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Yes. Cue’s COVID-19 test can detect Omicron, subvariants such as BA.5, BQ.1, BQ1.1, and other prevalent variants of concern. Like other COVID-19 viral diagnostic tests, Cue’s test cannot specify which variant has been detected. The test will only indicate if your result is positive or negative for the SARS-CoV-2 virus. Cue’s COVID-19 test is a nucleic acid amplification test (NAAT), also referred to as a molecular test. Like a PCR lab test, Cue’s test targets genetic material of the virus and can reliably detect small amounts of the virus.

Since the start of the pandemic, Cue’s scientists and bioinformatic experts have actively monitored available genomic data on the virus. They analyze genomic sequences as the virus changes over time to ensure that Cue’s molecular test can identify the variants as their genome changes.

Our scientists have found that the primers used in Cue's COVID-19 test perfectly match greater than 99% of the published sequences for the prevalent BA.4 and BA.5 Omicron variants, as well as new BJ, BQ, and XBB variants. In general, Cue’s test is the most accurate COVID-19 self-test on the market. In a clinical study with lay users, the Cue COVID-19 Test for Home and Over The Counter (OTC) Use demonstrated sensitivity of 97% (% positive agreement) and specificity of 99% (% negative agreement). Importantly, the study showed the test was 100% accurate in people infected with the virus who were asymptomatic.

Accuracy claim based on clinical study results submitted to the FDA for other EUA molecular home tests.

Please discuss treatment options with your doctor or another healthcare provider. They will work with you to determine how best to care for you based on the test result along with your medical history and your symptoms.

Please also follow the latest CDC guidance and other federal, state, and local recommendations to limit spreading the virus to others, such as self-isolation. Cue cannot provide any medical advice.

If you test positive for COVID-19, you may be a candidate for prescription antiviral treatment via Cue Care^™, our virtual healthcare consultation and same-day prescription delivery service. To learn more about Cue Care, click here.

You may also choose to consult with a board-certified doctor in our U.S.-based virtual care network through the Cue Health App via secure in-app messaging. This service is available to Cue+^™ Members at a discounted rate of 20% off* and to non-members at full price.

You may also find these additional resources helpful:

• Cue^® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions for Use
• Centers for Disease Control and Prevention, If Your Test is Positive

*Exclusions may apply to the 20% discount.

Please discuss treatment options with your doctor or another healthcare provider. They will work with you to determine how best to care for you based on the test result along with your medical history and your symptoms.

Please also follow the latest CDC guidance and other federal, local, and state recommendations to limit spreading the virus to others, such as self-isolation. Cue Health cannot provide any medical advice.

If you test positive for COVID-19, you may be a candidate for prescription antiviral treatment via Cue Care^™, our virtual healthcare consultation and same-day prescription delivery service. To learn more about Cue Care, click here.

You may also choose to consult with a board-certified doctor in our U.S.-based virtual care network through the Cue Health App via secure in-app messaging. This service is available to Cue+^™ Members at a discounted rate of 20% off* and to non-members at full price.

*Exclusions may apply to the 20% discount.

Cue^® is a healthcare technology company whose mission is to empower people to live their healthiest lives. Cue has been developing cutting-edge diagnostics and healthcare technologies since 2010. We developed the first molecular diagnostic test authorized by the U.S. Food and Drug Administration (FDA) for consumers to use without a prescription at home or in other non-clinical settings. This landmark test, the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, received Emergency Use Authorization from the FDA in 2021.

Cue’s COVID-19 OTC Test is just one step in our journey to provide people with connected, lab-quality diagnostics within minutes, anywhere. Ultimately, we think this will help power the digital transformation of healthcare. Cue is proudly headquartered in San Diego, California.

Learn more about Cue and our journey at:
About Cue
Cue Health Pressroom

Cue Health is a publicly traded company. On September 24, 2021, Cue began trading on the Nasdaq Global Select Market under the ticker symbol "HLTH."

For financial, governance, and investing information, please visit Cue Health’s Investor Relations website at https://investors.cuehealth.com/investor-relations.

The Cue Integrated Care Platform combines the hardware of the Cue Health Monitoring System (Cue Cartridge Reader) with cloud-based analytics and security to run and report high-quality diagnostic tests for people within minutes, anywhere through the Cue Health Mobile Application (Cue Health App). The platform is capable of integrating seamlessly and securely to provide valuable services, including test proctoring, telehealth consultations, and electronic prescription requests.

Our landmark Cue COVID-19 Test for Home and Over The Counter (OTC) Use is now available for purchase without a prescription. Using our Cue Health Monitoring System (Reader), the Cue COVID-19 molecular test provides lab-quality accuracy in approximately 20 minutes and can be administered anywhere by consumers or by healthcare providers.

Cue’s platform builds on a decade of development, with many more products and services on the way. Cue is developing additional tests in areas such as respiratory (including flu and respiratory syncytial virus, or RSV), sexual, cardiac, and metabolic health. It is expected that future tests will also use the Cue Reader to analyze and report results.

The Cue Health Monitoring System consists of a compact, rechargeable, and portable Reader that pairs with the Cue Health App installed on a mobile smart device. The Reader is used with a test-specific Cue Cartridge and sample collection device (Cue Sample Wand) to run lab-quality diagnostic tests. The Reader automatically analyzes the results, then communicates them digitally through a secure Bluetooth® connection to the Cue Health App.

For additional information on how to use your Cue Health Monitoring System, please see the Cue^® Health Monitoring System User Manual.

The Cue Health Monitoring System (Reader) is an integral part of the Cue Integrated Care Platform. The Cue Health Monitoring System consists of a Cue Cartridge Reader paired with the Cue Health App that translates and communicates diagnostic test results securely, conveniently, and quickly. Other components of the Cue Integrated Care Platform are Cue tests, which include a self-contained, test-specific Cue Test Cartridge, a Cue Sample Wand for collecting samples to be tested, and other digital health services such as antiviral prescription and delivery services, when medically indicated for people who test positive for COVID-19, and real-time supervised testing by a virtual proctor. These services are offered to Cue+ Members at a discounted rate of 20% off* and to non-members at full price.

*Exclusions may apply to the 20% discount.

Cue’s COVID-19 test is being used throughout the U.S. in clinical and point-of-care settings, such as community health clinics, doctor’s offices, nursing homes, correctional facilities, and schools, as well as in homes and other nonclinical settings. Since June 2020, Cue has been helping to meet the COVID-19 testing needs of rural communities, tribal nations, world class organizations, and federal agencies such as the U.S. Department of Defense and the U.S. Department of Health and Human Services.

Cue’s COVID-19 molecular test was authorized for professional use in June 2020 and for consumer use without a prescription in March 2021.

Yes! With a Cue+^™ Membership, you can access virtual care through Cue Care^™, our same-day antiviral prescription and delivery service for people who test positive for COVID-19, and real-time supervised testing by a virtual proctor at a discounted rate of 20% off*. Non-members can also utilize these services at full price. Virtual care is part of Cue’s commitment to empower consumers like you to better manage health through real-time, actionable, and connected health data.

Access secure, in-app messaging with U.S.-based, board-certified doctors on your mobile smart device 24/7 through the Cue Health App when and where you need help. This Cue+ benefit is provided in collaboration with 98point6, a nationwide primary care telehealth program.

You will need to establish a virtual care profile before using Cue’s telehealth services. Please allow 30 minutes after completing your profile information for your virtual care profile to be activated.

*Exclusions may apply to the 20% discount.

Yes! If you are a Cue+ Member, you and your dependents can receive virtual care.

Dependents ages 18 years and older: Your dependents who are 18 or older will need to establish their own profile through your Cue+ Membership account by signing in to the Cue Health App using their mobile phone number. They will be able to access virtual care after verifying their identity.

Dependents ages 1–17 years old: Virtual care for children ages 1–17 years must be requested by a parent or legal guardian who is eligible for telehealth services through their Cue+ Membership.

Yes. If you would like your medical record sent to another provider, please download a 98point6 medical record request form and send the completed form, along with a copy of government-issued identification (driver’s license or passport) to support@98point6.com.

Yes. When appropriate, telehealth doctors can prescribe medications, renew prescriptions, and order lab tests for you and for your dependents who are linked to your Cue profile.

If a prescription is part of your treatment plan, the virtual care doctor will send the prescription electronically to a U.S. pharmacy of your choice. They will not prescribe controlled substances (such as opioids) or lifestyle medications (such as Viagra and Propecia). See 98point6 for more information.

If a 98point6 telehealth doctor determines that lab work is necessary, they can order a diagnostic test from a nearby LabCorp or Quest Diagnostics location. When your results are ready, the virtual care doctor will reach out to you to discuss your results with you.

As a reminder, Cue’s COVID-19 Test for Home and Over The Counter (OTC) Use is available without a prescription. To order, please see https://shop.cuehealth.com.

Cue’s virtual care program does not cover the cost of prescriptions. Please check with your insurer or other drug coverage plan for cost and payment options.

Cue’s virtual care program does not cover the cost of lab tests. Please check with your insurer or the lab conducting the test for cost and payment options.

As a reminder, Cue’s COVID-19 Test for Home and Over The Counter (OTC) Use is available without a prescription. To order, please see https://shop.cuehealth.com.

Yes! Our telehealth provider, 98point6, supports affiliated physicians with interpreters in over 350 languages to help you communicate with the telehealth physician. Some 98point6 telehealth services may only be available in English.

Please reach out to the 98point6 customer support team through this Contact Us form. A support representative will be in touch to help resolve your issue.

The Cue Cartridge Reader (Reader), also known as the Cue Health Monitoring System, is a sophisticated device used with Cue tests (sold separately) and the Cue Health App to run Cue diagnostic tests. Compact and reusable, the Cue Reader automatically processes, analyzes, and communicates test results digitally to the Cue Health App through an encrypted Bluetooth® signal.

For more information on the Reader, Cue Health App, and Cue tests:

• Cue^® Health Monitoring System Quick Start Guide
• Cue^® Health Monitoring System User Manual

The Cue Reader is quick and easy to set up. The Cue Health Mobile Application (Cue Health App) provides step-by-step instructions.

1. Download the Cue Health App to a compatible mobile smart device.
2. Plug-in the Cue Reader with the provided charging cable.
3. Pair the Cue Reader with your mobile smart device by scanning the QR code, located on the bottom of the Cue Reader.

Note: The Cue Reader needs to remain on a flat, level surface when the Cue Test Cartridge is inserted and preheating, and while the test is running. Do not move the Reader while the test is running.

For more information:

• Cue^® Health Monitoring System Quick Start Guide
• Cue^® Health Monitoring System User Manual

The Cue Reader is compatible only with Cue Test Cartridges, which are purchased as part of a Cue test, such as a Cue COVID-19 test.

To get started, you’ll need a mobile smart device that is compatible with the Cue Health App to connect to the Cue Reader via Bluetooth®.

The Cue Health App is compatible with both Apple® and Android™ operating systems and mobile devices. For system requirements and links to download the Cue Health App from the Apple App® Store® or Google Play Store™, visit our Compatible Devices page. Use of devices other than those listed on the Cue website have not been validated and are considered “Off-Label Use.”

The Cue Reader fits in the palm of your hand, making it easy to use, whenever and wherever. The Cue Reader can be transported repeatedly, with no need to calibrate or take additional steps before use.

It is important to keep the Cue Reader on a flat, level surface while using the device. Do not move the Cue Reader while the test is running.

The Cue Reader should be cleaned and disinfected after each use. Wipe the outside of the Reader thoroughly with a germicidal wipe, such as Clorox® Germicidal Wipes or an equivalent (0.55% sodium hypochlorite) solution.

Do not try to clean the inside of the Cue Reader. Avoid spraying any cleaning solution directly in the Reader or cartridge port or putting the Reader under water or any other liquid.

A Cue Test Cartridge (Cartridge) is a single-use, disposable unit that contains all of the materials needed to perform a specific diagnostic test. The Cartridge works in conjunction with the Cue Reader and the Cue Sample Wand.

Cue Cartridges are designed to run either a molecular nucleic acid amplification test (NAAT) or immunoassays -- two of the most commonly used diagnostic technologies -- which are typically conducted in central laboratories and may take hours or days to report results. All of the steps of the Cue tests take place within the Cartridge in just minutes.

Yes, Cue Cartridges expire and cannot be used after 11:59 PM local time the day before the Use By date. The Use By date is printed on the Cue Cartridge box and on the label of the foil pouch containing the cartridge. The date is also programmed into all Cue Cartridges, preventing tests from running after a cartridge expires.

Based on ongoing Cue Cartridge stability studies, some Cartridges may be given a shelf-life extension. If you have a cartridge that qualifies for an extended Use By date, Cue will send you a Customer Notice of Shelf-Life Extension with a new expiration date. For the new Use By date to take effect, you will need to update the Cue Health App on your mobile smart device before you insert the Cartridge into the Cue Cartridge Reader.

For more information on shelf-life extensions, see our FAQ "What is a Customer Notice of Shelf-Life Extension?"

No. The Use By date is programmed into Cue Cartridges, which prevents the test from being processed after the cartridge expires.

In some cases, however, Cartridges may be given an extended shelf-life based on results of Cue’s ongoing cartridge stability studies. If you have a Cue Cartridge that qualifies for an extended Use By date, Cue will send you a Customer Notice of Shelf-Life Extension with a new expiration date. For the new Use By date to take effect, you will need to update the Cue Health App on your mobile smart device before you insert the Cartridge into the Cue Cartridge Reader.

For more information about Customer Notices, see our FAQ "What is a Customer Notice of Shelf-Life Extension?"

A Customer Notice of Shelf-Life Extension informs consumers that one or more Cue Test Cartridges that they have purchased qualifies for a revised Use By (expiration) date. The new date, which will be later than the date printed on the product packaging, is based on results of ongoing stability studies of Cue Cartridges.

For the new Use By date to take effect, you will need to update the Cue Health App on your mobile smart device before you insert the Cartridge into the Cue Cartridge Reader. You may then use the Cue Cartridge until 11:59 p.m. local time the day before the extended Use By date noted in the Customer Notice of Shelf-Life Extension.

A Cue Wand is a small, single-use device used to collect a specific type of sample from the person being tested, such as nasal secretions, saliva, blood, or urine. The proprietary device is compatible with Cue Cartridges and consists of a plastic handle and a flocked tip.

When a Wand, with sample, is inserted into the pre-heated Cartridge, the Cue Cartridge Reader automatically begins the test, reporting results in minutes via Bluetooth® to the Cue Health App.

For more information:

• Cue^® Health Monitoring System Quick Start Guide
• Cue^® Health Monitoring System User Manual

No. Do not use your Cue Sample Wand if it has been dropped, cracked, or is damaged when opened. Discard the Wand in your household or general trash.

The Cue Health App is our secure, user-friendly mobile application that gives registered Cue users access to the Cue Integrated Care Platform. Downloading the Cue Health App on a compatible mobile device is required to run Cue diagnostic tests and to receive results.

In the Cue Health App, you can:

• Follow step-by-step, video-supported instructions on running a Cue test with a Cue Reader
• Receive and view test results
• Access historical test results at any time
• Print or digitally share your results
• Access other services such as virtual care and Cue Care treatment delivery (available for an additional cost)

The Cue Health App complies with administrative, physical, and technical safeguards and standards of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). For more information, see the Cue Health Privacy Policy (for users in the United States).

Yes. Before you can purchase any Cue products, you must establish a user account.

To use the Cue Integrated Care Platform, a Cue Cartridge Reader, or a Cue test, you must download the Cue Health App on a compatible mobile smart device and agree to the Cue^® Health Terms of Use and End User License Agreement and Cue^® Health Privacy Policy.

The Cue Health App allows you to access the results of your Cue tests and other features of the Cue Integrated Care Platform, such as virtual care and supervised testing for eligible Cue+ members.

For more information about the app, see What Is the Cue Health App?

After creating a Cue account and downloading the Cue Health App on a mobile smart device, you’ll have the option to create and manage multiple profiles. Adding a new profile to the Cue Health App requires a name and some identifying information. To run a test on an existing or new profile, click the name and select BEGIN NEW TEST.

Your privacy is of utmost importance to us. We developed the Cue Health App with data security at its core. To protect the confidentiality and security of your personal and health information, we manage the Cue Health App on secure, cloud-based servers compliant with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and located and operated within the United States.

When you use the Cue Health Monitoring System, the Cue Cartridge Reader transfers your results to your Cue Health App account through a secure Bluetooth® connection. Your test results and other personal information are then deleted from the Cue Reader memory. No individual is identified in any information reported to public health agencies or used for research purposes.

For more information, see the Cue^® Health Privacy Policy on the User Agreements page.

Your privacy is of utmost importance to us. We developed the Cue Health App with data security at its core. We collect personal information to provide services to our users as well as to comply with regulatory mandates.

To protect the confidentiality and security of your personal and health information, we manage the Cue Health App on secure, cloud-based servers compliant with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and located and operated within the United States.

For more information, see the Cue^® Health Privacy Policy on our User Agreements page.

Cue uses personal information to provide services to our users in accordance with our Cue^® Health Privacy Policy, found on our User Agreements page. In some cases, like our Cue COVID-19 tests, results are automatically and anonymously reported to relevant public health authorities to meet local, state, and federal requirements. This anonymous information is sent to public health officials securely using the Cue Health App and the Cue Health cloud server. The information helps public health agencies monitor for and, hopefully, prevent the spread of COVID-19.

When a test is complete, the Cue Cartridge Reader transfers the results using a secure Bluetooth® connection to the Cue Health App profile linked to the test. The results are saved in the Cue Health App then automatically removed from the Reader memory. Your Reader, therefore, does not retain any personal health information or personally identifiable information. Your information within the Cue Health App is accessible only to those you choose to share it with, such as your healthcare provider.

Cue may be required to report test results to relevant public health authorities, depending on the type of test, and local, state, or federal requirements. If so, your anonymous data will be sent to public health officials automatically and securely using the Cue Health App and the Cue Health cloud server. Public health authorities that receive results anonymously will not be able to identify any individuals connected to those results.

The Cue Health App is compatible with both Apple® and Android™ operating systems and mobile devices. For system requirements and links to download the Cue Health App from the Apple App® Store® or Google Play Store™, visit our Compatible Devices page.

The Cue Health App is downloaded and installed the same way as other apps on your mobile smart device and should only take a few minutes. Occasionally, the Apple App® Store® or Google Play Store™ might have intermittent delays or other problems. If the problem persists, please contact us at support@cuehealth.com or 833.CUE.TEST (833.283.8378) with details about the problems you are experiencing. Our Customer Support Team will let you know if there are system problems and when to expect them to be resolved, or a team member will help you successfully download the app.

Your Cue test will continue to run even when your mobile smart device is no longer within Bluetooth® range of the Cue Cartridge Reader, as long as the Reader has power and nothing else directly interferes with the Cue Reader, Cue Test Cartridge, or Cue Sample Wand, such as moving any of these devices.

For the Cue Health App to receive and upload the results, the App must be open, and your mobile smart device must be within range of the Cue Reader’s Bluetooth® signal.

Yes, your test will be valid even if you close the Cue Health App or use a different app while the test is running. Your Cue test will continue to run as long as the Cue Cartridge Reader has power and nothing else directly interferes with the Cue Reader, Cue Test Cartridge, or Cue Sample Wand, such as moving any of these devices.

The Cue Reader should connect seamlessly via Bluetooth® to an in-range mobile smart device. Please check the following:

• Your mobile smart device is Bluetooth®-enabled and ready to pair with another device
• Battery level of the mobile smart device
• Battery level of the Cue Reader
• Power source connection of the Cue Reader

For more information on the Cue Reader, check our Cue^® Health Monitoring System User Manual.

If the Cue Reader is unresponsive and doesn’t “wake” when plugged into a power source, you can reset the Reader manually. Using a thin wire or the end of a paperclip, insert, press, and hold the Manual Reset Button (located on the back of the Reader) for one second. Do not hold the button for more than 3 seconds. Holding the button for more than 10 seconds will return the Reader to factory settings.

For more information on the Cue Reader, check our Cue^® Health Monitoring System User Manual.

Yes. Once a test is correctly started, you can close the Cue Health App without interfering with the Cue Cartridge Reader or the analysis inside a Cue Cartridge. Losing power on your mobile smart device will also not interfere with the test. After the test has finished, your results will automatically upload via secure Bluetooth® connection to your Cue Health App when the app is open and the mobile smart device is in range of the Cue Reader.

The Cue Health App will attempt to troubleshoot any issues with the Cue Reader or test. Follow the instructions in your app.

The Reader needs to remain on a flat, level surface when the Cue Test Cartridge (Cartridge) is inserted and preheating, and while the test is running. Do not tilt or move the Cue Reader while the test is running, otherwise the Cue Health App and the Reader may automatically cancel the test.

If the Reader becomes unresponsive during the test or if you receive an invalid or cancelled test result, you must retest. You cannot reuse the same Cartridge or Cue Sample Wand. Dispose of the used Cartridge with the Wand still inserted in your household or general trash. Use a new Cartridge and Wand and select START RETEST NOW on the Cue Health App.

No. The Cue Health App will attempt to troubleshoot any issues with a Cue test. Follow the instructions on the app screen. When you receive an invalid or cancelled test result, you cannot reuse the Cue Cartridge or the Cue Sample Wand. Dispose of the used Cartridge with the Wand still inserted in your household or general trash. Use a new Cartridge and Wand and select START RETEST NOW on the Cue Health App.

Do you have a question about using a Cue product or taking a Cue test? Do you want to find out the status of your order? Connect with our customer service team by completing the online form at https://cuehealth.com/contact/support/.

You can also drop us an email at support@cuehealth.com or call us at 833.CUE.TEST (833.283.8378). Our offices are open Monday through Friday, 6:00am to 6:00pm Pacific Time.

Yes. Cue Health Inc. warrants each Cue Health Monitoring System (Reader) for a period of one year from the date of the original purchase. If during this time your Reader does not work properly because of a defect in materials or workmanship, Cue will replace the Reader free when it is proven to be defective and subject to warranty. This warranty only applies to the original purchaser of the Cue Reader. For more details on the warranty, please refer to the Cue^® Health Monitoring System User Manual.

Because Cue has stringent quality assurance requirements as it is a medical device and product, returns and exchanges are not permitted. See the Cue Terms of Use and End User License Agreement for more details.

For assistance with your Cue Reader, Cue Test Cartridges, or Cue Health App, please contact our technical support team, email support@cuehealth.com, or call us at 833.CUE.TEST (833.283.8378).

All of Cue’s Test Cartridges are proudly manufactured and sourced in the United States. The biochemistry contained in the cartridges, such as critical enzymes, antibodies, and primers, are also produced at our ISO 13485 certified facilities in San Diego, California.

Nearly all of Cue’s packaging can be recycled as labeled. We use recyclable materials in our products whenever possible and continually look for ways to move from non-recyclable to recyclable materials.

Our products are also designed to use post-consumer (recycled) materials, such as paper, cardboard, and low-density polyethylene (LDPE) plastic when feasible.

Our Cue Test Cartridges currently cannot be recycled. We are continually seeking to adapt recyclable materials whenever possible. We also follow several other environmentally friendly practices as part of our commitment to minimize our environmental footprint while providing innovative, responsibly produced, and effective products.

Our mission is to empower people to live their healthiest lives. Operating our business to protect our communities, our environment, and our future from the threats of climate change is at the heart of everything we do. We are committed to minimizing our environmental footprint while providing innovative, responsibly produced, and effective products.

Science and engineering drive our environmental strategy and inform continuous improvement of our products and processes. We work across our operations and with our key suppliers to address climate change by managing environmental risks and pursuing sustainability initiatives, such as reducing carbon emissions and waste, implementing recycling and reuse initiatives, and expanding use of renewable energy to conserve natural resources.

Our products meet key environmental regulations for manufacturers of electronic products such as REACH, RoHS, and WEEE. These regulations restrict the use of hazardous chemicals during production and encourage manufacturers to design electronic products that are environmentally safe for recycling and disposal.

We use post-consumer and recyclable materials in our products whenever possible. In addition, Cue Test Cartridges and other Cue components are manufactured and sourced domestically, reducing the carbon impact of shipping imported materials.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that combines the diagnostic accuracy of a central lab with the speed and convenience of an at-home test. Cue’s COVID-19 OTC Test is self-contained (no need to mix fluids) and easy to run. The portable device fits in the palm of your hand and delivers accurate results directly to your mobile smart device in about 20 minutes.

Cue’s COVID-19 test uses nucleic acid amplification that was found to be equivalent to polymerase chain reaction (PCR) in an independent study conducted by Mayo Clinic. The study found 97.8% agreement between Cue’s COVID-19 test and central lab PCR testing. In a separate clinical study with lay users, the Cue’s COVID-19 OTC Test demonstrated sensitivity of 97% (% positive agreement) and specificity of 99% (% negative agreement). Importantly, the study showed the test was 100% accurate in people infected with the virus who were asymptomatic.

Most other COVID-19 self-tests are antigen tests. Compared to molecular tests, antigen tests are less sensitive and more likely to give false negative results, especially among people who are infected but asymptomatic. Healthcare providers may suggest a follow-up molecular test to verify the results of an antigen test.

Unlike many other COVID-19 diagnostic tests, with Cue, you don’t need a healthcare professional to administer the test or to analyze the results. And, with lab-quality results, including for emerging variants, there’s no need for additional, confirmatory testing.

Molecular, antigen, and antibody tests are all common tests for SARS-CoV-2, the virus that causes COVID-19. Both molecular tests and antigen tests are viral tests that can detect active SARS-CoV-2 infections, while antibody tests only indicate a previous SAR-CoV-2 infection.

Cue’s COVID-19 OTC Test is a molecular test, also known as a nucleic acid amplification test (NAAT). Molecular tests for COVID-19 detect genetic material of SARS-CoV-2, specifically, ribonucleic acid (RNA). Molecular tests are the most sensitive diagnostic tests for COVID-19.

Most molecular tests are performed by a healthcare professional, sent to a central lab for analyzing, and often take hours or days to provide results. COVID-19 tests that can be self-administered can be complicated, such as requiring the user to mix chemicals to test the sample, unlike Cue’s easy-to-use test, which is self-contained and does not require the user to mix any substances.

Cue’s COVID-19 OTC Test is the first molecular diagnostic test of any kind authorized by the FDA that is available without a prescription to consumers at home or in a non-clinical setting. With Cue, there’s no need for a healthcare professional, a central lab, or mixing or handling liquids.

Sometimes referred to as rapid tests, antigen tests detect specific proteins on the surface of the SARS-CoV-2 virus. Most antigen tests can be self-administered, often without a prescription.  Antigen tests, however, are generally less sensitive than molecular tests, and give more false negative results, especially in people who do not have symptoms. In some cases, a molecular test might be needed to confirm the antigen test results.

Cue’s COVID-19 OTC Test is highly accurate and comparable to a PCR Test, which is considered the “gold standard” in molecular diagnostic testing. In a clinical study with lay users, the Cue COVID-19 Test for Home and Over The Counter (OTC) Use demonstrated sensitivity of 97% (% positive agreement) and specificity of 99% (% negative agreement). Importantly, the study showed the test was 100% accurate in people infected with the virus who were asymptomatic.

To find study results, see the Cue^® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions For Use on the product documentation page of our website.

Results from your Cue COVID-19 Test for Home and Over The Counter (OTC) Use will be sent to the Cue Health App on your mobile smart device within approximately 20 minutes from the time the Sample Wand is locked into the Cue COVID-19 Test Cartridge and the test automatically begins.

To avoid unnecessary delays, be sure that your mobile smart device is charged and close enough to the Cue Cartridge Reader to receive the results through a direct, secure Bluetooth® connection.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is authorized for use by consumers at home and in non-clinical settings without a prescription. Cue’s COVID-19 OTC Test can be self-administered by adults or administered to children ages 2 or older with adult assistance. Cue’s OTC Test is appropriate for individuals experiencing symptoms and those who are asymptomatic.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use analyzes a sample, or specimen, that you take from the lower part of the inside of both nostrils with the Cue Sample Wand. The test detects genetic material of the SARS-CoV-2 virus, which causes COVID-19. Specifically, Cue’s test identifies the ribonucleic acid, or RNA, sequences that comprise the genetic material of the virus.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use, which is a molecular test, provides greater accuracy than antigen tests. Molecular tests are the most sensitive, or “gold standard,” diagnostic tests for COVID-19. Molecular tests detect genetic material of SARS-CoV-2, specifically, ribonucleic acid (RNA). Antigen tests are generally less sensitive than molecular tests, and give more false negative results, especially in people who are asymptomatic. 

Cue provides access to a lab-quality, molecular COVID-19 test without a prescription or a visit to a healthcare provider. Results are delivered directly to a connected Cue Health App on a mobile smart device.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is highly accurate. In a clinical study with lay users, Cue’s COVID-19 OTC Test demonstrated sensitivity of 97% (% positive agreement) and specificity of 99% (% negative agreement). Importantly, the study showed the test was 100% accurate in people infected with the virus who were asymptomatic. 

To find study results, see the Cue^® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions For Use on the product documentation page of our website. 

Cue has not determined a particular time window when the Cue COVID-19 Test for Home and Over The Counter (OTC) Use is most accurate. In general, molecular tests like Cue’s are most accurate during the acute phase of infection. In addition, COVID-19 molecular tests can be used to detect the virus in people who are asymptomatic as well as those with symptoms.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use has Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for over-the-counter use without a prescription at home and in other non-clinical settings. The test can also be used in professional clinical and point-of-care settings.

To read the FDA authorizations, visit our product documentation page.

Yes. In Canada, Cue’s COVID-19 Test is authorized by the Health Canada Interim Order for both consumer self-testing at home and for professional use. In the European Union (CE Mark) and in India (CDSCO), Cue’s COVID-19 Test is authorized for professional use.

At this time, Cue products can be purchased only by consumers with a valid shipping address in the United States or its territories. Cue products are not yet available for sale to individuals residing outside of the United States or its territories.

Before purchasing or using the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, you will need to download the Cue Health App and set up a Cue Health account. The Cue Health App is compatible with both Apple® and Android™ operating systems and mobile smart devices.

To use a Cue COVID-19 test, you will need:

• a Cue COVID-19 test, which includes a self-contained Test Cartridge and a Sample Wand (for lower nasal swab)
• a Cue Health Monitoring System (Reader)
• a compatible mobile smart device with Bluetooth® and Wi-Fi or cellular service
• the Cue Health App installed on your compatible mobile smart device.

For system requirements and links to download the Cue Health App from the Apple App® Store® or Google Play Store™, visit our Compatible Devices page.

The Cue COVID-19 test includes:

• One single-use, sterile Cue COVID-19 Test Cartridge
• One single-use, sterile Cue Sample Wand

The test comes in a foil pouch labeled “Cue^® COVID-19 Test Cartridge Pouch.” The test must be used with the Cue Cartridge Reader (sold separately) and the Cue Health App.

The Cue COVID-19 Test Cartridge is a single-use, disposable unit that contains the reagents (chemicals and other substances) needed to detect the SARS-CoV-2 virus. You do not need to mix any fluids or to calibrate the Cartridge to effectively run a Cue COVID-19 test.

The Cartridge fits smoothly into and is powered by the Cue Health Monitoring System ( Reader). The Cartridge runs a nucleic acid amplification test (NAAT) on a specimen collected from the lower part of the nose using the Cue Sample Wand. The Cartridge automatically begins analyzing the sample after the Wand is inserted into the Cartridge.

The Cue COVID-19 Test Cartridge and Cue Sample Wand comprise Cue’s COVID-19 test.

For specifications, including storage and usage temperatures, see the Cue^® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions for Use on our product documentation page.

Yes, Cue Cartridges expire. Cue COVID-19 Test Cartridges cannot be used after 11:59 p.m. local time the day before the Use By date. The Use By date is printed on the Cartridge box and on the label of the foil pouch containing your Cartridge and Sample Wand. The date is also programmed into the Cartridge to prevent a test from running after the Cartridge expires.

As of July 1, 2021, Cue COVID-19 Test Cartridges have a shelf life of 9 months. Based on ongoing Cue Cartridge stability studies, some cartridges may be given a shelf-life extension. If you have a Cartridge that qualifies for an extended Use By date, Cue will send you a Customer Notice of Shelf-Life Extension with a new expiration date. For the new Use By date to take effect, you will need to update the Cue Health App on your mobile smart device before you insert the Cartridge into the Cue Cartridge Reader.

Customer Notices of Shelf-Life Extension are also posted in the Product Updates section of the Cue COVID-19 Test website.

For more information about Customer Notices, see our FAQ "What is a Customer Notice of Shelf-Life Extension?"

No. The Use By date is programmed into Cue Cartridges, which prevents the test from being processed after the cartridge expires.

In some cases, however, Cue Cartridges may be given an extended shelf-life based on results of Cue’s ongoing cartridge stability studies. If you have a Cue Cartridge that qualifies for an extended Use By date, Cue will send you a Customer Notice of Shelf-Life Extension with a new expiration date. For the new Use By date to take effect, you will need to update the Cue Health App on your mobile smart device before you insert the Cartridge into the Cue Cartridge Reader.

The Cue Sample Wand is a pain-free, single-use, sterile, disposable swab used to collect a nasal sample from the lower part of each nostril. The Wand consists of a plastic handle and a flocked tip.

No. The Cue Wand can only be used once to collect a specimen from both nostrils for testing.

In addition, do not remove the Wand after it has been inserted into the Cue COVID-19 Test Cartridge for testing. When your Cue COVID-19 test is done, remove the cartridge from the Cartridge Reader and simply discard the cartridge -- with the Wand still inserted -- into your household or general trash.

Cue Cartridges must remain at temperatures from 59°F (15°C) to 86°F (30°C) while storing and while testing. For more details, please refer to the Cue^® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions For Use.

Part of revolutionizing diagnostics is making our tests as user-friendly as possible. To administer Cue’s COVID-19 OTC Test, you will need to download, launch, and log in to the Cue Health App, where step-by-step instructions and videos on running the test are displayed. Below are key steps to running Cue’s COVID-19 OTC Test:

1. Log in to the Cue Health App on your mobile smart device. Go to the Dashboard screen, tap “BEGIN NEW TEST,” and follow the on-screen instructions.
2. Insert the Cue COVID-19 Test Cartridge into the Cue Cartridge Reader to preheat.
3. Collect one sample from both nostrils using the same Cue Sample Wand. Insert the tip of the Cue Sample Wand into one nostril about 1 inch or up to the marker on the Wand. If resistance is felt, do not insert any further. Keep gentle pressure on the outer wall of one nostril and rotate the Wand against the wall 5 times. Repeat in the other nostril. A video in the Cue Health App shows how to collect a nasal sample following these instructions.
4. Insert the Cue Wand into the pre-heated Cue Cartridge. You must insert the Sample Wand with nasal sample into the Cue COVID-19 Cartridge within 5 minutes of collecting the nasal sample.
5. Avoid moving the Cue Cartridge Reader or Cartridge while the test is running.
6. The Cartridge and Reader work together to complete the test and communicate the progress to you through the Cue Health App.
7.  View results in about 20 minutes in the Cue Health App on your compatible mobile smart device.

For detailed steps, precautions, and other important information regarding Cue’s COVID-19 OTC Test, please read

• Cue^® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions for Use
• Cue^® Health Monitoring System Quick Start Guide
• Cue^® Health Monitoring System User Manual

No. The Cue Wand for Cue’s COVID-19 test is designed to be minimally invasive and pain-free. Use the Cue Wand to collect a sample from the inside of each nostril in the anterior (front) portion of the nose.

We understand your concern -- other COVID-19 tests may use longer swabs to collect either a mid-turbinate or nasopharyngeal sample, which are more invasive and can be uncomfortable for a brief period.

We designed Cue’s COVID-19 OTC Test to be as intuitive and easy-to-use as possible, with multiple safety and quality checks to mitigate any potential user errors. The Cue Health App informs the user of any errors detected by the Cue Cartridge Reader to ensure that the user performs the test correctly and limits the chances of inaccurate results.

If, for any reason, the Cue Reader is unable to provide a valid positive or negative result, the user will receive notification of an invalid or canceled result through the Cue Health App.

An invalid result means that the Cue Cartridge Reader is unable to provide a positive or negative result. You might receive an invalid result because a processing error occurred inside the Cue Test Cartridge or the sample was insufficient. Storing or using the Reader or the Cartridge in temperatures that are too high or too low can also lead to an invalid result.

Discard the used Cartridge with the Cue Sample Wand still inserted in your household or general trash. Use a new Cartridge and Wand and select START RETEST NOW on the Cue Health App screen.

You will see a test result of “canceled” if you purposely cancel the test or if the Cue Health Monitoring System cancels the test due to an error such as:

• The Cue Cartridge Reader was moved or tilted while the test was running
• The Cue Test Cartridge was removed from the Reader before the test finished.
• The Sample Wand was inserted into the Cartridge too soon or too late.

Discard the used Cue Cartridge with the Cue Wand still inserted in your household or general trash. Use a new Cue Cartridge and Cue Wand and select START RETEST NOW on the Cue Health App screen.

Cue provides highly accurate, lab-quality diagnostics. If the Cue COVID-19 Test for Home and Over The Counter (OTC) Use has returned a positive result, then SARS-CoV-2 has been detected in the sample, and it is likely that you currently have a COVID-19 infection. Tell a healthcare provider about your result and seek medical care if your illness becomes severe. Follow all local, state, and federal recommendations around isolating yourself and limiting the spread of COVID-19.

Find information about understanding the test results, see

• Cue^® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions for Use.
•  Centers for Disease Control and Prevention, If Your Test is Positive.

Children ages 2 and older can be tested with Cue’s COVID-19 OTC Test. If your child’s test result is positive, then SARS-CoV-2 has been detected in the sample, and it is likely that your child currently has a COVID-19 infection. Discuss your child’s result with their pediatrician or other qualified healthcare provider. Follow all local, state, and federal recommendations around isolating and limiting the spread of COVID-19, including notifying your child’s school or daycare center.

Cue provides highly accurate, lab-quality diagnostics. If the Cue COVID-19 Test for Home and Over The Counter (OTC) Use has returned a negative result, SARS-CoV-2 has not been detected in the sample, and it is unlikely that you currently have a COVID-19 infection. Discuss your results with a healthcare provider, including the possibility of a false negative result.

For more information about understanding the test results, see

• Cue^® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions for Use.
• Centers for Disease Control and Prevention, If Your Test Is Negative.

The Cue Health App makes it easy to share or store your COVID-19 test result. Go to the Test Center in the app to show your result right on your mobile smart device screen. Or, click “PRINT” in the upper right corner of the test result screen to print your result in a PDF format or to send your result electronically by email.

Cue does not notify your healthcare provider about your results. You can show your result to your healthcare provider from your mobile smart device screen. Or, click “PRINT” in the upper right corner of the test result screen to print your result in a PDF format or to send your result electronically by email.

Yes, anonymously. Cue is required to ensure that test results are automatically reported to relevant public health authorities in accordance with local, state, and federal requirements. Your anonymous test results are sent to public health officials automatically and securely using the Cue Health App through the Cue Health secure cloud server. The information helps public health agencies monitor the spread of COVID-19.

Cue Cartridges are designed to be safely disposed of in household or general trash. Do not remove the Wand from the Cartridge. Before discarding, however, remember to remove the Cue Cartridge from the reusable Cue Cartridge Reader.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is portable, compact, and easy to use anywhere, at any time, making it easy to pack and use while traveling or after you arrive at your travel destination.

If you travel internationally, you might want to use Cue’s supervised test option,* to obtain certified COVID-19 test results.

To ensure the integrity of Cue’s COVID-19 OTC Test and Cue Cartridge Reader while traveling, please note the following:

• To conduct a Cue COVID-19 test, you must be in an environment from 59°F (15°C) to 86°F (30°C)
• Cue COVID-19 Test Cartridges need to be stored in environments from 59°F (15°C) to 86°F (30°C).
• Cue Readers need to be stored in environments from 39°F (4°C) to 100°F (38°C).

When traveling by air on commercial airlines, we recommend bringing your compact Cue Reader with you on the plane. The Reader has an installed (nonremovable) lithium-ion battery, which should be stored in carry-on baggage when possible, according to the Federal Aviation Administration.

For more specifications, see:

• Cue^® COVID-19 Test for Home and Over The Counter (OTC) Use Instructions For Use
• Cue^® Health Monitoring System User Manual

*Cue’s supervised test by virtual proctor is available to Cue+^™ Members at a discounted rate of 20%* and non-members at full price. To become a Cue+ Member, visit our Cue+ Membership page. Please confirm destination country’s testing requirements.

*Exclusions may apply to the 20% discount.

Cue recommends bringing two Cue COVID-19 Test Cartridges, per traveler, for each travel entry or departure point where a test result must be presented. In the unlikely event that you receive an invalid result, having an extra cartridge with you gives you the option to easily retest.

For international air travel from the United States, please verify local requirements for your outbound destination with your airline, the local government, and the U.S. State Department.

Supervised testing for Cue’s COVID-19 OTC Test is available to Cue+^™ Members at a discount of 20% off* and non-members at full price.

To conduct a Cue COVID-19 Test for Home and Over The Counter (OTC) Use that is supervised by a telehealth proctor, you will need:

1. Purchase the service. Cue+ Members get 20% off products and services*, including supervised testing.
2. A valid driver’s license or passport to verify the identity of the user being tested
3. Cue Cartridge Reader
4. Cue’s COVID-19 OTC Test
5. A compatible mobile device with the Cue Health App downloaded. The Cue Health App provides step-by-step instructions for the supervised test and automatically updates the result in the registered user’s account.

*Exclusions may apply to the 20% discount.

You must present to the proctor a valid driver’s license or passport in the user’s name prior to starting the Cue COVID-19 Test for Home and Over The Counter (OTC) Use.

Supervised testing, also known as proctored testing, is available at a discounted rate of 20% off* to Cue+^™ Members and to non-members at the full price.

If you are a registered Cue user, you can follow step-by-step instructions for taking a supervised test in the Cue Health App on your mobile device.

After you tap “BEGIN NEW TEST” in the app, select the profile of the person to be tested. You will then answer whether you would like a supervised test for work, school, or travel. Select “yes” for a supervised test and follow the instructions to take a supervised test.

Your proctor must verify the identity of the person being tested with a valid driver’s license or passport before taking the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. Once the App instructs you to begin, follow the steps as the proctor watches.

*Exclusions may apply to the 20% discount.

After your Cue COVID-19 Test for Home and Over The Counter (OTC) Use is complete, your result will be saved in your Cue Account profile on the Cue Health App. You can find your result in the Test Center of the app. You will also receive a copy of the results by email.

The result of your supervised Cue COVID-19 Test for Home and Over The Counter (OTC) Use appears in the Test Center of the Cue Health App within the account of the person who was tested -- just like unsupervised test results are saved.

Cue offers several convenient ways to share your result with airline representatives or others who require proof of negative test results:

• Show the results screen from your mobile smart device.
• From the results screen, click on the print button and print a copy of your test result to give to the representative.
• From the results screen, click on the print button and email a pdf of the test result.

You can purchase Cue’s COVID-19 OTC Test online through Cuehealth.com or through the Cue Health App. The Cue Health App is compatible with both Apple® and Android™ operating systems and mobile devices. For system requirements and links to download the Cue Health App from the Apple App® Store® or Google Play Store^™, visit our Compatible Devices page.

Cue also offers a membership subscription called Cue+^™. Cue+ Membership includes a 20% discount off* Cue products and services, including on-demand access to in-app messaging with healthcare providers, virtual telehealth services, certified test results for travel, work, and school, and e-prescription services.

*Exclusions may apply to the 20% discount.

In addition to the Cue Reader (also known as the Cue Health Monitoring System), you will need a Cue COVID-19 test, which includes a Cartridge and a Wand. You will also need to download the free Cue Health App on a compatible mobile smart device.

How often you reorder Cue’s COVID-19 tests will depend on how frequently you need to test yourself and others linked to your Cue account.

Health insurance plans cover the costs of at-home COVID-19 tests. Please check with your health plan for information about your policy.

The Internal Revenue Service considers the cost to diagnose COVID-19 an eligible medical expense for tax purposes. Therefore, the cost of home testing for COVID-19 can be paid or reimbursed under health flexible spending arrangements (health FSAs), health savings accounts (HSAs), health reimbursement arrangements (HRAs), or Archer medical savings accounts (Archer MSAs). Please check with your provider for information about your policy.

Yes! Cue offers a 5% discount on purchases of 10-pack COVID-19 tests ($750 value for $712.50, plus shipping).

Cue+^™ Members receive 20% off* additional tests purchased while you are an active member. With Cue+ you will also have access to 20% off* services like telehealth services, prescription delivery, and certified test results for home, school, and travel.

You can purchase up to 150 Cue COVID-19 tests in a single order. If you need more than 150 tests at a time, please complete our form on the customer support web page. You can also reach us at:

Email: Support@cuehealth.com
833.CUE.TEST (833.283.8378)

*Exclusions may apply to the 20% discount.

Cue+ Membership offers members 20% off products and services* including:

• Antiviral prescription and delivery service
• Supervised testing with certified results for school, work, and travel
• Cue Reader and COVID-19 tests

For more information:

• Cue^® Health Terms of Use and End User License Agreement
• Cue+^™ Membership

*Exclusions may apply to the 20% discount.

Cue+ Membership offers you 20% off* products and services designed to help you make timely, informed decisions about your health. From convenient, intuitive, and easy-to-use lab-quality tests to diagnosis and treatment options from healthcare professionals, accessible in-app and on-demand, Cue+ puts you on the cutting edge of the digital transformation of healthcare.

Get virtual care, e-prescriptions and refills when you need them, and certified test results for travel, work, and school.

Learn more on our Cue+ Membership page.

*Exclusions may apply to the 20% discount.

All Cue+ Membership fees are charged monthly.

For more information:

• Cue^® Health Terms of Use and End User License Agreement
• Cue+^™ Membership

Cue+^™ Members can share virtual care and other benefits with family members. Learn more on our Cue+ Membership page.

The Cue+ Complete and Cue+ Essential Membership fees are charged monthly for one year. Your annual Cue+ Complete or Cue+ Essential Membership will not automatically renew. When your current membership term ends, you can enroll in the new monthly Cue+ membership. The new Cue+ Membership subscription is billed monthly (30 days) and you may cancel at any time in the Cue Health Application, or by sending an email to customer support at support@cuehealth.com.

At checkout, enter the discount code (CUEPLUS) to receive your first month promotional discount. Only new subscribers will receive one month (30 days) free. This is a promotional code and is not for resale, has no cash value, and will not be replaced if lost or stolen. Subscription will renew for $20/month after the promotion ends until canceled. Subscriptions can be canceled at any time in the Cue Health app or by emailing support@cuehealth.com. If a subscriber does not cancel during the promotional month (30 days), the subscription will be renewed. For purposes of Cue+, “one month” is defined as 30 calendar days.