Chen Ying-Ying, Xiang Wen-Qing, Guo Ya-Jun, Shen Zheng, Li Wei
Department of Clinical Laboratory, The Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.
Pediatr Res. 2025 Apr 30. doi: 10.1038/s41390-025-04101-1.
Respiratory syncytial virus (RSV), adenovirus (ADV), human parainfluenza virus (hPIV), and Mycoplasma pneumoniae (MP) are prevalent pathogens causing acute respiratory infections (ARIs) in children. Prompt and precise detection of these pathogens is essential for early differentiation. This study sought to assess the diagnostic efficacy of a fully automatic real-time fluorescence PCR assay utilizing microfluidic technology (PCR-MT) for the rapid detection of RSV, hPIV, ADV, and MP in children in a hospital setting in Zhejiang, China.
The study was conducted on 420 children with ARIs from March to December 2022 at our hospital. Throat swab samples were collected and detected for RSV, hPIV, ADV, and MP using both PCR-capillary electrophoresis fragment analysis (PCR-CEFA) and PCR-MT. The results obtained from the PCR-MT method were compared with those from PCR-CEFA.
With PCR-CEFA as the gold standard, the sensitivity and specificity of the PCR-MT method were as follows: 94.4% and 100.0% for RSV, 96.0% and 99.1% for hPIV, 100.0% and 98.6% for ADV, and 93.5% and 98.8% for MP, respectively.
The PCR-MT method demonstrates substantial potential for clinical application in the early diagnosis of RSV, hPIV, ADV, and MP in an outpatient setting, offering robust sensitivity and specificity.
Rapid, accurate, and convenient multiple pathogen detection technologies represent a significant area of research in the medical field. The method evaluated in this study enables simultaneous detection of four pathogens on a single chip, covering various subtypes, with results available within half an hour. Although some multi-pathogen detection chips are already commercially available, they may still have limitations such as sensitivity, specificity, and cost. Ongoing technological advancements could make pathogen detection more efficient, accurate, and economical. Continued attention to the development, validation, and optimization of these technologies in clinical practice will better serve patients.
呼吸道合胞病毒（RSV）、腺病毒（ADV）、人副流感病毒（hPIV）和肺炎支原体（MP）是引起儿童急性呼吸道感染（ARI）的常见病原体。及时、准确地检测这些病原体对于早期鉴别至关重要。本研究旨在评估利用微流控技术的全自动实时荧光PCR检测法（PCR-MT）在中国浙江某医院环境中对儿童RSV、hPIV、ADV和MP进行快速检测的诊断效能。
2022年3月至12月在我院对420例ARI儿童进行了研究。采集咽拭子样本，采用PCR-毛细管电泳片段分析（PCR-CEFA）和PCR-MT两种方法对RSV、hPIV、ADV和MP进行检测。将PCR-MT法获得的结果与PCR-CEFA法的结果进行比较。
以PCR-CEFA作为金标准，PCR-MT法的灵敏度和特异性如下：RSV分别为94.4%和100.0%，hPIV分别为96.0%和99.1%，ADV分别为100.0%和98.6%，MP分别为93.5%和98.8%。
PCR-MT法在门诊环境中对RSV、hPIV、ADV和MP的早期诊断具有很大的临床应用潜力，具有较高的灵敏度和特异性。
快速、准确、便捷的多种病原体检测技术是医学领域的一个重要研究方向。本研究评估的方法能够在单个芯片上同时检测四种病原体，涵盖多种亚型，半小时内即可出结果。虽然一些多病原体检测芯片已经上市，但它们可能仍存在灵敏度、特异性和成本等方面的局限性。持续的技术进步可以使病原体检测更加高效、准确和经济。在临床实践中持续关注这些技术的开发、验证和优化将更好地为患者服务。
