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. Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.

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. You do not need to perform repeat testing if you have a positive result at any time. Refer to your healthcare provider for more information and refer to federal, state, and local guidelines.

To increase the chance that the negative result for COVID-19 is accurate, you should:

• Test again in 48 hours if you have symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if you do not have symptoms on the first day of testing.

A negative test result indicates that the virus that causes COVID-19 was not detected in your sample. A negative result is presumptive, meaning it is not certain that you do not have COVID-19. You may still have COVID-19 and you may still be contagious. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR. If you test negative and continue to experience COVID-19-like symptoms, (e.g., fever, cough, and/or shortness of breath) you should seek follow up care with your doctor/primary care physician.

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.