Li Runqing, Gai Wei, Zhu Dong, Lok Chonghou, Song Cuidan, Dong Jingxiao, Han Ning, Zhang Yan, Zhao Xiuying
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, 168 Litang Road, Changping District, Beijing, 102218, People's Republic of China.
National Engineering Research Center for Beijing Biochip Technology, 18 Life Science Parkway, Changping District, Beijing, 102206, People's Republic of China.
AMB Express. 2019 May 28;9(1):77. doi: 10.1186/s13568-019-0791-8.
We introduced a novel micro/nanofluidic chip platform (MNCP), which is based on an isothermal nucleic acid amplification method. This study aimed to evaluate the MNCP method for influenza A and B viruses detecting and subtyping using throat swab samples from patients with influenza-like illness (ILI). A total of 266 throat swab samples from 266 non-repeated patients with ILI were tested for influenza A and B viruses using three methods, MNCP, a rapid influenza diagnostic test (RIDT), and real-time reverse transcription polymerase chain reaction (rRT-PCR). The results of MNCP were compared to those obtained by rRT-PCR and RIDT and the performance of MNCP was further evaluated. Compared with rRT-PCR results, the rates of sensitivity, specificity, overall concordance, and the kappa value of MNCP were 98.89%, 96.97%, 97.65%, and 0.95 for influenza A virus; 94.95%, 99.38%, 97.68%, and 0.95 for influenza B virus, respectively. Subtypes of influenza A viruses, e.g., A(H1N1)pdm09, A(H3N2), and A(not subtyped), and influenza B viruses could be distinguished in one MNCP assay within 1 h. Compared with rRT-PCR and MNCP, RIDT showed poor clinical sensitivity for influenza virus detection. This study showed MNCP is rapid, sensitive and versatile detecting system with potential for clinical application in pathogen diagnosis for patients with ILI.
我们引入了一种基于等温核酸扩增方法的新型微纳流控芯片平台（MNCP）。本研究旨在评估MNCP方法用于检测和分型甲型和乙型流感病毒，使用的样本是流感样疾病（ILI）患者的咽拭子。总共对266例非重复的ILI患者的咽拭子样本进行了甲型和乙型流感病毒检测，采用了三种方法：MNCP、快速流感诊断试验（RIDT）和实时逆转录聚合酶链反应（rRT-PCR）。将MNCP的结果与rRT-PCR和RIDT的结果进行比较，并进一步评估MNCP的性能。与rRT-PCR结果相比，MNCP对甲型流感病毒的敏感性、特异性、总体一致性和kappa值分别为98.89%、96.97%、97.65%和0.95；对乙型流感病毒分别为94.95%、99.38%、97.68%和0.95。在一次MNCP检测中，1小时内可区分甲型流感病毒的亚型，如A(H1N1)pdm09、A(H3N2)和A（未分型）以及乙型流感病毒。与rRT-PCR和MNCP相比；RIDT对流感病毒检测的临床敏感性较差。本研究表明MNCP是一种快速、灵敏且通用的检测系统，在ILI患者病原体诊断中具有临床应用潜力。
