Evaluating the performance of the InnowaveDx MTB/RIF/INH for simultaneous detection of Mycobacterium tuberculosis and resistance to rifampicin and isoniazid

IF 3.7 3区医学 Q2 INFECTIOUS DISEASES

Journal of global antimicrobial resistance Pub Date : 2026-01-01 Epub Date: 2026-01-07 DOI:10.1016/j.jgar.2025.12.016

Dapeng Fan, Hao Li, Xuechai Shang, Miaofen Yang, Huanyu Li, Yongning Yue, Long Cai

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引用次数: 0

Abstract

Objective

To evaluate the diagnostic performance of the InnowaveDx MTB/RIF/INH assay for the simultaneous detection of Mycobacterium tuberculosis and resistance to rifampicin and isoniazid.

Methods

We evaluated the performance of the InnowaveDx MTB/RIF/INH (InnowaveDx) assay in diagnosing pulmonary tuberculosis and detecting rifampicin and isoniazid resistance at the Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine.

Results

Using the clinical final diagnosis as the standard, the sensitivity of InnowaveDx was 68.0%, which was higher than that of acid-fast bacilli smear, MGIT culture, and Xpert (P < .001). The specificity was 97.1%, which was higher than acid-fast bacilli smear (P < .001). The agreement between InnowaveDx and MGIT phenotypic drug sensitivity, as well as Xpert, for detecting rifampicin resistance, had kappa values of 0.783 and 0.940, respectively. The agreement between InnowaveDx and MGIT phenotypic drug sensitivity, as well as multicolor melting curve analysis, for detecting isoniazid resistance, had kappa values of 0.915 and 1. The discrepancies in rifampicin- and isoniazid-resistance detection were observed in 11 and 4 cases, respectively.

Conclusions

The InnowaveDx MTB/RIF/INH assay demonstrates good performance in detecting M. tuberculosis as well as rifampicin and isoniazid resistance. The discrepancies in rifampicin-resistance results and phenotypic resistance are mainly the result of borderline resistance mutations.

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评估InnowaveDx MTB/RIF/INH同时检测结核分枝杆菌和对利福平和异烟肼的耐药性的性能。

背景：在中国，耐多药或利福平耐药结核病（MDR/RR-TB）的早期准确诊断对于确保适当治疗至关重要。迫切需要开发一种同时检测结核分枝杆菌（MTB）以及对利福平和异烟肼耐药的诊断方法。方法：评价InnowaveDx MTB/RIF/INH （InnowaveDx）检测在浙江省中西医结合医院诊断肺结核及检测利福平和异烟肼耐药中的表现。结果：以临床最终诊断为标准，InnowaveDx的敏感性为68.0%，高于AFB涂片、MGIT培养和Xpert （P < 0.001）。特异性为97.1%，高于AFB涂片（P < 0.001）。InnowaveDx与MGIT表型药物敏感性（pDST）和Xpert检测利福平耐药的Kappa值一致性分别为0.783和0.940。InnowaveDx与MGIT pDST以及MMCA检测异烟肼耐药性的Kappa值分别为0.915和1。利福平耐药和异烟肼耐药检测差异分别为11例和4例。结论：InnowaveDx MTB/RIF/INH检测方法对MTB以及利福平和异烟肼耐药具有良好的检测效果。利福平耐药结果与表型耐药差异主要是由于临界耐药突变所致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of global antimicrobial resistance INFECTIOUS DISEASES-PHARMACOLOGY & PHARMACY

CiteScore

8.70

自引率

2.20%

发文量

285

审稿时长

34 weeks

期刊介绍： The Journal of Global Antimicrobial Resistance (JGAR) is a quarterly online journal run by an international Editorial Board that focuses on the global spread of antibiotic-resistant microbes. JGAR is a dedicated journal for all professionals working in research, health care, the environment and animal infection control, aiming to track the resistance threat worldwide and provides a single voice devoted to antimicrobial resistance (AMR). Featuring peer-reviewed and up to date research articles, reviews, short notes and hot topics JGAR covers the key topics related to antibacterial, antiviral, antifungal and antiparasitic resistance.