{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T15:19:50Z","timestamp":1771859990399,"version":"3.50.1"},"reference-count":8,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,11,20]],"date-time":"2025-11-20T00:00:00Z","timestamp":1763596800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:p>\n                    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\u2019s 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\n                    <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n                    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\u201397.1%) and a specificity of 100% (25\/25; 95% CI: 83.4\u2013100%). 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 (&amp;gt;36), suggesting detection challenges in paucibacillary specimens. The test exhibited a rapid average turnaround time of 18\u202fmin 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.\n                  <\/jats:p>","DOI":"10.3389\/fpubh.2025.1663233","type":"journal-article","created":{"date-parts":[[2025,11,20]],"date-time":"2025-11-20T11:44:36Z","timestamp":1763639076000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Diagnostic performance of a RHAM-based point-of-care test for Mycobacterium tuberculosis"],"prefix":"10.3389","volume":"13","author":[{"given":"Xiang","family":"Chen","sequence":"first","affiliation":[{"name":"Health Care Center, The First Affiliated Hospital of Shantou University Medical College","place":["Shantou, Guangdong, China"]},{"name":"Department of Biomedical Sciences, University of Sassari","place":["Sassari, Italy"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giovanni","family":"Ladu","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences, University of Sassari","place":["Sassari, Italy"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincenzo","family":"Lai","sequence":"additional","affiliation":[{"name":"Department of Microbiology and Virology, AOU Sassari","place":["Sassari, Italy"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leonardo Antonio","family":"Sechi","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences, University of Sassari","place":["Sassari, Italy"]},{"name":"Department of Microbiology and Virology, AOU Sassari","place":["Sassari, Italy"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paola","family":"Molicotti","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences, University of Sassari","place":["Sassari, Italy"]},{"name":"Department of Microbiology and Virology, AOU Sassari","place":["Sassari, Italy"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2025,11,20]]},"reference":[{"key":"ref1","year":""},{"key":"ref2","doi-asserted-by":"publisher","first-page":"850","DOI":"10.1016\/S0140-6736(24)02479-6","article-title":"Tuberculosis","volume":"405","author":"Trajman","year":"2025","journal-title":"Lancet"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"eabj4124","DOI":"10.1126\/scitranslmed.abj4124","article-title":"Point-of-care diagnostic tests for tuberculosis disease","volume":"14","author":"Hong","year":"2022","journal-title":"Sci Transl Med"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"178","DOI":"10.3390\/microorganisms13010178","article-title":"A comprehensive review of the diagnostics for pediatric tuberculosis based on assay time, ease of operation, and performance","volume":"13","author":"Basu","year":"2025","journal-title":"Microorganisms"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"e0042122","DOI":"10.1128\/jcm.00421-22","article-title":"Accuracy of tongue swab testing using Xpert MTB-RIF ultra for tuberculosis diagnosis","volume":"60","author":"Andama","year":"2022","journal-title":"J Clin Microbiol"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"e00537-19","DOI":"10.1128\/JCM.00537-19","article-title":"GeneXpert MTB\/RIF is superior to BBD max MDR-TB for diagnosis of tuberculosis (TB) in a country with low incidence of multidrug-resistant TB (MDR-TB)","volume":"57","author":"Mokaddas","year":"2019","journal-title":"J Clin Microbiol"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"13978","DOI":"10.1038\/s41598-024-64406-9","article-title":"Comparison of the diagnostic accuracy of the Pluslife Mini dock RHAM technology with Abbott ID now and Cepheid GenXpert: a retrospective evaluation study","volume":"14","author":"Herrmann","year":"2024","journal-title":"Sci Rep"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"37","DOI":"10.1186\/s12941-024-00695-2","article-title":"Performances of two rapid LAMP-based techniques for the intrapartum detection of group B Streptococcus vaginal colonization","volume":"23","author":"Charfi","year":"2024","journal-title":"Ann Clin Microbiol Antimicrob"}],"updated-by":[{"DOI":"10.3389\/fpubh.2026.1789832","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T00:00:00Z","timestamp":1771804800000}}],"container-title":["Frontiers in Public Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2025.1663233\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T14:27:53Z","timestamp":1771856873000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2025.1663233\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,20]]},"references-count":8,"alternative-id":["10.3389\/fpubh.2025.1663233"],"URL":"https:\/\/doi.org\/10.3389\/fpubh.2025.1663233","relation":{},"ISSN":["2296-2565"],"issn-type":[{"value":"2296-2565","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,20]]},"article-number":"1663233"}}