{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T04:39:00Z","timestamp":1787027940535,"version":"build-2736575974"},"reference-count":44,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T00:00:00Z","timestamp":1771200000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background. Over the past decade, the World Health Organization has highlighted the need for rapid molecular diagnostics as first-line tools for detecting Mycobacterium tuberculosis complex (MTBC) to strengthen global tuberculosis control. At the same time, infections caused by non-tuberculous mycobacteria (NTM) have become increasingly prevalent, particularly in low TB-burden countries such as Italy. This changing epidemiological scenario underscores the necessity for fast and reliable methods capable of distinguishing NTM from MTBC, a critical step for guiding appropriate treatment. This study evaluated the diagnostic accuracy and potential applications of the STANDARD\u2122 M10 MTB\/NTM assay, which simultaneously detects and differentiates MTBC and NTM. Methods. A total of 155 clinical specimens (78.1% respiratory) from patients with suspected mycobacterial infection were tested by fluorescence microscopy, GeneXpert MTB\/RIF Ultra (respiratory samples only), STANDARD\u2122 M10 MTB\/NTM and culture, used as the reference method. Results. Culture detected MTBC in 54% and NTM (predominantly slow-growing species) in 46% of samples. STANDARD\u2122 M10 showed overall sensitivity and specificity of 70% and 100%, respectively. For MTBC, sensitivity was 85.1% with almost perfect agreement with culture (\u03ba = 0.866), while for NTM, sensitivity was 50% with moderate agreement (\u03ba = 0.566). Sensitivity decreased in microscopy-negative\/culture-positive specimens, particularly for NTM. Compared with GeneXpert MTB\/RIF Ultra, STANDARD\u2122 M10 exhibited slightly lower sensitivity for MTBC but retained excellent specificity. Conclusions. STANDARD\u2122 M10 MTB\/NTM represents a rapid, fully automated tool to support early etiological diagnosis and MTB\/NTM differentiation, mainly in selected samples or high-risk patients, but it does not replace culture or molecular tests providing species identification and MTBC drug-resistance profiling.<\/jats:p>","DOI":"10.3390\/diagnostics16040594","type":"journal-article","created":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T14:55:47Z","timestamp":1771253747000},"page":"594","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Molecular Techniques for MTBC and NTM Differentiation: Diagnostic Accuracy of STANDARD\u2122 M10 MTB\/NTM and Potential Applications"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-5385-6502","authenticated-orcid":false,"given":"Mattia","family":"Genco","sequence":"first","affiliation":[{"name":"Department of Public Health and Paediatrics, University of Turin, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Alizzi","sequence":"additional","affiliation":[{"name":"Microbiology and Virology Unit, University Hospital Citt\u00e0 della Salute e della Scienza di Torino, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Valesella","sequence":"additional","affiliation":[{"name":"Microbiology and Virology Unit, University Hospital Citt\u00e0 della Salute e della Scienza di Torino, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Camaggi","sequence":"additional","affiliation":[{"name":"Microbiology and Virology Unit, Azienda Ospedaliero-Universitaria Maggiore della Carit\u00e0 di Novara, 28100 Novara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Iannaccone","sequence":"additional","affiliation":[{"name":"Microbiology and Virology Unit, University Hospital Citt\u00e0 della Salute e della Scienza di Torino, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0585-9247","authenticated-orcid":false,"given":"Valeria","family":"Allizond","sequence":"additional","affiliation":[{"name":"Department of Public Health and Paediatrics, University of Turin, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2219-0223","authenticated-orcid":false,"given":"Giuliana","family":"Banche","sequence":"additional","affiliation":[{"name":"Department of Public Health and Paediatrics, University of Turin, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1979-3229","authenticated-orcid":false,"given":"Alessandro","family":"Bondi","sequence":"additional","affiliation":[{"name":"Department of Public Health and Paediatrics, University of Turin, 10126 Turin, Italy"},{"name":"Microbiology and Virology Unit, University Hospital Citt\u00e0 della Salute e della Scienza di Torino, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Simona","family":"Caroppo","sequence":"additional","affiliation":[{"name":"Microbiology and Virology Unit, Azienda Ospedaliero-Universitaria Maggiore della Carit\u00e0 di Novara, 28100 Novara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3999-5298","authenticated-orcid":false,"given":"Rocco Francesco","family":"Rinaldo","sequence":"additional","affiliation":[{"name":"Division of Respiratory Medicine, Cardiovascular and Thoracic Department, University Hospital Citt\u00e0 della Salute e della Scienza di Torino, 10126 Turin, Italy"},{"name":"Medical Sciences Department, University of Turin, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3972-2871","authenticated-orcid":false,"given":"Paolo","family":"Solidoro","sequence":"additional","affiliation":[{"name":"Division of Respiratory Medicine, Cardiovascular and Thoracic Department, University Hospital Citt\u00e0 della Salute e della Scienza di Torino, 10126 Turin, Italy"},{"name":"Medical Sciences Department, University of Turin, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Corcione","sequence":"additional","affiliation":[{"name":"Medical Sciences Department, University of Turin, 10126 Turin, Italy"},{"name":"Tufts Medical Center, School of Medicine, Tufts University, Boston, MA 02111, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2534-8815","authenticated-orcid":false,"given":"Andrea","family":"Calcagno","sequence":"additional","affiliation":[{"name":"Department of Translational Medicine, University of Eastern Piedmont, 28100 Novara, Italy"},{"name":"SCDO Malattie Infettive, Ospedale \u201cMaggiore della Carit\u00e0\u201d, 28100 Novara, Italy"},{"name":"Stop TB Italy, 20159 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonella","family":"Rossati","sequence":"additional","affiliation":[{"name":"SCDO Malattie Infettive, Ospedale \u201cMaggiore della Carit\u00e0\u201d, 28100 Novara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6549-4553","authenticated-orcid":false,"given":"Cristina","family":"Costa","sequence":"additional","affiliation":[{"name":"Department of Public Health and Paediatrics, University of Turin, 10126 Turin, Italy"},{"name":"Microbiology and Virology Unit, University Hospital Citt\u00e0 della Salute e della Scienza di Torino, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8101-4196","authenticated-orcid":false,"given":"Antonio","family":"Curtoni","sequence":"additional","affiliation":[{"name":"Department of Public Health and Paediatrics, University of Turin, 10126 Turin, Italy"},{"name":"Microbiology and Virology Unit, University Hospital Citt\u00e0 della Salute e della Scienza di Torino, 10126 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"326","DOI":"10.1016\/j.cmi.2024.10.013","article-title":"Why Don\u2019t We Talk about Tuberculosis Stewardship?","volume":"31","author":"Riccardi","year":"2025","journal-title":"Clin. 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