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Xpert MTB/XDR: a 10-Color Reflex Assay Suitable for Point-of-Care Settings To Detect Isoniazid, Fluoroquinolone, and Second-Line-Injectable-Drug Resistance Directly from Mycobacterium tuberculosis-Positive Sputum
Journal of Clinical Microbiology ( IF 6.1 ) Pub Date : 2021-02-18 , DOI: 10.1128/jcm.02314-20
Yuan Cao 1 , Heta Parmar 1 , Rajiv L Gaur 2 , Deanna Lieu 2 , Shobana Raghunath 2 , Nova Via 2 , Simone Battaglia 3 , Daniela M Cirillo 3 , Claudia Denkinger 4 , Sophia Georghiou 4 , Robert Kwiatkowski 2 , David Persing 2 , David Alland 5 , Soumitesh Chakravorty 2, 5
Affiliation  

We describe the design, development, analytical performance, and a limited clinical evaluation of the 10-color Xpert MTB/XDR assay (CE-IVD only, not for sale in the United States). This assay is intended as a reflex test to detect resistance to isoniazid (INH), fluoroquinolones (FLQ), ethionamide (ETH), and second-line injectable drugs (SLIDs) in unprocessed sputum samples and concentrated sputum sediments which are positive for Mycobacterium tuberculosis. The Xpert MTB/XDR assay simultaneously amplifies eight genes and promoter regions in M. tuberculosis and analyzes melting temperatures (Tms) using sloppy molecular beacon (SMB) probes to identify mutations associated with INH, FLQ, ETH, and SLID resistance. Results can be obtained in under 90 min using 10-color GeneXpert modules. The assay can differentiate low- versus high-level resistance to INH and FLQ as well as cross-resistance versus individual resistance to SLIDs by identifying mutation-specific Tms or Tm patterns generated by the SMB probes. The assay has a limit of detection comparable to that of the Xpert MTB/RIF assay and successfully detected 16 clinically significant mutations in a challenge set of clinical isolate DNA. In a clinical study performed at two sites with 100 sputum and 214 clinical isolates, the assay showed a sensitivity of 94% to 100% and a specificity of 100% for all drugs except for ETH compared to that of sequencing. The sensitivity and specificity were in the same ranges as those of phenotypic drug-susceptibility testing. Used in combination with a primary tuberculosis diagnostic test, this assay should expand the capacity for detection of drug-resistant tuberculosis near the point of care.

中文翻译:


Xpert MTB/XDR:适用于现场护理设置的 10 色反射测定,可直接从结核分枝杆菌阳性痰液中检测异烟肼、氟喹诺酮和二线注射药物耐药性



我们描述了 10 色 Xpert MTB/XDR 检测(仅限 CE-IVD,不在美国销售)的设计、开发、分析性能和有限的临床评估。该测定旨在作为反射测试,检测结核分枝杆菌阳性的未处理痰样本和浓缩痰沉积物中对异烟肼 (INH)、氟喹诺酮类药物 (FLQ)、乙硫异烟胺 (ETH) 和二线注射药物 (SLID) 的耐药性。 Xpert MTB/XDR 检测同时扩增结核分枝杆菌中的八个基因和启动子区域,并使用草率分子信标 (SMB) 探针分析解链温度 ( T m s),以识别与 INH、FLQ、ETH 和 SLID 耐药性相关的突变。使用 10 色 GeneXpert 模块可在 90 分钟内获得结果。该检测可以通过识别 SMB 探针生成的突变特异性T m s 或T m模式来区分对 INH 和 FLQ 的低水平耐药性与高水平耐药性,以及对 SLID 的交叉耐药性与个体耐药性。该测定的检测限与 Xpert MTB/RIF 测定相当,并成功检测到临床分离 DNA 挑战组中的 16 个临床显着突变。在两个地点进行的一项临床研究中,涉及 100 份痰液和 214 份临床分离株,结果显示,与测序相比,该检测对除 ETH 之外的所有药物的敏感性为 94% 至 100%,特异性为 100%。敏感性和特异性与表型药敏试验的范围相同。 该检测与原发性结核病诊断测试结合使用,可扩大护理点附近耐药结核病的检测能力。
更新日期:2021-02-18
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