The NIHR Newcastle In Vitro Diagnostics Co-operative are part of a national partnership awarded £1.3M to robustly evaluate new COVID-19 tests.

A key part of our response to the COVID-19 pandemic is the development of accurate tests to: identify individuals infected with SARS-Cov-2 (the virus causing COVID-19); monitor the progression of the disease and find out whether individuals have developed immunity. The life science sector has responded swiftly to this demand, developing over 240 CE marked tests related to COVID-19. Some of these tests have the potential to increase the speed and convenience of testing. However, due to the urgency of the situation, many of these tests have received emergency use authorisation based on limited preliminary data. There is a need to rigorously evaluate the performance of these tests, particularly in a real-life context, so we can introduce the most effective and reliable new tests as soon as possible.

The National Institute for Health and Care Research (NIHR) Newcastle In Vitro Diagnostics Co-operative (Newcastle MIC), a partnership between Newcastle Upon Tyne Hospitals NHS Foundation Trust and Newcastle University, have received funding from the NIHR, UK Research and Innovation, Asthma UK and British Lung Foundation to form CONDOR (COVID-19 National DiagnOstic Research and Evaluation Platform) with partners across England who are fellow experts in evaluating new diagnostic tests. The platform has been recognised as nationally prioritised by the Urgent Public Health Panel and will allow us to have a co-ordinated approach to rapidly and robustly assessing new tests for COVID-19.  This includes ones which have been prioritised by the government and its scientific advisors within the New Tests Approvals Group and Viral Detection Tests Approvals Group.

The Newcastle MIC’s infection theme lead, Dr. Ashley Price, consultant in infectious diseases at Newcastle Hospitals, and Prof. Mark Wilcox (NIHR Leeds In Vitro Diagnostics Co-operative) are leading CONDOR’s analysis of the new tests’ performance in the laboratory. We will produce data to verify the results if needed using hospital laboratory resources in Newcastle.

We will assess the performance of tests outside of the controlled laboratory environment, in the real world, in a number of settings. Newcastle Hospitals will be a site for CONDOR’s evaluation of new tests which could potentially be used near the hospital bedside. Prof. Rick Body (Manchester Diagnostics and Technology Accelerator) is leading this work with the Newcastle MIC providing support with the statistical analysis of these studies.

The Newcastle MIC are leading “care pathway analysis” studies, to assess the benefits of these new tests within patient pathways and understand where best to place specific technologies to address unmet clinical needs. This will involve collaborating with the National Institute for Health and Care Excellence (NICE) to review the lessons learned from the pandemic so far and to inform recommendations for the next winter season.

Dr. Ashley Price from the NIHR Newcastle MIC 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 NICE, we believe this will speed up the delivery of these tests into practice.

Led by Prof. Gail Hayward (NIHR Community Healthcare Medtech and In Vitro Diagnostics Co-operative), CONDOR will also validate the accuracy of tests used out in the community, such as in care homes, general practices and hospital at home settings. Further work, led by London In Vitro Diagnostics Co-operative, will provide valuable insights regarding the practical feasibility and suitability of the tests.

We believe this research will help to identify the most effective and scalable diagnostics, a key part of the UK’s response to the COVID-19 pandemic.

Read more about the platform on the NIHR and CONDOR websites.