该研究的目的是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和石蜡包埋（FFPE）组织的病因检测能力。
我们前瞻性地从因诊断不明确且病理提示肉芽肿性病变而接受手术活检的患者中收集标本。通过mNGS和组织病理学测试FFPE组织。计算mNGS的病因检出率，并与组织病理学进行比较。.
在最终纳入的69个案例中，41例(59.42%)被诊断为感染性肉芽肿。肉芽肿病变中mNGS的总体真菌和分枝杆菌病原学检出率为87.80%(36/41)。与组织病理学相比，mNGS的检出率提高了68.29%(28/41)，差异有统计学意义(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％）中的检出率明显高于组织病理学（8/12，66.67％和0/27，0.00％；均P=0.00）。mNGS一次检测到2例（2/2.100％）合并感染。所有基于mNGS的临床决定均在2天内做出。
mNGS能准确、快速地从术后肉芽肿标本中检测出FFPE标本中的真菌和分枝杆菌，并对病原菌进行菌种鉴定。
中国临床试验注册中心ChiCTR2000035464.
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, P = 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 P = 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.
