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Pilot COVID-19 At-Home Test

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

Pilot COVID-19 At-Home Test

(The test’s ability to detect a true positive)

Pilot COVID-19 At-Home Test

(The test’s ability to detect a true negative)

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. The 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. Approved for the detection of COVID-19 with or without symptoms for ages 2 and up. Adult collection required for children 2-13 years old.

The package of four tests easily allows for family and/or serial testing. FSA/HSA eligible. The Pilot COVID-19 At-Home Test detects all known variants of COVID-19, including the Omicron and Delta variants.

With over 125 years of experience, Roche continues to search for better ways to prevent, diagnose and treat diseases to make a sustainable contribution to society. The Pilot COVID-19 At-Home Test brings the brand healthcare providers trust to your home.

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

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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.  You do not need to perform repeat testing if you have a positive result at any time.

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 the control line (C) is visible, but the test line (T) is not visible, the test is negative.

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.

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.

navify pass on mobile phone

navify Pass

A personal COVID-19 application

Allowing an easy digitalization of a Self Test result.

navify Pass allows individuals to register a self performed Pilot COVID-19 At-Home Test on their mobile device. The submitted test result is visible in the navify Pass app as a self performed test result and can be transmitted to public health agencies for reporting.

Find out more about the navify Pass app to record, share, and report test results here.

 

navify Pass can be downloaded from both the App Store and Google Play.

navify Pass is not a medical device; it does not interpret test results nor is the primary source of test data.

navify is a trademark of Roche.

Check below to see when your

Pilot COVID-19 At-Home Test expires
 

On December 11, 2023, the U.S. Food and Drug Administration (FDA) granted an additional four (4) month shelf life extension to the Pilot COVID-19 At-Home Test distributed by Roche. This authorization extends the test’s shelf life from twelve (12) months to a total of sixteen (16) months.

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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. 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.

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)
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