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NCT05674370 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05674370
Other study ID # 22-011258
Secondary ID 75A50122C00039
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date April 30, 2023

Study information
Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients being tested for COVID 19 or Influenza Exclusion Criteria: - Patients < 18 years of age

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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