RESULT IN 15 MIN. FACT SHEET-3 FOR PATIENTS
(Continuation. For beginning please see SHEET-1-2)
What are the differences between antigen tests and other COVID-19 tests?
There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection.
If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test is needed, and when you should discontinue home isolation.
If you will not have an additional test to determine if you are contagious, the CDC currently recommends that you should stay home until three things have happened:
- You have had no fever for at least 72 hours (that is three full days of no fever without the use of medicine that reduces this symptom)
- Other symptoms have improved (for example, when your cough or shortness of breath has improved)
- At least 10 days have passed since your symptoms first appeared.
For more information, the CDC has provided guidelines on how to prevent the spread of COVID-19 if you are sick: https://www.cdc.gov/coronavirus/2019-ncov/downloads/sick-with-2019-nCoV-fact-sheet.pdf
Is this test FDA-approved or cleared?
No. This test has not yet been approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA).
The EUA for this test 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 for the detection and/ or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs unless it is terminated or revoked by FDA (after which the test may no longer be used).