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

NCT ID: NCT05674370

Last Updated: 2024-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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COVID-19 Influenza

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

GRIP Electronic Diagnostic Chip

Intervention Type DEVICE

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

Laboratory-based nucleic acid amplification tests (NAATs)

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients being tested for COVID 19 or Influenza

Exclusion Criteria

* Patients \< 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Matthew J. Binnicker

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Binnicker, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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75A50122C00039

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22-011258

Identifier Type: -

Identifier Source: org_study_id

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