ANTIBODY BASED TESTS FOR SARSCoV-2 COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings

Texas Cardiac Arrhythmia Research Foundation

Status: Unknown

Conditions: Covid19

Treatments: Diagnostic Test: CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test

Study type: Observational

Funder types: Other

Identifiers

NCT04352764

TCAI_COVID-19

Details and patient eligibility

About

This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies.

Full description

This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies. The blood test data will be collected as allowed by the EUA using the CoronaCideTM COVID-19 IgM/IgG Rapid Test and the Premier Biotech COVID-19 IgM/IgG Rapid Test. Both COVID-19 IgM/IgG Rapid Tests are intended for Over-The-Counter/Professional use as a screening aid in the diagnosis of primary and secondary SARSCoV-2 infections, and are only for use under the FDA's EUA.

The RNA test data will be collected via a nasopharyngeal swab and processed using the Abbott ID NOW COVID-19 diagnostic test.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient is Under the care of Texas Cardiac Arrhythmia, and Presenting to the hospital OR Presenting to a clinic conducted by Texas Cardiac Arrhythmia Or

  • An employee of Texas Cardiac Arrhythmia Or
  • An employee or healthcare professional working with patients receiving cardiac electrophysiology care at a hospital. Or A professional first responder to include Emergency Medical Services (EMS), Police or Fire departments.

Exclusion criteria

• Any person who refuses to undergo study procedures