Facilitating AcceLerated Clinical evaluation Of Novel diagnostic tests for COVID-19

In response to the COVID-19 pandemic, multiple in vitro diagnostics tests (IVDs) have been rapidly developed to detect SARS-CoV-2 infection or immunity. To meet the urgent demand for increased testing capacity, many IVDs have received emergency use authorization. However, clinical evaluations to date have mainly been single-centre, employing differing reference standards with variable protocols. There remains an urgent need for a multi-site, rapid, and methodologically robust approach to in-context clinical validation.

The COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) will contribute to the coordinated national effort to improve COVID-19 diagnostics by providing a collaborative national platform for clinical evaluation. The Facilitating AcceLerated Clinical evaluation of Novel diagnostics for COVID-19 (FALCON-C19) study feeds into the CONDOR programme by evaluating novel diagnostic tests for COVID-19 in hospital settings. Meanwhile, a separate study, called the Expanding RAPid community Test evaluation capacity fOR COVID-19 within the RCGP Research and Surveillance Centre (RCGP-RSC) network (RAPTOR-C19) study will separately evaluate novel diagnostic tests for COVID-19 in a community setting.

FALCON will provide in-context clinical validation for multiple IVDs in a hospital setting, specifically applied to high-priority use cases. This collaborative platform will also place the UK in a unique position to rapidly evaluate and adopt novel diagnostics into clinical practice when faced with future pandemics.