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BinaxNow COVID-19 Antigen Self Test Instructions

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Overview

  • Perform the test as prompted (approximately 20 minutes).

  • Complete your test in one sitting. Interruptions (i.e. phone calls) can lead to inaccurate results.

  • It is recommended gloves (not provided) also be used during testing.

  • 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. 

  • There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests.  This means that there is a higher chance this test will give you a negative result when you have a COVID-19.

  • 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.  

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; and,
The emergency use of 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.

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