Background: As pathogens such as influenza virus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can easily cause pandemics, rapid diagnostic tests are crucial for implementing efficient quarantine measures, providing effective treatments to patients, and preventing or containing a pandemic infection. Here, we developed the immunochromatography-NanoSuit® method, an improved immunochromatography method combined with a conventional scanning electron microscope (SEM), which enables observation of immunocomplexes labeled with a colloidal metal. Methods and Findings: The detection ability of our method is comparable to that of real-time reverse transcription-polymerase chain reaction and the detection time is approximately 15 min. Our new immunochromatography-NanoSuit® method suppresses cellulose deformity and makes it possible to easily focus and acquire high-resolution images of gold/platinum labeled immunocomplexes of viruses such as influenza A, without the need for conductive treatment as with conventional SEM. Electron microscopy (EM)-based diagnosis of influenza A exhibited 94% clinical sensitivity (29/31) (95% confidence interval [95%CI]: 78.58-99.21%) and 100% clinical specificity (95%CI: 97.80-100%). EM-based diagnosis was significantly more sensitive (71.2%) than macroscopic diagnosis (14.3%), especially in the lower influenza A-RNA copy number group. The detection ability of our method is comparable to that of real-time reverse transcription-polymerase chain reaction. Conclusions: This simple and highly sensitive quantitative analysis method involving immunochromatography can be utilized to diagnose various infections in humans and livestock, including highly infectious diseases such as COVID-19.

中文翻译：

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通过扫描电子显微镜对临床样品进行灵敏的定量和快速免疫色谱诊断-为将来的爆发做好准备

背景：由于诸如流感病毒和严重急性呼吸系统综合症冠状病毒2（SARS-CoV-2）之类的病原体很容易引起大流行，因此快速诊断测试对于实施有效的检疫措施，为患者提供有效治疗以及预防或控制大流行至关重要。感染。在这里，我们开发了一种免疫色谱-NanoSuit®方法，它是一种改进的免疫色谱方法，与常规扫描电子显微镜（SEM）结合使用，可以观察用胶体金属标记的免疫复合物。方法与发现：我们的方法的检测能力与实时逆转录聚合酶链反应相当，检测时间约为15分钟。我们的新免疫色谱-NanoSuit®方法可抑制纤维素变形，并可以轻松聚焦和采集金/铂标记的病毒（例如A型流感）免疫复合物的高分辨率图像，而无需像常规SEM一样进行导电处理。基于电子显微镜（EM）的甲型流感诊断显示出94％的临床敏感性（29/31）（95％的置信区间[95％CI]：78.58-99.21％）和100％的临床特异性（95％CI：97.80-100） ％）。基于EM的诊断比宏观诊断（14.3％）的敏感性要高得多（71.2％），尤其是在较低的流感A-RNA拷贝数组中。我们方法的检测能力与实时逆转录聚合酶链反应相当。结论：