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

点击翻译按钮获取中文摘要

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.