Smartphone-Based High-Throughput Fiber-Integrated Immunosensing System for Point-of-Care Testing of the SARS-CoV-2 Nucleocapsid Protein
Smartphone-Based High-Throughput Fiber-Integrated Immunosensing System for Point-of-Care Testing of the SARS-CoV-2 Nucleocapsid Protein
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DOI：
10.1021/acssensors.2c00754
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发表时间：
2022-06
期刊：
影响因子：
8.9
通讯作者：
Ze Wu;Cong Wang;Bochao Liu;C. Liang;Jinhui Lu;Jinfeng Li;Xi Tang;Chengyao Li;Tingting Li
中科院分区：
文献类型：
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作者：
Ze Wu;Cong Wang;Bochao Liu;C. Liang;Jinhui Lu;Jinfeng Li;Xi Tang;Chengyao Li;Tingting Li
为了控制2019冠状病毒病（COVID-19）大流行，迫切需要简单，快速和可靠的检测方法来识别严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染，特别是在社区医院或临床中心。SARS-CoV-2核衣壳蛋白（NP）是诊断COVID-19的重要指标。本文提出了一种基于智能手机的高通量光纤集成免疫传感系统（HFIS），用于在45 min内检测血清样品中的SARS-CoV-2 NP。对于NP标准品的检测，线性检测范围为7.8-1000 pg/mL，检测限为7.5 pg/mL，截断值为8.923 pg/mL。对25份临床确诊的COVID-19患者血清样本和100份健康献血员阴性对照样本进行了HFIS检测，并将所得结果与ELISA和Simple Western分析结果进行了比较。结果表明，HFIS检测的敏感性和特异性分别为72%（95%CI：52.42-85.72%）和100%（95%CI：96.11 ~ 100%），与市售ELISA试剂盒和SimpleWestern分析结果具有显著相关性。这种便携式高通量HFIS检测方法可以作为现场检测血液样本中SARS-CoV-2 NP的替代检测方法。
To control the coronavirus disease 2019 (COVID-19) pandemic, there is an urgent need for simple, rapid, and reliable detection methods to identify severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, especially in community hospitals or clinical centers. The SARS-CoV-2 nucleocapsid protein (NP) is an important index for diagnosis of COVID-19. Here, we proposed a smartphone-based high-throughput fiber-integrated immunosensing system (HFIS) for detecting the SARS-CoV-2 NP in serum samples within 45 min. For the testing of NP standards, the linear detection range was 7.8–1000 pg/mL, the limit of detection was 7.5 pg/mL, and the cut-off value was 8.923 pg/mL. Twenty-five serum samples from clinically diagnosed COVID-19 patients and 100 negative control samples from healthy blood donors were tested for SARS-CoV-2 NP by HFIS, and the obtained results were compared with those of ELISA and Simple Western analysis. The results showed that the HFIS sensitivity and specificity were 72% [95% confidence interval (CI): 52.42–85.72%] and 100% (95% CI: 96.11–100%), respectively, which significantly correlated with those from the commercial ELISA kit and Simple Western analysis. This portable high-throughput HFIS assay could be an alternative test for detecting SARS-CoV-2 NP in blood samples on site.