What is the MediConcepts Covid-19 Antigen Detection self test?

The MediConcepts Covid-19 is a rapid antigen test that detects the SARS-CoV-2 antigen in nasal swabbed specimens. This compact, portable test is intended for at-home or on-the-go self-testing use. This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization ( EUA)

This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens;
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.

What type of test is this?

This test uses a nasal swab in both nostrils to take a sample and test for the presence or lack of presence of Covid-19 antigens. For a demonstration on how this test works, please watch

Where can I get a MediConcepts At-Home Covid-19 Test?

You can order the MediConcepts At-Home Covid-19 Test from this website:

How many times must I test with the MediConcepts Covid-19 Antigen Detection At-Home Test Kit?

The MediConcepts Covid-19 Antigen Detection At-Home Test Kit is designed to give you accurate results with 1 test. It is suggested for you to test again if your test is Invalid and re-test again if you show symptoms after the first test being Negative.

Is there an age requirement to take this test.

This test is acceptable for use on people 2 years old or older with adult supervision. It is recom-mended that a person be above the age of 14 before administering this self test alone.

If I do not have Covid-19 symptoms, will the test work?

Anyone is eligible to take this test whether they are symptomatic or have no visible symptoms of Covid-19 at all.

Do I have to swab my nasal passages or can I swab my throat or my ear?

Please only swab your nose to collect a sample and follow all instructions. This test does not work if you swab your ear or throat.

If I lose the swab that comes in my kit can I use another type of cotton swab like a Q-Tip?

The swab provided with the kit is packed in a sealed package. Please do not use any other swab except the one that is included in your kit. If you need customer assistance email the helpdesk at: Contact@MediConcepts.net

How deep do I insert the swab into my nostril?

The test is designed for you to insert the swab one half inch to three quarters of an inch into your nostril. This may be shorter for small children. PLEASE NOTE: If the swab is not inserted deep enough it could result in a false-negative reading.

Do I have to swab both nostrils?

Yes. To ensure an accurate result, please swab both nostrils according to the instructions.

How long do I swab each nostril?

Firmly rub and rotate the swab in a circular motion around the inside wall of the nostril 5 full rotations. Make sure that you collect any nasal drainage with the swab. For a more detailed guide to this process please read the instruction manual or watch the instructional video.

I cannot find my instructions or instructions in my language, how should I proceed?

If you cannot find your instructions or if the instructions are not in your language, you can email the helpdesk at: Contact@MediConcepts.net You can also read the instruction manual here or watch the instructional video.

There are parts missing from my MediConcepts Covid-19 Self Test. What to I do?

If you cannot find any part that should be included in your kit, please contact the company you purchased from or email the helpdesk at ( Contact@MediConcepts.net)

What do I do if I spill my solution?

If you spill your solution, please do not use your test. Please buy or use a new test kit .

How long do I stir the swab in the test solution?

You should insert the swab into the solution and rotate the swab in the solution for 5 rotations. Then squeeze the extraction tube with your fingers and move the swab up and down three times to wring out any sample solution from the swab. After that, remove the swab and discard it.

How much solution do I put into the loading well – marked S – on the testing device?

After firmly putting the tube cap on the sample extraction tube, gently squeeze the tube and add 3 drops of the sample solution into the loading well – marked S.

How long do I wait before I get the results?

Your results will be available in 15 minutes. PLEASE NOTE: You must check for results between 15 and 20 minutes. Results after 30 minutes may not be accurate and is considered as INVALID RESULTS.

Is this test painful?

This test is not painful and should not cause pain in any way. The unfamiliar feeling of the swab inside your nostril may cause some discomfort. If for any reason you do feel pain, please stop the test and seek advice from a healthcare professional.

Who should NOT use this test?

This test is not to be used on children under 2 years old. Also, any individual who is prone to nosebleeds or has had head injuries or surgeries in the past 6 months should use caution or avoid using the test.

Are there any known risks or benefits of this test?

The potential risks of using the MediConcepts™ Covid-19 Self Test are: possible discomfort dur-ing the nasal swab process.

The potential benefits of using this test are: The test, along with other information, can help you and your healthcare provider make informed decisions about your care, and the information you receive from this test may help you take the necessary steps to help prevent the spread of Covid-19.

If the test result on the device is very light or pinkish is the test result still valid?

If you see a red, pink, or very light line at the T-line, the test result is positive and the test is still valid.

What is the difference between Antigen, Molecular, and Antibody tests?

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) de-tect genetic material from the virus. Antigen tests, such as the MediConcepts COVID-19 Anti-gen Home Test detect proteins from the virus. Antigen tests are very specific for the COVID-19 virus but are not as sensitive as molecular tests. This means that a positive result is highly accu-rate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test is necessary and if you should continue isolating at home.

Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been produced by your immune system in response to a previous COVID-19 infection or vac-cination. Antibody tests are not suitable for diagnosing an active COVID-19 infection.

For more information on the different kinds of COVID-19 tests, please visit: https://www.fda.gov/consumers/consumer- updates/coronavirus-disease-2019-testing-basics

What does a positive test result mean?

A positive test result means that antigens from COVID-19 were detected and it is very likely you currently have COVID-19. There is a very small chance that this test can give a positive result that is wrong (a false-positive result).

If you test positive you should self-isolate at home per CDC recommendations to stop spreading the virus to others. Please consult the CDC recommendations regarding self-isolation at www.cdc.gov/coronavirus. Seek follow-up care with your healthcare provider immediately. Your healthcare provider will work with you to determine how best to care for you based on your test result(s), medical history and symptoms.

What does a negative test result mean?

A negative test result indicates no antigens for COVID-19 were detected. It is possible for this test to give a negative result that is incorrect (a false-negative result) in some people with COVID-19. 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 infection status after test-ing or think you may need follow-up testing, please contact your healthcare provider.

What if my test result is invalid?

If you do not get a line at the C-line on your test device, you have an invalid test. An invalid test result indicates that not enough specimen volume was collected or incorrect test operation are the likely reasons for an invalid result. Please review the instructions again and repeat the test with a new test kit.

What is a false-positive and a false-negative test result?

A false positive is a test result that indicates a person has a specific disease or condition when the person actually does not have the disease or condition. A false-negative test result indicates a person does not have a specific disease or condition when the person actually does have the disease or condition. Incorrect specimen collection and sample preparation can result in false-negative and false-positive test results. Therefore, before you begin the test, it is very important to watch the instructional video, and read the instructions provided in the test package, and closely follow all instructions.

Is this test acceptable for travel? Can I use it for proof of Negative Covid-19 Test?

The type of testing and documentation required for your international or domestic air travel may or may not be acceptable based on your travel destination, airline, and state requirements. We recommend you contact your airline carrier or visit the CDC/TSA website, and view your local health department’s website for the latest requirements on the type of acceptable testing and documentation required for where you are traveling to.

I was vaccinated. Will this test work for me?

Yes. The MediConcepts™ COVID-19 Antigen Home Test is designed to detect Covid-19 Antigens whether you are symptomatic or not. It does not matter if you are vaccinated or not.

Can I reuse this test?

No, the MediConcepts™ COVID-19 Antigen Home Test is a single use test and should not be reused.

Is there a MediConcepts™ COVID-19 Antigen Home Test CPT code to bill insurance?

The test is available for self-test at home without a prescription. Please consult with your health insurance to find out if your test will be covered.

What is the nasal swab made of? Is it sterile?

The tip of the nasal swab is made of polyurethane foam and is sterile and safe to use as directed.

Should I refrigerate my MediConcepts COVID-19 Antigen Home Test?

No. Your MediConcepts COVID-19 Antigen Home Test is designed to optimally work at room temperature. There is no need to refrigerate it. If you received your delivery in a very cold out-door temperature, and the package got chilled or frozen, please allow it to warm up to room tem-perature before proceeding with your At-Home test.

I have a question that these FAQ’s did not answer, how can I get more information?

If you cannot find an answer to your question, you can review our website, the instruction manual here, or watch the instructional video. If you still cannot find your answer, please email the helpdesk at: Contact@MediConcepts.net