Analytical and clinical validation of a novel MeltPlus TB-NTM/RIF platform for simultaneous detection of Mycobacterium tuberculosis complex, Non-Tuberculous Mycobacteria and rifampicin resistance.

IF 4.6 2区医学 Q2 IMMUNOLOGY

Frontiers in Cellular and Infection Microbiology Pub Date : 2025-02-10 eCollection Date: 2025-01-01 DOI:10.3389/fcimb.2025.1534268

Zhuo Wang, Yuanwu Zou, Zihan Wei, Guanghong Bai, Xiaolin Wang, Shaoyi Qu, Jie Shi, Yaping Jiang, Cuijiao Gu

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引用次数: 0

Abstract

Background: Rapid and accurate diagnosis of tuberculosis, particularly rifampin (RIF)-resistant tuberculosis (RR-TB) and Non-Tuberculous Mycobacteria (NTM), is essential for implementing appropriate proper therapy to benefit patients and improve TB/NTM patient management.

Methods: In this study, we developed a novel MeltPlus MTB-NTM/RIF platform, designed to simultaneously detect Mycobacterium tuberculosis complex (MTBC), NTM and RIF resistance. The platform was evaluated for its limit of detection (LOD) and specificity before clinical validation, followed by a prospective single-center study in patients with presumptive TB cases.

Results: The calculated LOD for MTBC, NTM and RIF susceptibility was found to be 10.31 CFU/mL, 57.55 CFU/mL and 48.584 CFU/mL, respectively. The assay showed a sensitivity of 98.76% (95% CI: 96.41-99.74%) and a specificity of 94.42% (95% CI: 90.82-96.92%) for MTBC detection compared to the bacteriological TB standard. For NTM detection, the assay demonstrated a sensitivity of 91.98% (95% CI: 76.32-98.14%) and a specificity of 99.59% (95% CI: 98.54-99.95%). RIF resistance detection showed a sensitivity of 90.24% (95% CI:76.87-97.28%) and specificity of 95.98% (95% CI: 91.89-98.37%), with a high level of diagnostic agreement (Kappa: 0.8338) compared to GeneXpert. Sanger sequencing revealed that novel assay correctly classifies 98.6% of study cases as RIF resistant or susceptible, slightly higher that of GeneXpert.

Discussion: These findings indicate that the novel MeltPlus MTB-NTM/RIF platform provides a rapid and accurate method for the simultaneously detecting MTBC, NTM, and RIF resistance, making it a promising tool for clinical TB/NTM diagnosis and management, further multi-center and field studies are recommended to validate its broader applicability.

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来源期刊

Frontiers in Cellular and Infection Microbiology IMMUNOLOGY-MICROBIOLOGY

CiteScore

7.90

自引率

7.00%

发文量

1817

审稿时长

14 weeks

期刊介绍： Frontiers in Cellular and Infection Microbiology is a leading specialty journal, publishing rigorously peer-reviewed research across all pathogenic microorganisms and their interaction with their hosts. Chief Editor Yousef Abu Kwaik, University of Louisville is supported by an outstanding Editorial Board of international experts. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide. Frontiers in Cellular and Infection Microbiology includes research on bacteria, fungi, parasites, viruses, endosymbionts, prions and all microbial pathogens as well as the microbiota and its effect on health and disease in various hosts. The research approaches include molecular microbiology, cellular microbiology, gene regulation, proteomics, signal transduction, pathogenic evolution, genomics, structural biology, and virulence factors as well as model hosts. Areas of research to counteract infectious agents by the host include the host innate and adaptive immune responses as well as metabolic restrictions to various pathogenic microorganisms, vaccine design and development against various pathogenic microorganisms, and the mechanisms of antibiotic resistance and its countermeasures.