Rapid SARS-CoV-2 Antigen Test Card (FDA EUA Authorization)
Product Details
1. Product Introduction
The Rapid SARS-CoV-2 Antigen Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
2. FAQ
Q: WHAT IS COVID-19?
A: COVID-19 is an acute respiratory infectious disease caused by the SARS-CoV-2 virus, a novel Betacoronavirus. SARS-CoV-2 is mostly spread person-to-person, both by individuals with symptoms of COVID-19 and by infected people without symptoms. Based on the current knowledge, the incubation period is 1 to 14 days, mostly 4-5 days. Symptoms include fever, fatigue, and cough. For a full list of symptoms, see: https://www.cdc.gov/ coronavirus/2019- ncov/symptoms-testing/symptoms.html.
Q: WHAT DOES AN INVALID TEST RESULT MEAN?
A: If no control line shows up on the test, the result is invalid (even if any test line shows up). An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and the test should be run again, using all new test components.
Q: WILL THIS TEST HURT?
A: No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from your healthcare provider.
Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN TEST AND A MOLECULAR TEST?
A: There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests, such as the Rapid SARS-CoV-2 Antigen Test detect proteins from the virus. Antigen tests are very specific for the COVID-19 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 necessary and if you should continue isolating at home.
3. Statement
• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA;
• This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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