QuickVue® At-Home COVID-19 Rapid Nasal Test Kit 2 Tests Per Kit
QuickVue® At-Home COVID-19 Rapid Nasal Test Kit comes with 2 tests. It is over the counter and does not require a prescription.
Special Price
$22.69
Regular Price
$28.36
SKU
20402
Details
If you are experiencing symptoms COVID-19 or have been in contact with a tested positive person there is now no reason you can’t test in the comfort of your own home! The QuickVue® At-Home COVID-19 Rapid Nasal Test Kit comes with 2 swabs which means you can test yourself or family 2 times per kit.
Features & Benefits
- Works for symptomatic and asymptomatic individuals
- The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid proteins 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
- Contains pre-filled vials – no counting of drops or errors in dispensing too much or too little of the liquid reagent solution
- Positive results indicate the presence of viral foreign agent, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status
- Results may help limit the spread of Covid-19 to your family and others in your community
- In a clinical study, the QuickVue at Home OTC Covid-19 test identified positive cases 83.5% of the time, and identified negative cases 99.2% of the time
- For Use Under an Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- Product ships with minimum 30 days dating
- The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of nucleocapsid proteins 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 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 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
What's Included
- 2 Individually Wrapped Sterile Foam Swabs
- 2 Single-Use Test Strips
- 2 Pre-Filled Tubes
- 1 Tube Holder
- 1 Instruction Sheet
- 1 Fact Sheet for Individuals
Specifications
| Manufacturer | Quidel |
| SKU | 20402 |
| Application | Rapid Test Kit |
| Contents | Individually Wrapped Sterile Foam Swabs, Individually Packaged, (2) Single-Use Test Strips, Pre-Filled Tubes, Tube Holder, Instruction Sheet, Fact Sheet for Individuals |
| Number of Tests | 2 Tests |
| Reading Type | Visual Read |
| Sample Type | Direct Anterior Nasal (NS) Swab Sample |
| Storage Requirements | USP Controlled Room Temperature |
| Test Format | Test Strip Format |
| Test Method | Lateral Flow Immunoassay |
| Swab Use | Nasal |
| Time to Results | 10 Minutes |
| User guide | DOWNLOAD |
FAQ's
Q: How many tests are included in the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit?
A: 2
Q: Is a prescription required to perform the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit?
A: You do not need a doctor’s prescription to purchase and perform this test
Q: How use the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit?
A: Each kit should come with an instruction manual and fact sheet. However you can also watch this instructional video HERE, or download the instructions HERE.
Q: If I am positive after the first QuickVue® At-Home COVID-19 Rapid Nasal Test, do I have to take another test?
A: 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.
Q: What if my QuickVue® At-Home COVID-19 Rapid Nasal Test Kit are negative?
A: Negative results should be considered in the context of an individual’s recent exposures. If you are still concerned, please contact your doctor.
Q: Will the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit test for things like strep throat and the flu?
A: No. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
Q: Will my school or office take the results of the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit?
A: Each situation is different and you will need to check with the reporting agency as to which kits are acceptable for results reporting.
Q: What is the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit?
A: The QuickVue At-Home OTC (over the counter) 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.
Q: How does the QuickVue At-Home OTC COVID-19 Test work?
A: 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.
Q: How long does it take to get results?
A: Results are available in as little as 10 minutes in the privacy of your own home.
Q: Do I always need to perform two tests?
A: No. 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.
Q: How accurate is the QuickVue At-Home OTC COVID-19 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.
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.
Q: What is the age range for the QuickVue At-Home OTC COVID-19 Test?
A: 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
Q: If I see pink shading on the QuickVue At-Home OTC COVID-19 Test strip bordering the black label, is this a positive result?
A: 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.
Q: Will the QuickVue At-Home OTC COVID-19 Test work if I don't have symptoms?
A: The test is intended for the individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.
Q: Is this QuickVue At-Home OTC COVID-19 Test acceptable for travel? Can it be used for proof of a negative COVID-19 test?
A: 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.
Q: Will the QuickVue At-Home OTC 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 differences between antigen tests (like the QuickVue At-Home OTC COVID-19 Test) and other COVID-19 tests?
A: 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.
Q: What is the difference between an antigen test (like the QuickVue At-Home OTC COVID-19 Test) and PCR or molecular tests?
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 long should I wait between the first and second QuickVue At-Home OTC COVID-19 Test?
A: 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.
Q: Will the QuickVue At-Home OTC COVID-19 Test detect COVID-19 variants?
A: 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.
Q: Where is the QuickVue At-Home OTC COVID-19 Test made?
A: The test is made in San Diego, California.
A: 2
Q: Is a prescription required to perform the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit?
A: You do not need a doctor’s prescription to purchase and perform this test
Q: How use the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit?
A: Each kit should come with an instruction manual and fact sheet. However you can also watch this instructional video HERE, or download the instructions HERE.
Q: If I am positive after the first QuickVue® At-Home COVID-19 Rapid Nasal Test, do I have to take another test?
A: 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.
Q: What if my QuickVue® At-Home COVID-19 Rapid Nasal Test Kit are negative?
A: Negative results should be considered in the context of an individual’s recent exposures. If you are still concerned, please contact your doctor.
Q: Will the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit test for things like strep throat and the flu?
A: No. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
Q: Will my school or office take the results of the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit?
A: Each situation is different and you will need to check with the reporting agency as to which kits are acceptable for results reporting.
Q: What is the QuickVue® At-Home COVID-19 Rapid Nasal Test Kit?
A: The QuickVue At-Home OTC (over the counter) 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.
Q: How does the QuickVue At-Home OTC COVID-19 Test work?
A: 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.
Q: How long does it take to get results?
A: Results are available in as little as 10 minutes in the privacy of your own home.
Q: Do I always need to perform two tests?
A: No. 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.
Q: How accurate is the QuickVue At-Home OTC COVID-19 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.
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.
Q: What is the age range for the QuickVue At-Home OTC COVID-19 Test?
A: 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
Q: If I see pink shading on the QuickVue At-Home OTC COVID-19 Test strip bordering the black label, is this a positive result?
A: 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.
Q: Will the QuickVue At-Home OTC COVID-19 Test work if I don't have symptoms?
A: The test is intended for the individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.
Q: Is this QuickVue At-Home OTC COVID-19 Test acceptable for travel? Can it be used for proof of a negative COVID-19 test?
A: 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.
Q: Will the QuickVue At-Home OTC 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 differences between antigen tests (like the QuickVue At-Home OTC COVID-19 Test) and other COVID-19 tests?
A: 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.
Q: What is the difference between an antigen test (like the QuickVue At-Home OTC COVID-19 Test) and PCR or molecular tests?
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 long should I wait between the first and second QuickVue At-Home OTC COVID-19 Test?
A: 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.
Q: Will the QuickVue At-Home OTC COVID-19 Test detect COVID-19 variants?
A: 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.
Q: Where is the QuickVue At-Home OTC COVID-19 Test made?
A: The test is made in San Diego, California.
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