Covid-19
Rapid
Antigen Test
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Results in
10 Minutes
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Using the same trusted technology used by healthcare professionals for decades, the QuickVue At-Home OTC COVID-19 test is an OTC (“Over the Counter”) rapid antigen kit used for detecting SARS-CoV-2 from individuals with or without symptoms. Get rapid results in 10 minutes from the comfort of your home with the QuickVue At-Home OTC COVID-19 test. Everything you need is in the package and taking the test is simple.
Avoid office visits or lab appointments and delays in receiving your results from labs or mail-order testing services. Take 10 minutes. Take charge.
The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests. 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.
This home test has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This home test 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 authorization is terminated or revoked sooner.
The QuickVue At-Home OTC COVID-19 Test is a type of test called an antigen test. Antigen tests are designed to detect proteins from the virus that causes COVID-19, in anterior nasal swabs.
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: https://quickvueathome.com/#video_testkit-2
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.
Results are available in as little as 10 minutes in the privacy of your own home.
The QuickVue At-Home OTC COVID-19 Test is intended to be used for serial testing or used twice by the same individual over two or three days with at least 24 hours or no more than 36 hours between tests. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection.
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.
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.
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.
The test is intended for the individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.
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.
The type of testing and documentation required for air travel may differ based on travel destination, airline, and state requirements. We encourage you to visit the CDC/TSA website as well as your local airport and health department’s website for the latest requirements on the type of acceptable testing and documentation for your travel destination.
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.
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.
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.
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.
COVID-9 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.
The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19. The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
The test kit comes with two tests intended to be used for the same patient.
Individuals with or without symptoms can still utilize this test, as needed, regardless of vaccination status.
The QuickVue At-Home OTC COVID-19 Test is intended to be used for serial testing or used twice by the same individual over two or three days with at least 24 hours or no more than 36 hours between tests.
If you test positive with the QuickVue At-Home 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.
The test is available for at-home use without a prescription. Please consult with your specific health insurance to make sure your test will be covered.
You do not need a doctor’s prescription to purchase and perform this test.
If you have a positive test result, it is very likely that you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive result). If you test positive with the QuickVue At-Home OTC 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.
A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID- 19 even though the test is negative. The amount of antigen in a sample may decrease the longer you have symptoms of infection. Specimens collected after you have had symptoms for more than five days may be more likely to be negative compared to a molecular assay. If you test negative and continue to experience COVID19 like symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider. For example, your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. It is important that you work with your healthcare provider to help you understand the next steps you should take.
Quidel has completed testing on recombinant several variant strains and the QuickVue At-Home OTC COVID-19 Test was able to detect the mutations. We are confident that the performance of the QuickVue At-Home OTC COVID-19 Test remains unaffected by the known variants. Quidel monitors the variants closely and will inform the FDA promptly, should any issues be detected.
The test is made in San Diego, California.
