Researchers from Manchester University NHS Foundation Trust (MFT) and The University of Manchester (UoM) are to assess the effectiveness of tests that may give doctors COVID-19 results in minutes rather than days.
Testing for coronavirus infection could become quicker, more convenient and more accurate, following the launch of the multicentre national programme of research – of which the Manchester project is part – that will evaluate how new diagnostic tests perform in hospitals, general practices and care homes.
The COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) – funded by the National Institute for Health Research (NIHR), UK Research and Innovation (UKRI), and Asthma UK and British Lung Foundation – will create a single national route for evaluating new diagnostic tests in hospitals and in community healthcare settings. This programme of research brings together experts who are highly experienced in evaluating diagnostic tests and generating the robust evidence required for a test to be used in the NHS.
Determining who has been infected with the novel coronavirus is a key part of the response to the COVID-19 pandemic. Getting quick and accurate test results when people show symptoms ensures that they receive appropriate care and reduces the chance of the disease being passed on.
The main test currently used to detect coronavirus infection (reverse transcription polymerase chain reaction [RT-PCR]) often involves sending samples away to laboratories, which can take up to 72 hours to provide results.
The research team will work with the government and its scientific advisors to identify which new commercially developed diagnostic tests could be most valuable in the NHS.
The effectiveness of the prioritised tests will then be evaluated in a number of possible health and care settings – emergency departments, critical care, acute medical care, primary care, care homes and hospital at home teams. The research will assess multiple diagnostic tests at once at sites across the country and can be adapted to add in new tests as they become available.
CONDOR will take place across Greater Manchester, including Manchester Royal Infirmary (MRI) – part of Manchester University NHS Foundation Trust – and Salford Royal, part of the Northern Care Alliance.
The hospital-setting arm of the study, FALCON, is led by Co-Primary Investigator, Professor Rick Body, Professor of Emergency Medicine at the University of Manchester, Consultant at Manchester University NHS Foundation Trust and Director of DiTA – the Manchester-based NHS Diagnostics and Technology Accelerator.
It will evaluate the accuracy of between 10 to 20 new COVID-19 tests – already identified as a high priority for the NHS – in hospitals. Approximately 30 hospital sites are expected to recruit patients to the FALCON study, which aims to start by the end of June 2020.
Professor Body said: “By validating the accuracy of new clinical tests through CONDOR, we can get novel tests out across the health and care system that are more convenient for patients and get more accurate results. This will mean that patients get better care and we can make more informed, early decisions about how to control spread of the virus.
“One application of CONDOR will be to follow-up patients who test positive with an antibody test, to find out whether they develop new infections, and help to understand whether people with antibodies are immune to reinfection and how long this immunity might last.”
Professor Body added: “The FALCON study could mean that clinicians can make fast, accurate decisions about a patient’s care – sometimes within minutes. That includes decisions about which wards or areas a patient can receive care in, rather than the standard laboratory tests, which can take 24 hours or more.
Lord Bethell, Minister for Innovation at the Department of Health and Social Care, said: “We need the fastest, most accurate tests in the NHS to help keep COVID-19 under control.
“I’m delighted we’re committing £1.3 million to this brilliant new national research programme, to evaluate how new diagnostic tests perform in health and social care settings – so we can track levels of infection and immunity across the country and help keep people safe.”
“That’s important because it will reduce the risk of infection for patients without COVID, while ensuring that those with COVID can get specialist care at an early stage.”
Professor Graham Lord, Vice-President and Dean of the Faculty of Biology, Medicine and Health at The University of Manchester said: “In a matter of weeks, clinical and research communities have worked hard to create new diagnostic testing for COVID-19 and then rapidly increase our capacity to perform them.
“Now we move on to CONDOR as a platform which aims to improve the efficiency and accuracy of the way testing is carried out.”
Professor Neil Hanley, Director of Research and Innovation at Manchester University NHS Foundation Trust, said: “I am delighted by this success for Rick and DiTA. This is exactly why we set up the Accelerator and to have such backing from UK Government is immensely reassuring.
“I am confident Rick and his team will build on this with highly impactful results.”
CONDOR co-investigator, Professor Paul Dark, is Honorary Critical Care Consultant at Salford Royal, Professor of Critical Care Medicine at The University of Manchester and NIHR National Specialty Lead for Critical Care.
Professor Dark said: “Making rapid diagnostic decisions for patients who are critically ill remains a significant challenge. I am delighted to support the CONDOR programme to help develop the best evidence for the best diagnostic tests available for use with front-line healthcare staff and their patients aimed at delivering the safest and most effective care.”