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-19
  • Start & end year

    2020
    2022
  • Known Financial Commitments (USD)

    $757,673.76
  • Funder

    Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)
  • Principle Investigator

    Pending
  • Research Location

    United Kingdom, Europe
  • Lead Research Institution

    Manchester University NHS Foundation Trust, University of Oxford
  • Research Category

    Pathogen: natural history, transmission and diagnostics

  • Research Subcategory

    Diagnostics

  • Special Interest Tags

    Gender

  • Study Subject

    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.