Pilot COVID-19 At-Home Test

The Pilot COVID-19 At-Home Test 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 with symptoms of COVID-19 within the first 6 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 6 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 14 years or older, or adult-collected anterior nasal 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.

In addition to requirements set by the travel provider, please refer to the CDC guidelines on requirements for proof of negative COVID-19 test or documentation of recovery from COVID-19.

The Pilot COVID-19 At-Home Test, distributed by Roche, has been granted another three month shelf-life extension by the U.S. Food and Drug Administration (FDA). This extends the shelf-life of the tests to a total of twelve months.

To confirm the expiration date of your test, access our convenient search tool to find your test by its lot number. 

No, the test should not be used when the expiration date has passed. To confirm the expiration date for your COVID-19 At-Home Test, access our convenient search tool to find your test by its lot number.

A positive test result means it is very likely that you have COVID‑19. Refer to your healthcare provider for more information and refer to federal, state, and local guidelines.

A negative test result indicates no antigens for SARS-CoV-2 were detected. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19, and negative results are presumptive and may need to be confirmed with a molecular test. This means that you could possibly still have COVID-19 even though the test is negative. If you test negative and continue to experience symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider immediately. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. If you are concerned about your COVID-19 status after testing or think you may need follow up testing, please contact your healthcare provider.

Test performance can be impacted if the Pilot COVID-19 At-Home Test is used while it is still cold from being left outside in freezing temperatures. The Pilot COVID-19 At-Home Test should be stored at temperatures between 36-86 °F (2-30 °C ) and brought to room temperature (59-86 °F /15-30 °C) before use. If the test is delivered in below freezing temperatures, the FDA recommends bringing the package inside your home and leaving it unopened at room temperature for at least two hours before opening it to ensure appropriate test performance. Once the package is at room temperature, it can be used in accordance with authorized instructions. If the test lines appear as described in the instructions, the test is performing appropriately. If the lines do not appear as specified by the instructions, then the results may not be accurate. For more information on this topic, please visit the FDA website.