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

Mayo Clinic

Status: Completed

Conditions: COVID-19; Influenza

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05674370

75A50122C00039 (Other Grant/Funding Number)

22-011258

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients being tested for COVID 19 or Influenza

Exclusion criteria

• Patients < 18 years of age

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Diagnostic Test: Laboratory-based nucleic acid amplification tests (NAATs)

Device: GRIP Electronic Diagnostic Chip