What does it mean if I have an invalid test result? - QuickVue At-Home
Download Our App:

What does it mean if I have an invalid test result?

An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and you should test again with a new test.

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.

Partners of:

  • San Diego Padres logo
    San Diego Padres
  • San Diego Loyal logo
    San Diego Loyal
  • Chicago Blackhawks logo
    Chicago Blackhawks
  • New York Jets logo
    New York Jets
  • Los Angeles Rams logo
    Los Angeles Rams

Quick Links

Contact Us

QuidelOrtho
9975 Summers Ridge Road
San Diego, CA 92121, USA
MON – FRI 8am to 8pm EST

FOLLOW US

QuidelOrtho:
QuickVue At-Home:
Careers

Legal Notice

Copyright ©2023 QuidelOrtho Corporation. All rights reserved. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to QuidelOrtho, its subsidiaries or affiliates. No use of any QuidelOrtho trademark, trade name, or trade dress in this site may be made without the prior written authorization of QuidelOrtho, except to identify the product or services of the company. By accessing, browsing and/or using this website, you acknowledge that you have read, understood, and agree to be bound by QuidelOrtho’s Website Terms and Conditions, Privacy Notice and to comply with all applicable laws and regulations. If you do not agree to these terms, do not use the website. Additionally, this website contains information on products that is targeted to many different audiences and could contain product details or information otherwise not accessible or valid in your country. Please be aware that we do not take any responsibility for your accessing such information that may not comply with any legal process, regulation, registration, or usage in the country of your origin.