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

Not Applicable

Completed

• Conditions: Influenza; COVID-19
• Interventions: Device: GRIP Electronic Diagnostic Chip; Diagnostic Test: Laboratory-based nucleic acid amplification tests (NAATs)

• Registration Number: NCT05674370
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-06
• Study Start: 2023-02-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Results First Submitted: 2024-02-19
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Results First Posted: 2024-03-21
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients being tested for COVID 19 or Influenza

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Exclusion Criteria

• Patients < 18 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novel, graphene-based, point-of-care device	GRIP Electronic Diagnostic Chip	Subjects will receive one additional nasal swab at the same time as clinical collection.
Novel, graphene-based, point-of-care device	Laboratory-based nucleic acid amplification tests (NAATs)	Subjects will receive one additional nasal swab at the same time as clinical collection.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States