QuickVue At-Home OTC COVID-19 Test Kit Features
- 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
- Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status
- 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
- 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.
For In Vitro Diagnostic (IVD) Use
- This kit has not been FDA cleared or approved but has been authorized by FDA under an EUA.
- It has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- The emergency use of this covid 19 test kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs 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 the declaration is terminated or authorization is revoked sooner.
QuickVue Test Kit Safety Information
- This test kit is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms of COVID-19. 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.
- Read the written instructions fully before starting the test procedure
- To ensure correct results, you must follow the instructions
- Keep test kit and materials out of the reach of children and pets before and after use
- Wear safety mask or other face covering when collecting swabs from children or others
- Use of personal protection materials such as gloves are recommended
- Do not open the materials until ready for use. If the test strip is open for an hour or longer, invalid test results may occur.
- Improper swab collection may result in incorrectly negative (false negative) results
- 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.
- Do not use a test kit that is expired
- Do not touch the swab head when handling the swab
- Avoid exposure of your skin, eyes, nose, or mouth to the solution in the tube.
Hazardous Ingredients for Liquid Reagent
The solution in the tube contains hazardous ingredients -
- Sodium Phosphate Monobasic Monohydrate 0.7% (Concentration)
- Sodium Phosphate Dibasic Anhydrou 0.7%
- C12-14-Alkyldimethyl-betaines 0.03%
- ProClin 300 0.03%
- EDTA Tetrasodium Salt 0.2%
How does 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:
Note - Before you begin the test, it's important to first read and closely follow the detailed instructions, included in the package.
QuickVue At-Home COVID 19 Test Kit User Manual
More information about QuickVue At-Home 20402 COVID 19 Test
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.
How does QuickVue Home Covid Test?
QuickVue OTC COVID 19 Test Kit FAQ;s
Q. Will QuickVue COVID-19 Test hurt?
A. 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.
Q. What are the known and potential risks and benefits of QuickVue At-Home Test?
A. 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.
Q. What is Serial Testing?
A. 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.
Q. What is the difference between an antigen and molecular test?
A. 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.
Q. How Accurate is QuickVue At-Home OTC Test?
A. 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.
Indication to use Quidel QuickVue AT-Home
- 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.
- The QuickVue At-Home OTC COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal specimens during the acute phase of infection.
- 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.
- Positive results indicate the presence of viral antigens, 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.
- For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with as a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection.
- Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.
- Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider.
- Individuals should provide all results obtained with this product to their healthcare provider for public health reporting.
- All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.
- The QuickVue At-Home OTC COVID-19 Test is authorized for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory setting.
- The QuickVue At-Home OTC COVID-19 Test is only for use underthe Food and Drug Administration's Emergency Use Authorization.