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

其目的是开发一种护理点(POC)设备，可以在10分钟内从针刺血样中确定个人对SARS-CoV-2的免疫状态。POC设备在其核心具有一次性单个样品盒，该样品盒包含多达八个薄膜体声谐振器(FBAR)阵列。FBAR传感器具有显著推进新冠肺炎检测的最先进水平的潜力，因为它们具有小的外形因素(每个传感器在0.7 mm的硅芯片上具有100x300微米的有效面积)、高灵敏度、高动态范围、规模化制造，并且可以测量全血样本中蛋白质的结合而不需要裂解、离心或其他预处理。FBAR传感器阵列与集成的微流体一起封装在一次性使用的卡盒中，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，再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达到MHRA用于微血量血清学的目标产品配置文件所需的高特异性和灵敏度。随着新冠肺炎疫情的持续，该产品将使快速定量检测新冠肺炎免疫状态成为可能。它将与基于快速RT-PCR的病毒检测(如造父变种)合作，作为关键测试，指导医疗保健和其他存在高传播风险的环境中的感染控制，使检测变得大众化。

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.