#

Contact us
Home » Disease Areas » Respiratory Disease Diagnostics » COVID-19 – SARS-CoV-2 » COVID-19 Antigen Home Test

ImmuView® COVID-19 Antigen Home Test 

The ImmuView® COVID-19 Antigen Home Test is designed
to let you easily perform a COVID-19 self test.

FDA EUA – OTC COVID-19 Antigen Home Test for Ages 2 and Older: The ImmuView® COVID-19 Antigen Home Test is intended for the detection of SARS-CoV-2 (the virus that causes COVID-19). This self-administered test is for individuals ages 14 years and older. Adult collection is required for testing children ages 2-13 years old.

ImmuView® COVID-19 Antigen Home Test 
Instructions for use
Package Inserts
Monitoring of SARS-CoV-2 variants
Fact Sheet
CDC Guidelines

Items in your kit

Items in your kit

Test with Confidence

Fast Results in 15 minutes

Test with Confidence

How To Interpret Your Results?

Positive Test- course of action: The test is positive when you have two visible lines visible.
The C line shows that the control worked. The Ag line in shows that COVID-19 virus has been detected. A positive antigen test develops a C-line and an Ag line. Every visible Ag line is a positive result regardless of band intensity.

Positive Test- course of action

Negative Test- course of action: The test result is negative when you see a line in front of the C only. A negative antigen test only develops a C-line. If your test is negative, but you’re experiencing symptoms of COVID-19, please see your healthcare provider for next steps.

Negative Test- course of action

Invalid Test- course of action: If the test does not work as, it should (e. g. by not developing a line in front of C), the test must be considered INVALID. No C-line means your result is invalid. Try taking a new test. If you get the same result, please contact us through here.

Invalid Test- course of action

Do’s and Don’ts

DO’S 

  • Swab both nostrils using the same swab.
  • Check the expiration date of the test before using it.
  • Use a flat, well-lit surface to perform your test.
  • Clean your test surface before opening the test kit.
  • Blow your nose before testing.
  • Wash your hands with soap and water or sanitize before starting testing.
  • Read the instructions before testing and follow the steps in order.

Don’ts

  • Do Not use the kit if the items are damaged, opened, or missing.
  • Do Not touch your cheeks, teeth, gums or any other surfaces with the fabric tip of the swab.
  • Do Not insert the swab any deeper if you feel resistance or pain.
  • Do Not move the cassette after adding the 3 drops of sample.
  • Do Not reuse any test item(cassette, buffer, nozzle, and swab).
  • Do Not throw the kit box away for 2 and 5 test kits until all tests are used up.
  • Do Not read results before 15 minutes and past 30 minutes.
  • Do Not use on anyone under two years of age.
  • Do Not use/mix items from other test kits.

See How Easy It is To Perform the ImmuView® COVID-19 Antigen Home Test

Customer Support

If you have a question about your test and would like to request support from our Technical Support team, please fill out the form below.

To help us process your information quickly and effectively, please provide as much information as possible. If you would like to speak to one of our Technical Support team members, please call +1-833-919-0617




    FAQ
    What is COVID-19?

    COVID-19 is caused by the SARS-CoV-2 virus, a new virus in humans causing a contagious respiratory illness. COVID-19 can present with mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age with underlying medical conditions have a higher risk of severe illness from COVID-19. Severe outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A complete list of symptoms of COVID-19 can be found at the following link: https://www.cdc.gov/covid/signs-symptoms/?CDC_AAref_Val=https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

    What is the difference between an antigen and molecular test?

    There are different kinds of tests for the SARS-CoV-2 virus that causes COVID-19. Molecular tests
    detect genetic material from the virus. Antigen tests, such as the ImmuView® 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 false negative result when you have COVID-19 than a
    molecular test would.

    What is EUA?

    The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Services (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19. The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs unless terminated or revoked (after which the test may no longer be used).

    Where can I learn more about COVID-19 test reimbursement?

    As of January 15, 2022, over-the-counter COVID-19 tests approved under the FDA Emergency Use Authorization (EUA) are eligible to be reimbursed by your private insurance. Learn more here.
    For more information on Medicare and OTC COVID-19 Tests, click here