About the Test - QuickVue At-Home

Is there a way to share a result record from the QuickVue At-Home OTC COVID-19 Test?

Yes, QVue, the companion app to the QuickVue At-Home OTC COVID-19 Test, provides access to shareable digital results records, in addition to simple-to-follow animated instructions, built-in timers, and assisted result interpretation.

Is there a QR code for my result that can be scanned and verified by a third-party (employer, school, travel)?

No, the QuickVue At-Home OTC COVID-19 Test kit does not produce a QR code that can be scanned and verified by a third party. However, if you download QVue, the companion app to the QuickVue At-Home OTC COVID-19 Test, you can use the app to perform the test and receive a digital result record that is shareable with whomever you want, whenever you want. Please open your iPhone App Store or Android Play Store and search for QVue.

Do I need to download an additional app to scan the QR code on the box?

No, your iPhone or Android camera app is sufficient. Point the camera at the QR code and tap the notification link to proceed to the website.

Other kits with similar expiration dates were extended, but my kit wasn’t. Why was my kit expiration not extended?

The expiration date is dependent upon different factors. Although the lot numbers are similar, the expiration date of the components within the kit may be different and may impact if the kit is extended.

Can I use my kit even if it is expired? How long is my kit good for after the expiration date?

QuidelOrtho does not recommend using expired kits.

What is my Test Kit’s new expiration date?

To find out if your test kit’s expiration date has been extended and to verify the new expiration date, please select the link below and search for your kit’s lot number. The updated expiration date will be listed in the “Now have this extended expiration date” column. If your lot number is not found on this list, it has not been date-extended, and the expiration date listed on the kit box should be used. Link: https://www.fda.gov/media/162056/download” rel=”noopener” target=”_blank” class=”faq_disclaimer” data-bs-toggle=”modal” data-bs-target=”#DisclaimerPopup” data-link=”https://www.fda.gov/media/162056/download” rel=”noopener” target=”_blank”>https://www.fda.gov/media/162056/download”>https://www.fda.gov/media/162056/download” rel=”noopener” target=”_blank”>https://www.fda.gov/media/162056/download

Has my Test Kit expiration date been extended?

The QuickVue At-Home OTC COVID-19 Test has been granted FDA EUA authorization to extend expiration dating from 12 months to 16 months. A copy of the letter is available here. Please note the expiration dates on the outer kit box may not reflect the 16-month dating for product that is already distributed.

To verify if the expiration date for a particular lot has been extended:

  • Go to the FDA Webpage »
  • You will require the lot number on your test kit box. If your lot number is not found on this list, it has not been date-extended, and the expiration date listed on the kit box should be used.

  • Symbol for Expiration Date

    Symbol for Expiration Date

    Where can I get information about the Say Yes! COVID Test campaign?

    Please visit the Say Yes! COVID Test website for more information. The FAQ can be found here.

    Is a prescription required to perform this test?

    You do not need a doctor’s prescription to purchase and perform this test.

    How many times should I use this test?

    Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.

    The QuickVue At-Home OTC COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

    This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first six days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The QuickVue At-Home OTC COVID-19 Test does not differentiate between SARS-CoV and SARS-C0V-2.

    *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.

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