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

Clinical Evaluation of the GRIP Influenza and SARS-CoV-2 Point-of-care Assays Using Fresh Patient Nasal Swab Samples

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

Study Overview

• Status: Completed
• Conditions: COVID-19; Influenza
• Intervention / Treatment: Device: GRIP Electronic Diagnostic Chip; Diagnostic test: Laboratory-based nucleic acid amplification tests (NAATs)

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients being tested for COVID 19 or Influenza

Exclusion Criteria:

• Patients < 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Percent Agreement	Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing	One hour
Negative Percent Agreement	Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing	One hour

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: Matthew Binnicker, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 22-011258; 75A50122C00039 (Other Grant/Funding Number: United States Department of Health and Human)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes