Department of Infection, Royal London Hospital, Barts Health NHS Trust, London, UK.
Centre for Immunobiology Blizard Institute, Queen Mary University of London, London, UK.
Eur J Clin Microbiol Infect Dis. 2020 Jul;39(7):1321-1327. doi: 10.1007/s10096-020-03847-2. Epub 2020 Feb 20.
Tuberculosis in London occurs at a rate of 19 cases per 100,000 population, with a significant proportion diagnosed as extra-pulmonary infection. At Barts Health NHS Trust, our TB rates are much higher than the London average and approximately 60% cases are extra-pulmonary in nature. We evaluated the BD MAX™ MDR-TB assay as a molecular tool for rapid diagnosis of TB. One hundred twenty-eight specimens, encompassing pulmonary (70) and extra-pulmonary (58) infection, were tested using the BD MAX™ MDR-TB assay and compared with smear and liquid culture results, to determine PCR performance. The BD MAX™ MDR-TB assay was also compared with the Xpert MTB/RIF assay, where applicable. TB was successfully detected in 50/66 Mycobacterium tuberculosis culture positive specimens, with additional detections in 2 of the culture negative specimens. The BD MAX™ MDR-TB assay demonstrated higher sensitivity with the pulmonary samples (92%) compared with the extra-pulmonary samples (52%), although the performance with fluids and biopsies demonstrated greater potential than the remaining extra-pulmonary samples. Rifampicin and/or isoniazid resistance was successfully detected by the BD MAX™ in 2/3 samples, where WGS susceptibility results were available. The BD MAX™ MDR-TB assay was comparable with the performance of the Xpert MTB/RIF assay. TB can successfully be diagnosed, in both pulmonary and extra-pulmonary samples, using the BD MAX™ MDR-TB assay.
伦敦的结核病发病率为每 10 万人中有 19 例，其中很大一部分被诊断为肺外感染。在 Barts Health NHS Trust，我们的结核病发病率远高于伦敦的平均水平，大约 60%的病例是肺外感染。我们评估了 BD MAX™ MDR-TB 检测作为快速诊断结核病的分子工具。使用 BD MAX™ MDR-TB 检测对 128 个标本进行了检测，包括肺部（70 个）和肺外（58 个）感染，并将其与涂片和液体培养结果进行了比较，以确定 PCR 性能。BD MAX™ MDR-TB 检测还与 Xpert MTB/RIF 检测进行了比较，在适用的情况下。在 66 例分枝杆菌培养阳性标本中成功检测到了 50 例结核病，在 2 例培养阴性标本中也检测到了结核病。BD MAX™ MDR-TB 检测对肺部样本的敏感性（92%）高于肺外样本（52%），尽管对液体和活检的检测显示出比其余肺外样本更大的潜力。BD MAX™ 在 2/3 例有全基因组测序药敏结果的样本中成功检测到利福平及/或异烟肼耐药。BD MAX™ MDR-TB 检测与 Xpert MTB/RIF 检测的性能相当。BD MAX™ MDR-TB 检测可成功诊断肺部和肺外样本中的结核病。
