FALCON C-19 [COVID-19] [UPH]
Research type
Research Study
Full title
Facilitating Accelerated CLinical evaluation Of Novel diagnostic tests for COVID-19 (FALCON C-19)
IRAS ID
284229
Contact name
Richard Body
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
ISRCTN Number
ISRCTN86124626
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
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.
Summary of Results
During the COVID-19 pandemic, early diagnosis of infection was extremely important to prevent further spread. The 'gold standard' test is PCR, which requires dedicated equipment in a central laboratory. It can take many hours for a PCR result to arrive, which is too long when patients are waiting in an Emergency Department or wheh people in the community need to know whether they ought to self isolate. The FALCON C-19 study aimed to test the accuracy of rapid near-patient tests for the virus that causes COVID-19 (SARS-CoV-2), mainly in a hospital environment but later also in the community.
This was a 'platform study', which means that the study included several evaluations different tests in different hospitals and contexts. We undertook numerous evaluations in hospital Emergency Departments, where we invited patients with suspected infection to take part. If they consented, we took a swab sample from the nose and/or throat and we tested this using a near-patient test. We then worked out the accuracy of the results by comparing the near-patient test result with the gold standard PCR result from the central laboratory. In another arm of the study, we invited people with recently confrimed COVID-19 infection to attend a drive-through testing centre. If they consented, they attended the drive-through centre and provided nose/throat swabs. The staff then analysed those samples with near-patient tests called lateral flow tests. We could then work out how often the lateral flow tests successfully identified the virus causing the infection.
In total, we included over 8,500 participants and we evaluated over 20 near-patient tests. The results were fed back to the Department of Health and Social Care and the Test Validation Group, and wherever possible we have published our findings. Our evaluation of lateral flow tests showed that they could detect the majority of infections, particularly in patients with high viral loads who were likely to be most infectious. Our findings informed the national roll-out of lateral flow testing for mass population screening. Our findings also helped to inform the pandemic response by guiding clinicians about the accuracy of different near-patient tests that were available.REC name
Wales REC 5
REC reference
20/WA/0169
Date of REC Opinion
27 May 2020
REC opinion
Favourable Opinion