The availability of accurate and rapid diagnostic tools for COVID-19 is essential for tackling the ongoing pandemic. In this context, researchers in the UK have started testing a new Lateral Flow Device (LFD) based on proprietary Biotinylated anti SARS-CoV-2 S1 Affimer(R) technology that binds to the SARS-CoV2-S1 protein in anterior nasal swab samples, generating an ultra-sensitive method for detection. This international study aimed to compare its performance against other available antigen-detecting rapid diagnostic tests (Ag-RDTs) in a real-world clinical setting. The study was completed under the frame of Project SENSORNAS RTC-20176501 in collaboration with MiRNAX Biosens Ltd. and Hospital Carlos III, it was documented internally and deposited in agreement to the ISO 13485 norm. All the data obtained are currently under submission and review from the Ethics Committee of Universidad Autonoma de Madrid.
Comparative diagnostic performance of the new chromatographic Affimer(R)-based rapid antigen detection against SARS-CoV-2 and other standard antigen tests for COVID-19 in a clinical setting.