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

Primary Purpose

COVID-19, Influenza

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GRIP Electronic Diagnostic Chip

Laboratory-based nucleic acid amplification tests (NAATs)

About this trial

This is an interventional diagnostic trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients being tested for COVID 19 or Influenza Exclusion Criteria: Patients < 18 years of age

Sites / Locations

Mayo Clinic Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Novel, graphene-based, point-of-care device

Arm Description

Subjects will receive one additional nasal swab at the same time as clinical collection.

Outcomes

Primary Outcome Measures

Positive Percent Agreement

Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing

Negative Percent Agreement

Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing

Secondary Outcome Measures

Full Information

NCT ID

NCT05674370

First Posted

December 21, 2022

Last Updated

May 19, 2023

Sponsor

Mayo Clinic

Collaborators

Department of Health and Human Services

1. Study Identification

Unique Protocol Identification Number

NCT05674370

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

April 30, 2023 (Actual)

Study Completion Date

April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Influenza

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Novel, graphene-based, point-of-care device

Arm Type

Experimental

Arm Description

Subjects will receive one additional nasal swab at the same time as clinical collection.

Intervention Type

Device

Intervention Name(s)

GRIP Electronic Diagnostic Chip

Intervention Description

Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab

Intervention Type

Diagnostic Test

Intervention Name(s)

Laboratory-based nucleic acid amplification tests (NAATs)

Intervention Description

Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab

Primary Outcome Measure Information:

Title

Positive Percent Agreement

Description

Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing

Time Frame

Baseline

Title

Negative Percent Agreement

Description

Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients being tested for COVID 19 or Influenza Exclusion Criteria: Patients < 18 years of age

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew Binnicker, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Minnesota

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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