Analytical and clinical performance evaluation of the STANDARD™ M10 MTB/NTM assay for the simultaneous detection of Mycobacterium tuberculosis and nontuberculous mycobacteria
In brief
Automated test matched two lab assays in all 70 sputum samples
In a clinical comparison of 70 sputum specimens, the automated test for tuberculosis and nontuberculous mycobacteria agreed with two established laboratory assays in every sample. Laboratory testing also found strong detection across several mycobacterial species, including some missed by the comparators. Because there was no independent reference standard, full agreement does not establish diagnostic accuracy in patients.
- Journal
- Diagnostic microbiology and infectious disease (Q2)
- Published
- 17 October 2026
- Study design
- Unclassified
- Evidence level
- Level 5, Expert Opinion (CEBM 5)
- Authors
- Eun-Soon Son, Se Yeon Lee, Moon-Joo Lee, Sia Kang, Sunyoung Lee, Jong Seok Lee
- PMID
- 42901040
- DOI
- 10.1016/j.diagmicrobio.2026.117692
Why clinicians should know about it
- Picked for Microbiology (medical) (top studies of the week, 25 October 2026): Evaluates automated rapid PCR detection of MTB and NTM
Abstract
The global surge in nontuberculous mycobacteria (NTM) infections, which clinically mimic Mycobacterium tuberculosis (MTB) infections, underscores the need for rapid differential diagnosis. This study evaluated the analytical and clinical performance of the STANDARD™ M10 MTB/NTM assay, a fully automated, cartridge-based, sample-to-result real-time PCR system. Analytical performance was assessed using contrived artificial sputum samples to evaluate inclusivity (3 MTB-complex, 12 NTM species), cross-reactivity (65 respiratory pathogens), and interference (33 substances). The limit of detection (LoD) was compared with two commercial assays, the AdvanSure™ TB/NTM Real-time PCR and the Anyplex™ MTB/NTMe Real-time Detection, using three MTB-complex strains (M. tuberculosis H37Rv, M. bovis, and M. bovis BCG Pasteur) and 15 NTM species. Clinical validation was performed using 70 clinical sputum specimens against both comparators. The STANDARD™ M10 MTB/NTM demonstrated excellent inclusivity and high specificity, with no cross-reactivity or analytical interference (△Ct ≤ 2.0). In the LoD comparison, the STANDARD™ M10 MTB/NTM achieved a lower LoD for MTB H37Rv (101 CFU/mL) and major NTM species (M. avium, M. intracellulare, M. abscessus subsp. abscessus) than the comparators, demonstrating superior analytical sensitivity. Moreover, the STANDARD™ M10 MTB/NTM successfully detected M. xenopi, M. scrofulaceum, and M. malmoense, which were missed by alternative assays. In clinical evaluation, it demonstrated 100% overall agreement (95% confidence interval (CI), 94.8-100.0) with the AdvanSure™ TB/NTM Real-time PCR and Anyplex™ MTB/NTMe Real-time Detection assays across a Ct range of 27.41-33.17. The STANDARD™ M10 MTB/NTM assay offers exceptional analytical sensitivity, broad coverage, and, in the absence of an independent reference standard, complete agreement with two established laboratory-based platforms. By incorporating a fully automated workflow and minimizing turnaround time, this system serves as a reliable tool for rapid MTB/NTM differentiation in point-of-care settings.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.