlin Zhao 1*
  • 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

The final, formatted version of the article will be published soon.

    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

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.