ANTIBODY BASED TESTS FOR SARSCoV-2 COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- prevalence of COVID-19 exposure [Mar-Dec 2020]
To evaluate the prevalence of COVID-19 exposure to healthcare staff, community 1st responders and patients. and patient population within a subspecialty
Secondary Outcome Measures
- correlation between the test results with the presence or lack of COVID-19 symptoms or illness [Mar-Dec 2020]
correlation between the test results with the presence or lack of COVID-19 symptoms or illness
- correlate pre-existing risk factors with test results and baseline symptoms [Mar-Dec 2020]
correlate pre-existing risk factors with test results and baseline symptoms
- correlate subsequent healthcare utilization with test results and baseline symptoms [Mar-Dec 2020]
correlate subsequent healthcare utilization with test results and baseline symptoms
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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An employee of Texas Cardiac Arrhythmia Or
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. David's Medical Center | Austin | Texas | United States | 78705 |
Sponsors and Collaborators
- Texas Cardiac Arrhythmia Research Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TCAI_COVID-19