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

Covid19 Clinical Trial

— CoviDx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750629
• Other study ID #: 21 0115
• Status: Completed
• Start date: February 8, 2021
• Est. completion date: May 14, 2021

Study information

• Verified date: June 2021
• Source: Lumos Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 14, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• SARS-CoV-2

Intervention

Device:
• POC CoviDx™ Rapid Antigen Test
All patients will have a nasal swab for CoviDx™ Rapid Antigen testing

Locations

Country	Name	City	State
United States	Doral Medical Research	Hialeah	Florida
United States	Comprehensive Clinical Research	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Lumos Diagnostics	Rapid Pathogen Screening

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	30 days