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

Lumos Diagnostics

Status: Completed

Conditions: Covid19; SARS-CoV-2

Treatments: Device: POC CoviDx™ Rapid Antigen Test

Study type: Observational

Funder types: Industry

Identifiers

NCT04750629

21 0115

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 1 patient group

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

Description:

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.

Treatment:

Device: POC CoviDx™ Rapid Antigen Test