Official Title
Use of the ANTIBODY BASED LATERAL FLOW IMMUNOASSAY TESTS FOR SARSCoV-2 THAT CAUSES CORONAVIRUS DISEASE 2019 (COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings
Brief Summary

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

Detailed 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.

Status
Unknown status
Conditions
COVID19
Interventions

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

The tests are being distributed under section IV.D of the current United States Food and Drug Administration (FDA) policies for diagnostic tests for coronavirus disease 2019. The test is available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service's (HHS's) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

St. David's Medical Center
Austin, Texas, United States

Investigator: Andrea Natale, MD FACC FHRS
dr.natale@gmail.com

Investigator: Andrea Natale, MD FACC FHRS

Contacts

Andrea Natale, MD
512-544-8186
dr.natale@gmail.com

Deb Cardinal, RN
512-431-4868

Sponsors / Collaborators
Texas Cardiac Arrhythmia Research Foundation
NCT Number
NCT04352764
MeSH Terms
COVID-19