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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT05403346
Status
Terminated
Sponsor
Lumos Diagnostics

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.