COVID-19 At-Home Test

COVID-19 At-Home Test

The COVID-19 At-Home Test: Accuracy Matters

95.3% relative sensitivity and 100% relative specificity



The accuracy of the 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.

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 COVID-19 At-Home Test detects COVID-19, including the Omicron and Delta variants.

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Instructions for Use

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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.

 

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Rapid Antigen Test

Frequently Asked Questions

General Questions

General Questions

 

The 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.

 

The test can quickly and reliably identify the presence of SARS-CoV-2 or lack thereof. The testing can be performed without specific training and in the comfort of one’s home.

COVID-19 antigen tests perform best when the viral load is at its highest during an infection. Outside of this window, such as at the start of the infection, or late infection, the test may not detect the virus. Therefore, regular testing (such as every few days) increases the chance of detecting COVID-19.

The self test is available for use for ages 2 and up. Individuals ages 14 years and older can self-collect. An adult must collect the sample for individuals ages 2 through 13. 

No, this test is authorized for non-prescription home use. 

Antigen tests are fairly accurate, particularly when someone is experiencing symptoms and their viral load is very high. However, they can be less accurate when someone has a lower viral load, such as in someone without symptoms. This could lead to false-negative test results. If you suspect you have COVID-19, test twice over three days with at least 24 hours (no more than 48 hours) between tests.

Test performance can be impacted if the COVID-19 At-Home Test is used while it is still cold from being left outside in freezing temperatures. The 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.

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.

Kit Components

Kit Components

 

Each test kit contains everything you need in order to perform  a test. The components that you need to perform a test are:

 

 

Test kits with damaged or missing components should not be used. Use a new test kit containing each component described in the Quick Reference Instructions.

 

The COVID-19 At-Home Test is currently being distributed in kits containing components to perform four tests.

Test Specifications

Test Specifications

Relative sensitivity: 95.3%, Relative specificity: 100%

  • Relative sensitivity: Percent of samples with positive results that were also positive when tested with an FDA emergency use authorized comparator method

  • Relative specificity: Percent of samples with negative results that were also negative when tested with an FDA emergency use authorized comparator method

Test results are available 20-30 minutes after performing the test procedure. Test results read after 30 minutes may be inaccurate.

The manufacturing and expiry date can be found on the label of the kit box and on the back of the foil pouches inside the test kit.

No, the test should not be used when the expiration date has passed.

The COVID-19 At-Home Test detects SARS-CoV-2, including current variants of concern including Omicron and Delta variants, among others. 

Firmly and slowly rotate the swab at least 5 times, brushing against the inside walls of the nostril, for a total of 15 seconds. Do not spin the swab. Gently remove the swab and, using the same swab, repeat in the second nostril with the same end of the swab. 

No, the sample must be collected from both nostrils using the same swab.

Yes, the COVID-19 At-Home Test can be used by vaccinated individuals. 

How to Handle the Test

How to Handle the Test

The test should be stored in a dry, cool place without direct sunlight exposure.

No. Swabs must be sterile for your own safety.

 

According to the Quick Reference Instructions, exactly 4 drops of the extracted sample should be added to the test device. If more than 4 drops are added and the subsequent result is negative, repeat the testing with a new test strip to confirm the results.

 

No. Inaccurate test interpretations may occur if results are read before 20 minutes or after 30 minutes.

Dispose of the test in the household trash. Do not flush or pour liquids down a drain.

Result Interpretation

Result Interpretation

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.

If you suspect that you have an infection (i.e., if you have prolonged symptoms or if your symptoms are worsening), contact your doctor/primary care physician. 

 

Carefully read the Quick Reference Instructions and repeat the test on a different test device. If your test result is still invalid, please contact your doctor/primary care physician.. 

 

As long as you can see the control line visible with the naked eye, there is no concern and the test should be considered valid.

What's In the Box?

COVID-19 At-Home Test

Kit content overview

Your COVID-19 At-Home Test kit contains the following components:

  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

Contact Us

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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. COVID-19 At-Home Test Package Insert
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  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)
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  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)