Starting Price: $84.00
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What are the known and potential risks and benefits of the test?
Potential risks include:
Possible discomfort or other complications that canhappen during sample collection.
Possible incorrect test result (see below for moreinformation).
Potential benefits include:
The results, along with other information, canhelp your healthcare provider make informedrecommendations about your care.
What does it mean if I have a positive test result?
If you have a positive test result, it is possible that youhave or previously had COVID-19 and that you havedeveloped an antibody response to the virus. Yourhealthcare provider will work with you to determinehow best to care for you based on the test resultsalong with other factors of your medical history, yoursymptoms, possible exposures, and geographiclocation of places you have recently traveled. There isalso a chance that this test can give a positive resultthat is wrong (a false positive result).
Even a high-performing antibody test when used in apopulation without many cases of COVID-19 infectionmay produce as many or more false results as truehas been infected is very small. Your healthcare providerwill work with you to determine the likelihood of falseresult.
Is this test FDA-approved or cleared?
Yes. This test has FDA EUA approval. The FDA can make tests available under an emergency accessmechanism called an Emergency Use Authorization(EUA). This test is supported by the Secretary ofHealth and Human Services (HHSs) declaration thatcircumstances exist to justify the emergency use ofinvitro diagnostics for the detection and/or diagnosisof the virus that causes COVID-19. This EUA willremain in effect (meaning this test can be used) forthe duration of the COVID-19 declaration justifyingemergency of IVDs, unless it is terminated or revokedby FDA (after which the test may no longer be used).
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