Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Diagn Microbiol Infect Dis. 2023 May;106(1):115925. doi: 10.1016/j.diagmicrobio.2023.115925. Epub 2023 Feb 22.
Rapid diagnosis of tuberculosis and drug resistance in extrapulmonary specimens can be challenging. The BD MAX™ multidrug resistant (MDR)-TB assay (BD MAX™) has demonstrated high sensitivity and specificity for the detection of the Mycobacterium tuberculosis complex (MTBC) as well as resistance to INH and Rifampin (RIF) in pulmonary specimens but has not been rigorously assessed in extrapulmonary samples. We evaluated the diagnostic accuracy of the BD MAX™ assay for the detection of MTBC and drug resistance in extrapulmonary specimens spiked with MTBC from the Johns Hopkins strain collection. A total of 1083 tests were performed across multiple sample types, with an overall percent agreement of 94.8% (795/839) for detection of MTBC and 99% (379/383) and 96.4% (323/335) for determination of INH and RIF resistance-conferring mutations, respectively. The BD MAX™ assay provides same day detection of MTBC and drug-resistance results and could be a beneficial diagnostic test in extrapulmonary sample types.
快速诊断肺外标本中的结核病和耐药性具有挑战性。BD MAX™多药耐药（MDR）-TB 检测试剂盒（BD MAX™）已被证明在检测结核分枝杆菌复合群（MTBC）以及检测肺标本中的异烟肼和利福平（RIF）耐药方面具有较高的灵敏度和特异性，但尚未在肺外样本中进行严格评估。我们评估了 BD MAX™检测试剂盒在检测从约翰霍普金斯菌株库中添加 MTBC 的肺外标本中的 MTBC 和耐药性的诊断准确性。总共在多种样本类型中进行了 1083 次检测，对于 MTBC 的检测总体符合率为 94.8%（795/839），对于 INH 和 RIF 耐药相关突变的检测符合率分别为 99%（379/383）和 96.4%（323/335）。BD MAX™检测试剂盒可当天检测 MTBC 和耐药性结果，可能是肺外样本类型的有益诊断检测方法。
