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Rapid community point-of-care testing for COVID-19 (RAPTOR-C19): protocol for a platform diagnostic study.

Brian D Nicholson1, Gail Hayward2, Philip J Turner2

  • 1Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. Brian.nicholson@phc.ox.ac.uk.

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Summary
This summary is machine-generated.

The RAPTOR-C19 study evaluates point-of-care tests (POCTs) for COVID-19 in community settings. Accurate POCTs are crucial for managing SARS-CoV-2 transmission and public health.

Keywords:
COVID-19Community testingDiagnostic testsPoint-of-care testsPrimary care

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Area of Science:

  • Infectious Diseases
  • Diagnostics
  • Public Health

Background:

  • The COVID-19 pandemic highlighted the need for rapid diagnostic testing in community settings.
  • Existing diagnostic methods often involve delays, impacting timely clinical and public health decisions.
  • The RApid community Point-of-care Testing fOR COVID-19 (RAPTOR-C19) initiative was established to address these limitations.

Purpose of the Study:

  • To assess the diagnostic accuracy of various point-of-care tests (POCTs) for detecting active and past SARS-CoV-2 infections.
  • To provide a community testbed for the COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR).
  • To evaluate POCTs in real-world community settings, including symptomatic adults and children with suspected current infection and symptomatic adults with suspected past infection.

Main Methods:

  • Prospective observational parallel diagnostic accuracy studies comparing SARS-CoV-2 POCTs against laboratory reference standards.
  • Inclusion of adults and children with suspected current SARS-CoV-2 infection undergoing RT-PCR testing.
  • Recruitment of adults with suspected past symptomatic infection, with blood samples collected for antibody testing at baseline and 28 days.

Main Results:

  • Diagnostic accuracy metrics including sensitivity, specificity, positive predictive value, and negative predictive value will be calculated for each POCT.
  • POCTs will be compared against both laboratory RT-PCR for current infection and laboratory antibody testing for past infection.
  • Composite reference standards incorporating patient-reported outcomes and electronic health records will also be used for comparison.

Conclusions:

  • High-performing POCTs for community use have the potential to significantly impact public health by reducing transmission and improving surveillance.
  • Real-time results from accurate POCTs can inform personal health decisions and broader public health strategies.
  • Thorough community-based diagnostic accuracy evaluations are essential before widespread implementation of POCTs to avoid potential negative consequences of poorly performing tests.