What does it mean to be EUA authorized?
The test has gone through the
rigorous review process of the United States Food and Drug Administration (FDA)
against an extensive set of well-established
requirements/parameters; authorization means the covidSHIELD saliva test fulfilled all the requirements of the
FDA before being authorized for use
in CLIA-certified laboratories for COVID testing, specifically during public
health emergencies such as the current
COVID-19 pandemic.
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Is the covidSHIELD test authorized by the FDA?
Yes! The covidSHIELD test has had FDA Emergency Use Authorization ("EUA") since March 1st, 2021. The EUA was updated to increase the scope of the test on April 2nd, 2021. Information about the covidSHIELD EUA from the FDA can be found here: Most ...
What do my results mean?
The covidSHIELD test looks for three markers which are specific to the SARS-CoV-2 virus plus a control substance which is added during the testing process. The results of the test can be interpreted as follows: Negative – The test did not find any of ...
What does X or U option mean for the Sex field in the patient roster?
o X is used to indicate the patient does not identify as Male or Female o U is used to indicate the patient does not wish to disclose this information
Do I need to have another test to confirm my covidSHIELD results
No. Follow-up testing is not needed. The covidSHIELD saliva-based test is a definitive rtPCR diagnostic test authorized by the FDA.
Can I take this test at home?
At the present time, the SHIELD Illinois test must be completed in the testing room under observation of the collection staff. SHIELD must maintain chain of custody due to FDA, EUA, and CLIA lab regulations.