This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies.
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 Type
OBSERVATIONAL
Enrollment
5,000
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
St. David's Medical Center
Austin, Texas, United States
RECRUITINGprevalence of COVID-19 exposure
To evaluate the prevalence of COVID-19 exposure to healthcare staff, community 1st responders and patients. and patient population within a subspecialty
Time frame: Mar-Dec 2020
correlation between the test results with the presence or lack of COVID-19 symptoms or illness
correlation between the test results with the presence or lack of COVID-19 symptoms or illness
Time frame: Mar-Dec 2020
correlate pre-existing risk factors with test results and baseline symptoms
correlate pre-existing risk factors with test results and baseline symptoms
Time frame: Mar-Dec 2020
correlate subsequent healthcare utilization with test results and baseline symptoms
correlate subsequent healthcare utilization with test results and baseline symptoms
Time frame: Mar-Dec 2020
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