Abbott ID NOW COVID-19

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    2882
  • sponsor
    University of Calgary
Updated on 23 May 2022

Summary

Although there are several licensed vaccines for SAR-CoV-2 (COVID-19) in Canada, none of them are approved for use in children under the age of 12, leaving five million children under 12 years unvaccinated. There is a need to find methods of mass rapid point of care testing in unvaccinated populations such as in schools that can be performed by a lay individual. This multi-center study will evaluate the clinical sensitivity of buccal swabs with the ID NOW COVID-19 device in comparison to standard of care COVID-19 testing at 15 pediatric emergency centres across Canada.

Description

This study will enroll approx 2882 participants under the age of 18 at 15 pediatric emergency centres across Canada. The purpose of the study is to evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOW COVID-19device to detect SARS-CoV-2 infection among children aged 0-<18.0 years old presenting to the emergency department with an indication for SARS-CoV-2 testing as determined by the clinical care team. The study also seeks to identify factors that influence the accuracy of the testing approach and to examine the feasibility and perception of self/caregiver buccal swab sample collection.

In this prospective study, we will validate a self collected buccal swab that is analyzed with the Abbott ID NOW COVID-19 device against a reference RT-PCR nasal, nasopharyngeal (NP) or throat swab (or others) deemed standard of care at participating sites. The standard of care swabs will be collected by a qualified health professional and assessed by local laboratory services.

Individuals presenting to the emergency department that are identified as meeting the criteria as per local guidelines to be tested for SARS-CoV-2 (i.e. droplet precautions) will be appropriately consented and screened for participation in the study.

Eligible, consented participants will have their past medical history, COVID-19 symptom assessment, vaccination status, and physical exam findings collected from their charts.

A qualified healthcare professional will obtain a standard of care RT-PCR Swab from the participant. The results from this swab will be collected from the participants chart once available.

Depending on age, the study team will then train the participant/caregiver how to perform and obtain a buccal swab from the inside of the cheek. The collected buccal swab will be analyzed by the study team using the Abbott ID NOW COVID-19 device and results obtained within approx 15 mins.

Participants and their families will be notified of the qualitative result from the buccal swab.

Participants and their caregivers will be asked to complete pain assessment and acceptability questionnaires for both the standard of care and buccal swab tests.

Details
Condition COVID-19, SARS-CoV-2 Infection
Treatment Buccal Swab- Copan flocked swab, Standard of Care COVID-19 swab, Buccal Swabc- Copan flocked swab
Clinical Study IdentifierNCT05040763
SponsorUniversity of Calgary
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age <18.0 years old
Presenting to a participating emergency department
Consented to undergo local standard of care SARS-CoV-2 test
Able to read/speak English or French

Exclusion Criteria

Inability or unwillingness of individual or legal guardian/representative to give written informed consent or child to give assent
Clear my responses

How to participate?

Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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