Help & Support

Need help getting started or have questions about Cue? We’ve got you covered.

PDFFDA EUA LetterPDFInstructions For Use (IFU)PDFFact Sheet for IndividualsPDFFact Sheet for Healthcare ProfessionalsPDFCue COVID-19 Test FAQ

This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

PDFFDA EUA LetterPDFInstructions For Use (IFU)PDFQuick Reference Instructions (QRI)PDFFact Sheet for Healthcare ProvidersPDFFact Sheet for Patients

This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

About the Cue Health Platform

What is the Cue Health Monitoring System? How does it work?

The Cue Health Monitoring System is designed to perform in vitro diagnostic testing and consists of the Cue Reader, Power Adaptor, and Charging Cable.

For additional information on how to use your Cue Health Monitoring System please refer to the Cue Health Monitoring System User Manual.

What is the Cue Reader?

The Reader is an automated analyzer of test results and is used with the Cue Cartridges, Cue Wands, and the Cue Health Mobile Application (Cue Health App).

Are there any actions by the user that would influence the accuracy of the Cue test?

The Cue platform is turn-key and easy-to-use where user errors are mitigated significantly. The Cue Reader in conjunction with the Cue Health App ensures that the user performs the test correctly. The Cue Health App provides instructions and informs the user of any errors detected by the Reader to preclude inaccurate results.

Can the Cue Reader be transported repeatedly without revalidation?

Yes, the Reader can be transported repeatedly without revalidation. The Reader should not be moved while a test is in progress as it may cause automatic test cancelation.

Can the Cue Reader be moved while the test is running?

The Reader needs to be on a flat level surface during the test. If tilted beyond 20 degrees during preheat, an error message will appear on the Cue Health App warning the user to return the Reader to a flat surface. If tilted beyond 20 degrees during the test, the test will cancel.

How is the Cue Reader cleaned? How often is it cleaned?

The Reader is cleaned by wiping the outside with a germicidal wipe. The Reader should be cleaned/disinfected after each use. Wipe with Clorox® Germicidal Wipes or equivalent (0.55% sodium hypochlorite).

What other tests are available for the Cue Health Monitoring System?

Cue has partnered with the Biomedical Advance Research Development Authority (BARDA), a division of HHS since 2018, to develop the Cue Influenza Test. Cue has already started analytical and clinical validation for the at-home Influenza Test Cartridge.

What is Cue’s post-sale technical service? What is the extended warranty?

The Reader has a one-year warranty. We have an internal technical support team. To contact us for technical support, email support@cuehealth.com or call us at 833.CUE.TEST (833.283.8378).

What is the manufacturer’s suggested retail price of the Cue Health Monitoring System?

The manufacturer’s suggested retail price (MSRP) for the Cue Health Monitoring System is $249.00.

What is the Cue Cartridge? How does it work?

The Cartridge is a single-use, disposable unit that contains the reagents and associated materials required to convert test samples to digital results. The Cartridge works in conjunction with the Cue Wand and Cue Reader.

Do Cue Cartridges expire? If so, where can I find the Use By date of my Cue Cartridge?

Yes, Cartridges expire. Cartridges may be used up until 11:59 PM local time the day before the Use By date printed on the Cartridge packaging. In some cases, a Cartridge may have been authorized by the FDA for a shelf-life extension, in which case the Cartridge may be used up until 11:59 PM local time the day before the extended Use By date as indicated by a Customer Notice of Shelf-Life Extension.

You may find the Use By date on the Cartridge box and on the label of the foil pouch containing your Cartridge. You may find any Customer Notices of Shelf-Life Extension in the Product Updates section of the test’s webpage.

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

What is a Customer Notice of Shelf-Life Extension?

Cue Cartridge expiration dating is supported by ongoing cartridge stability studies. Cue intends to periodically update the expiration dating based on the stability demonstrated during the ongoing studies. In the event of a shelf-life extension, a Cue Health App update can allow for use of certain Cue Cartridges beyond the Use By date printed on the Cartridge packaging.

When Cue updates the expiration dating for certain Cartridge lots, a Customer Notice of Shelf-Life Extension will be issued to describe the Use By date extension and the Cartridges to which the extension applies. You may find any Customer Notices in the Product Updates section of the test’s webpage.

Can I use a Cue Cartridge after its Use By date?

Unless a Customer Notice of Shelf-Life Extension has been issued, Cue Cartridges cannot be used after the Use By date listed on the Cartridge packaging. The Use By date is programmed into the Cartridge, which will prevent the test from being processed after the Use By date. In the event of a shelf-life extension, a Customer Notice of Shelf-Life Extension will be issued and a Cue Health App update will allow for use of certain Cue Cartridges beyond the Use By date printed on the Cartridge packaging. For more information about Customer Notices, see our FAQ “What is a Customer Notice of Shelf-Life Extension?”

Can the Cue Cartridge, Cue Reader, or Cue Health App be updated to allow for use of Cartridges after the Use By date printed on the packaging?

In the event of a shelf-life extension, a Cue Health App update can allow for use of certain Cue Cartridges beyond the Use By date printed on the Cartridge packaging. When this occurs, a Customer Notice of Shelf-Life Extension will be issued indicating the extended Use By date and the Cartridges to which the extension applies. You may find any existing Customer Notices in the Product Updates section of the test’s webpage.

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

What is the Cue Wand? How does it work?

The Cue Wand is a single-use, sterile, disposable swab used for collection of a nasal sample from the lower portion of the human nose. The Wand consists of a plastic handle and flocked tip. The flock fiber material, fiber adhesive, and Wand handle have been tested and validated to be biocompatible.

What are Cue External Control Swabs?

Cue External Control Swabs may be used to verify that a Cue test is working properly. Control Swabs are tested using the same procedure as for a patient sample.

Is the nasal swab for Cue’s test uncomfortable or painful?

No. It’s a simple lower nasal swab, which is pain free. The Cue Wand nasal swab is gently inserted one inch into each nostril vs. other methods such as nasopharyngeal swab which is more invasive.

What is the Cue Health App?

The Cue Health App, which may be installed on the user’s compatible device, receives and displays test results from the Cue Reader. The Cue Health App allows users who have access to a Cue Health Monitoring System to register for individual accounts and receive the results of the test. The test results will be displayed automatically through the Cue Health App about twenty (20) minutes after the insertion of the Cue Wand into the Cartridge inside the Reader.

How are test results reported on the Cue Health App?

Results are transferred via Bluetooth from the Cue Reader to the Cue Health App that has been downloaded and installed on the user’s compatible device. Test results can be emailed or printed in a PDF format.

What kind of compatible device can I use for testing with the Cue Health Monitoring System?

Visit our Compatible Devices page for a list of compatible devices and system requirements, and to download the Cue Health App. Use of devices other than those listed on the Cue website have not been validated and are considered “Off Label Use.”

What operating systems is the Cue Health App available on?

For system requirements and to learn where the Cue Health App can be downloaded, visit our Compatible Devices page.

Does the Cue System report results to relevant governmental authorities?

Authorized Laboratories
As required by applicable law, reporting is the responsibility of the administering Authorized Laboratory or the healthcare provider who orders the test or other entity operating under the supervision of the Authorized Laboratory. The Cue COVID-19 Test results may be printed and then manually entered into the electronic reporting system; Cue Health is not involved in that process. Authorized Laboratories may work with Cue Health to gain assistance for reporting; however, all reporting is the responsibility of the Authorized Laboratory or the healthcare provider who orders the test or other entity operating under the supervision of the Authorized Laboratory.

Over the Counter
When consumers use the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, automatic test result reporting will be performed by Cue Health using the Cue Health App and the Cue Health secure cloud server. This helps public health efforts to monitor if and where COVID-19 is spreading. The information shared with public health agencies is not linked to your name.

In addition to the Bluetooth/Smartphone interface, is your analyzer also able to interface with a customer’s LIS, middleware, or directly to the EMR?

Not at this time; however, all of the test data goes into our HIPAA compliant backend database. We are working on developing APIs to connect our backend to a customer’s EMR or LIS.

Is the Cue Health App compatible with Single Sign On (SSO)?

Not at this time. However, we are planning to implement Single Sign On in the near future.

Does Cue administer tests?

No. Cue is a manufacturer of the tests and does not administer them.

To learn who can administer each Cue test, please reference the Product Documentation for the test you are interested in.

What is the relationship between Cue, an Authorized Laboratory, and a customer?

Cue is the device manufacturer. A customer is the person or entity who purchases the tests. A customer may, in some cases, also be an Authorized Laboratory. For example, a hospital would likely be both an Authorized Laboratory and a customer because the hospital would both purchase and administer the tests. Depending on the usage guidelines of a particular test, an Authorized Laboratory may or may not be required to administer the test.

To learn who can administer each Cue test, please reference Product Documentation for the test you are interested in.

What are CLIA Certified Laboratories and Patient Care Settings?

Laboratories with a CLIA Certification
Under CLIA, a laboratory is defined as a facility that performs applicable testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings. The labs are CLIA certified by CMS acting through the states.

Point-of-Care Settings with a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
Point-of-care includes settings such as hospital rooms, physician offices, urgent care, outreach clinics, pharmacies, and temporary patient care settings that have appropriately trained personnel to perform the test and are operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

If an entity has the appropriate CLIA certificates and follows applicable CLIA regulations, state regulations, and guidelines, a laboratory’s CLIA certificate can be extended to cover testing in areas outside of the designated primary site such as contiguous buildings, or any other designated temporary overflow location in its facility or temporary remote location, such as a parking lot. CMS also defines temporary testing sites to include mobile units.

Further, CMS requires applicants for a CLIA Certificate of Waiver to identify as to their type of testing entity on the CLIA application. Please note that these entities may include healthcare providers, HMOs, and other settings, including school/student health services and practitioners. In addition to healthcare providers and ancillary sites, a CLIA Certificate of Waiver can be obtained for health fairs, by independent or industrial organizations, insurance organizations, mobile laboratories, pharmacies, and school/student health services.

How does an entity obtain a CLIA Waiver?

CLIA Waiver Certificates may be obtained by submitting the application form (CMS-116, CLIA Application Form) to the state where the laboratory is located. The state contacts for submission are indicated in a document issued by CMS at this link: https://www.cms.gov/files/document/qso-20-21-clia.pdf-0.

This CMS document indicates that once the laboratory has identified a qualified laboratory director and has provided all required information on the CMS-116 application, a CLIA number will be assigned and the laboratory can then begin testing as long as the applicable CLIA requirements have been met.

What is pooling?

Pooling is the process of combining multiple swabs in one viral transport media (VTM) sample. It can save time and resources. If the pool result is Positive, individuals included in the pool need to return for repeat testing.

About the Cue COVID‑19 test

What is the Cue COVID-19 test, how does it work, and what type of test is it?

The Cue COVID-19 test is a fast, lab-quality molecular test. Specifically, it has been authorized by the Federal Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for the detection of nucleic acid from SARS-CoV-2. The Cue COVID-19 test is conducted using the Cue Health Monitoring System, the Cue COVID-19 Cartridge, and the Cue Health App.

Both Cue’s COVID-19 test and laboratory tests (commonly known as PCR) are molecular nucleic acid amplification tests (NAAT) that detect the SARS-CoV-2 virus genetic material. Other types of molecular tests are PCR, RT-PCR, and LAMP. Molecular tests are more accurate than other methods such as antigen tests. The Cue COVID-19 test uses isothermal nucleic acid amplification technology for the molecular amplification reaction that is an equivalent alternative amplification method to polymerase chain reaction (PCR).

For information on how the Cue COVID-19 test is performed, please visit Product Documentation and refer to the Quick Reference Instructions (QRI) and the Instructions For Use (IFU).

You can find more information about the Cue COVID-19 test here.

What is the Cue COVID-19 Cartridge? How does it work?

The Cartridge is a single-use, disposable unit that contains the reagents and associated materials required for detection of the SARS-CoV-2 virus in direct nasal swabs, or in previously collected nasal specimens in viral transport media from individuals who are suspected of having COVID-19 by their healthcare provider.

What is the difference between the two Cue COVID-19 tests?

The Cue COVID-19 Test for Professional Use and the Cue COVID-19 Test for Home and Over The Counter (OTC) Use are identical except for their respective FDA Emergency Use Authorizations. There is no form or technological difference between the tests except for who is authorized to purchase and administer the tests, the product labeling differences required by those authorizations, and the in-app experience related to each test.

The Cue COVID-19 Test for Professional Use may be purchased and administered by Authorized Laboratories.

The Cue COVID-19 Test for Home/OTC Use may be purchased and self-administered (or administered with adult assistance for ages 2 and up) by individual consumers without a prescription.

To learn more about who can administer each test, please reference the Product Documentation for the test you are interested in.

What is the manufacturer’s suggested retail price of the Cue Health Monitoring System and the Cue COVID-19 test kits?

The manufacturer’s suggested retail price (MSRP) for the Cue Health Monitoring System is $249.00 and the COVID-19 test kits are $75.00.

What is the Cue COVID-19 test actually measuring?

The Cue COVID-19 test detects the genetic material (nucleic acid/RNA) of the SARS CoV-2 virus, which causes COVID-19.

What is the difference between an antigen test, an antibody test, and a molecular test?

A molecular test detects the presence of virus genetic material (SARS-CoV-2 RNA). Molecular tests determine if you have a current infection.

An antigen test detects specific proteins on the surface of the SARS-CoV-2 virus. Antigen tests also determine if you have a current infection, but antigen tests are generally less sensitive than molecular tests.

An antibody test detects the presence of antibodies to the SARS-CoV-2 virus, which reflects the body’s immune response. Antibody tests determine if you had a past infection of COVID-19.

Does Cue have recommended best practice uses for its COVID-19 test? Is there a window of time when the test is most accurate?

No, Cue has not established a particular time window when the Cue COVID-19 test is most accurate. Generally, molecular tests are most accurate during the acute phase of infection.

How has Cue validated its test?

All studies required by the FDA were performed and are reported in the Instructions For Use (IFU) for each COVID-19 test. You can find these IFUs in the Product Documentation for each test.

How do you perform a Cue COVID-19 test?

The Cue COVID-19 Cartridge is inserted into the Cue Reader to preheat. The user of the test collects a nasal swab from the lower portion of both nostrils using the included Cue Wand, and inserts it into the pre-heated Cartridge. The Cartridge and Reader work together to complete the test and communicate the progress and results in about 20 minutes to a compatible device that is running the Cue Health App.

What are the storage requirements for the Cue COVID-19 Cartridges?

Cue Cartridges must remain at room temperature. For more details, please reference the Instructions for Use (IFU) for your specific Cue COVID-19 test.

Who may be tested using a Cue COVID-19 test? Does the individual need to be symptomatic?

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use

The Cue OTC Test is authorized for nonprescription home use and may be used in adults (self-swabbing) or children ≥2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19.

Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories

The Cue COVID-19 Test administered by professionals may be used for individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.

Cue is a molecular, point-of-care COVID-19 test. How does that differ from the antigen tests currently on the market?

A molecular test detects the presence of virus genetic material (SARS-CoV-2 RNA). Molecular tests determine if you have a current infection.

An antigen test detects specific proteins on the surface of the SARS-CoV-2 virus. Antigen tests also determine if you have a current infection, but are generally less sensitive than molecular tests.

Are there accuracy differences between molecular and antigen COVID-19 testing?

Antigen tests have a higher chance of missing an active infection. If an antigen test shows a negative result indicating that you do not have an active COVID-19 infection, your healthcare provider may order a molecular test to confirm the result.

Is the Cue COVID-19 test available for home use? Can I administer the test myself?

Yes, the Cue COVID-19 Test for Home and Over the Counter (OTC) Use was granted Emergency Use Authorization from the FDA for use with symptomatic and asymptomatic individuals ages 2 and older. Tests may be purchased and self-administered (or administered on a minor with adult assistance) in non-clinical settings by individual consumers without a prescription.

Can I purchase Cue tests outside of the U.S. and U.S. territories?

Currently, the Cue COVID-19 test is only distributing within the U.S. and its territories. To stay up to date on Cue's availability, submit an inquiry or subscribe to our newsletter.

What regulatory authorizations have the Cue COVID-19 tests received?

Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories
The Cue COVID-19 Test was granted Emergency Use Authorization (EUA) from the FDA for the detection of nucleic acid from SARS-CoV-2. The Cue COVID-19 Test may be used to test symptomatic and asymptomatic individuals. Testing may be performed by CLIA certified laboratories or at the point-of-care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The Cue COVID-19 Test has also received the CE Mark authorizing it for sale and distribution within the EU.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use
The Cue COVID-19 Test for Home and Over The Counter (OTC) Use was granted an EUA from the FDA for symptomatic and asymptomatic individuals, ages 2 and older. Tests may be purchased and self-administered (or administered on minors with adult assistance) by individual consumers without a prescription.

Are the Cue COVID-19 tests authorized for pooling?

No, neither Cue COVID-19 test is authorized for pool testing at this time.

Pooling is the process of combining multiple swabs in one viral transport media (VTM) sample. It can save time and resources. If the pool result is Positive, individuals included in the pool need to return for repeat testing.

How accurate are the Cue COVID-19 OTC Test results?

In a clinical study with lay users, the Cue OTC test demonstrated sensitivity of 97% (% positive agreement), specificity of 99% (% negative agreement), and the Lower Limit of Detection is 20 viral genome copies. Performance characteristics of diagnostic assays are generally expressed as relative numbers compared to another method. To best understand the performance characteristics, it is recommended to review the Test Performance Section of the Cue COVID-19 Test Instructions for Use (IFU) for home/OTC.

Does Cue have data on how well the OTC Test performs on asymptomatic patients?

Clinical evaluation of the Cue COVID-19 OTC Test demonstrated 100% accuracy in asymptomatic individuals. For more information, you may review the Test Performance Section of the Cue COVID-19 Test Instructions for Use (IFU) for home/OTC.

What is the difference between the Cue COVID-19 OTC Test and other consumer COVID-19 tests on the market?

The Cue COVID-19 OTC Test is the first molecular diagnostic test available over the counter in the United States. This means that Cue can be purchased and administered without a prescription. The Cue COVID-19 OTC Test delivers results comparable to that of gold-standard laboratory PCR testing methods.

Who can use the Cue COVID-19 OTC Test?

Cue was granted an EUA from the FDA for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use for symptomatic and asymptomatic individuals, ages 2 and older. Tests may be purchased and self-administered (or administered with adult assistance) by individual consumers without a prescription.

Where can I buy the Cue COVID-19 OTC Test?

Cue will be announcing distribution for the Cue COVID-19 OTC Test closer to the public launch of the product. For announcements and updates on product availability, subscribe to our newsletter.

How accurate are the Cue COVID-19 test results?

Across 4 clinical studies, the Cue COVID-19 test demonstrated sensitivity of 99% (% positive agreement) and specificity of 98% (% negative agreement). The Lower Limit of Detection is 20 viral genome copies. Performance characteristics of diagnostic assays are generally expressed as relative numbers compared to another method. To best understand the performance characteristics, it is recommended to review the Test Performance Section of the Cue COVID-19 Test Instructions For Use (IFU) for professionals.

An independent clinical study by the Mayo Clinic published in Diagnostic Microbiology and Infectious Disease found that the overall concordance between the Cue COVID-19 test and reference laboratory nucleic acid amplification tests (NAAT) was 97.8%.

Does Cue have data on how well the test performs on asymptomatic patients?

Clinical evaluation of Cue's COVID-19 test with lay users demonstrated 100% accuracy in asymptomatic individuals. For more information, you may review the Test Performance Section of the Cue COVID-19 Test Instructions for Use (IFU).

What is the stability of the Cue COVID-19 Cartridges and Quality Control materials?

The current shelf life for the Cue Cartridges is four months, and the shelf life for the control swabs is six months at room temperature (59-86ºF). Cue is conducting ongoing stability studies and expects to be able to support longer shelf life stability claims soon.

What is the viral copy number of the positive control?

The positive control swab is prepared with synthetic (non-infectious) RNA at approximately 150 copies per swab.

To what entities may Cue ship the Cue COVID-19 Test?

The Cue COVID-19 Test may only be provided/shipped to an entity that meets the definition of a CLIA certified laboratory or at point-of-care settings (i.e., patient care settings) operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation (referred to collectively as Authorized Laboratory). If Cue contracts with a customer that is NOT an Authorized Laboratory, then that customer must have a partnership with an Authorized Laboratory that will perform the COVID-19 testing services, and the customer must clearly identify and name the Authorized Laboratory either in the contract (preferably) or in written notice to Cue. The Cue COVID-19 Test may only be shipped to addresses designated by the Authorized Laboratory. The addresses may be included in the contract or provided to Cue by written notice.

For example, the Star Company wants to contract with Cue to purchase the Cue COVID-19 Test. The Star Company is NOT an Authorized Laboratory as defined above. The Star Company partners with XYZ Laboratories that has a CLIA Certificate of Compliance and also has CLIA Certificates of Waiver for their extension locations that do diagnostic testing at point-of-care. XYZ Laboratories is named in the Cue customer contract with Star Company as the Authorized Provider for Cue COVID-19 testing. XYZ Laboratories wants the Cue product shipped to XYZ Laboratories, c/o: Star Company at Star company’s address. This would be allowed as long as the Cue customer contract with Star Company names XYZ as the Authorized Provider XYZ designates the ship to address.

What are the FDA requirements for Authorized Laboratories that use the Cue COVID-19 Test?

- Authorized Laboratories using the Cue COVID-19 Test must include with test result reports all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.

- Authorized Laboratories must use the Cue COVID-19 Test as outlined in the authorized labeling. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents, and authorized materials required to use the Cue COVID-19 Test are not permitted.

- Authorized Laboratories that receive the Cue COVID-19 Test must notify the relevant public health authorities of their intent to run the product prior to initiating testing.

- Authorized Laboratories using the Cue COVID-19 Test must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.

- Authorized Laboratories must collect information on the performance of the Cue COVID-19 Test and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUAReporting@fda.hhs.gov) and Cue Health Inc. Technical Support (support@cuehealth.com) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the Cue COVID-19 Test of which they become aware.

- All operators using the Cue COVID-19 Test must be able to perform and interpret the test results, use appropriate personal protective equipment, and use the product in accordance with the authorized labeling.

- Authorized Laboratories using the Cue COVID-19 Test must ensure that any records associated with this EUA are maintained until otherwise notified by the FDA. Such records will be made available to the FDA for inspection upon request.

Should the customer expect frequent changes in lot numbers?

At current production scale, expect a new lot for every shipment from Cue, and possibly mixed lots in the shipment. Cue recommends that a positive and negative control be run with each new lot. For more details, refer to the Cue COVID-19 Test Instructions for Use (IFU) for professionals.

Does the Cue COVID-19 Cartridge Pack include controls? Or are the controls sold separately?

A Cue Wand nasal swab for collecting a patient sample is included with each Cartridge. The Cue COVID-19 Test External Control Swabs are sold separately. The Cue COVID-19 Test External Control Swabs Pack DOES NOT include test cartridges.

How is the privacy of the COVID-19 Test data safeguarded?

The Cue COVID-19 Test is administered by laboratories or point-of-care settings with the appropriate CLIA certifications. Laboratories are subject to the Federal Health Insurance Portability and Accountability Act (HIPAA). When the laboratory administers the test and the Cue Reader analyzes the Cue COVID-19 Cartridge, the result is transmitted to Cue’s secure cloud-based database and is provided to the test operator on their business device. Cue safeguards this test data in accordance with the HIPAA security standards when it is being transmitted and maintained in its database. The security of the device and the operator's account credentials are the responsibility of the operator.

Cue does not use or disclose Personal Health Information (PHI) for purposes other than providing the services and as otherwise permitted under HIPAA. Cue will sign a Business Associate Agreement with laboratories upon request.

If the test is administered by an organization with a CLIA Certificate of Waiver (for example) that is not a covered entity and therefore is not subject to HIPAA, Cue applies the exact same safeguards and standards to that organization’s personal information.

Where is the Cue COVID-19 test manufactured?

All manufacturing of Cue’s Cartridges takes place in our ISO 13485 certified facilities in San Diego, using fully automated, highly scalable production lines adhering to Good Manufacturing Practice (GMP) guidelines.

Where is Cue's COVID-19 test currently being used?

Cue’s COVID-19 tests are currently being used in healthcare, educational, and enterprise settings throughout the United States.

Privacy

Is an account with Cue required to use the product?

Yes. Before an operator or administrator of a test uses the Cue Health App, they must register for an account and agree to the Cue Health App Terms of Use (End User License Agreement) and Privacy Policy. Upon user consent, a verification email is triggered to complete the account creation process.

Does the Cue Reader collect and store data?

Once a test result is transferred from the Cue Reader to the Cue Health App on a compatible device, the test result is deleted from the Reader memory. Therefore, the Reader does not retain any Personal Health Information (PHI) or Personally Identifiable Information (PII).

Where is the Customer Data stored: Cue's own servers or a cloud-based storage solution?

The Customer Data (including test results and identifiers) are stored in MongoDB which is a SAAS solution that provides cloud-based HIPAA compliant storage. Cue has executed a HIPAA Business Associate Agreement with MongoDB to protect Customer Data.

Is Cue willing to sign a Business Associate Agreement with Authorized Laboratories?

Yes, Cue is willing to sign a Business Associate Agreement (BAA) with Authorized Laboratories that are covered entities under the Health Insurance Portability and Accountability Act (HIPAA). Whether or not Cue signs a BAA, it protects all its data in accordance with the HIPAA privacy, security, and data breach notification rules.

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support@cuehealth.com
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