Detection of extensive drug resistance by the Xpert MTB/XDR assay in multidrug resistant tuberculosis cases at a tertiary care centre in northern India, and therapeutic decision making for the six-month BPaLM regimen

IF 2 Q3 INFECTIOUS DISEASES

Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Pub Date : 2025-03-21 DOI:10.1016/j.jctube.2025.100520

Richa Misra , Parijat Das , Alok Nath , Zafar Neyaz

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引用次数: 0

Abstract

The Xpert MTB/XDR assay has been approved by World Health Organization (WHO) as a reflex test on sputum samples after testing for rifampicin resistance. Recently, the Union Health Ministry of India in September 2024 approved the introduction of the six-month BPaLM regimen under its National TB Elimination Program (NTEP). In this study, the Xpert MTB/XDR assay was used to detect extensive drug resistance in pulmonary and extra-pulmonary tuberculosis patients with positive result for MTBC, and RIF resistance by the Xpert MTB/RIF ULTRA assay. We also aimed to assess the eligibility of patients for the BPaLM regimen based on the drug susceptibility profile of this test in a high burden Indian setting.

We conducted a single centre prospective cohort study between January 2023 to August 2024 on 42 old, and 68 new patients presenting with MDR/RR tuberculosis. A total of 110 samples (82 pulmonary and 28 extra pulmonary samples) were included in the study. The Xpert MTB/XDR assay was used to determine the susceptibilities to isoniazid, fluoroquinolones, amikacin, kanamycin, capreomycin, and ethionamide.

Out of 110 samples processed, 13 samples were ‘not detected’ by the assay while three gave invalid results. Resistance to isoniazid, fluoroquinolones, amikacin, kanamycin, capreomycin and ethionamide was detected in 85/94 cases (90·42%), 74/94 cases (78·72%), 08/94 cases (8·5%), 13/94 cases (13·83%), 08/94 cases (8·5%), and 14/94 cases (14·89%) respectively.

With the updated definitions of drug-resistant TB and high burden of fluoroquinolone resistance the Xpert MTB/XDR assay has a limited application in India.

Detection of extensive drug resistance by the Xpert MTB/XDR assay in multidrug resistant tuberculosis cases at a tertiary care centre in northern India, and therapeutic decision making for the six-month BPaLM regimen.

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在印度北部的一个三级保健中心，Xpert MTB/XDR测定法在耐多药结核病病例中发现了广泛的耐药性，并为6个月BPaLM方案做出了治疗决策

Xpert MTB/XDR测定法已被世界卫生组织（世卫组织）批准作为检测利福平耐药性后痰样本的反射试验。最近，印度联邦卫生部于2024年9月批准在其国家结核病消除规划（NTEP）下引入为期6个月的BPaLM方案。本研究采用Xpert MTB/XDR法检测肺结核和肺外结核患者广泛耐药，MTBC阳性，Xpert MTB/RIF ULTRA法检测RIF耐药。我们还旨在评估在印度高负担环境下，基于该试验的药物敏感性特征的患者是否适合BPaLM方案。我们在2023年1月至2024年8月期间对42名老结核病患者和68名新结核病患者进行了单中心前瞻性队列研究。本研究共纳入110份样本（82份肺样本和28份肺外样本）。采用Xpert MTB/XDR法测定对异烟肼、氟喹诺酮类药物、阿米卡星、卡那霉素、卷曲霉素和乙酰胺的敏感性。在处理的110个样品中，有13个样品未被检测到，而3个样品给出了无效结果。异烟肼、氟喹诺酮类药物、阿米卡星、卡那霉素、卷曲霉素和乙酰胺耐药分别为85/94例（90.42%）、74/94例（78.72%）、08/94例（8.5%）、13/94例（13.83%）、08/94例（8.5%）和14/94例（14.89%）。随着耐药结核病的最新定义和氟喹诺酮类药物耐药性的高负担，Xpert MTB/XDR测定法在印度的应用有限。在印度北部的一个三级保健中心，Xpert MTB/XDR测定法在耐多药结核病病例中发现了广泛的耐药性，并为6个月BPaLM方案做出了治疗决策。

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来源期刊

Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Medicine-Pulmonary and Respiratory Medicine

CiteScore

4.00

自引率

5.00%

发文量

审稿时长

30 weeks

期刊介绍： Journal of Clinical Tuberculosis and Mycobacterial Diseases aims to provide a forum for clinically relevant articles on all aspects of tuberculosis and other mycobacterial infections, including (but not limited to) epidemiology, clinical investigation, transmission, diagnosis, treatment, drug-resistance and public policy, and encourages the submission of clinical studies, thematic reviews and case reports. Journal of Clinical Tuberculosis and Mycobacterial Diseases is an Open Access publication.