ABSTRACT
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 AffimerR technology that binds to the SARS-CoV2-S1 protein in anterior nasal swab samples, generating an ultrasensitive 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.
ABSTRACT
Background and aims: Quick, user-friendly, and sensitive diagnostic tools are the keys to controlling the spread of the SARS-CoV-2 pandemic in the new epidemiologic landscape. The aim of this work is to characterize a new COVID-19 antigen test that uses an innovative chromatographic Affimer..-based technology designed for the qualitative detection of SARS-CoV-2 antigen. As rapid technology to detect COVID-19, the test was extensively characterized in vitro. Once the analytical parameters of performance were set, the test system was challenged in a test field study. The aim of this study was to evaluate its diagnostic accuracy, as compared by the gold standard RT-PCR and other existing lateral flow tests.