Clinical Evaluation of the GRIP Influenza and SARS-CoV-2 Point-of-care Assays Using Fresh Patient Nasal Swab Samples
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Negative Percent Agreement
Study Overview
Brief Summary
The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.
Detailed Description
GRIP has developed a novel, graphene-based detection system for potential use in point-of-care settings. This study will compare the performance of the GRIP device to routine PCR testing for detection of COVID-19 and influenza viruses. When patients present for routine testing for COVID-19 and influenza, they will also have a separate nasal swab collected that will be tested by the GRIP point-of-care device.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients being tested for COVID 19 or Influenza
Exclusion Criteria
- •Patients < 18 years of age
Outcomes
Primary Outcomes
Negative Percent Agreement
Time Frame: One hour
Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing
Positive Percent Agreement
Time Frame: One hour
Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing
Secondary Outcomes
No secondary outcomes reported
Investigators
Matthew J. Binnicker
Principal Investigator
Mayo Clinic