About QuickVue COVID-19 Rapid Self-Test Kit
Take charge of your health with the QuickVue At-Home OTC COVID-19 Test, which provides rapid results in just 10 minutes using a simple, non-invasive nasal swab. This FDA Emergency Use Authorized and FSA/HSA eligible over-the-counter kit offers easy-to-interpret results in four straightforward steps (Swab, Swirl, Dip, Results) and effectively detects the SARS-CoV-2 Omicron variant. The test is authorized for serial testing for individuals with or without symptoms (ages 14+ self-collected, ages 2+ adult-collected), and you can enhance your experience using the companion QVue mobile app for guided instructions and result sharing.
Key Benefits & Features
- Rapid At-Home COVID-19 Results: Get clear, easy-to-read results in just 10 minutes from the privacy of your own home.
- Simple 4-Step Process: Requires only a gentle anterior nasal swab, followed by swirling the swab in the pre-filled tube and dipping the test strip.
- Highly Effective: Designed to detect the nucleocapsid protein antigen from SARS-CoV-2, including the Omicron variant and other variants.
- Broad Authorization: Authorized for non-prescription, at-home use for ages 14+ and ages 2+
- QVue Mobile App Companion: Download the QVue app for simple, animated guided instructions, sharing test results, and accessing historical test results on Apple (iOS 13+) and Android (9+) phones.
- Convenient Kit Contents: Each test kit contains everything you need, including 2 sterile foam swabs and pre-filled solution tubes
- FDA Emergency Use Authorized and FSA/HSA Eligible
QuickVue COVID-19 Rapid Self-Test Kit FAQs
What is the QuickVue At-Home OTC COVID-19 Test for?
This test is intended for the qualitative detection of nucleocapsid proteins from SARS-CoV-2. It can be used by individuals with or without symptoms or other reasons to suspect COVID-19, when tested twice over two or three days with 24 to 36 hours between tests.
Who can use this test?
It is authorized for nonprescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years and older, or with adult-collected anterior nasal swab samples from individuals aged 2 years or older.
What are the known and potential risks of this test?
Potential risks include possible discomfort during sample collection and possible incorrect test results. (Refer to the Warnings and Results Interpretation sections of the instructions for more information).
What are the known and potential benefits of this test? Potential benefits include:
- The results, along with other information, can help you and 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.
What is the difference between an antigen and a molecular test?
Molecular tests detect genetic material from the virus, while antigen tests, such as the QuickVue At-Home OTC COVID-19 Test, detect proteins from the virus. Antigen tests generally have a lower sensitivity, meaning there's a higher chance of a false negative result compared to a molecular test.
How accurate is this test?
Antigen tests, like this one, show more accurate results for COVID-19 infection when taken multiple times over several days. Repeat (serial) testing is recommended to improve accuracy and minimize the risk of incorrect results.
What if I have a Positive Test Result?
A positive result means it's very likely you have COVID-19 because viral proteins were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice.
What if I have a Negative Test Result?
A negative result indicates that antigens from the virus were not detected in your sample.
- If you have symptoms: And your first test is negative, you should test again in 48 hours.
- If you do not have symptoms: And received a negative result, you should test at least two more times, with 48 hours between tests, for a total of three tests.
- A negative result does not rule out SARS-CoV-2 infection; you may still be infected and infect others. Work with your healthcare provider for next steps.
What does an Invalid Test result mean?
An invalid result means the test could not determine if you have COVID-19. If you get an invalid result, you should use a new swab to collect a new nasal specimen and test again with a new test kit.
Should I use this test as the only guide for managing my illness?
No, it is important not to use this test as the only guide to manage your illness. Consult your healthcare provider if your symptoms persist or become more severe.
Is this test CLIA waived?
Yes, this test is CLIA Waived.
How long does it take to get results?
Results are intended to be read at 10 minutes. Reading the test too early or more than 5 minutes after the indicated read time (i.e., after 15 minutes) may lead to inaccurate results, and the test should be repeated.
Is this test designed to detect other viruses?
No, this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
