QuickVue At-Home OTC COVID-19 Test
Fast. Easy. Ready When You Are.
QuickVue At-Home OTC COVID-19 Test lets you get rapid results, in the privacy of your own home. Available over-the-counter, everything you need is in the package and taking the test is simple.
The test is authorized for home use with self-collected anterior nasal (nares) swab samples in individuals aged 2 and older. This test is also authorized for home use for individuals aged 2 through 14 with an adult performing the test. The test is intended to be used twice over two to three days, with at least 24 hours and no more than 36 hours between tests.
Our test kits also have a shelf life of 24 months from the date of manufacturing, ensuring that you will have access to testing at all times.
How Does the QuickVue At-Home OTC COVID-19 Test Work?
The test uses a gentle self-collected anterior nasal (nares) 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.
Here’s a quick overview of how it works:
Detailed video instructions below (ENG):
Download the instructions here:
ENG
中文
Bahasa Melayu
MOH Guide on ART test kits
Detailed video instructions below (CHI):
Detailed video instructions below (BM):
Frequently Asked Questions (FAQs)
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.
What are the known and potential risks and benefits of this test?
Potential risks include:
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Possible discomfort during sample collection.
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Possible incorrect test results (see Results section).
Potential benefits include:
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The results, along with other information, can help your healthcare provider make informed recommendations about your care.
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The results of this test may help limit the spread of COVID-19 to your family and others in your community.
What is Serial Testing?
COVID-19 Serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection.
What is the difference between an antigen and molecular test?
An antigen test, such as the QuickVue At-Home OTC COVID-19 Test, detects proteins from the virus. Molecular tests detect genetic material from the virus. Antigen tests are very specific for the virus, but not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider on whether an additional test is necessary and if you should continue isolating at home.
How Accurate is this Test?
Based on the interim results of a clinical study where the QuickVue At-Home OTC COVID-19 Test was compared to an
FDA EUA authorized molecular SARS-CoV-2 test, QuickVue At-Home OTC COVID-19 Test correctly identified 83.5% of
positive specimens and 99.2% of negative specimens.
The performance of this test is still being studied in patients without signs and symptoms of respiratory infection and for serial screening. Performance may differ in these populations.
I've tested positive, what happens now?
In the event of a positive test result, you'll need to go to your nearest PHMCA-licensed HCIs and approved offsite premises for a confirmation test and follow MOH guidelines.
The list of approved Polymerase Chain Reaction (PCR) test providers can be downloaded here[.pdf 1.10MB]
About Quidel® and its QuickVue® At-Home OTC COVID-19 Test
Quidel is a California-based leading diagnostic manufacturer focused on improving the quality of healthcare throughout the globe. As a trusted innovator in the medical device industry for over 40 years, Quidel launched the QuickVue brand in 1986 with visually read rapid diagnostics focusing on women’s health and respiratory diseases. In 1999, QuickVue Influenza A+B was the first visually read rapid test cleared by the FDA for professional use.
Now, the QuickVue At-Home OTC COVID-19 Test utilizes trusted technology used for decades by healthcare professionals and makes simple, easy-to-use COVID-19 tests accessible for the good of our families, our communities and the world.
Media Coverage on QuickVue® At-Home
Corporate/B2B Purchase
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