A Study of the GRIP Influenza and SARS-CoV-2 POC Assays

Purpose

The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.

Conditions

  • COVID-19
  • Influenza

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients being tested for COVID 19 or Influenza

Exclusion Criteria

  • Patients < 18 years of age

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Novel, graphene-based, point-of-care device 		Subjects will receive one additional nasal swab at the same time as clinical collection.
  • Device: GRIP Electronic Diagnostic Chip
    Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab
  • Diagnostic Test: Laboratory-based nucleic acid amplification tests (NAATs)
    Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab

Recruiting Locations

More Details

NCT ID
NCT05674370
Status
Completed
Sponsor
Mayo Clinic

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.