Jin Wenting, Pan Jue, Miao Qing, Ma Yuyan, Zhang Yao, Huang Yingnan, Yao Yumeng, Su Yi, Wang Qingqing, Wang Mengran, Li Bing, Bao Rong, Gao Xiaodong, Wu Honglong, Hu Bijie
Department of Infectious Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Microbiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Ann Transl Med. 2020 Sep;8(17):1065. doi: 10.21037/atm-20-2274.
To evaluate the diagnostic accuracy of metagenomic next-generation sequencing (mNGS) for active tuberculosis (TB).
We retrospectively collected 820 samples at Zhongshan Hospital, Fudan University in Shanghai, China, between 1 April 2017 and 31 March 2018. They were classified into TB cases (125, 15.2%) and NOT TB cases (695, 84.8%) according to the clinical diagnosis. Specimens were evaluated by a regular clinical microbiological assay and mNGS performed in parallel.
Sixty-one confirmed TB cases and 64 clinical TB cases were included. The overall sensitivity of mNGS was 49.6% [95% confidence interval (95% CI), 40.6-58.6%], and the specificity was 98.3% (95% CI, 96.9-99.1%), with peak sensitivities of 88.9% (95% CI, 50.7-99.4%) for lung tissue, 55.0% (95% CI, 32.0-76.2%) for bronchoalveolar lavage fluid (BALF), and 50.0% (95% CI, 32.8-67.2%) for serous fluids. The overall sensitivity of mNGS was superior to that of the culture assay (35.2%, 95% CI, 27.0-44.3), but no superior sensitivity for sputum was observed in mNGS compared with the culture assay (mNGS: 52.3%, 95% CI, 31.1-72.6%; culture: 60.9%, 95% CI, 38.8-79.5%). In clinical TB cases, mNGS detected additional positive results (40.6%, 26/64). mNGS reduced the turnaround time from 2-6 weeks to 32-36 hours.
mNGS may be a promising technology for the early auxiliary diagnosis of active TB, especially sputum-negative pulmonary TB (PTB) and tuberculous serous effusion.
评估宏基因组下一代测序（mNGS）对活动性肺结核（TB）的诊断准确性。
我们回顾性收集了2017年4月1日至2018年3月31日期间在中国上海复旦大学附属中山医院的820份样本。根据临床诊断将它们分为TB病例（125例，15.2%）和非TB病例（695例，84.8%）。通过常规临床微生物检测对标本进行评估，并同时进行mNGS检测。
纳入61例确诊TB病例和64例临床TB病例。mNGS的总体敏感性为49.6% [95%置信区间（95%CI），40.6 - 58.6%]，特异性为98.3%（95%CI，96.9 - 99.1%），肺组织的峰值敏感性为88.9%（95%CI，50.7 - 99.4%），支气管肺泡灌洗液（BALF）为55.0%（95%CI，32.0 - 76.2%），浆液性液体为50.0%（95%CI，32.8 - 67.2%）。mNGS的总体敏感性优于培养检测（35.2%，95%CI，27.0 - 44.3），但与培养检测相比，mNGS对痰液的敏感性无优势（mNGS：52.3%，95%CI，31.1 - 72.6%；培养：60.9%，95%CI，38.8 - 79.5%）。在临床TB病例中，mNGS检测到额外的阳性结果（40.6%，26/64）。mNGS将周转时间从2 - 6周缩短至32 - 36小时。
mNGS可能是一种有前景的技术，用于活动性TB的早期辅助诊断，尤其是痰涂片阴性肺结核（PTB）和结核性浆液性胸腔积液。
