Description

The On/Go 10-minute COVID-19 Antigen Self-Test

The On/Go™ COVID-19 Antigen Self-Test is an over-the-counter, self-administered rapid test that delivers results in just 10 minutes, with 95% accuracy.* On/Go is proudly manufactured in the United States.

This test is authorized for non-prescription home use for individuals with symptoms of COVID-19 within the first 7 days of symptom onset. The On/Go Self-Test is also suitable for individuals without symptoms or other epidemiological reasons to suspect a COVID-19 infection when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

• 95% accurate*
• Rapid results at 10 minutes
• Detects the antigen protein of all known major COVID-19 variants of concern (including Delta and Omicron)
• Authorized for non-prescription self-use for individuals 14 years or older or adult-collected samples from individuals 2 years or older
• For individuals with or without symptoms
• Qualitative detection of SARS-CoV-2 nucleocapsid protein antigen via lower nasal swab samples
• Only for use under the Emergency Use Authorization (EUA)
• Single test for individuals with symptoms within 7 days of onset or two tests over two or three days for individuals without symptoms
• For in vitro diagnostic use only

* PPA: 87%, NPA: 98% (see IFU for more details)

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, and 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.

Test Expiration Update
Per the FDA's authorization letter, as of January 20th the expiration dates for all On/Go tests are extended three months from the labeled expiration date. Please click here for more information and impacted LOT numbers.

For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

On/Go 10-minute COVID-19 Antigen Self-Test Overview:

• Quick and Easy to Use: The On/Go COVID-19 Antigen Self-Test by Intrivo uses a shallow nasal swab for maximum comfort, with collection you can perform for yourself or another at home or any place where you can find a flat surface.
• Quality You Can Trust: In just 10 minutes, On/Go delivers results with 95% accuracy and can be used to detect the antigen proteins from all major known COVID-19 variants of concern.
• Step-by-Step Instructions: The On/Go companion app, downloadable by scanning the QR code on box or available in the Apple App Store and Google Play, guides you seamlessly through each test step, from specimen collection to results interpretation.
• Shareable Test History: With the On/Go app, you can easily view, track and share test results with family and friends, all in one place.
• User Friendly For All Ages: The On/Go Self-Test is indicated for children as young as 2 years old when administered by an adult, and for all people 14 and older to self-perform.
• Proudly Made in the USA: Manufactured in the United States with 30 years' experience and full quality controls. Each box includes 2 tests.
• How to Use the On/Go Covid-19 Self Test

FAQ's about the On/Go™ 10-minute COVID-19 Antigen Self-Test

1) 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!

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

2) 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.

3) 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.

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

Yes! On/Go can be used to detect the antigen proteins from all major known COVID-19 variants of concern including Delta. When new variants arise, we rigorously perform tests to ensure the variants do not affect the performance of the test.

5) 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."

6) 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

7) How do I know if I'm positive or negative?

After completing all the steps on the On/Go app, your results will be interpreted as positive, negative or invalid.

• A negative result (COVID-19 Not Detected) will show only a pink or red line next to the “C” on the test device but no other lines.
• A positive result (COVID-19 Detected) will show a pink or red line next to the “C” on the test device AND a purple line next to the “T.” The purple line may be very faint.
• An invalid result can occur either due to an invalid barcode or the absence of a colored line next to the “C” on the test device.

**Full FAQ available from the manufacturer On/Go Here**

Need more information about the On/Go 10-minute COVID-19 Antigen Self-Test?

Download more information here:

• FDA Emergency Use Authorization (EUA) Letter
• Expiry Date Extension Letter
• Update To FDA EUA Labeling
• Updated Variant Brief (Omicron)
• Instructions For Use
  
• Quick User Instructions
• Fact Sheet For Healthcare Professionals
• Fact Sheet For Individuals
• FDA Shelf Life Extension For On/Go and Carestart