A Highly Sensitive Point-of-Care Covid-19 Serological Test using Immuno-PCR in 35 Mins

2021 21st International Conference on Solid-State Sensors, Actuators and Microsystems (Transducers) Pub Date : 2021-06-20 DOI:10.1109/Transducers50396.2021.9495696

Pengfei Zhang, Liben Chen, Jiumei Hu, Alexander Y. Trick, Fan-En Chen, K. Hsieh, Yang Zhao, Tza-Huei Wang

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Abstract

Serological tests play important roles in the fight against the Coronavirus Disease 2019 (COVID-19). The most commonly used methods, enzyme-linked immunosorbent assays (ELISA), provide reliable and sensitive antibody measurement though they require bulky laboratory infrastructure as well as lengthy turnaround time. Conversely, lateral flow immunoassays (LFIA) are suitable for rapid point-of-care tests but with limited sensitivity. To combine the best attributes of ELISA and LFIA, we developed a novel streamlined immuno-PCR assay and applied it to a portable magnetofluidic instrument for point-of-care serological tests. In testing 107 clinical samples, our point-of-care serological test showed 98.3% (58/59) specificity and 93.8% (45/48) agreement with benchtop immunoassays. Moreover, 100% agreement was achieved by only slightly increasing the total assay time to 45 min, demonstrating its potential as a new point-of-care serological test for COVID-19 and beyond.

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一种35分钟内使用免疫pcr的高灵敏度护理点Covid-19血清学检测方法

血清学检测在抗击2019冠状病毒病(COVID-19)中发挥着重要作用。最常用的方法是酶联免疫吸附测定法(ELISA)，它提供了可靠和敏感的抗体测量，尽管它们需要庞大的实验室基础设施以及较长的周转时间。相反，侧流免疫测定法(LFIA)适用于快速的即时检测，但灵敏度有限。为了结合ELISA和LFIA的最佳特性，我们开发了一种新型流线型免疫pcr检测方法，并将其应用于便携式磁流体仪器，用于即时血清学检测。在107份临床样本中，我们的即时血清学检测结果的特异性为98.3%(58/59)，与台式免疫检测结果的一致性为93.8%(45/48)。此外，仅将总检测时间略微增加到45分钟，就实现了100%的一致性，这表明它有潜力成为COVID-19及其他疾病的新型护理点血清学检测方法。

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2021 21st International Conference on Solid-State Sensors, Actuators and Microsystems (Transducers)

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