Over-the-Counter Covid Antigen Test
iHealth

Description

Over-the-counter COVID antigen test

The iHealth COVID antigen test is a self-test to detect both asymptomatic and symptomatic COVID-19 in only 15 minutes. Authorized for over-the-counter use, the iHealth antigen test makes it easier for individuals with or without symptoms to test themselves anytime, anywhere.

With Emergency Use Authorization for over-the-counter use, iHealth can meet the testing needs of:

• Self
• Employers
• Schools or universities
• Entertainment or sports venues large or small

This test will not determine if you have had COVID-19 in the past or if you have developed immunity.

To properly administer the test and interpret results, scan the QR code on the box to download the app and follow the step-by-step instructional video.

Use the test kit within 1 hour after opening the foil pouch. Avoid contact of the extraction liquid in the tube with skin and eyes.

Accuracy

The iHealth test results were compared to highly sensitive molecular FDA Authorized SARS-CoV-2 assays to determine test performance. The iHealth COVID-19 rapid antigen test correctly identified 94.3% of the positive samples and correctly identified 98.1% of the negative samples.

This test is intended to be used as an aid to the clinical diagnosis of a current COVID-19 infection. Do not use this test as the only guide to manage illness.

This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA.
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
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.