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

Completed

• Conditions: SARS-CoV-2; Covid19
• Interventions: Device: POC CoviDx™ Rapid Antigen Test

• Registration Number: NCT04750629
• Lead Sponsor: Lumos Diagnostics

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

Study Timeline

• Study Start: 2021-02-08
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Primary Completion: 2021-05-07
• Study Completion: 2021-05-14
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing	POC CoviDx™ Rapid Antigen Test	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Comprehensive Clinical Research; 🇺🇸 West Palm Beach, Florida, United States

Doral Medical Research; 🇺🇸 Hialeah, Florida, United States