We are pleased to announce the launch of our newly updated QuickVue COVID-19 Test. This test is similar to the QuickVue At-Home OTC COVID-19 Test with an updated look and FDA 510(k) clearance. Please ensure you are referencing the User Instructions that came with your kit as there are small differences in the labeling between the two test kits. The FAQs shown below are specific to the new QuickVue COVID-19 Test only. For questions pertaining to the QuickVue At-Home OTC COVID-19 Test for Emergency Use Authorization (EUA), contact us.
About the test
What is the QuickVue COVID-19 Test?
The QuickVue COVID-19 Test is a type of test called a rapid antigen test. Antigen tests are designed to detect proteins from the virus that causes COVID-19, in anterior nasal swabs.
How does the QuickVue COVID-19 Test work?
The test uses a gentle nasal swab sample to determine a positive or negative COVID-19 result. The swab is swirled in a tube of reagent solution, then removed, before a test strip is inserted. After ten minutes, you can take the strip out of the tube and see your results.
For a demonstration on how the test works, watch the instructional video here.
General steps for conducting the test are:
Before you begin the test, it’s important to first read and closely follow the detailed user instructions included in the package.
What is the difference between the previous version of this test, the QuickVue At-Home OTC COVID-19 Test?
The test was previously authorized under Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) as QuickVue® At-Home OTC COVID-19 Test (EUA210269). Now it has FDA 510(k) clearance (K231795) with a new name, updated part numbers, updated labeling and smaller packaging.
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.
How accurate is the test?
Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at quidelortho.com/quickvue.
How long does it take to get results?
Results are available in as little as 10 minutes in the privacy of your own home.
Where can I purchase the QuickVue COVID-19 Test?
Please visit Where to Buy to view the list of retailers.
Will this test detect COVID-19 variants?
At QuidelOrtho, we continuously monitor the evolution and activity of COVID-19 variants in circulation and will continue to be vigilant in evaluating our tests with real-world virus samples to assure you of our product’s efficacy. QuidelOrtho has completed testing on several variant strains and the test was able to detect the mutations. Because the test detects a part of the virus that is less susceptible to mutation, the likelihood of detecting new or emerging variants is high. QuidelOrtho monitors the variants closely and will inform the FDA promptly, should any issues be detected.
What are the differences between antigen tests and other COVID-19 tests?
There are different kinds of tests for diagnosing COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection.
What is the difference between an antigen test and PCR or molecular tests?
There are different kinds of tests for the SARS-CoV-2 virus that causes COVID-19. Molecular tests detect genetic material from the virus. Antigen tests, such as the QuickVue COVID-19 Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.
Is the solution in the tube harmful?
The solution in the tube contains small amounts of hazardous ingredients (see table in the User Instructions here). If the solution contacts the skin or eye, flush with plenty of water. If irritation persists, seek medical advice at https://www.poison.org/contact-us or 1.800.222.1222.
What is the age range for the test?
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.
Will this test hurt?
No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a healthcare provider.
Will the test work if I don't have symptoms?
The test is intended for the individuals with symptoms or other epidemiological reasons to suspect COVID-19.
What are the known and potential risks and benefits of this test?
Potential risks include:
- Possible discomfort during sample collection.
- Possible incorrect test results (see Results section).
Potential benefits include:
- The results, along with other information, can help your healthcare provider make informed recommendations about your care.
- The results of this test may help limit the spread of COVID-19 to your family and others in your community.
How many tests come in a kit?
The test kit comes with two tests intended to be used for the same patient. A 25-test kit is also available.
Should people who are vaccinated use this test?
Individuals with symptoms can still utilize this test, as needed, regardless of vaccination status.
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.
Is a prescription required to perform this test?
You do not need a doctor’s prescription to purchase and perform this test.
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.
Is there a way to share a result record from the QuickVue COVID-19 Test?
Yes, QVue, the companion app to the QuickVue 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.
Using the test
I see a pink line, but it’s not in the same spot as in the User Instructions. Is this a positive result?
Only a pink line about a half of a centimeter below the blue control line in the Test Line Region should be considered a positive result. Pink lines in any other area of the test strip should not be called a positive result.
If I see pink shading on the strip bordering the black label(s), is this a positive result?
Only a pink line about half of a centimeter below the blue control line should be considered a positive result. A pink line bordering the black label with the arrows, a vertical pink line or a faint grey line next to the blue control line is not considered a positive test line and should not be called a positive result.
How much liquid should be in the tube?
The tube contains a small amount of liquid that only fills the bottom, as illustrated below. The amount of liquid may not look exactly like the photo in the User Instructions. The liquid in the tube should cover the bottom of the swab and test strip when immersed. The entire swab tip and arrows on the test strip do not need to be completely covered by the liquid. Please ensure to stir the swab 3-4 times in the liquid before the 1-minute incubation step.
Examples of expected liquid solution levels:
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.
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 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:
Where can I find the kit expiration date?
The expiration date is labeled on the outside of the kit box, above the lot number, next to “EXP.”
What is the storage temperature?
The QuickVue 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).
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
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.
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.
Results
What might cause a false positive result?
The following may lead to incorrect test results:
Failure to follow the instructions.
Incorrect sample collection or handling.
The presence of Rheumatoid Factor (an autoantibody) at higher than 1.12 IU/mL concentrations in nasal samples.
Who should and should not use this test?
The QuickVue COVID-19 Test is authorized for use with self-collected anterior nasal (nares) swab samples from individuals 14 years or older or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older. Do not use this test on anyone under 2 years of age or who is prone to nosebleeds or has had facial injuries or head injuries/surgery in the past six months.
Do I need to repeat the test?
You do not need to perform repeat testing if you have a positive result at any time. Repeat testing is needed to improve accuracy. Please follow the table below when interpreting test results for COVID-19. Results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.
| Status on First Day of Testing | First Result Day | Second Result Day 3 | Interpretation |
With Symptoms
| Positive | N/A | Positive for COVID-19 |
| Negative | Positive | Positive for COVID-19 | |
| Negative | Negative | Negative for COVID-19 |
Where can I obtain documentation of my result?
Download QVue, the companion app to the QuickVue COVID-19 Test, and 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.
What do I do if I test positive?
Individuals who test positive with the QuickVue COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
If I am positive after the first test, do I have to take another test?
If you test positive with the QuickVue COVID-19 Test you should self-isolate and seek follow-up care with your healthcare provider as additional testing may be necessary. Your healthcare provider will work with you to determine how best to care for you based on your test result(s) along with your medical history, and your symptoms.
What does it mean if I have a Positive test result?
A positive test result means that the virus that causes COVID-19 was detected in your sample and it is very likely you have COVID-19 and are contagious. Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding self-isolation. There is a very small chance that this test can give a positive result that is incorrect (a false positive).
What does it mean if I have a Negative test result?
A negative test result indicates that the virus that causes COVID-19 was not detected in your sample. A negative result is presumptive, meaning it is not certain that you do not have COVID-19. You may still have COVID-19 and you may still be contagious. If your first test result is negative, you should test again in 48 hours. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR. If you test negative and continue to experience COVID-19-like symptoms, (e.g., fever, cough, and/or shortness of breath) you should seek follow-up care with your healthcare provider.
What does it mean if I have an Invalid result?
If at 10 minutes the blue Control Line does not appear, the result is invalid, whether or not any shade of pink or red Test Line appears. If the test result is invalid, a new swab should be collected and the test should be performed again with a new pre-filled tube and test strip. If the second test is also invalid, call 833-QUICKVUE (833-784-2588) for assistance.
Reimbursement programs
Is this test covered by insurance?
Coverage varies based on the health insurance plan. Please check with your plan for details.
How can I get reimbursed for this test?
After the end of the PHE in May 2023, mandatory coverage for over-the-counter and laboratory-based COVID-19 tests ended. Coverage will vary depending on the health insurance plan. Details regarding coverage can be found in the following links:
QVue
How do I download the QVue app?
You can download the QVue app by searching and selecting “QVue” in the App Store® or Google Play™, or by scanning the QR code on the outside panel of the box. Learn more on our dedicated QVue™ mobile solutions page.
Do I need to use the Qvue app to take the test?
The QVue app is not required to take your QuickVue COVID-19 Test, but it can make your testing experience less stressful and increase confidence in your result. The app provides clear, visual step-by-step instructions from opening your test through result interpretation, taking the guesswork out of testing, and helping ensure your test and results are valid. By completing your test with the QVue app, you can easily access a history of results for you and your family from a single place and share a record of your result with whomever, whenever you want. For new and experienced testers, the QVue app provides an easy and stress-free way to test for COVID-19.
How can I share my test results from QVue?
QVue makes it convenient and super easy to share a record of your result with whomever, whenever you want. Select the “Test Result” tab on the menu, choose the user and then select the specific result from your history that you want to share. It’s as easy as sharing a photo with a friend. Select “Share,” then choose who you want to send it to and how—text, email or another app enabled on your phone.
Are you selling my data?
No, we are not selling your data. Protecting your private health information is our priority, and we do not sell, rent or lease user information to third parties. Read more about our privacy policy here.
Can I use my phone while waiting for the test results?
While taking the test and following the guided instructions, we recommend you stay in the app until the test is complete. Timing is critical to ensure a valid test result. You can open other apps or browse the web, but the app must remain open in the background. If you force close the app, you will have to start the testing process over and use new test components. We suggest keeping your phone sound volume on so that you receive an audible notification from the app when critical timing steps are complete.
Why is there a 5-minute countdown for reading my result?
Once the 10-minute development time is complete, you have an additional 5 minutes to read your results. Timing is essential to receiving a valid and reliable test result, so it is important to read your result as soon as possible. If you do not read and input the result before the end of the additional 5 minutes, you will receive a notification that your test has expired, and your result is invalid.
Why did I get an expired test notification and an invalid result?
Timing is critical to ensure you receive a valid and reliable test result. If you did not complete the steps to read and input your result into the app within the 5-minute countdown window, you receive an expired test notification and the result is recorded as invalid. The stability of the result is not reliable after 5 minutes. Therefore, we enforce that the result is read and recorded during this time to ensure we provide you with the most reliable result reading. Please perform a new test with a new nasal swab sample and test strip and be sure to read your result within the 5-minute window.
What do I do if I experience an issue with the app?
First, make sure that you have the latest version of the app installed. If the issue persists, try uninstalling the QVue app and reinstalling it. Please get in touch with Technical Support if you continue to experience problems on our Contact Us page.
For questions, product updates, news and more, contact us.
