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OpenTrials
Completed

NCT Number: NCT05674370

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza Influenza, Human Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients being tested for COVID 19 or Influenza

Exclusion criteria

  • Patients < 18 years of age

Treatment and study plan

GRIP Electronic Diagnostic Chip

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)

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

Primary outcomes

  1. Positive Percent Agreement

    Time frame: One hour

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

  2. Negative Percent Agreement

    Time frame: One hour

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2023
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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