UK sets up national programme to evaluate Covid-19 tests

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.

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 responded to the pandemic by developing new diagnostic tests both to detect current Coronavirus infection and to find out if someone has previously been infected. 

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 experienced in evaluating diagnostic tests and generating the evidence required for use 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.”

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.

Professor Fiona Watt, executive chair of the Medical Research Council, 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 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.

One application of CONDOR will be to follow up on patients who test positive with an antibody test, 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 also established a patient and public involvement group to support this project, with over 20 contributors with a wide variety of healthcare experience. 

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.

The partnership with the National Measurement Laboratory, hosted at LGC, enables 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.”