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

Sponsor

Lumos Diagnostics (Industry)

Overall Status

Completed

CT.gov ID

NCT04750629

Collaborator

Rapid Pathogen Screening (Industry)

140

Enrollment

Locations

3.1

Actual Duration (Months)

Patients Per Site

22.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Covid19	Device: POC CoviDx™ Rapid Antigen Test

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 with EUA as per standard of care and nasal swab collection for CoviDx Rapid Antigen testing.

Study Design

Study Type:

Observational

Actual Enrollment :

140 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 CoviDx™ Rapid Antigen Test

Actual Study Start Date :

Feb 8, 2021

Actual Primary Completion Date :

May 7, 2021

Actual Study Completion Date :

May 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing Sequentially enrolled symptomatic patients who present for COVID-19 testing and have a swab collected for high-sensitive, SARS-CoV-2 RT-PCR testing per Standard of Care AND a swab for CoviDx™ Rapid Antigen testing.	Device: POC CoviDx™ Rapid Antigen Test All patients will have a nasal swab for CoviDx™ Rapid Antigen testing

Arm

Intervention/Treatment

SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing

Sequentially enrolled symptomatic patients who present for COVID-19 testing and have a swab collected for high-sensitive, SARS-CoV-2 RT-PCR testing per Standard of Care AND a swab for CoviDx™ Rapid Antigen testing.

Device: POC CoviDx™ Rapid Antigen Test

All patients will have a nasal swab for CoviDx™ Rapid Antigen testing

Outcome Measures

Primary Outcome Measures

Sensitivity of SARS-CoV-2 antigen in nasal swab as compared to a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA [30 days]
The primary outcome is the presence of SARS-CoV-2 antigen in nasal swab as compared to confirmatory diagnosis SARS-CoV-2 as determined by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Doral Medical Research	Hialeah	Florida	United States	33016
2	Comprehensive Clinical Research	West Palm Beach	Florida	United States	33409

Sponsors and Collaborators

Lumos Diagnostics
Rapid Pathogen Screening

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lumos Diagnostics

ClinicalTrials.gov Identifier:

NCT04750629

Other Study ID Numbers:

21 0115

First Posted:

Feb 11, 2021

Last Update Posted:

Jun 18, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Lumos Diagnostics

Antigen

Rapid

Point of care testing

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jun 18, 2021