Xpert MTB/XDR Assay for Detection of Resistance to Isoniazid, Fluoroquinolone, Aminoglycoside, and Ethionamide Among Patients with Pulmonary Tuberculosis in Bangladesh.

IF 4.7 3区医学 Q1 INFECTIOUS DISEASES

Infectious Diseases and Therapy Pub Date : 2025-03-24 DOI:10.1007/s40121-025-01127-0

S M Mazidur Rahman, Noshin Nawer Ruhee, Amiyo Haider, Md Jahid Hasan, Rumana Nasrin, Ahammad Shafiq Sikder Adel, Mohammad Khaja Mafij Uddin, Shahriar Ahmed, Aung Kya Jai Maug, Sayera Banu

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引用次数: 0

Abstract

Introduction: Early detection of drug resistance in patients with tuberculosis (TB) is crucial for prompt and effective treatment. This study evaluated the performance of Xpert MTB/XDR assay (Xpert XDR) for detecting resistance to isoniazid (INH), fluoroquinolones (FLQ), aminoglycosides (AMG), and ethionamide (ETH) in patients with pulmonary TB (PTB) in Bangladesh.

Methods: Xpert XDR was performed on sputum samples from 793 Xpert MTB/RIF positive patients with PTB enrolled between April 2021 and March 2023. Results were compared with phenotypic drug susceptibility test (pDST) performed on Lowenstein-Jensen (L-J) media for the detection of resistance to INH, FLQ, AMG, and ETH. The performance of the assay was also compared between newly diagnosed or rifampicin (RIF)-sensitive versus re-treated or RIF-resistant patients with PTB.

Results: Of 793 samples tested by Xpert XDR, indeterminate results for INH, FLQ, AMG, and ETH were observed for 3 (0.4%), 5 (0.6%), 33 (4.2%), and 0 (0%) isolates, respectively. The assay's sensitivity and specificity compared to pDST was 94.0% (95% CI 90.5-96.4; 264/281) and 97.3% (95% CI 95.4-98.5; 495/509), respectively for INH; 86.0% (95% CI 78.2-91.8; 98/114) and 99.3% (95% CI 98.3-99.3; 669/674), respectively for FLQ; 85.7% (95% CI 42.1-99.6; 6/7) and 99.9% (95% CI 99.3-100.0; 752/753), respectively for AMG; and 25.0% (95% CI 19.0-31.7; 48/192) and 96.7% (95% CI 94.9-98.0; 581/601), respectively for ETH. Agreement of Xpert XDR with pDST was almost perfect for detecting resistance to INH, FLQ, and AMG (kappa: 0.91, 0.89, and 0.86, respectively), but fair for ETH (kappa: 0.28). Xpert XDR performed significantly better among re-treated or RIF-resistant patients with TB compared to newly diagnosed or RIF-sensitive cases.

Conclusions: Given the high performance, Xpert XDR assay can be programmatically implemented nationwide for rapid and accurate detection of resistance to INH, FLQ, and AMG in patients with PTB, aiding clinicians in selecting appropriate regimens for the treatment of drug-resistant TB.

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Xpert MTB/XDR法检测孟加拉国肺结核患者对异烟肼、氟喹诺酮、氨基糖苷和乙硫酰胺的耐药性

早期发现结核病患者的耐药性对于及时有效治疗至关重要。本研究评估了Xpert MTB/XDR法（Xpert XDR）检测孟加拉国肺结核（PTB）患者对异烟肼（INH）、氟喹诺酮类（FLQ）、氨基糖苷类（AMG）和乙硫酰胺（ETH）耐药的性能。方法：对2021年4月至2023年3月入组的793例Xpert MTB/RIF阳性PTB患者的痰样本进行Xpert XDR检测。结果与Lowenstein-Jensen （L-J）培养基上的表型药敏试验（pDST）检测INH、FLQ、AMG和ETH的耐药性进行比较。还比较了新诊断或利福平（RIF）敏感的PTB患者与重新治疗或RIF耐药的PTB患者的检测性能。结果：在Xpert XDR检测的793个样品中，INH、FLQ、AMG和ETH分别有3个（0.4%）、5个（0.6%）、33个（4.2%）和0个（0%）分离株结果不确定。与pDST相比，该检测的敏感性和特异性为94.0% (95% CI 90.5-96.4；264/281)和97.3% (95% CI 95.4-98.5；495/509)，分别为INH；86.0% (95% ci 78.2-91.8；98/114)和99.3% (95% CI 98.3-99.3；FLQ分别为669/674)；85.7% (95% ci 42.1-99.6；6/7)和99.9% (95% CI 99.3-100.0；752/753)，分别为AMG；25.0% (95% CI 19.0-31.7；48/192)和96.7% (95% CI 94.9-98.0；581/601)，分别为ETH。Xpert XDR与pDST在检测INH、FLQ和AMG耐药方面的一致性几乎是完美的（kappa分别为0.91、0.89和0.86），但对ETH耐药的一致性是一般的（kappa为0.28）。与新诊断或rif敏感病例相比，Xpert XDR在再治疗或rif耐药结核病患者中的表现明显更好。结论：鉴于Xpert XDR检测的高性能，可以在全国范围内规划实施，快速准确地检测PTB患者对INH、FLQ和AMG的耐药性，帮助临床医生选择合适的耐药结核病治疗方案。

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

Infectious Diseases and Therapy Medicine-Microbiology (medical)

CiteScore

8.60

自引率

1.90%

发文量

136

审稿时长

6 weeks

期刊介绍： Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.