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首页> 外文期刊>Journal of Clinical Microbiology >Mixed Mycobacterium tuberculosis Complex Infections and False-Negative Results for Rifampin Resistance by GeneXpert MTB/RIF Are Associated with Poor Clinical Outcomes
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Mixed Mycobacterium tuberculosis Complex Infections and False-Negative Results for Rifampin Resistance by GeneXpert MTB/RIF Are Associated with Poor Clinical Outcomes

机译：GeneXpert MTB / RIF对结核分枝杆菌的复杂复合感染和对利福平耐药的假阴性结果与不良的临床结果相关

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The Xpert MTB/RIF (Xpert) assay is becoming a principal screening tool for diagnosing rifampin-resistant Mycobacterium tuberculosis complex (MTBC) infection. However, little is known about the performance of the Xpert assay in infections with both drug-sensitive and drug-resistant strains (mixed MTBC infections). We assessed the performance of the Xpert assay for detecting rifampin resistance using phenotypic drug sensitivity testing (DST) as the reference standard in 370 patients with microbiologically proven pulmonary tuberculosis. Mixed MTBC infections were identified genetically through 24-locus mycobacterial interspersed repetitive-unit–variable-number tandem-repeat (MIRU-VNTR) analysis. Logistic regression was used to identify the factors associated with poor (defined as treatment failure, default, and death from any cause) or good (defined as cure or successful treatment completion) clinical outcomes. The analytic sensitivity of the Xpert assay for detecting rifampin resistance was assessed in vitro by testing cultures containing different ratios of drug-sensitive and drug-resistant organisms. Rifampin resistance was detected by the Xpert assay in 52 (14.1%) and by phenotypic DST in 55 (14.9%) patients. Mixed MTBC infections were identified in 37 (10.0%) patients. The Xpert assay was 92.7% (95% confidence interval [CI], 82.4% to 97.9%) sensitive for detecting rifampin resistance and 99.7% (95% CI, 98.3% to 99.9%) specific. When restricted to patients with mixed MTBC infections, Xpert sensitivity was 80.0% (95% CI, 56.3 to 94.3%). False-negative Xpert results (adjusted odds ratio [aOR], 6.6; 95% CI,1.2 to 48.2) and mixed MTBC infections (aOR, 6.5; 95% CI, 2.1 to 20.5) were strongly associated with poor clinical outcome. The Xpert assay failed to detect rifampin resistance in vitro when <90% of the organisms in the sample were rifampin resistant. Our study indicates that the Xpert assay has an increased false-negative rate for detecting rifampin resistance with mixed MTBC infections. In hyperendemic settings where mixed infections are common, the Xpert results might need further confirmation.
机译：Xpert MTB / RIF（Xpert）测定法正在成为诊断耐利福平的结核分枝杆菌复合体（MTBC）感染的主要筛选工具。但是，对于Xpert分析在药物敏感和耐药菌株（混合MTBC感染）感染中的性能知之甚少。我们使用表型药物敏感性测试（DST）作为参考标准，对370例经微生物学证实的肺结核患者的Xpert分析检测利福平耐药性的性能进行了评估。通过24位分枝杆菌散布的重复单位-可变数目串联重复（MIRU-VNTR）分析，从基因上鉴定出混合MTBC感染。使用逻辑回归分析来确定与不良（定义为治疗失败，默认和任何原因导致的死亡）或良好（定义为治愈或成功完成治疗）的临床结果相关的因素。通过测试含有不同比例的药物敏感性和抗药性生物的培养物，在体外评估了Xpert法检测利福平耐药性的分析敏感性。通过Xpert分析检测到52位患者（14.1％）和通过表型DST检测55位患者（14.9％）的利福平耐药性。在37名（10.0％）患者中发现了混合MTBC感染。 Xpert分析对于检测利福平耐药性敏感，灵敏度为92.7％（95％置信区间[CI]，为82.4％至97.9％），特异性为99.7％（95％CI，98.3％至99.9％）。当仅限于混合MTBC感染的患者时，Xpert敏感性为80.0％（95％CI，56.3至94.3％）。 Xpert假阴性结果（校正比值比[aOR]，6.6; 95％CI，1.2至48.2）和混合MTBC感染（aOR，6.5; 95％CI，2.1至20.5）与不良的临床结果密切相关。当样品中<90％的生物对利福平具有耐药性时，Xpert分析无法在体外检测到利福平抗性。我们的研究表明，Xpert测定法可提高混合MTBC感染对利福平耐药性的假阴性率。在混合感染较常见的高流行病环境中，Xpert结果可能需要进一步确认。

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