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

NCT05674370 | Completed Results FDA Device

• 2 other identifiers: 22-01125875A50122C00039
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

EXPERIMENTAL

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

Device: GRIP Electronic Diagnostic Chip; Diagnostic Test: Laboratory-based nucleic acid amplification tests (NAATs)

Interventions

GRIP Electronic Diagnostic Chip DEVICE

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

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

Laboratory-based nucleic acid amplification tests (NAATs) DIAGNOSTIC_TEST

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients being tested for COVID 19 or Influenza

You may not qualify if:

• Patients \< 18 years of age

Sponsors & Collaborators

• Mayo Clinic: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Results Point of Contact

• Title: Dr. Matthew Binicker
• Organization: Mayo Clinic

binnicker.matthew@mayo.edu

507-284-3697

Study Officials

• Matthew Binnicker, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 6, 2023
• Study Start: February 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)