NCT05674370

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• Influenza

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2023-01-06
• Last updated: 2024-03-21
• Results posted: 2024-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study