ORIGINAL RESEARCH article

Front. Cell. Infect. Microbiol.

Sec. Clinical Microbiology

Volume 15 - 2025 | doi: 10.3389/fcimb.2025.1600170

This article is part of the Research TopicAdvancements in Diversity and Drug Resistance Mechanisms in Mycobacterial DiseasesView all 9 articles

Innovo GenMax MTB-RIF/INH: A Moderate-Complexity Automated NAAT for Rapid Simultaneous Detection of Mycobacterium tuberculosis Complex and Rifampin/Isoniazid resistance

Provisionally accepted
Xichao OuXichao Ou1Bing ZhaoBing Zhao1Huiwen ZhengHuiwen Zheng2*Ruida XingRuida Xing1Qian SunQian Sun3Zhonghua QinZhonghua Qin4Lixia ZhangLixia Zhang4Kai CuiKai Cui1Yuanyuan SongYuanyuan Song1Yang ZhengYang Zheng1Yang ZhouYang Zhou1Shengfen WangShengfen Wang1Hui XiaHui Xia1Yanlin ZhaoYanlin Zhao1
  • 1Chinese Center For Disease Control and Prevention, Beijing, China
  • 2Beijing Children’s Hospital, Capital Medical University, Beijing, China
  • 3Beijing Changping district center for Disease Control and Prevention, Beijing, China
  • 4Tianjin Haihe Hospital, Tianjin, China

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Given the increase of treatment failure, relapse and acquired resistance observed in isoniazid (INH) resistance, there is an urgent to improve rifampin (RIF)priority based diagnostic strategies. Therefore, we To evaluated the performance of the Innovo GenMax MTB-RIF/INH (GenMax), a moderate-complexity automated nucleic acid amplification test (NAAT), for detecting Mycobacterium tuberculosis complex (MTBC) and resistance to rifampinRIF (RIF) and isoniazidINH (INH). Methods: Analytical sensitivity (limit of detection, LOD) was determined using serial dilutions of Mycobacterium tuberculosis H37Rv (ATCC 27249) MTB strains. Diagnostic accuracy was assessed in clinical sputum specimens against microbiological reference standards (MRS: smear, culture, or Xpert MTB/RIFpositive by smear microscopy, culture or Xpert MTB/RIF for diagnosis of TB) and phenotypic drug susceptibility testing (DST). Discordant results were resolved by sequencing resistance genes (IS6110, rpoB, katG, inhA, ahpC) and follow-up diagnosis results.

Keywords: Tuberculosis, Rifampin, Isoniazid, Drug Resistance, rapid molecular diagnosis

Received: 26 Mar 2025; Accepted: 10 Jun 2025.

Copyright: © 2025 Ou, Zhao, Zheng, Xing, Sun, Qin, Zhang, Cui, Song, Zheng, Zhou, Wang, Xia and Zhao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Huiwen Zheng, Beijing Children’s Hospital, Capital Medical University, Beijing, China

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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