Jiao Wei-Wei, Wang Gui-Rong, Sun Lin, Xiao Jing, Li Jie-Qiong, Wang Ya-Cui, Quan Shu-Ting, Huang Hai-Rong, Shen A-Dong
Key Laboratory of Major Diseases in Children, Beijing Key Laboratory of Pediatric Respiratory Infection Disease, Ministry of Education, National Key Discipline of Pediatrics (Capital Medical University), National Clinical Research Center for Respiratory Diseases, National Center for Children's Health, Beijing Pediatric Research Institute, Beijing Children's Hospital, Capital Medical University, Beijing, China.
National Tuberculosis Clinical Laboratory, Beijing Key Laboratory for Drug Resistance Tuberculosis Research, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing Chest Hospital, Capital Medical University, Beijing, China.
Front Microbiol. 2021 Dec 23;12:812690. doi: 10.3389/fmicb.2021.812690. eCollection 2021.
In this study, we evaluated the diagnostic accuracy of multiple cross displacement amplification (MCDA) combined with real-time PCR platform in pulmonary tuberculosis (PTB) patients. Total 228 PTB patients and 141 non-TB cases were enrolled. Based on the analysis of the first available sample of all participants, MCDA assay showed a higher overall sensitivity (64.0%), with a difference of more than 10% compared with Xpert MTB/RIF (Xpert) assay (51.8%, < 0.05) and combined liquid and solid culture (47.8%, < 0.001) for PTB diagnosis. In particular, MCDA assay detected 31 probable TB patients, which notably increased the percentage of confirmed TB from 57.9% (132/228) to 71.5% (163/228). The specificities of microscopy, culture, Xpert and MCDA assay were 100% (141/141), 100% (141/141), 100% (141/141), and 98.6% (139/141), respectively. Among the patients with multiple samples, per patient sensitivity of MCDA assay was 60.5% (52/86) when only the first available sputum sample was taken into account, and the sensitivity increased to 75.6% (65/86) when all samples tested by MCDA assay were included into the analysis. Therefore, MCDA assay established in this study is rapid, accurate and affordable, which has the potential in assisting the accurate and rapid diagnosis of PTB and speed up initiation of TB treatment in settings equipped with real-time PCR platform.
在本研究中，我们评估了多重交叉置换扩增（MCDA）联合实时PCR平台对肺结核（PTB）患者的诊断准确性。共纳入228例PTB患者和141例非结核病例。基于对所有参与者首个可用样本的分析，MCDA检测显示总体敏感性较高（64.0%），与Xpert MTB/RIF（Xpert）检测（51.8%，P<0.05）和液体与固体培养联合检测（47.8%，P<0.001）相比，在PTB诊断方面差异超过10%。特别是，MCDA检测发现了31例可能的结核病患者，这显著提高了确诊结核病的比例，从57.9%（132/228）增至71.5%（163/228）。显微镜检查、培养、Xpert检测和MCDA检测的特异性分别为100%（141/141）、100%（141/141）、100%（141/141）和98.6%（139/141）。在有多个样本的患者中，如果仅考虑首个可用痰样本，MCDA检测的患者个体敏感性为60.5%（52/86），而将MCDA检测的所有样本纳入分析时，敏感性增至75.6%（65/86）。因此，本研究中建立的MCDA检测快速、准确且经济实惠，在配备实时PCR平台的环境中，具有协助准确、快速诊断PTB以及加快结核病治疗启动的潜力。
