ORIGINAL RESEARCH article
Front. Cell. Infect. Microbiol.
Sec. Clinical and Diagnostic Microbiology and Immunology
Volume 15 - 2025 | doi: 10.3389/fcimb.2025.1560870
This article is part of the Research TopicAdvances in the Diagnosis and Management of Infectious DiseasesView all 19 articles
Development and evaluation of a multiplex molecular point-of-care assay for direct identification of Mycobacterium tuberculosis and prioritized nontuberculous Mycobacteria
Provisionally accepted
Qiaolian Yi1*
Yun Wu1
Shuang He2Meng-Li Feng2
Xiaoyu Liu1
Xin- Zhu Zhou1Hao-Tian Gao1*Yu-Fan Zhang2
Qiwen Yang1
Ying-Chun Xu1*- 1Peking Union Medical College Hospital (CAMS), Beijing, China
- 2Genewise Bio Co., Ltd, Beijing, China
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Objective: This study aimed to establish a multiplex molecular point-of-care assay called fastNTM incorporating an ultra-fast sample pre-treatment for direct identification of Mycobacterium tuberculosis complex (MTBC) and 8 non-tuberculous Mycobacteria (NTM) commonly prioritized in clinical settings, and to evaluate its performance in 149 clinical confirmed mycobacterial-positive samples.The study was divided into two stages: a pilot study to establish the methodology and a clinical validation study to evaluate its performance. In the pilot study, we established the fastNTM and analyzed its performance regarding limits of detection, reproducibility, specificity and efficiency. The clinical validation study was performed using 149 clinical confirmed mycobacterial-positive samples, with 16S rRNA identification as the reference standard. The complete process, from patient to result, was accomplished within 90 minutes.Results: Of the 149 positive clinical mycobacterial cultures analyzed, 136 were within the designed targets. Among these 136 cultures, 133 samples were correctly identified by fastNTM, achieving an accuracy rate of 97.79%.This study demonstrates that fastNTM with its high accuracy rate are capable to rapidly and effectively differentiate between MTBC and the major NTM species.
Keywords: Non-tuberculous mycobacteria, Mycobacterium tuberculosis, IDENTIFICATION, Point-of-care testing, Molecular diagnosis
Received: 15 Jan 2025; Accepted: 22 Jul 2025.
Copyright: © 2025 Yi, Wu, He, Feng, Liu, Zhou, Gao, Zhang, Yang and Xu. 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:
Qiaolian Yi, Peking Union Medical College Hospital (CAMS), Beijing, China
Hao-Tian Gao, Peking Union Medical College Hospital (CAMS), Beijing, China
Ying-Chun Xu, Peking Union Medical College Hospital (CAMS), 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.