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.

中文翻译：

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基于智能手机的高通量光纤集成免疫传感系统，用于 SARS-CoV-2 核衣壳蛋白的即时检测

为了控制2019冠状病毒病（COVID-19）大流行，迫切需要简单、快速、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。在这里，我们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 分钟内检测血清样本中的 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，截止值为8.923 pg/mL。通过 HFIS 对临床诊断的 COVID-19 患者的 25 份血清样本和健康献血者的 100 份阴性对照样本进行 SARS-CoV-2 NP 检测，并将获得的结果与 ELISA 和 Simple Western 分析的结果进行比较。结果显示，HFIS 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%)，与商业化显着相关。 ELISA 试剂盒和简单的 Western 分析。这种便携式高通量 HFIS 检测可以作为现场检测血液样本中 SARS-CoV-2 NP 的替代测试。