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COVID-19

At-Home Test

Easy to Use - simple nasal swab test

Fast Results - in 15 min or less

Available under FDA Emergency Use Authorization. Only available in the US.

Testing made easy

COVID-19 Antigen Self Test - Right in the comfort of your own home!

The MaximBio COVID-19 Antigen Home Test is an antigen test that allows you to detect proteins from the virus that causes COVID-19.

 

Made easy - An over the counter, no prescription needed test you can do yourself and get results in 15 minutes, anywhere!

 

The MaximBio COVID-19 Antigen Home Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms tested twice over three days with at least 36 hours between tests.

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HOW IT WORKS

1

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SWAB

2

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MIX

3

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INSERT TEST

4

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GET RESULTS

Note: Before using the test, it is important to read the instructions for use (IFU) for more detailed instructions (included in the package).

 

WHERE TO FIND

 

FREQUENTLY ASKED QUESTIONS

Who can use this test?


This test is suitable for anyone ages 2 and up with or without symptoms.




Does this test hurt?


No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a healthcare provider.




What is the difference between an Antigen and Molecular Test?


An antigen test, such as the MaximBio COVID-19 Antigen Home Test, detects proteins from the virus. Molecular tests detect genetic material from the virus. Antigen tests are very specific for the virus, but not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider on whether an additional test is necessary and if you should continue isolating at home.




What is Serial Testing?


COVID-19 serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce the spread of infection.




What is COVID-19?


COVID-19 is casued by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. A full list of symptoms of COVID-19 can be found at the following link: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.




What are the known and potenital risks and benefits of this test?


Potential risks include:

  • Possible discomfort during sample collection
  • Possible incorrect test results (see Results section)

Potential benefits include:

  • The results, along with other information, can help your healthcare provider make informed recommendations about your care.
  • The results of this test may help limit the spread of COVID-19 to your family and others in your community.




What is Emergency Use Authorization (EUA)?


  • FDA emergency access mechanism.
  • Health & Human Services declare when circumstances exist to justify use of diagnostics under EUA during public health emergencies.
  • It is not full FDA clearance or approval and is temporary, until the declaration is terminated or revoked.




What do I need to know from my results from Serial Testing?


If your first or second test is positive, the proteins from the virus causing COVID-19 has been found in your sample and you likely have COVID-19. If you test positive with the MaximBio COVID-19 Antigen Home Test, you should self-isolate and seek follow-up care with your healthcare provider to determine the next steps you should take. You may need additional testing, depending on your personal health history and other factors.

If your first test is negative, you should test again in 24-36 hours. If both your fist and second tests are negative, you may not have COVID-19, however, you should follow up with your healthcare provider if you are at high risk for COVID-19 infection. If you test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider. For example, your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. It is important that you work with your healthcare provider to help you understand the next steps you should take.




How accurate is this test?


Based on the interim results of a clinical study where the MaximBio COVID-19 Antigen Home Test was compared to an FDA authorized high sensitivity SARS-CoV-2 test, MaximBio COVID-19 Antigen Home Test correctly identified X% of positive specimens and X% of negative specimens.

The performance of this test is still being studied in patients without signs and symptoms of respiratory infection and for serial screening. Performance may differ in these populations.

Based on this information, negative results may require additional testing to confirm your result. Please talk to your healthcare provider to determine if you need additional testing.