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

Mayo Clinic45 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

COVID-19 Influenza

Interventions

GRIP Electronic Diagnostic ChipDEVICE

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)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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients being tested for COVID 19 or Influenza Exclusion Criteria: * Patients \< 18 years of age

Locations (1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Positive Percent Agreement

Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing

Time frame: 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

Time frame: One hour

Data from ClinicalTrials.gov

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