Wyss Institute for Biologically Inspired Engineering, Harvard University, 02115, USA.
Wyss Institute for Biologically Inspired Engineering, Harvard University, 02115, USA; Vascular Biology Program, Boston Children's Hospital, And Harvard Medical School, 02115, USA; Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, 02115, USA.
Biosens Bioelectron. 2023 Mar 1;223:115037. doi: 10.1016/j.bios.2022.115037. Epub 2022 Dec 24.
The current coronavirus disease 2019 (COVID-19) pandemic is caused by several variants of severe acute respiratory syndrome coronavirus-2 virus (SARS-CoV-2). With the roll-out of vaccines and development of new therapeutics that may be targeted to distinct viral molecules, there is a need to screen populations for viral antigen-specific SARS-CoV-2 antibodies. Here, we report a rapid, multiplexed, electrochemical (EC) device with on-chip control that enables detection of SARS-CoV-2 antibodies in less than 10 min using 1.5 μL of a patient sample. The EC biosensor demonstrated 100% sensitivity and specificity, and an area under the receiver operating characteristic curve of 1, when evaluated using 93 clinical samples, including plasma and dried blood spot samples from 54 SARS-CoV-2 positive and 39 negative patients. This EC biosensor platform enables simple, cost-effective, sensitive, and rapid detection of anti-SARS-CoV-2 antibodies in complex clinical samples, which is convenient for evaluating humoral-responses to vaccination or infection in population-wide testing, including applications in point-of-care settings. We also demonstrate the feasibility of using dried blood spot samples that can be collected locally and transported to distant clinical laboratories at ambient temperature for detection of anti-SARS-CoV-2 antibodies which may be utilized for serological surveillance and demonstrate the utility of remote sampling.
当前的 2019 年冠状病毒病(COVID-19)大流行是由几种严重急性呼吸系统综合征冠状病毒 2 型(SARS-CoV-2)病毒变体引起的。随着疫苗的推出和针对不同病毒分子的新型治疗方法的开发,需要对人群进行病毒抗原特异性 SARS-CoV-2 抗体筛查。在这里,我们报告了一种快速、多重、电化学(EC)设备,具有片上控制功能,可在不到 10 分钟的时间内使用 1.5 μL 的患者样本检测 SARS-CoV-2 抗体。该 EC 生物传感器在使用 93 个临床样本进行评估时,包括来自 54 个 SARS-CoV-2 阳性和 39 个阴性患者的血浆和干血斑样本,显示出 100%的灵敏度和特异性,以及 1 的接收者操作特征曲线下面积。这种 EC 生物传感器平台能够在复杂的临床样本中简单、经济高效、敏感和快速地检测抗 SARS-CoV-2 抗体,这方便了在人群广泛检测中评估对疫苗接种或感染的体液反应,包括在即时检测环境中的应用。我们还证明了使用干血斑样本的可行性,这些样本可以在当地采集,并在环境温度下运送到遥远的临床实验室进行抗 SARS-CoV-2 抗体检测,这可能用于血清学监测,并展示了远程采样的实用性。