Status:
COMPLETED
Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals
Lead Sponsor:
UnitedHealth Group
Collaborating Sponsors:
Quest Diagnostics-Nichols Insitute
Bill and Melinda Gates Foundation
Conditions:
Infections, Respiratory
Fever
Eligibility:
All Genders
Brief Summary
Operational project to compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic s...
Detailed Description
This work will serve both the Everett Clinic and broader UnitedHealth Group patient populations as well as advance the public health emergency (PHE) response to the community spread of SARS-CoV-2 viru...
Eligibility Criteria
Inclusion
- Able to consent and agree to participate in the project after discussing the project
- Coming to The Everett Clinic during the operational project duration
- Evidence of upper respiratory symptoms suggesting higher risk of testing positive for SARS-CoV-2 virus.
Exclusion
- Not able to demonstrate understanding of the study
- Not willing to commit to having all four samples collected
- Medical history evidencing any of the following
- Active nosebleed in the past 24 hours
- Nasal surgery in the past two weeks
- Chemotherapy treatment with low platelet and low white blood cell counts
- Acute facial trauma
Key Trial Info
Start Date :
March 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 23 2020
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT04321369
Start Date
March 9 2020
End Date
March 23 2020
Last Update
May 4 2022
Active Locations (1)
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1
Everett Clinic
Seattle, Washington, United States, 98133