Gazelle COVID-19 Test Clinical Accuracy Protocol

August 8, 2022 updated by: Hemex Health
Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Bellingham, Washington, United States, 98226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive subjects of all ages who visit the facility for covid 19 testing (symptomatic and asymptomatic).

Description

Symptomatic study:

Inclusion Criteria:

The presence of clinical signs and symptoms consistent with COVID-19. Signs and symptoms include:

  • Fever
  • Coughing
  • Shortness of breath
  • Recent loss of sense of smell or taste
  • Chills
  • Repeated shaking with chills
  • Muscle pain
  • Headache
  • Sore throat

  • Vomiting or diarrhea

    • Within 1-5 days of symptom onset
    • Informed consent for all the samples will be obtained from the subject or obtained from the parent/guardian in case the patient is a minor
    • All ages
    • All genders
    • Pregnant women

Exclusion Criteria:

  • Severe disease requiring immediate medical intervention
  • Inability to tolerate sampling procedure (nasal swab)
  • Failure to provide informed consent
  • Nasal deformities preventing sampling by swab
  • Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
  • Asymptomatic patients

Asymptomatic study:

Inclusion criteria:

  • Present to the facility for a COVID-19 test without symptoms
  • Informed consent for all specimens will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor

Exclusion Criteria:

Exclusion criteria include one or more of the following:

  • Severe disease requiring immediate medical intervention
  • Inability to tolerate sampling procedure
  • Is below 2 years old
  • Failure to provide informed consent
  • Nasal deformities preventing sampling by swab
  • Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
  • Presence of typical symptoms of COVID-19 (fever, sore throat, fatigue, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) will be measured
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity on at least 30, maximum 65, SARS-CoV-2 positive patient samples will be assessed
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hemex Health

Investigators

  • Principal Investigator: Ryan Robert Fortna, MD, PhD, Northwest Pathology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2021

Primary Completion (ANTICIPATED)

December 15, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (ACTUAL)

August 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZL-FC10-PTL-0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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