BRIEF RESEARCH REPORT article
Front. Public Health
Sec. Infectious Diseases: Epidemiology and Prevention
This article is part of the Research TopicWorld TB Day 2025: Yes! We Can End TB: Commit, Invest, DeliverView all 10 articles
Diagnostic performance of an RHAM-based Point-of-Care Test for Mycobacterium tuberculosis
Provisionally accepted
- 1The First Affiliated Hospital of Shantou University Medical College, Shantou, China
- 2Universita degli Studi di Sassari, Sassari, Italy
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Tuberculosis (TB) remains a global health crisis, hampered by significant diagnostic delays, particularly for extrapulmonary TB and in resource-limited settings. The development of point-of-care tests (POCTs) meeting the WHO's ASSURED criteria is crucial. This prospective laboratory-based study evaluated the diagnostic performance of a novel, affordable POCT based on RNase Hybridization-Assisted Amplification (RHAM) technology for detecting Mycobacterium tuberculosis complex. The test was evaluated using a variety of clinical specimens collected consecutively from suspected TB patients, compared against standard methods (PCR, Microscopy, culture). The RHAM-based POCT demonstrated promising sensitivity of 83.3% (10/12; 95% CI: 50.9%-97.1%) and a specificity of 100% (25/25; 95% CI: 83.4%-100%). All five non-tuberculous mycobacteria samples were correctly identified as negative. The two false-negative results occurred in samples with very high PCR cycle threshold values (>36), suggesting detection challenges in paucibacillary specimens. The test exhibited a rapid average turnaround time of 18 minutes and requires minimal infrastructure, operating via a portable, low-power consumption device, even compatible with mobile phone or car chargers. Its closed-cartridge system enhances biosafety by minimizing aerosol generation. Furthermore, the estimated cost per test is substantially lower than leading commercial molecular assays. This study indicates that the RHAM-based POCT is a rapid, user-friendly, and cost-effective diagnostic tool with high specificity. Its ability to function with diverse specimen types positions it as a potential game-changer for TB diagnosis in field and resource-poor environments, though larger-scale studies are warranted to confirm sensitivity, especially in low-bacterial-load scenarios.
Keywords: Mycobacterium tuberculosis, laboratory, diagnostic method, Point-of-care test, ASSURED criteria
Received: 10 Jul 2025; Accepted: 31 Oct 2025.
Copyright: © 2025 Chen, Lai, Sechi and Molicotti. 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: Xiang Chen, 17f1xchen5@stu.edu.cn
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.