COVID-19
Antigen Home Test
EASY TO USE – simple nasal swab test
FAST RESULTS – in 15 Minutes
SIMPLE. ACCESSIBLE. RAPID. SECURE.
COVID-19 Antigen Home Test – testing right from the privacy and comfort of your own home!
The MaximBio ClearDetect™ 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 nasal swab test you can do anywhere & anytime. Know your COVID-19 status in as little as 15 minutes!
The MaximBio ClearDetect™ COVID-19 Antigen Home Test is intended for non-prescription self-use and/or as applicable, for an adult lay user testing another aged 2 years or older in a non-laboratory setting. The MaximBio ClearDetect™ COVID-19 Antigen Home Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.
Now available at select retailers
HOW IT WORKS
MaximBio ClearDetect COVID-19 Antigen Test Tutorial
1. SWAB
Collect Nasal Swab Specimen
2. MIX
Mix swab with the Buffer in the tube
3. INSERT
Snap off swab handle, insert test strip, & cap tube
4. RESULTS
Wait 15 minutes and read results visually
Note: Before using the test, it is important to read the user instructions for more detailed instructions and additional details (included in the package).
ClearDetect COVID-19 Antigen Home Test FAQ
1. What are the known and potential risks and benefits of this test?
Potential risks include:
- Possible discomfort during sample collection.
- Possible incorrect test results (see Warnings and Result Interpretation sections for more information).
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.
- For more information on EUAs go here: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
2. What is the difference between an antigen and molecular test?
There are different kinds of tests for the virus that causes COVID-19. Molecular tests detect genetic material from the virus. Antigen tests, such as the MaximBio ClearDetectTM COVID-19 Antigen Home Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a negative result when you have COVID-19 than a molecular test would.
3. How accurate is this test?
Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at www.maximbio.com.
4. What if I have a positive test result?
A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. You should self- isolate from others and contact a healthcare provider for medical advice about your positive result.
5. What if I have a negative test result?
A negative test result indicates that antigens from the virus that causes COVID-19 were not detected in your sample. However, if you have symptoms of COVID-19, and your first test is negative, you should test again in 48 hours since antigen tests are not as sensitive as molecular tests. If you do not have symptoms and received a negative result, you should test at least two more times with 48 hours in between tests for a total of three tests. If you have a negative result, it does not rule out SARS-CoV-2 infection; you may still be infected and you may still infect others. It is important that you work with your healthcare provider to help you understand the next steps you should take.
6. What does an invalid test result mean?
An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and you should test again with a new test.
FOR USE UNDER FDA EMERGENCY USE AUTHORIZATION (EUA) ONLY
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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.