Facilitating AcceLerated Clinical validation Of novel diagnostics for COVID-19
What is FALCON?
Having access to accurate tests for COVID-19 is essential for those who require care in a hospital setting. For patients who have symptoms of a coronavirus infection, having access to rapid test results is critically important. For those who have COVID-19, having access to rapid test results will allow us to provide early treatment and to successfully isolate affected patients, preventing spread of infection to other patients and to staff.
For those who do not have COVID-19, having rapid test results not only allows those patients to receive early reassurance but also means that those patients can be safely sent to areas of the hospital that are not affected by COVID-19, reducing the risk to all our patients.
In the FALCON study, we will determine the accuracy of several new diagnostic tests for COVID-19. The care that patients receive will not change during the study and the results of new tests will not be used to guide clinical decisions. Patients will continue to undergo all the standard tests for COVID-19. However we will invite patients to take part in the Falcon study. Those who take part will be asked to provide additional samples, which will be used to run the new tests. We will ask patients to provide samples of blood, saliva and swab samples from their noses and throats.
The results of the new tests will then be compared to the results of the tests that are already being used in clinical practice. The tests that are currently being used in clinical practise use a method called RT- PCR, and we call this the reference method or gold standard. We will then analyse our results to see if the new tests are as accurate as the reference method.
It is likely that we will evaluate approximately 10 new tests in the Falcon study. Many of those tests are likely to be point of care tests, which can be done at the patient's bedside and which often return results in as little as five minutes. We will endeavour to publish our findings in scientific journals. We hope that this work will allow companies to get their new tests to the market faster and will allow patients and the NHS to benefit from the best new testing technologies as soon as we know that it is safe to use them in practice.
Other studies within the CONDOR Platform
Focussed on community settings, such as GP surgeries and COVID-19 testing centres.
The CONDOR-CH study is looking at rapid testing specifically in care home settings.
Care Pathways Analysis
"Care pathway mapping” studies will identify where new technologies could have the most impact on patient health during the different phases of the pandemic.
Human Factors Evaluation
Analysing the interaction between people and technologies in real-world healthcare.
Evaluating which tests should be trialled in the different clinical settings and putting the right ones forward into our clinical studies.