Rapid Multi-antigen COVID-19 Point-of-Care Antibody Test from a Pin-Prick Blood Sample

其目的是开发一种即时（POC）设备，以确定一个人的免疫状态，以SARS-CoV-2从针刺血液样本在10分钟内。POC设备的核心是一个一次性的单个样品盒，其中包含多达八个薄膜体声波谐振器（FBAR）的阵列。FBAR传感器具有显著推进COVID-19测试最新技术水平的潜力，因为它们提供了小尺寸（每个传感器在0.7mm硅芯片上具有100 × 300微米的有效面积）、高灵敏度、高动态范围、经济的大规模制造，并且可以测量来自全血样品内的蛋白质的结合而不需要裂解，FBAR传感器阵列与集成的微流体一起封装在一次性盒中，将同时定量针对多个SARS-CoV-2蛋白结构域（S1、S2、受体结合结构域、N蛋白）的抗体，以及已知对病毒中和至关重要的表位。这种多重定量，加上传感器的高灵敏度和小型阅读器中的自动解释算法，将使我们能够以前所未有的速度实现MHRA目标产品谱所需的高特异性和灵敏度，用于微量血液的血清学。该产品将允许在COVID-19爆发持续的情况下快速定量COVID-19免疫状态。它将与基于快速RT-PCR的病毒检测（例如Cepheid）合作，作为指导医疗保健和其他存在高传播风险的环境中感染控制的关键检测，使检测的获取民主化。

The aim is to develop a point-of-care (POC) device to determine the immune status of an individual to SARS-CoV-2 from a pin prick blood sample in under 10 minutes. The POC device have at its core a disposable, single sample cartridge containing an array of up to eight film bulk acoustic resonator (FBAR). FBAR sensors have the potential to significantly advance the state-of-the-art in COVID-19 testing as they offer a small form factor (each sensor has an active area of 100x300 micron on a 0.7 mm silicon die), high sensitivity, high dynamic range, economical manufacture at scale, and can measure binding of proteins from within whole blood samples without the need for lysis, centrifugation or other pre-processing.The FBAR sensor array, encased in a single use cartridge together with integrated microfluidics, will simultaneously quantitate antibodies against multiple SARS-CoV-2 protein domains (S1, S2, receptor binding domain, N protein), as well as epitopes known to be critical for viral neutralisation. This multiplexed quantitation, together with the high sensitivity of the sensors and automated interpretation algorithms in a small form factor reader, will allow us to achieve the high specificity and sensitivity required by MHRA's target product profile for serology with tiny blood volumes at unprecedented speed.The product would allow rapid quantitation of COVID-19 immune status as the COVID-19 outbreak persists. It would partner rapid RT-PCR based viral detection (e.g. Cepheid) as key tests directing infection control in healthcare and other settings where high transmission risk exists, democratising access to testing.