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Status:

COMPLETED

Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)

Lead Sponsor:

Lumos Diagnostics

Collaborating Sponsors:

Rapid Pathogen Screening

Conditions:

SARS-CoV-2

Covid19

Eligibility:

All Genders

1+ years

Brief Summary

Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.

Detailed Description

All patients who present with Covid-19-like symptoms within 5 days prior to consult, who consent to participate in the study, will undergo a nasopharyngeal swab (NP) collected for SARS-CoV-2 RT-PCR wi...

Eligibility Criteria

Inclusion

  • Nasopharyngeal swab collected for SARS-CoV-2 RT-PCR with EUA as per standard of care within 3 hours of CoviDx Rapid Antigen Swab collection
  • First onset of COVID-19-like symptoms within the last 5 days
  • ≥ 1 year of age
  • Signed Informed Consent

Exclusion

  • Unable or unwilling to provide signed, Informed Consent
  • Less than 1 year of age
  • SARS-Cov-2 RT-PCR collection that occurred \> 3 hours from CoviDx Rapid Antigen Swab collection
  • First onset of COVID-19-like symptoms occurring more than 5 days from study visit
  • Invalid or missing PCR test results
  • Use of a non-high-sensitive SARS-CoV-2 test as the qualifying SARS-CoV-2 RT-PCR test (e.g., Abbott ID NOW, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study)
  • Enrollment in another study involving the collection of a nasopharyngeal or nasal swab
  • Receipt of a COVID-19 vaccine or participation in a COVID-19 vaccine study

Key Trial Info

Start Date :

February 8 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 14 2021

Estimated Enrollment :

140 Patients enrolled

Trial Details

Trial ID

NCT04750629

Start Date

February 8 2021

End Date

May 14 2021

Last Update

June 18 2021

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

Doral Medical Research

Hialeah, Florida, United States, 33016

2

Comprehensive Clinical Research

West Palm Beach, Florida, United States, 33409