University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
Northwestern University, Chicago, Illinois, USA.
EBioMedicine. 2021 Aug;70:103527. doi: 10.1016/j.ebiom.2021.103527. Epub 2021 Aug 11.
The prevalence of non-tuberculous mycobacteria (NTM) has been increasing worldwide in both developed and developing countries. NTM infection is clinically indistinguishable from tuberculosis and therefore poses significant challenges in patient management, especially in patients chronically treated for pulmonary TB. In this study, we evaluated a new highly sensitive Multiplex MTB/NTM assay that can differentiate M. tuberculosis complex (MTBC) from all NTM, including the treatable and most common NTM, M. avium complex (MAC).
We developed and optimized a new open- Multiplex MTB/NTM assay with two gene-targets for MTBC (IS6110/senX3-regX3) and two targets for MAC (IS1311/DT1) with samples spiked with stored strains and testing 20 replicates. Patients with presumptive TB and NTM were enrolled at the Respiratory Disease Department of The University Teaching Hospital of Point G, in Mali.
In the development stage, the new assay showed a high analytic performance with 100% detections of MTBC and MAC at only 5 colony forming units (CFUs). Overall, without the treatment failure cases, the Multiplex assay and the Xpert showed a sensitivity, specificity, PPV and NPV of 83·3% [66·4-92·6], 96·6% [88·6-99·0], 92·5% [82·3-96·5] and 92·2% [82·7-96·5] and the Xpert had values of 96·7% [83·3-99·4], 80·0% [68·2-88·1], 70·7 [55·5-82·3] and 97·9% [89·3-99·6], respectively. The Multiplex assay successfully detected all (5/5) the MAC cases.
Our new Multiplex assay demonstrates better specificity than Xpert for all group studied, in addition to detecting potential NTM cases. The assay could therefore complement the widely used Xpert assay and enhance discrimination of TB and NTM infections.
This work was supported by the National Institutes of Health (R03AI137674, U54EB027049, D43TW010350 and UM1AI069471) and Northwestern University's Institute for Global Health Catalyzer Fund.
非结核分枝杆菌（NTM）的流行率在发达国家和发展中国家都在不断上升。NTM 感染在临床上与结核病无法区分，因此给患者管理带来了重大挑战，尤其是在慢性治疗肺结核的患者中。在这项研究中，我们评估了一种新的高灵敏度的 MTB/NTM 多重检测方法，该方法可以区分结核分枝杆菌复合群（MTBC）和所有 NTM，包括可治疗和最常见的鸟分枝杆菌复合群（MAC）。
我们开发并优化了一种新的 MTB/NTM 多重检测方法，该方法有两个 MTBC 基因靶点（IS6110/senX3-regX3）和两个 MAC 靶点（IS1311/DT1），用储存的菌株进行了样本加标，并进行了 20 次重复检测。在马里的 Point G 教学医院呼吸科，对疑似结核病和 NTM 的患者进行了入组。
在开发阶段，新的检测方法显示出很高的分析性能，仅需 5 个菌落形成单位（CFU）即可检测到 100%的 MTBC 和 MAC。总体而言，不包括治疗失败的病例，多重检测方法和 Xpert 的灵敏度、特异性、PPV 和 NPV 分别为 83.3%[66.4-92.6]、96.6%[88.6-99.0]、92.5%[82.3-96.5]和 92.2%[82.7-96.5]，Xpert 的灵敏度、特异性、PPV 和 NPV 分别为 96.7%[83.3-99.4]、80.0%[68.2-88.1]、70.7%[55.5-82.3]和 97.9%[89.3-99.6]。多重检测方法成功地检测到了所有 5 例 MAC 病例。
与 Xpert 相比，我们的新多重检测方法在所有研究组中具有更好的特异性，同时还能检测潜在的 NTM 病例。因此，该方法可以补充广泛使用的 Xpert 检测方法，并提高对结核和 NTM 感染的鉴别能力。
这项工作得到了美国国立卫生研究院（R03AI137674、U54EB027049、D43TW010350 和 UM1AI069471）和西北大学全球健康催化基金的支持。
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