Jiang Jianping, Wei Yunqi, Li Shumin, Mo Juanfen, Li Xiaosi, Cao Mengqing, Wang Haiqin
Department of Respiratory Medicine, The Second Affiliated Hospital of Jiaxing University, 1518 Huanchen North Road, Jiaxing, 314000, Zhejiang, China.
Department of Respiratory Medicine, Jiaxing University Master Degree Cultivation Base, Zhejiang Chinese Medical University, Jiaxing, 314000, Zhejiang, China.
J Transl Med. 2024 Dec 2;22(1):1092. doi: 10.1186/s12967-024-05788-2.
To investigate the clinical application value of microfluidic-based in vitro diagnostic (IVD) technology in pathogenic detection of respiratory tract infections.
A total of 300 clinical samples, including blood, bronchoalveolar lavage fluid, and pleural effusion, were collected from patients with respiratory tract infections. The samples were randomly divided into three groups: A, B, and C, with 100 cases in each group. Group A used traditional microbiological detection methods, Group B used metagenomic next-generation sequencing (mNGS) technology, and Group C used both microfluidic-based IVD technology and traditional microbiological detection methods to detect pathogenic microorganisms in the clinical samples. The positive detection rate, detection time, and detection cost were compared among the groups. The diagnostic performance of each group was compared using the Receiver Operating Characteristic (ROC) curve.
Traditional microbiological detection identified 38 positive samples (38%), including 45 pathogens; mNGS technology identified 95 positive samples (95%), including 210 pathogens; microfluidic-based IVD technology identified 96 positive samples (96%), including 158 pathogens. Microfluidic-based IVD technology had a significantly higher positive detection rate for pathogenic microorganisms compared to traditional culture techniques (96% vs 38%, χ2 = 122.0, P < 0.01), and it was also faster and cheaper than mNGS technology. ROC analysis showed that compared to traditional microbiological culture results, microfluidic-based IVD technology had significantly increased sensitivity and specificity, similar to mNGS technology.
In respiratory infectious diseases, microfluidic-based IVD technology had a higher detection rate for pathogenic microorganisms than traditional culture methods, and it had advantages in detection time and cost compared to mNGS technology. It could also detect critical drug-resistant genes of pathogens. Hence, microfluidic-based IVD technology can be a viable option for diagnosis and treatment of respiratory infectious diseases.
探讨基于微流控的体外诊断（IVD）技术在呼吸道感染病原体检测中的临床应用价值。
收集300例呼吸道感染患者的临床样本，包括血液、支气管肺泡灌洗液和胸腔积液。将样本随机分为A、B、C三组，每组100例。A组采用传统微生物检测方法，B组采用宏基因组下一代测序（mNGS）技术，C组采用基于微流控的IVD技术和传统微生物检测方法检测临床样本中的致病微生物。比较各组的阳性检出率、检测时间和检测成本。采用受试者工作特征（ROC）曲线比较各组的诊断性能。
传统微生物检测鉴定出38份阳性样本（38%），包括45种病原体；mNGS技术鉴定出95份阳性样本（95%），包括210种病原体；基于微流控的IVD技术鉴定出96份阳性样本（96%），包括158种病原体。与传统培养技术相比，基于微流控的IVD技术对致病微生物的阳性检出率显著更高（96%对38%，χ2 = 122.0，P < 0.01），并且比mNGS技术更快、更便宜。ROC分析表明，与传统微生物培养结果相比，基于微流控的IVD技术的敏感性和特异性显著提高，与mNGS技术相似。
在呼吸道感染性疾病中，基于微流控的IVD技术对致病微生物的检出率高于传统培养方法，与mNGS技术相比在检测时间和成本方面具有优势。它还可以检测病原体的关键耐药基因。因此，基于微流控的IVD技术可成为呼吸道感染性疾病诊断和治疗的可行选择。
