Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19

The aim of this study is to evaluate the accuracy of a number of commercially available tests for diagnosing COVID-19 infection within hospitals. Accurate diagnosis of infection, identification of immunity and monitoring the progress of the infection are of great importance to our response to COVID-19. Widespread population testing has proved difficult in western countries and has been limited by availability of tests, staff availability and long turnaround times (up to 72 hours). This has limited our ability to control the spread of infection and to develop effective ways to ensure early self- isolation of infected patients and early treatment for those most at risk. Industry has developed a number of new in vitro (outside the human body) diagnostic tests. To take advantage of the potential benefit of those tests we need effective assessment of the tests. This study will evaluate tests in three priority areas: – Evaluation of the accuracy of in vitro tests for the diagnosis of active infection with COVID-19; – Evaluation of tests to show the immune response to COVID-19; – Evaluation of tests for predicting the likely course of the disease in patients with suspected or confirmed COVID-19 infection. (This will not be done immediately but may start later). The study will take place in both primary healthcare (in the community) and secondary healthcare (generally hospitals) settings. The study described in this application (referred to as FALCON) focuses only on hospitals. A separate study (RAPTOR) will look at primary healthcare settings.