PERC Health Canada COVID-19 Study

A Multi-Center Evaluation of Buccal Swabs with the Abbott ID NOWTM COVID-19 for Point-of-Care Detection SARS-CoV-2 in Pediatric Emergency Departments

Study Summary

There is a need to gather more information on alternative sampling techniques and devices for COVID-19 tests. In particular, the ability to have samples collected by non-healthcare personnel that are non-invasive which can be tested using a point of care device that provides results in a timely manner has the potential to significantly enhance our ability to screen at risk children who are asymptomatic or pre-symptomatic for SARS-CoV-2 infection. This study will use The Abbott ID NOWTM COVID-19 device to test a buccal (cheek) swab. The device tests for SARS-CoV-2 nucleic acid, using specimens which do not need any processing and provides results in 15 minutes. We will be evaluating the sensitivity of this device using buccal (cheek) swabs collected by children or their caregivers. These swabs are technically easy to perform and painless and thus could be performed by non-healthcare personnel. We will be prospectively enrolling children who present to an emergency department (ED) for care in 15 pediatric EDs across Canada and are tested for SARS-CoV-2 infection using the local standard of care approach. 

Objectives

  1. To evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOWTM COVID-19 device to detect SARS-CoV-2 infection among children aged 0 to <18.0 years old presenting to the emergency department with an indication for SARS-CoV-2 testing as determined by the clinical care team
  2. To identify factors which influence the accuracy of the testing approach
  3. To examine the feasibility and perception of self/caregiver buccal swab sample collection

Principal Study Investigator: Dr. Stephen Freedman

Project Lead: Kelly Kim

Study Team: Dr. Quynh Doan, Dr. Simon Berthelot, Dr. Naveen Poonai, Dr. Roger Zemek, Dr. Maala Bhatt, Dr. Jocelyn Gravel, Dr. Jason Emsley, Dr. Robert Porter, Dr. Ahmed Mater, Dr. Anne Moffat, Dr. April Kam, Dr. Bruce Wright, Dr. Andrew Dixon, Dr. Darcy Beer, Dr. Gabrielle Freire, Dr. David Goldfarb, Dr. Richard Webster