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iHealth COVID-19 Antigen Rapid Test (OTC), (90 Kits) 180 Tests/Case Learn About iHealth COVID-19 Antigen Rapid Test The iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. Please refer to the downloads section below for a full test facts sheet, FDA-EUA documentation, and the instructions for use documents. For use with anterior nasal swab specimens For in vitro Diagnostic Use Only This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA) Does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. FAQs About the iHealth COVID-19 Antigen Rapid Test How does the iHealth COVID-19 Test work? The iHealth COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. When COVID-19 is present in the body, your nasal secretions can also contain the SARS-CoV-2 virus (the virus that causes COVID-19). The iHealth COVID-19 Antigen Rapid Test is able to detect small parts of theSARS-CoV-2 virus, known as N protein or antigens, in your nasal secretions. For a demonstration on how the iHealth COVID-19 test works, watch this video What are the differences between a COVID-19 antigen, molecular and antibody test? There are different kinds of tests for detecting COVID-19. 1) Molecular tests (also known as PCR tests)detect genetic material from the virus. 2) 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. Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been made by your immune system in response to a previous COVID-19 infection or vaccination. Antibody tests are not suitable to diagnose an active COVID-19 infection. Is this iHealth COVID-19 Antigen Rapid Test Kit FDA approved or cleared? No. Currently, the iHealth COVID-19 antigen rapid test is not yet FDA approved or cleared. The FDA can issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test is supported by the Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify 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 the emergency of IVDs, unless it is terminated or authorization is revoked by FDA (after which the test may no longer be used). What are the approved alternatives for antigen tests? There are no approved alternative COVID-19 antigen tests. The FDA has issued EUAs for other tests that can be found at: FDA.gov What is the age range for the iHealth COVID-19 test? The iHealth COVID-19 antigen rapid test is authorized for nonprescription at home use with self-collected (unobserved) anterior nasal swab specimens from individuals aged 15 years and older or with adult-collected anterior nasal swab samples from individuals aged 2 years or older. What is serial testing? Serial testing is when a single person has been tested for COVID-19 more than once. Because antigen tests are less sensitive than other COVID-19 tests and false results may occur, repeated testing may identify individuals with COVID-19 more reliably than a single test. By repeating testing, it may be possible to more quickly identify cases of COVID-19 and reduce spread of infection. Additional testing with molecular COVID-19 tests may be necessary, depending on your individual risk factors and test results. It is important that you work with your healthcare provider to help you understand the next steps you should take. Serial testing (i.e., testing everyday or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms. Testing for asymptomatic individuals should be performed at least twice over three days, with at least twenty-four hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing. Will I always need to perform two COVID tests? If you have COVID-19 symptoms and are within the first 7 days of symptom onset, you can use one single iHealth COVID-19 Antigen Rapid Test. You may also choose to perform two tests if you wish. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. If you do not have COVID-19 symptoms or have been having symptoms for more than 7 days, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests. Can this test be used as proof of a negative COVID-19 test for travel? No. Currently, the iHealth COVID-19 Antigen Rapid Test cannot be accepted as proof of a negative COVID-19 test for travel. Will the test work if I don't have any symptoms of COVID-19? Yes. If you do not have COVID-19 symptoms, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests. Should people who are vaccinated use the iHealth COVID-19 test? Individuals can utilize the iHealth COVID-19 rapid antigen test, as needed, regardless of their vaccination status. Is iHealth’s COVID-19 test covered by insurance? This COVID-19 test is available for self-testing at home without a prescription. Please consult with your health insurance provider to make sure if using the iHealth COVID-19 test will be covered. Is a prescription required to perform this COVID-19 test? You do not need a doctor’s prescription to purchase and perform this COVID-19 test at home. Need more information about the iHealth COVID-19 Antigen Rapid Test? Downloads: FDA Emergency Use Authorization Documentation Fact Sheet For Healthcare Providers Healthcare Provider Instructions For Use Document Home Testing Instructions For Use Document FDA Authorization Letter: https://www.fda.gov/media/153925/download