Department of Molecular Pathobiology, Division of Biomaterials, Bioengineering Institute, New York University College of Dentistry, New York, NY 10010, USA.
Vilcek Institute of Graduate Biomedical Sciences, New York University School of Medicine, New York, NY 10016, USA.
Biosensors (Basel). 2022 Aug 10;12(8):621. doi: 10.3390/bios12080621.
As of 8 August 2022, SARS-CoV-2, the causative agent of COVID-19, has infected over 585 million people and resulted in more than 6.42 million deaths worldwide. While approved SARS-CoV-2 spike (S) protein-based vaccines induce robust seroconversion in most individuals, dramatically reducing disease severity and the risk of hospitalization, poorer responses are observed in aged, immunocompromised individuals and patients with certain pre-existing health conditions. Further, it is difficult to predict the protection conferred through vaccination or previous infection against new viral variants of concern (VoC) as they emerge. In this context, a rapid quantitative point-of-care (POC) serological assay able to quantify circulating anti-SARS-CoV-2 antibodies would allow clinicians to make informed decisions on the timing of booster shots, permit researchers to measure the level of cross-reactive antibody against new VoC in a previously immunized and/or infected individual, and help assess appropriate convalescent plasma donors, among other applications. Utilizing a lab-on-a-chip ecosystem, we present proof of concept, optimization, and validation of a POC strategy to quantitate COVID-19 humoral protection. This platform covers the entire diagnostic timeline of the disease, seroconversion, and vaccination response spanning multiple doses of immunization in a single POC test. Our results demonstrate that this platform is rapid (~15 min) and quantitative for SARS-CoV-2-specific IgG detection.
截至 2022 年 8 月 8 日，导致 COVID-19 的 SARS-CoV-2 已在全球范围内感染了超过 5.85 亿人，并导致超过 642 万人死亡。虽然已批准的基于 SARS-CoV-2 刺突（S）蛋白的疫苗可在大多数个体中诱导强烈的血清转化，显著降低疾病严重程度和住院风险，但在老年人、免疫功能低下个体和患有某些预先存在健康状况的患者中观察到较差的反应。此外，很难预测通过疫苗接种或先前感染获得的针对新出现的关注病毒变体（VoC）的保护作用，因为它们会不断出现。在这种情况下，一种能够定量检测循环 SARS-CoV-2 抗体的快速即时（POC）血清学检测方法将使临床医生能够根据加强针的时机做出明智的决策，允许研究人员测量在先前免疫和/或感染个体中针对新 VoC 的交叉反应性抗体水平，并有助于评估适当的恢复期血浆供体，以及其他应用。我们利用芯片实验室生态系统，提出了一种 POC 策略的概念验证、优化和验证，用于定量检测 COVID-19 的体液保护。该平台涵盖了疾病的整个诊断时间线，包括血清转化和多次免疫接种的疫苗反应，可在单个 POC 测试中完成。我们的结果表明，该平台在 SARS-CoV-2 特异性 IgG 检测方面快速（~15 分钟）且定量。
