24 June 2020
Testing for coronavirus infection could become quicker, more convenient and more accurate, following the launch of a multicentre national programme of research that will evaluate how new diagnostic tests perform in hospitals, general practices and care homes.
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]) involves sending samples away to laboratories, which can take up to 72 hours to provide results.
The life sciences industry has rapidly responded to the pandemic by developing brand new diagnostic tests both to detect current coronavirus infection and to find out if someone has previously been infected. These new tests – some of which may be able to provide near immediate results at the bedside in hospitals, in GP surgeries or during home visits – have the potential to increase the speed and convenience of testing.
However, many of these new diagnostic tests have yet to be thoroughly evaluated in the settings where they’re likely to be used.
The COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) – funded by the National Institute for Health Research, UK Research and Innovation, Asthma UK and the 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.
Co-primary investigator Professor Gail Hayward, Associate Professor at Oxford University’s Nuffield Department of Primary Care Health Sciences and Deputy Director of the NIHR Community Healthcare MedTech and IVD Co-operative, said: “While a new diagnostic test might work well in a lab under controlled conditions, there are many different factors that could make it less accurate when you take that test out of the lab and into the real world. These include the range of ways that COVID-19 can present itself, from non-symptomatic carriers to post-symptomatic people who have recovered, the range of other illnesses people might have and the challenges of performing tests in a busy clinical environment.
“Right now there’s a critical gap in how we road-test new diagnostics for COVID-19. By robustly evaluating these diagnostics in health and care settings, the CONDOR programme will help the government and clinicians to understand the real-world accuracy of these tests in patients presenting with COVID-19 symptoms in the NHS.”
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.”
Professor Fiona Watt, Executive Chair of the Medical Research Council, part of UK Research and Innovation, said: “The life sciences industry is developing faster and more accurate coronavirus tests, but we need to know if they work as well in the difficulties of real-world settings as they do in a controlled lab environment.
“The CONDOR platform will put the new tests through their paces. The best ones can then be chosen for deployment in healthcare settings, care homes and the community, boosting our ability to detect and control the virus that causes COVID-19.”
The programme is led by Manchester University NHS Foundation Trust, the University of Manchester and the University of Oxford, in collaboration with four NIHR Medtech and In vitro diagnostics Co-operatives (MICs) – NIHR Community Healthcare MIC, NIHR Leeds MIC, NIHR London MIC and the NIHR Newcastle MIC – Manchester University NHS Foundation Trust’s Diagnostics and Technology Accelerator (DiTA), the University of Nottingham and the National Measurement Laboratory, hosted at LGC.
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 these 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.
Co-primary investigator Professor Richard Body, Professor of Emergency Medicine at the University of Manchester, Consultant at Manchester University NHS Foundation Trust and Director of DiTA, 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 on patients who test positive with an antibody test, he adds, to find out whether they develop new infections, thus helping to understand whether people with antibodies are immune to reinfection and how long this immunity might last.
Dissemination and national rollout of promising tests will be led by the Academic Health Science Networks in North East and North Cumbria and in Yorkshire and Humber. The networks have established a patient and public involvement group to support this project, with over 20 contributors with a wide variety of healthcare experience. They have already provided helpful insights into concerns about care home diagnostics and ensuring inclusion of samples from black, Asian and minority ethnic groups.
The £1.3 million research programme will also have an analytical validation workstream that will evaluate the accuracy of tests in laboratory settings, a workstream to assess the benefits of these new tests within patient pathways (in collaboration with NICE), and a workstream evaluating the practical suitability and feasibility of tests.
“For example, we’re going to look at tests that use different approaches to collecting samples other than the nose and throat swabs, which are uncomfortable,” said Prof Body. “Some tests in development at the moment measure the virus in saliva, which is much easier and more convenient to collect.”
The partnership with the National Measurement Laboratory, hosted at LGC, will enable the independent validation of new molecular point-of-care tests against an international reference measurement procedure and of emerging serological tests against an assay developed using validated antibodies.
This study is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care, to expedite its delivery in the health and care system.
The research will be supported by the expertise of NIHR MICs, existing teams in NHS organisations and universities that work with companies and specialise in evaluating, and generating high quality evidence on, in vitro diagnostic tests.
Dr Michael Messenger, Deputy Director of the NIHR Leeds MIC and now seconded to the government as a Scientific Advisor to the COVID-19 Testing Programme, said: “We’ve got a wealth of expertise in the NIHR MICs, with Newcastle providing care pathway analysis expertise, the experts in Oxford leading on evaluating tests in community settings, Leeds and Newcastle advising on analytical validation of tests, and London specialising in human factors in diagnostic testing. We’ve also brought in DiTA, which has expertise in evaluating tests in acute care environments.
“The MICs allow us to instantly access a network of experts across the country who specialise in evaluating in vitro diagnostics and provide a valuable infrastructure in the government response to COVID-19.”
Professor George Hanna, Director of the NIHR London MIC at Imperial College that is leading on the human factors issues in test development, said: “CONDOR provides an evaluation route not just for laboratory validity but also for real world use. In the past, the absence of a proper focus on end-user needs has meant that many failures and safety issues have occurred with diagnostics. We can now overcome these barriers by applying our unique human factors approach within CONDOR.”
Dr Ashley Price, Lead for Infection at the NIHR Newcastle MIC, which is leading on the care pathway analysis workstream, said: “The care pathway analysis workstream will map out patients’ journeys with suspected COVID-19, ensuring that the diagnostic tests are evaluated in the most suitable clinical setting, such as hospitals or care homes, and the evidence developed by CONDOR will be appropriate for the practical use of the test. Working with the National Institute for Health and Care Excellence, we believe this will speed up the delivery of these tests into practice.”
Dr Samantha Walker, Director of Research and Innovation at Asthma UK and British Lung Foundation, said: “We are delighted to be able to support this national research programme in the search to find fast and reliable diagnostic tests for COVID-19. Reducing viral outbreaks through effective testing could help to protect the millions of people in the UK with a lung condition who are more likely to experience severe symptoms.
“It has been incredible to see such a fast response to the coronavirus from the life sciences industry and we look forward to seeing the results of this study.”