iHealth® Downloadable Resources

FDA EUA Letter
Fact Sheet for Health Providers
Healthcare Provider Instructions for Use
Quick Start Guide for Consumers

iHealth® About the test

How does the iHealth® COVID-19 Antigen Rapid Test work?

The iHealth ® COVID-19 Antigen Rapid Test is an antigen test. When COVID-19 is present in the body, your nasal secretions can also contain the SARS-CoV-2 virus (the virus that causes COVID-19). The iHealth ® COVID-19 Antigen Rapid Test is able to detect small parts of theSARS-CoV-2 virus, known as N protein or antigens, in your nasal secretions.

For a demonstration on how the test works, watch the instructional video here.

Will this test detect COVID-19 variants?

iHealth has completed testing on several heat inactivated variant strains and the iHealth® COVID-19 Antigen Rapid Test was able to detect the mutations. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

What are the differences between a COVID-19 antigen, molecular and antibody test?

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests)detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen test sare very specific for the virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. Another typeof test is an antibody test. A COVID-19 antibody test detects antibodies that have been made by your immune system in response to a previous COVID-19 infection or vaccination. Antibody tests are not suitable to diagnose an active COVID-19 infection.

For more information on COVID-19 testing, please see the following link:https://www.fda.gov/consumers/consumer-updates/coronavirus-disease-2019-testing-basics

Is this iHealth® COVID-19 Antigen Rapid Test Kit FDA approved or cleared?

No. This test is not yet approved or cleared by the United States FDA. FDA can issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or authorization is revoked by FDA (after which the test may no longer be used).

What are the approved alternatives?

There are no approved available alternative antigen tests. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

What is the age range for the test?

This test is authorized for nonprescription home use with self-collected (unobserved) anterior nasal swab specimens from individuals aged 15 years and older or with adult-collected anterior nasal swab samples from individuals aged 2 years or older.

What is serial testing?

Serial testing is when a single person is tested for COVID-19 more than once. Because antigen tests are less sensitive than other COVID-19 tests and false results may occur, repeated testing may identify individuals with COVID-19 more reliably than a single test. By repeating testing, it may be possible to more quickly identify cases of COVID-19 and reduce spread of infection. Additional testing with molecular COVID-19 test may be necessary, depending on your individual risk factors and test results. It is important that you work with your healthcare provider to help you understand the next steps you should take. Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms.

Testing for asymptomatic individuals should be performed at least twice over three days, with at least twenty-four hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.  

Do I always need to perform two tests?

If you have COVID-19 symptoms and are within the first 7 days of symptom onset, you can use one single test of the iHealth® COVID-19 Antigen Rapid Test. You may also choose to perform two tests if you wish. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection.

If you do not have COVID-19 symptoms or have been having symptoms for more than 7 days, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests. 

Can this test be used as proof of a negative COVID-19 test for travel?

No. Currently, the iHealth® COVID-19 Antigen Rapid Test cannot be accepted as proof of a negative COVID-19 test for travel.

Will the test work if I don't have symptoms?

Yes. If you do not have COVID-19 symptoms, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests.

Should people who are vaccinated use this test?

Individuals can utilize this test, as needed, regardless of vaccination status.

Is this test covered by insurance?

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

Is a prescription required to perform this test?

You do not need a doctor’s prescription to purchase and perform this test.

On/Go™ COVID Test Basics

What is a rapid antigen test?

A rapid antigen test is a tool that identifies proteins of the virus, called antigens. A positive test result will occur when the virus is “live” and replicating, meaning the test taker is able to transmit it to other people. Because of this, rapid antigen tests are a helpful tool to figure out if you’re actually at risk of spreading COVID-19. Plus, unlike PCR tests which can take up to 3 days to get results, rapid antigen tests, like On/Go, provide results in as little as 10 minutes because all the pieces needed for analysis are in the test itself!

Who should use an antigen test?

Individuals aged 14 or older can perform the test directly. Adults can help perform the test for children aged 2 or older. The test can be used for individuals with or without symptoms, as often as you’d like.

What are common symptoms of COVID-19?

Symptoms of COVID-19 may appear 2-14 days after exposure and may include fever, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, or a runny nose, nausea or vomiting and diarrhea. It is also possible for someone infected with COVID-19 to have no symptoms.

When does my test expire? Why does my expiration date seem so soon?

Currently, the test expires on the last date of the month printed on your box (i.e. January 2022 means January 31, 2022). However, with medical products under EUA, such as On/Go, the FDA, after close studies, grants rolling expiration extensions. We expect the expiration date to be extended before the end of January and another expiration extension  again early in spring. We will continue to closely update this page as well as our website when the expiration date gets extended.

Does the On/Go test work with COVID-19 variants?

Does the On/Go test work with COVID-19 variants?

Where can I get an On/Go test kit?

You can purchase a test on our website. You have the option for free shipping or free local delivery within 6 hours.

Can you pay for On/Go tests with an FSA or HSA?

Yes, On/Go is FSA eligible. COVID tests are approved medical expenses under IRS rules.  Save your receipts for your taxes and/or contact your program administrator for more details.

On/Go™ The App

Are you selling my data?

No, we are not selling you data. Protecting your private information is our priority and we do not sell, rent, or lease user information to third parties. Here is a link to read more in our privacy policy: https://www.intrivo.com/privacy-policy

How do I download the On/Go app?

You can download the On/Go app by searching “On/Go” in the Google Play or Apple App stores or by scanning the QR code on the box.

Do I need to use the On/Go app to take the test?

Symptoms of COVID-19 may appear 2-14 days after exposure and may include fever, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, or a runny nose, nausea or vomiting and diarrhea. It is also possible for someone infected with COVID-19 to have no symptoms.

What happens if I wait longer than 10 minutes to take a picture for results?

Once you apply your sample to the sample well, the app will begin a 10 minute timer. After the first timer is complete, your results are ready to be interpreted. You will have 5 minutes to take a picture of your results, shown on the screen through another timer. If you wait longer than 5 minutes, the results are not valid (and may provide false negative or false positive results) and you will need to start a new test.

On/Go™ Taking The Test

How do I test myself?

Testing yourself is easy, even if you’ve never completed a COVID-19 test before. All test contents are in the box--the only thing you need is a smartphone to download the On/Go app. Simply open up your app and you will be provided with real-time, illustrated step-by-step instructions, which are also included in every test box.  You’ll have your results in no time. It’s as easy as "tap, swab, snap."

What are the known and potential risks and benefits of the test?

Potential risks include:

  • Possible discomfort or other complications that can happen during sample collection
  • Possible incorrect test result

Potential benefits include:

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

No! The On/Go test uses a lower nasal swab, not the “brain-tickling” swab you ​​may associate with COVID-19 tests. You only need to insert the swab less than ¾ of an inch into your nose, which can be seen by following the simple instructions provided on the On/Go mobile app. While it might tickle, it should not hurt. If you feel pain, please stop the test and seek advice from a healthcare provider. 

How long does it take to get results?

You’ll have your results quicker than you think. On/Go Self-Tests provide results in 10 minutes. You should check your results after 10 minutes and no longer than 15 minutes after sample application. 

The picture in Step 2 of the instructions looks like the tray requires the removal of a cover. If I don’t have a cover, is something wrong?

Everything is ok. Tests sealed on the box flap have individually sealed components (swab, test, vial) in the tray. No cover on the tray is necessary.

How many tests come in a pack?

Depending on the box you purchase, there will either be 2 or 20 tests (and swabs, caps, and vials) included. Besides the items in the box, all you need is a smartphone and you’re ready to take your test!

How long should people wait between taking On/Go Self Tests?

The tests should be administered twice over two or three days, with 24-48 hours between tests.

What is included in the box?

Depending on what you purchased, there will be 2 or 20 tests included in the box. Each test comes with everything needed to perform a test: a vial, cap, swab, and test device. The only other thing you need is a smartphone to get started.  

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