Sun Wenwen, Dong Zhengwei, Zhou Yiming, Xiong Kunlong, Liu Hongcheng, Zhang Zhemin, Fan Lin
Department of Tuberculosis and Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital Affiliated to School of Medicine, Tongji University, Shanghai, China.
Department of Pathology, Shanghai Pulmonary Hospital Affiliated to School of Medicine, Tongji University, Shanghai, China.
Expert Rev Mol Diagn. 2022 Apr;22(4):461-468. doi: 10.1080/14737159.2022.2052046. Epub 2022 Mar 15.
The purpose of the study is to assess the etiology detection ability of Metagenomic Next-Generation Sequencing (mNGS) on formalin fixation and paraffin embedding (FFPE) tissue from postoperative biopsy specimens.
We prospectively enrolled specimens from patients undergone surgery biopsy due to undefinite diagnosis and pathologically indicated granulomatous lesions. FFPE tissues were tested by mNGS and histopathology. The etiology detection rate of mNGS was calculated and compared with histopathology..
Among the 69 cases eventually included, 41 (59.42%) were diagnosed with infectious granuloma. The overall fungi and mycobacteria etiology detection rates of mNGS in granuloma lesions was 87.80% (36/41). The mNGS increased the detection rate by 68.29% (28/41) compared with histopathology, the difference was statistically significant (χ2 = 28.97, = 0.00). The detection rates of mNGS in fungal infections (12/12,100%) and in mycobacterium infections (22/27, 81.48%) were significant higher than those of histopathology (8/12, 66.67% and 0/27, 0.00%; both = 0.00). Two (2/2.100%) cases of co-infection were detected at one time by mNGS. All mNGS-based clinical decisions were made within 2 days.
The mNGS could accurately and quickly detect fungi and mycobacteria in FFPE specimens from postoperative granuloma specimens and identify the pathogens to the species level.
China Clinical Trial Registry ChiCTR2000035464.
本研究旨在评估宏基因组下一代测序（mNGS）对术后活检标本中福尔马林固定石蜡包埋（FFPE）组织的病因检测能力。
我们前瞻性纳入了因诊断不明确且病理显示为肉芽肿性病变而接受手术活检的患者的标本。对FFPE组织进行mNGS检测和组织病理学检查。计算mNGS的病因检出率，并与组织病理学结果进行比较。
最终纳入的69例病例中，41例（59.42%）被诊断为感染性肉芽肿。mNGS在肉芽肿病变中的总体真菌和分枝杆菌病因检出率为87.80%（36/41）。与组织病理学相比，mNGS使检出率提高了68.29%（28/41），差异具有统计学意义（χ2 = 28.97，P = 0.00）。mNGS在真菌感染（12/12，100%）和分枝杆菌感染（22/27，81.48%）中的检出率显著高于组织病理学（8/12，66.67%和0/27，0.00%；P均为0.00）。mNGS一次性检测出2例（2/2，100%）合并感染病例。所有基于mNGS的临床决策均在2天内做出。
mNGS能够准确、快速地检测术后肉芽肿标本FFPE中的真菌和分枝杆菌，并将病原体鉴定到种水平。
中国临床试验注册中心ChiCTR2000035464。
