Hataji Osamu, Ushiro Kengo, Inoue Remi, Nakanishi Kentaro, Esumi Seiya, Fujiura Yuki, Suzuki Yuta, Sakaguchi Tadashi, Ito Kentaro, Nishii Yoichi, Tarukawa Tomohito, Fujimoto Hajime, Yasuma Taro, Taguchi Osamu, Nishio Miho, Maeda Natsue, Nishimura Haruka, D'Alessandro-Gabazza Corina, Kobayashi Tetsu, Gabazza Esteban C
Respiratory Center, Matsusaka Municipal Hospital, Tonomachi 1550, Matsusaka, Mie, 515-8544, Japan.
Department of Clinical Laboratory, Matsusaka Municipal Hospital, Tonomachi 1550, Matsusaka, Mie, 515-8544, Japan.
Respir Investig. 2025 Sep;63(5):974-982. doi: 10.1016/j.resinv.2025.07.020. Epub 2025 Aug 2.
Recently developed molecular diagnostic tools facilitate rapid pathogen detection; however, their clinical application in Japan remains limited due to insufficient comparative data. This study aimed to evaluate the pathogen detection rates of the pneumonia panel relative to bacterial culture and compare viral detection rates between pneumonia and respiratory panels in Japanese patients.
This retrospective study included 354 Japanese patients with suspected respiratory infections. Pathogen detection was performed using the BioFire® FilmArray® Pneumonia and Respiratory 2.1 panels. A total of 403 specimens were analyzed with the pneumonia panel, 223 of which were also tested using the respiratory panel, and 373 underwent simultaneous bacterial culture.
The pneumonia panel demonstrated a significantly higher positivity rate (60.3 %) than bacterial culture (52.8 %), exhibited substantial concordance (77.2 %) with bacterial culture results, and identified viral co-infections. Among the specimens, sputum exhibited a markedly higher positivity rate (64 %) within the pneumonia panel. Staphylococcus aureus isolates harboring resistance genes exhibited significantly higher culture positivity rates, whereas Enterobacter cloacae complex isolates lacking resistance genes were more frequently recovered in culture. The detection rates of Rhinovirus/Enterovirus and Respiratory syncytial virus were comparable between the pneumonia and respiratory panels, despite using different specimen types.
The pneumonia panel showed superior pathogen detection compared to bacterial culture, reinforcing its clinical value in pneumonia management. Comparable viral detection between pneumonia and respiratory panels suggests diagnostic interchangeability. These findings provide Japan-specific evidence, where insurance coverage remains limited, supporting molecular diagnostics to improve respiratory infection management and guide future healthcare policy decisions.
最近开发的分子诊断工具有助于快速检测病原体;然而,由于比较数据不足,它们在日本的临床应用仍然有限。本研究旨在评估肺炎检测板相对于细菌培养的病原体检测率,并比较日本患者肺炎检测板和呼吸道检测板之间的病毒检测率。
这项回顾性研究纳入了354名疑似呼吸道感染的日本患者。使用BioFire® FilmArray®肺炎和呼吸道2.1检测板进行病原体检测。共对403份标本进行了肺炎检测板分析,其中223份也使用呼吸道检测板进行了检测,373份同时进行了细菌培养。
肺炎检测板显示出显著高于细菌培养(52.8%)的阳性率(60.3%),与细菌培养结果具有高度一致性(77.2%),并识别出病毒合并感染。在这些标本中,痰液在肺炎检测板中的阳性率明显更高(64%)。携带耐药基因的金黄色葡萄球菌分离株的培养阳性率显著更高,而缺乏耐药基因的阴沟肠杆菌复合体分离株在培养中更常被检出。尽管使用了不同的标本类型,但肺炎检测板和呼吸道检测板之间鼻病毒/肠道病毒和呼吸道合胞病毒的检测率相当。
与细菌培养相比,肺炎检测板显示出更好的病原体检测效果,增强了其在肺炎管理中的临床价值。肺炎检测板和呼吸道检测板之间可比的病毒检测表明诊断具有互换性。这些发现提供了日本特有的证据,在日本,保险覆盖范围仍然有限,支持分子诊断以改善呼吸道感染管理并指导未来的医疗政策决策。