Pilot COVID-19 At-Home Test

NOTICE: Roche is pleased to introduce the Pilot COVID-19 At-Home Test, previously known as the COVID-19 At-Home Test. As we transition to this new brand, customers may receive a product with the previously authorized COVID-19 At-Home Test labeling. The Pilot COVID-19 At-Home Test kits contain the same easy-to-use rapid antigen tests to provide you the confidence to take control.

The Pilot COVID-19 At-Home Test: Accuracy Matters

Pilot COVID-19 At-Home Test
Pilot COVID-19 At-Home Test

The accuracy of the Pilot COVID-19 At-Home Test provides you with a result you can trust and the confidence you need to take control.  When you need a COVID-19 test, Accuracy Matters.

Pilot COVID-19 At-Home Test is an easy-to-use, accurate and reliable rapid antigen test that delivers results in as few as 20 minutes. It can be self-administered by individuals ages 14 and up, and adults can administer the test for children ages 2 to 13.

Roche continues to monitor the evolution of SARS-CoV-2 variants and remains committed to providing high-quality testing solutions that aid in the diagnosis of patients with SARS-CoV-2. The Pilot COVID-19 At-Home Test detects COVID-19, including the Omicron and Delta variants.

What comes with the Pilot COVID-19 At-Home Test

COVID-19 At-Home Test

infographic

 

 

  1. Test device (x4)
  2. Buffer tube holder (x1)
  3. Nasal swab (x4)
  4. Tube with liquid (x4)
  5. Nozzle cap (x4)
  6. Quick Reference Instructions
 
Each kit comes with everything you need to complete your COVID-19 test, including full illustrated instructions.

Instructions for Use

Form Successfully Submitted!
Thank you for your submission!
text

infographic

Interpreting the Results

COVID-19 At-Home Test

Positive Result

If a test line (T) is visible together with a control line (C), this means that the result is positive. Look carefully at the result: The test should be considered positive if two lines are visible - even if they are faint. 

A positive test result means it is very likely that you have COVID‑19. 

Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding self‑isolation. Your doctor may require you to undergo a molecular PCR test to confirm the result. There is a very small chance that this test can give a positive result that is incorrect (a false positive).

COVID-19 At-Home Test

Negative Result

If a control line (C) is visible (regardless of how faint it is) and a test line (T) is not visible, this means that the result is negative. It is unlikely that you have COVID‑19. 

However, even if your test is negative, continue to observe all hygiene and safety measures. If you suspect that you have an infection (i.e., if you have prolonged symptoms or if your symptoms worsen), contact your doctor/primary care physician. You may have another infection, or your test result may be false. Negative results do not rule out COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If you do not have COVID-19 symptoms and your result is negative, you should test again with at least 24 hours and no more than 48 hours between tests.

COVID-19 At-Home Test

Invalid Result

If a control line (C) is not visible, the result must be considered invalid. The test is not working correctly and you should perform another test using a different test kit. 

You may have performed the test incorrectly. Carefully read the Quick Reference Instructions and repeat the test. If your test result is still invalid, please contact your doctor or a COVID‑19 test center.

Check below to see when your

Pilot COVID-19 At-Home Test expires
 

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

Form Successfully Submitted!
Thank you for your submission!
text

Where to find your lot number on your test kit box

Where to find your lot number on the Pilot COVID-19 At-Home Test Kit box

 

Are you a Healthcare Professional, Educator, Retailer, or Employer Group?

 

Visit this page for more information on bulk supply and order fulfillment.

 

Learn More

Rapid Antigen Test

Frequently Asked Questions

 

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 a shelf-life extension of three months by the U.S. Food and Drug Administration (FDA). This extends the shelf-life of these tests to a total of nine months from the manufactured date. 

To confirm the shelf-life for 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.

Contact Us

infographic

Form Successfully Submitted!
Thank you for your submission!
text

infographic

Form Successfully Submitted!
Thank you for your submission!
text

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.

References
 

  1. Pilot COVID-19 At-Home Test Package Insert
  2. Su S, Wong G, Shi W, et al.-Trends Microbiol. 2016;24(6):490–502.-2016-Elecsys Anti-SARS-CoV-2 -L (v1.0)
  3. Zhu, N., Zhang, D., Wang, W. et al.-N Engl J Med 382(8) 727-733-2020-Elecsys Anti-SARS-CoV-2 -Lit (v1.0)
  4. Chan, J.F., Yuan, S., Kok, K.H., To, K.K., Chu, H., Yang, J. et al.-Lancet. 395, 514–523.-2020- El (v1.0)
  5. U.S. CDC. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. Published April 2, 2021. Accessed June 11, 2021. 
  6. WHO. https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations. Published March 29, 2020. Accessed June 11, 2021
  7. Kampf, G., Todt, D., Pfaender, S., Steinmann, E.-J Hosp Infect. 104(3), 246–251.-2020- Elecsys Ant (v1.0)
  8. Letko, M., Marzi, A., Munster, V. (2020).-Nat Microbiol. 1–8. doi:10.1038/s41564-020-0688-y.-2020- (v1.0)
  9. Hoffmann, M., Kleine-Weber, H., Schroeder, S. et al.-[published online ahead of print, 2020 Mar 4]. (v1.0)
  10. WHO. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200403- sitrep-74-covid-19-mp.pdf. Published April 3, 2020. Accessed June 11, 2021. 
  11. Lauer SA et al.-Ann Intern Med 2020;172(9):577-82-The Incubation Period of COVID-19 (v1.0)
  12. Rothe, C et al-N Engl J Med 2020;382(10):970-971-2020-Lab Infectious Diseases Respiratory tract infec (v1.0)
  13. Kupferschmidt K-Science. https://www.sciencemag.org/news/2020/02/paper-non symptomatic-patienttrans (v1.0)
  14. Bai Y et al-JAMA 2020;323(14):1406-1407-2020-Lab Infectious Diseases Respiratory tract infections Co (v1.0)
  15. Mizumoto K et al-Euro Surveill 2020;25(10):2000180.-2020-Lab Infectious Diseases Respiratory tract (v1.0)
Form Successfully Submitted!
Thank you for your submission!
text