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

NCT04750629 | Completed FDA Device

• 1 other identifier: 21 0115
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

SARS-CoV-2; Covid19

Keywords

Antigen; Rapid; Point of care testing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

POC CoviDx™ Rapid Antigen Test DEVICE

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

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

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Symptomatic patients who are suspected of having SARS-CoV-2

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lumos Diagnostics: lead
• Rapid Pathogen Screening: collaborator

Study Sites (2)

Doral Medical Research

Hialeah, Florida, 33016, United States

Location

Comprehensive Clinical Research

West Palm Beach, Florida, 33409, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal Swabs

MeSH Terms

Conditions

COVID-19; Fasting

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 11, 2021
• Study Start: February 8, 2021
• Primary Completion: May 7, 2021
• Study Completion: May 14, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

US (2)