Using the Test - QuickVue At-Home

Glossary of symbols:

Image containing Glossary of Symbols

Is the test reusable?

No. Each test is designed for single use by one individual. We recommend keeping the User Instructions and tube holder until the second test is completed.

Why are the instructions in my test kit different than the instructions on the website? Which one do I use?

Quidel recently updated the kit instructions to clarify the best timeframe to use the test. Please refer to the User Instructions on Quidel.com for the most up-to-date instructions.

My test was negative at the 10-minute read time, but 1 hour later I noticed a faint pink line. Is this a positive result?

The test is intended to be read only at 10 minutes. If the test is read more than 5 minutes after the indicated read time, the result may be inaccurate and should not be used.

Can I swab my throat instead of my nose? Is this accurate?

The test is only authorized for use with nasal swab specimens and the accuracy and performance of throat swab specimens have not been evaluated. Throat swabs are not recommended and may not produce accurate results.

The kit components look different than the User Instructions. Is this normal or did I receive a defective kit?

The kit components may look slightly different than the User Instructions. You may observe the following kit differences:

  • A different sized tube
  • A different color cap on the tube (e.g., an orange or purple cap)
  • Different brands of swabs
  • A different tray and tube holder
  • A white or clear tray

What is the storage temperature?

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).

Where can I find the kit expiration date?

The expiration date is labeled on the outside of the kit box, under the lot number, next to the hourglass symbol. There is also a date printed next to the symbol of a building with a chimney and this is the date of manufacture.

Image of Symbol for Expiration Date

Is it alright if my test kit if it 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). Quidel 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.

Should the liquid in the tube cover the whole swab head when it’s immersed?

The amount of liquid should cover approximately ¾ of the swab when it is immersed. It is important to follow the User Instructions and stir the swab 3-4 times once immersed in the tube. After the 1-minute incubation in the solution, remove the swab from the TUBE by rubbing the swab head against the inside wall of the tube to squeeze out as much liquid as possible.

The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. 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. This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older.

*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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