Magnetofluidic immuno-PCR for point-of-care COVID-19 serological testing.

Magnetofluidic immuno-PCR for point-of-care COVID-19 serological testing.
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DOI:
10.1016/j.bios.2021.113656
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发表时间:
2022-01-01
影响因子:
12.6
通讯作者:
Wang TH
Wang TH
中科院分区:
工程技术1区
文献类型:
--
作者:
Zhang P;Chen L;Hu J;Trick AY;Chen FE;Hsieh K;Zhao Y;Coleman B;Kruczynski K;Pisanic TR 2nd;Heaney CD;Clarke WA;Wang TH

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血清学检测在抗击2019冠状病毒病(COVID-19)中发挥着重要作用,包括监测疫苗接种后的动态免疫反应、识别既往感染情况以及确定社区感染率。传统的血清学检测方法,例如酶联免疫吸附测定和化学发光免疫测定,提供可靠且灵敏的抗体检测,但需要复杂的实验室基础设施和/或漫长的测定时间。相反,侧流免疫测定适用于快速即时检测,但灵敏度有限。在这里,我们描述了快速、灵敏的磁流体免疫 PCR 平台的开发,该平台可以解决当前 COVID-19 护理点血清学检测方面的差距。我们的磁流体免疫 PCR 平台可在手掌大小的磁流体设备中自动执行基于磁珠的单结合和一次清洗免疫 PCR 测定,并在 ∼30 分钟内提供结果。在该设备中,可编程磁臂通过预装在配套塑料盒中的分析试剂吸引和运输磁性捕获的抗体,微型热循环仪和荧光检测器执行免疫 PCR 来检测抗体。我们使用 108 个临床血清/血浆样本评估了我们的磁流体免疫 PCR,达到了 93.8% (45/48) 的敏感性和 98.3% (59/60) 的特异性,证明了其作为快速、灵敏的 COVID-19 护理点血清学检测的潜力。
Serological tests play an important role in the fight against Coronavirus Disease 2019 (COVID-19), including monitoring the dynamic immune response after vaccination, identifying past infection and determining community infection rate. Conventional methods for serological testing, such as enzyme-linked immunosorbent assays and chemiluminescence immunoassays, provide reliable and sensitive antibody detection but require sophisticated laboratory infrastructure and/or lengthy assay time. Conversely, lateral flow immunoassays are suitable for rapid point-of-care tests but have limited sensitivity. Here, we describe the development of a rapid and sensitive magnetofluidic immuno-PCR platform that can address the current gap in point-of-care serological testing for COVID-19. Our magnetofluidic immuno-PCR platform automates a magnetic bead-based, single-binding, and one-wash immuno-PCR assay in a palm-sized magnetofluidic device and delivers results in ∼30 min. In the device, a programmable magnetic arm attracts and transports magnetically-captured antibodies through assay reagents pre-loaded in a companion plastic cartridge, and a miniaturized thermocycler and a fluorescence detector perform immuno-PCR to detect the antibodies. We evaluated our magnetofluidic immuno-PCR with 108 clinical serum/plasma samples and achieved 93.8% (45/48) sensitivity and 98.3% (59/60) specificity, demonstrating its potential as a rapid and sensitive point-of-care serological test for COVID-19.
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