Learn About Quidel QuickVue COVID-19 Rapid Test Kit At-Home Nasal Swab (OTC)
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.
This home 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. The test to be used in individuals within 6-days of symptom onset or individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
Positive results indicate the presence of virus-specific proteins, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the QuickVue At-Home OTC COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative 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, and confirmed with a molecular assay, if necessary, for patient management
Individuals should provide all results obtained with this product to their healthcare provider for public health reporting. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens
The test is intended to be read at 10 minutes; If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate and the test should be repeated
The Quickvue At-Home OTC COVID-19 test can accurately detect the Omicron variant (among others) of the Sars-CoV-2, the potentially deadly virus that can lead to COVID-19.
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.
What is the QuickVue At-Home OTC COVID-19 Test?
The QuickVue At-Home OTC 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 At-Home OTC 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.
How long does it take to get results?
Results are available in as little as 10 minutes in the privacy of your own home.
How accurate is the test?
Based on the interim results of a clinical study where the QuickVue At-Home OTC COVID-19 Test was compared to an FDA 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.
Quidel QuickVue COVID-19 Rapid Test Kit At-Home Nasal Swab (OTC) Features:
- Individually Wrapped Sterile Foam Swabs
- Individually Packaged, (2) Single-Use Test Strips
- Pre-Filled Tubes
- Tube Holder
- Instruction Sheet
- Fact Sheet for Individuals
|Application||Rapid Test Kit|
|Reading Type||Visual Read|
|Sample Type||Direct Anterior Nasal Swab Sample|
|Test Format||Test Strip Format|
|Test Method||Lateral Flow Immunoassay|
|Time to Results||10 Minute Results|
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