COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR)
Lead Research Organisation:
University of Manchester
Department Name: UNLISTED
Abstract
A key part of our response to the COVID-19 pandemic is to accurately find out who is infected. Getting rapid answers when patients are first seen ensures that we can give the best care, reducing the chance of others catching the infection. In community settings, we can take steps to isolate infected people and trace their contacts. Companies are developing new tests both to detect SARS-CoV-2 (the virus causing COVID-19) and to find out if someone is already immune to the virus. It is crucial that these tests do not miss infections, or whether people really are immune. We need ways to
rapidly assess whether these new tests are accurate enough to be used in the NHS. To
do this we need to know how tests work in different settings, including the community,
hospitals and care homes, and we must use high quality methods to evaluate them.
We will set up a national network of experts in evaluating diagnostic tests to assess the
accuracy of these new tests. We will prioritise tests that are likely to give the best
improvements in patient care by working with government bodies. We will ask patients to
take part if they have symptoms that could have been caused by COVID-19. We will take
blood samples and swabs from the nose/throat, and we will compare the results of new
tests to the results of proven methods to diagnose COVID-19. This will allow us to find out
which tests are best to use in the NHS.
rapidly assess whether these new tests are accurate enough to be used in the NHS. To
do this we need to know how tests work in different settings, including the community,
hospitals and care homes, and we must use high quality methods to evaluate them.
We will set up a national network of experts in evaluating diagnostic tests to assess the
accuracy of these new tests. We will prioritise tests that are likely to give the best
improvements in patient care by working with government bodies. We will ask patients to
take part if they have symptoms that could have been caused by COVID-19. We will take
blood samples and swabs from the nose/throat, and we will compare the results of new
tests to the results of proven methods to diagnose COVID-19. This will allow us to find out
which tests are best to use in the NHS.
Technical Summary
This project is jointly funded (50%/50%) Between UKRI and DHSC(NIHR). The figures shown on this record represents the UKRI total only.
In response to the COVID-19 pandemic, multiple in vitro diagnostics tests (IVDs) have been rapidly developed to detect SARS-CoV-2 infection or immunity. To meet the urgent demand for increased testing capacity, many IVDs have received emergency use authorization. However, clinical evaluations to date have mainly been single-centre, employing differing reference standards with variable protocols. There remains an urgent need for a multi-site, rapid,and methodologically robust approach to in-context clinical validation. CONDOR will contribute to the coordinated national effort to improve COVID-19 diagnostics by providing a collaborative national platform for clinical evaluation. Incorporating community, care home and in-hospital prospective multi-centre studies, CONDOR will provide in-context clinical validation for multiple IVDs, specifically applied to high-priority use cases. This collaborative platform will also place the UK in a unique position to rapidly evaluate and adopt novel diagnostics into clinical practice when faced with future pandemics. The platform has 4 main elements: 1) A central steering committee to create bespoke evaluation plans for Serology Task Force and VDTAG Priority novel IVDs and their associated use cases. 2) In context laboratory verification via a laboratory network. 3) Evaluation of in-context clinical performance (diagnostic accuracy) of IVDs (self-tests, POCTs and laboratory platforms) through efficient, prospective, multi-centre studies using established clinical networks. 4) Cross-cutting methodological workstreams. a. Care pathway analysis informing use case and TPP development (led by DHSC, RCPath and MHRA) and evidence framework development (in collaboration with NICE). b. Evaluating utility and usability in laboratory and clinical settings.
In response to the COVID-19 pandemic, multiple in vitro diagnostics tests (IVDs) have been rapidly developed to detect SARS-CoV-2 infection or immunity. To meet the urgent demand for increased testing capacity, many IVDs have received emergency use authorization. However, clinical evaluations to date have mainly been single-centre, employing differing reference standards with variable protocols. There remains an urgent need for a multi-site, rapid,and methodologically robust approach to in-context clinical validation. CONDOR will contribute to the coordinated national effort to improve COVID-19 diagnostics by providing a collaborative national platform for clinical evaluation. Incorporating community, care home and in-hospital prospective multi-centre studies, CONDOR will provide in-context clinical validation for multiple IVDs, specifically applied to high-priority use cases. This collaborative platform will also place the UK in a unique position to rapidly evaluate and adopt novel diagnostics into clinical practice when faced with future pandemics. The platform has 4 main elements: 1) A central steering committee to create bespoke evaluation plans for Serology Task Force and VDTAG Priority novel IVDs and their associated use cases. 2) In context laboratory verification via a laboratory network. 3) Evaluation of in-context clinical performance (diagnostic accuracy) of IVDs (self-tests, POCTs and laboratory platforms) through efficient, prospective, multi-centre studies using established clinical networks. 4) Cross-cutting methodological workstreams. a. Care pathway analysis informing use case and TPP development (led by DHSC, RCPath and MHRA) and evidence framework development (in collaboration with NICE). b. Evaluating utility and usability in laboratory and clinical settings.
Organisations
People |
ORCID iD |