QuickVue COVID-19 Test

You can store the testing kit at room temperature, 59°F to 86°F (15°C to 30°C).

• If your first test result is negative, you should test again in 48 hours.
• There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with COVID-19 as compared to a molecular test.
• All negative results with this test are presumptive and confirmation with a molecular assay may be necessary.
• If you continue to have symptoms of COVID-19, and both your first and second tests are negative, you may not have COVID-19, however you should follow-up with a healthcare provider.
• If the test is positive, then proteins from the virus that causes COVID-19 have been found in the sample and you likely have COVID-19.

• Read the written instructions fully before starting the test procedure. Failure to follow the instructions may result in inaccurate results.
• The test is not a substitute for consultation with a healthcare provider and should not be used to determine treatments without provider supervision. Persons with risk factors for severe disease from respiratory pathogens (e.g., chronic lung or heart disease, compromised immune system, diabetes, and other conditions listed by the CDC) should consult and followup with a healthcare provider, who will advise if additional testing or treatment are necessary.
• An anterior nasal swab sample can be self-collected by an individual 14 years and older. Children aged 2 to 13 years should be tested by an adult.
• Do not use on anyone under 2 years of age.
• Wear a safety mask or other face covering when collecting a specimen from a child or another individual.
• Do not use if any of the test kit contents or packaging is damaged. Test components are single-use. Do not reuse.
• Do not use kit past its expiration date.
• Do not open the materials until ready for use.
• Once opened, the test strip must be used within 120 minutes (2 hours). If the test strip is open for 2 hours or longer, invalid test results may occur.
• Do not touch the swab tip.
• Improper swab collection may result in incorrectly negative (false negative) results.
• Do not read test results before 10 minutes. Results read before 10 minutes or after 15 minutes may lead to false positive, false negative, or invalid results.
• Keep testing kit and kit components away from children and pets before and after use.
• Avoid contact with your skin, or eyes. Do not ingest any kit components. The reagent solution contains harmful chemicals (see Hazardous Ingredients for Liquid Reagent table below).
• If the solution contacts your skin or eyes, flush with large amounts of water.
• If irritation persists, seek medical advice. https://www.poisonhelp.org or 1-800-222-1222.
• For the most up-to-date information on COVID-19, please visit: www.cdc.gov/COVID19.
• For detailed instructions, please visit quidelortho.com/quickvue.

• There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with COVID-19 as compared to a molecular test, especially in samples with low viral load.
• The performance of this test was established based on the evaluation of a limited number of clinical specimens collected from 2021 through 2024. The clinical performance has not been established for all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARSCoV-2 and their prevalence, which change over time.
• All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary. If you continue to have symptoms of COVID-19, and both your first and second tests are negative, you may not have COVID-19, however you should follow up with a healthcare provider.
• Based on in vitro testing, the presence of Rheumatoid Factor at higher than 1.12 IU/mL concentrations in nasal samples may result in false positive results. However, it is unclear if such concentrations are clinically relevant.
• If the test is positive, then proteins from the virus that causes COVID-19 have been found in the sample and you likely have COVID-19.
• This test is read visually. Individuals with impaired vision or color impaired vision should ensure help in interpretation of their test results.
• Incorrect test results may occur if a specimen is incorrectly collected or handled.

The QuickVue COVID-19 Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 5 days from symptom onset. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

The performance characteristics for SARS-CoV-2 were established from January 2021 to February 2024 when COVID-19 variants Alpha, Delta and Omicron were dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

Repeat testing is needed to improve accuracy. Please follow the table below when interpreting test results for COVID-19. Results should be considered in the context of an individual's recent exposure, history, and the presence of clinical signs and symptoms consistent with COVID-19. 

COVID-19 Positive (+)

A POSITIVE result must show BOTH a BLUE line and PINK line next to the BLUE line in the results zone.

Look closely! Even a very faint, pink Test line and a blue Control line is a POSITIVE result. Pink shading or a line near the labels on the strip is not considered a positive result.

You do not need to perform repeat testing if you have a positive result at any time.

A positive test result means that the virus that causes COVID-19 was detected in your sample and it is very likely you have COVID-19 and are contagious. Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding self-isolation. There is a very small chance that this test can give a positive result that is incorrect (a false positive).

COVID-19 Negative (-)

A NEGATIVE result will show a BLUE line but NO PINK line in the results zone.

To increase the chance that the negative result for COVID-19 is accurate, you should test again in 48 hours if you have symptoms on the first day of testing.

A negative test result indicates that the virus that causes COVID-19 was not detected in your sample. A negative result is presumptive, meaning it is not certain that you do not have COVID-19. You may still have COVID-19 and you may still be contagious. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR. If you test negative and continue to experience COVID-19 symptoms, (e.g., fever, cough, and/or shortness of breath) you should seek follow up care with your health care provider.

Invalid

If there is NO LINE, or if there is ONLY a PINK line in the results zone, the test is INVALID and you should repeat the steps starting at the beginning using a new TUBE, SWAB, and TEST STRIP.

If at 10 minutes the blue Control Line does not appear, the result is invalid, whether or not any shade of pink or red Test Line appears.

If the test result is invalid, a new swab should be collected and the test should be performed again with a new pre-filled tube and test strip.

If the second test is also INVALID, call 833-QUICKVUE (833-784-2588) for assistance.

Please notify your Healthcare provider of the results of your QuickVue COVID-19 Test if you test positive or negative and continue to have symptoms suggestive of COVID-19. 

The Quick-Vue COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 virus. This test is intended to be used as an aid in the clinical diagnosis of active COVID-19. Do not use this test as the only guide to manage your illness. Please consult a healthcare professional to discuss your results and if any additional testing is required. 

The Quick-Vue COVID-19 Test is authorized for use with self- collected anterior nasal (nares) swab samples from individuals 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. Do not use this test on anyone under 2 years of age or who is prone to nosebleeds or has had facial injuries or head injuries/surgery in the past six months. 

Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. However, due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a negative result when you have COVID-19 than a molecular test would.  For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at quidelortho.com/quickvue. 

A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice about your positive result. 

A negative test result indicates that antigens from the virus that causes COVID-19 were not detected in your sample. However, if you have symptoms of COVID-19, and your first test is negative, you should test again in 48 hours since antigen tests are not as sensitive as molecular tests. If you have a negative result, it does not rule out SARSCoV-2 infection; you may still be infected and you may still infect others. It is important that you work with your healthcare provider to help you understand the next steps you should take. 

An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and you should test again with a new test.

Please notify your Healthcare provider of the results of your QuickVue COVID-19 Test if you test positive or negative and continue to have symptoms suggestive of COVID-19.

If the test does not perform as expected, call 833-QUICKVUE (833-784-2588).

Introduction
QuidelOrtho is committed to providing products designed with cybersecurity in mind. QuidelOrtho has an ongoing maintenance program for cybersecurity and systematically evaluates its products for threats and vulnerabilities. QuidelOrtho distributes software security patches via its product software release processes.

During product development, QuidelOrtho incorporates cybersecurity best practices into its product design, which are maintained throughout the Total Product Lifecycle (TPLC) management utilizing the Secure Product Development Framework (SPDF). Throughout the life of the product, QuidelOrtho maintains a system cybersecurity assessment that drives security design, development, and response to new threats and vulnerabilities. QuidelOrtho’s Information and Technology experts are continually monitoring our systems, and infrastructure security.

QuidelOrtho has a Cybersecurity Incident Response Plan and Team that maintains the security of our information systems, products, services, and data. QuidelOrtho utilizes the National Institute of Standards and Technology (NIST) Cybersecurity Framework to identify, protect, detect, respond, and recover from incidents in a timely manner.

QuidelOrtho is an active member of the Health Information Sharing and Analysis Center (H-ISAC). H-ISAC’s mission is to enable and preserve the public trust by advancing the global health sector’s cyber and physical security protection and resilience as well as enabling the ability to prepare for and respond to cyber and physical threats and vulnerabilities.

QuidelOrtho has a formalized Coordinated Vulnerability Disclosure (CVD) program for obtaining cybersecurity vulnerability information, acknowledging reported vulnerabilities, assessing vulnerabilities, developing remediation strategies, and disclosing the existence of vulnerabilities and remediation approaches to required stakeholders. Product vulnerabilities can be submitted to https://www.quidelortho.com/global/en/our-company/cybersecurity.

QVue Mobile App Supported Platforms
Supported for Android and Apple iOS mobile devices, the most recent and the previous Android versions being supported by Google with security updates, and the iOS version prior to the currently shipping version.

QVue Mobile App Updates
QuidelOrtho continuously monitors for product vulnerabilities and security patches for QVue mobile app. As with other mobile apps, updates are made available in the respective Android or Apple store and if the user version is no longer supported, the user is required to install the update to use the app. The QVue mobile application is authenticated with digital signatures and disallows earlier unsupported versions.

Virus and Malware Protection (Intrusion Detection)
The secure download and install of QVue mobile app with implemented digital signature confirmation ensures protection against virus or malware introduction, with a notification to the user of failure to install for any encountered virus or malware.

QVue Mobile App Dataflow Diagram

Above shows typical dataflow and workflows with QVue mobile app (left side) and exchanges with cloud based data repository (right side elements; PostgreSQL database). All data is protected in transit using TLSv1/SSLv3 at a minimum and at rest with AES256 encryption, compliant to healthcare security standards.

User Authentication and Access
QVue mobile app requires user registration with valid email and user set complex password with required number, letter upper and lower case, special characters and minimum length. QVue mobile app also uses the advantages of user access security available for Android and Apple iOS device access, such as fingerprints and facial recognition.

Password Reset
Users of QVue mobile app can reset the password with email verification in case of forgotten or lost password.

Data Backup and Restoration
By design QVue mobile app data is limited to user entered personal identifying information in addition to email and test result that is stored in the connected cloud host which allows users to reinstall the mobile app after removal or device loss and view user test history.  The cloud host for QVue mobile app has security ISO 27001 certified with 24/7 availability, redundant data backup, and appropriate data activity logging/tracking.

Third-Party Software Components: SBOM
List of third party software, or Software Bill of Materials (SBOM) available upon request, contact QuidelOrtho technical support.

Cybersecurity Incident
Any cybersecurity incident involving this QVue mobile app should be immediately communicated directly to the manufacturer by either calling 833-QUICKVUE (833-784-2588) in the U.S., or emailing technicalsupport@quidelortho.com.  If an unexpected incident occurs, the device should be disconnected from the customer network immediately, and the issue should be reported to customer IT for appropriate follow up and investigation.

Decommissioning
The mobile device is responsibility of owner and user and should be decommissioned appropriately to ensure that any sensitive, personal data be removed.

End of Life/End of Support
QVue mobile app has no end of life nor end of support currently scheduled, however notifications will prompt the user to update when available and necessary.

QVue mobile app has third-party components that may reach end of life/end of support, QuidelOrtho is committed to updating these components prior to end of life and will provide updates in QVue software releases.

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