Rapid community point-of-care testing for COVID-19 (RAPTOR-C19): protocol for a platform diagnostic study
subject: covid-19, primary care, Diagnostic Tests, point-of-care tests, community testing
description: Abstract Background The aim of RApid community Point-of-care Testing fOR COVID-19 (RAPTOR-C19) is to assess the diagnostic accuracy of multiple current and emerging point-of-care tests (POCTs) for active and past SARS-CoV2 infection in the community setting. RAPTOR-C19 will provide the community testbed to the COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR). Methods RAPTOR-C19 incorporates a series of prospective observational parallel diagnostic accuracy studies of SARS-CoV2 POCTs against laboratory and composite reference standards in patients with suspected current or past SARS-CoV2 infection attending community settings. Adults and children with suspected current SARS-CoV2 infection who are having an oropharyngeal/nasopharyngeal (OP/NP) swab for laboratory SARS-CoV2 reverse transcriptase Digital/Real-Time Polymerase Chain Reaction (d/rRT-PCR) as part of clinical care or community-based testing will be invited to participate. Adults (≥ 16 years) with suspected past symptomatic infection will also be recruited. Asymptomatic individuals will not be eligible. At the baseline visit, all participants will be asked to submit samples for at least one candidate point-of-care test (POCT) being evaluated (index test/s) as well as an OP/NP swab for laboratory SARS-CoV2 RT-PCR performed by Public Health England (PHE) (reference standard for current infection). Adults will also be asked for a blood sample for laboratory SARS-CoV-2 antibody testing by PHE (reference standard for past infection), where feasible adults will be invited to attend a second visit at 28 days for repeat antibody testing. Additional study data (e.g. demographics, symptoms, observations, household contacts) will be captured electronically. Sensitivity, specificity, positive, and negative predictive values for each POCT will be calculated with exact 95% confidence intervals when compared to the reference standard. POCTs will also be compared to composite reference standards constru…
creator: Brian D. Nicholson, Philip J. Turner, Rafael Perera, Jason Oke, Gail Hayward, F. D. Richard Hobbs, Thomas Fanshawe, Abigail Moore, Filipa Ferreira, Simon de Lusignan, Julian Sherlock, Maria Zambon, Constantinos Koshiaris, Rachel Byford, Joseph J. Lee, Alexandra Deeks, Mary Logan, Anna Seeley, James P. Sheppard, Uy Hoang, Vaishnavi Parimalanathan, George Edwards, Harshana Liyange, Joanna Ellis, Jamie Lopez Bernal, Gayatri Amirthalingam, Ezra Linley, Ray Borrow, Gary Howsam, Sophie Baines
source: Epidemiology and Health
publisher: Korean Society of Epidemiology
date: 2021
coverage: Medicine (General)