Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™) (CoviDx™)

Clinical Evaluation of a SARS-CoV-2 CoviDx™COVID-19 Antigen Self-Test

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

Study Overview

• Status: Terminated
• Conditions: Covid19; SARS-CoV-2
• Intervention / Treatment: Device: CoviDx™ Covid-19 Antigen Self-Test

Detailed Description

Subjects who are currently experiencing symptoms associated with COVID-19 will be enrolled. Each enrolled subject will either self-collect one sample from the anterior nares or have the sample collected by another lay individual. Each subject will then have a mid-turbinate nasal swab sample collected for comparator test

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33613
      • PAS Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Lay users who do not have medical or laboratory experience significant experience performing repeated self-testing. Subjects will be 2 years of age or older and have symptoms of COVID-19 that started ≤ 5 days from their study visit

Description

Inclusion Criteria:

• Mid-turbinate nasal swab collected for SARS-CoV-2 RT-PCR at the same time of CoviDx Rapid Antigen swab collection
• Symptomatic subjects suspected of having COVID-19, first onset of COVID-19-like symptoms (e.g., chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) should not have started more than 5 days from the time of the study visit. Symptoms must be present on the day of CoviDx testing.
• ≥ 2 years of age
• Participants between 2-13 years of age, inclusive, must participate with a guardian who will be collecting the swab.
• Signed Informed Consent

Exclusion Criteria:

• Participants with prior medical or laboratory training
• Unable or unwilling to provide signed, Informed Consent
• Less than 2 years of age
• Received a positive diagnostic test result for COVID-19 in the past 14 days
• Received a negative diagnostic test result for COVID-19 in the last 18 hours
• Study Comparator collection that occurred > 3 hours from CoviDx swab collection
• For symptomatic participants: first onset of COVID-19-like symptoms occurring more than 5 days from study visit
• Invalid or missing study comparator test results
• Use of a non-high-sensitive SARS-CoV-2 test as the comparator SARS-CoV-2 RT-PCR test (e.g., rapid molecular, 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, mid-turbinate nasal swab or anterior nasal swab within 6 hours of CoviDx testing.
• Indicates they would not use a COVID-19 diagnostic test kit in real life
• Taking any of the following medications or treatments within 7 days of study visit (antivirals (e.g., Remdesivir, Paxlovid) and/or monoclonal antibodies (e.g., REGEN-COV (casirivimab, imdevimab), Sotrovimab (Xevudy), Evusheld)
• Nasal spray administration in the last 48 hours

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SARS COv-2 RT-PCR AND Self collected CoviDx Covid-19 Antigen Self-Test; Sequentially enrolled symptomatic patients will have a nasal swab collected for high-sensitive SARS-CoV-2 RT-PCR testing as comparator and self collect a nasal swab for CoviDx™ Covid-19 Antigen self-testing. Order of tests will be performed following a randomization scheme.	Device: CoviDx™ Covid-19 Antigen Self-Test; All patients will self-collect a mid-turbinate nasal swab for CoviDx™ Covid-19 Antigen self-testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of CoviDx Covid-19 Antigen Self-Test in nasal swab as compared to a high-sensitive SARSCoV- 2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA	Evaluate the performance (positive percent agreement (PPA) and negative percent agreement (NPA)) of the CoviDx™ COVID-19 Antigen Self-Test for the detection of SARS-CoV-2 virus antigen in anterior nasal swab (NS) samples collected by lay users compared to results obtained from by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA (comparator test).	60 days

Collaborators and Investigators

• Sponsor: Lumos Diagnostics
• Collaborators: Rapid Pathogen Screening

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Antigen; Rapid Point of care testing; Self testing
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CLP-0010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No