OnGo™ COVID-19 Antigen Self-Test - 2 pack

Description

Key Features

• 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.
• 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.

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.

Test Details

• 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)

Disclaimer
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.