COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR)
- Funded by Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)
- Total publications:0 publications
Grant number: CONDOR/MC_PC_20008
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Key facts
Disease
COVID-19Start & end year
20202022Known Financial Commitments (USD)
$757,673.76Funder
Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)Principal Investigator
PendingResearch Location
United KingdomLead Research Institution
Manchester University NHS Foundation Trust, University of OxfordResearch Priority Alignment
N/A
Research Category
Pathogen: natural history, transmission and diagnostics
Research Subcategory
Diagnostics
Special Interest Tags
N/A
Study Type
Clinical
Clinical Trial Details
Not applicable
Broad Policy Alignment
Pending
Age Group
Unspecified
Vulnerable Population
Unspecified
Occupations of Interest
Unspecified
Abstract
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.