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Gazelle COVID-19 Test Clinical Accuracy Protocol

NCT04987918 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2022-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Covid19

Interventions

DIAGNOSTIC_TEST

Applied Biosystems TaqPath COVID- 19 Combo Kit

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Sponsors & Collaborators

  • Hemex Health

    lead INDUSTRY

Principal Investigators

  • Ryan Robert Fortna, MD, PhD · Northwest Pathology

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-20
Primary Completion
2022-12-15
Completion
2022-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04987918 on ClinicalTrials.gov