Is it all right if my test kit was exposed to temperatures outside of the storage temperature range printed on the box during shipping?

The QuickVue At-Home OTC COVID-19 Test should always be stored upon receipt according to the temperature printed on the kit box (59°F to 86°F or 15°C to 30°C). QuidelOrtho has performed studies that demonstrate the product performs as expected under different temperature conditions (i.e., heated, and frozen conditions) encountered during shipping. If you have any concerns about the shipping conditions of your test kit, please contact the retailer where you purchased the test.

The FDA also posted guidance to consumers on their website here.

*In the USA, this product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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.

Is it all right if my test kit was exposed to temperatures outside of the storage temperature range printed on the box during shipping?

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