Help & support

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

Product support & documentation for the Cue COVID-19 Test

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens. This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

FAQs

The Cue Health Monitoring System User Manual and the Cue COVID-19 Test Instructions For Use (IFU) cover the basics of your Cue Health Monitoring System and the Cue COVID-19 Test. If what you’re looking for is not in those documents, here’s more information to help you.

Top Three Questions

What is the Cue Health Monitoring System, the Cue COVID-19 Test Cartridge, and the Cue Health App? How do they work?

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

The Cue Cartridge Reader is an automated analyzer of test results and is used with the Cue COVID-19 Test Cartridges, Cue Sample Wands, and the Cue Health Mobile Application (Cue Health App).

The Cue COVID-19 Test 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 COVID-19 by their healthcare provider.

The Cue Sample Wand is a single-use, sterile, disposable swab used for collection of a nasal sample from the lower portion of the human nose. The Sample 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.

Cue Health App. The Cue Health Monitoring System allows for the delivery of COVID-19 Test results to healthcare providers via the Cue Health App, which may be installed on the test administrator’s Apple® iPhone® 8 Plus and/or newer mobile smart device with iOS 13 or higher operating system. The Cue Health App allows test administrators who have access to a Cue Health Monitoring System to register for individual accounts and receive the results of the COVID-19 Test. The test results will be displayed automatically through the Cue Health App in about twenty (20) minutes of the insertion of the Test Cartridge into the Reader.

Cue External Control Swabs. Cue COVID-19 Test External Control Swabs may be used to verify that the Cue COVID-19 Test is working properly. Control Swabs are tested using the same procedure as that for a patient sample.

For additional information on how to use your Cue Health Monitoring System and Cue COVID-19 Test, please refer to the Cue COVID-19 Test Quick Reference Instructions (QRI), the Cue COVID-19 Test Instructions For Use (IFU), and the Cue Health Monitoring System User Manual.

Are the Cue Health Monitoring System and the Cue COVID-19 Test Cartridges available for home use? Can I administer the Cue test myself?

Not at this time. The Cue COVID-19 Test is not authorized for self swabbing. While Cue is in the process of securing FDA authorization for home use, the Cue COVID-19 Test is currently available to be administered by any authorized healthcare professional with CLIA certification.

What type of test is Cue’s COVID-19 Test?

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 generic 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). To learn more, watch COVID-19 Testing Explained.

General - Product

What is the Cue COVID-19 Test and how does it work?

The Cue COVID-19 Test is a rapid, point-of-care 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 test is for use by Authorized Laboratories at the point-of-care (POC) (e.g., patient care settings) to test individuals as ordered or directed by a healthcare provider. Tests must be conducted by an Authorized Laboratory that has a Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certificate for moderate or complex testing or a CLIA Certificate of Waiver for point-of-care testing. If an organization does not have any CLIA certification, it may contract with a CLIA certified laboratory to administer Cue COVID-19 Tests. The Cue COVID-19 Test is conducted using the Cue Health Monitoring System, the Cue COVID-19 Test Cartridge, and the Cue Health App.

How accurate are the Cue COVID-19 Test results?

The concept of accuracy depends upon the comparator test used. The Cue website lists the Sensitivity as 99% (% positive agreement), the Specificity as 98% (% negative agreement), and the Lower Limit of Detection as 20 viral genome copies. It is important to understand that the 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).

Where are the Cue COVID-19 Tests available?

Please contact Cue to check on availability: https://www.cuehealth.com/get-cue, email: support@cuehealth.com, or call 833.CUE.TEST (833.283.8378).

How do you perform a Cue COVID-19 Test?

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

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 Sample 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 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 viral copy number of the positive control?

The positive control swab is prepared with synthetic (non-infectious) RNA at approximately 100 copies per swab.

How many Cartridge Readers can be connected to one iPhone?

Up to six Cue Cartridge Readers can connect to a single iPhone. Please see User Manual for further details.

Can the Cue Cartridge Reader be moved repeatedly without revalidation?

Yes, the Cue Cartridge Reader can be moved repeatedly without revalidation.

Can the Cue Cartridge 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 device cleaned? How often is it cleaned?

The Cue 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).

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

The Cue COVID-19 Test is a turn-key, easy-to-use test where user errors are mitigated to none. The Cue Cartridge 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.

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.

Where is the Cue COVID-19 Test manufactured?

All manufacturing of Cue’s test 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 currently being used?

The FDA EUA allows Cue’s COVID-19 Test to be used at the point-of-care, in conjunction with Authorized Laboratories, as directed by healthcare providers. Cue’s COVID-19 Tests are currently being used in healthcare, educational, and enterprise settings throughout the country. Some of our customers are Henry Schein, J&J, Impact Health, Mayo Clinic, and NBA to name a few.

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

No, the Cue COVID-19 Test is not registered for use in any countries outside the U.S. and its territories.

What are the storage requirements?

Cue COVID-19 Test Cartridges and the Cue COVID-19 Test External Control Swabs may remain at room temperature. See Cue COVID-19 Test Instructions For Use (IFU) for specifics.

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

The current shelf life for the Cue COVID-19 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.

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).

Does the Cue COVID-19 Test Cartridge Pack (quantity 10) include controls? Or are the controls sold separately?

A Cue Sample Wand nasal swab for collecting a patient sample is included with each test 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.

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. Contact us for technical support. Email us at support@cuehealth.com or call us at 833.CUE.TEST (833.283.8378).

Does Cue administer tests?

No. Authorized Laboratories administer the Cue COVID-19 Tests. Cue is a manufacturer of the tests. Organizations wishing to purchase Cue’s products must either be a CLIA certified laboratory or contract with an Authorized Laboratory to administer the tests, in accordance with the FDA conditions of authorization for the Cue COVID-19 Test.

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

Cue is the device manufacturer. A customer is the entity who purchases the tests. An Authorized Laboratory must administer 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. An Authorized Laboratory may have authorization to allow it to administer tests in numerous point-of-care settings, wherever testing is most needed. On the other hand, an enterprise or business is not likely to have CLIA certification to administer the tests itself. Therefore, if it wishes to implement testing, it would likely contract with an Authorized Laboratory to administer Cue tests.

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 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 applicable CLIA requirements have been met.

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

  • Authorized Laboratories using the Cue COVID-19 Test will include with result reports of the Cue COVID-19 Test all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media. The Letter of Authorization refers to “laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA),42 U.S.C. §263a, to perform complex, moderate, and waived complexity tests” as “Authorized Laboratories.”
  • Authorized Laboratories using the Cue COVID-19 Test will perform the Cue COVID-19 Test as outlined in the Cue COVID-19 Test Instructions For Use (IFU). Deviations from the authorized procedures, including authorized clinical sample types and authorized control materials required to perform 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 test prior to initiating testing.
  • Authorized Laboratories using the Cue COVID-19 Test will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
  • Authorized Laboratories will collect information on the performance of the test and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@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 test of which they have 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 will ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.

General - Science

How can Cue help address the challenges we are seeing with COVID-19 testing?

The Cue COVID-19 Test system is a portable, compact, connected diagnostic platform that provides the power of rapid and accurate lab-quality molecular testing at point-of-care when and where it is needed the most. The system is a complete diagnostic tool providing actionable health data at point-of-care for healthcare providers, organizations, and communities.

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.

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 antigen tests 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.

How does Cue’s COVID-19 Test compare to saliva-based tests?

Currently, all FDA EUA saliva-based tests are run on central laboratory systems (e.g., samples must be shipped to a central laboratory capable of running high complexity laboratory tests). There are no saliva tests among the COVID-19 molecular tests authorized by the FDA for use at point-of-care (POC) settings. Turnaround time is longer than the 20 minute point-of-care Cue COVID-19 Test. Existing saliva-based tests take at least three hours for results without including time for transport, processing, and result reporting. Cue COVID-19 Test is sensitive, easy-to-use, requires no sample preparation, and delivers results in approximately 20 minutes in a POC setting.

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

Testing of individuals suspected of COVID-19 infection or exposure is at the discretion of the healthcare provider ordering the test. FDA clarifies that “suspected of COVID-19 infection or exposure” can be symptomatic, pre-symptomatic, or asymptomatic. The FDA is clear that molecular diagnostic tests may be used in screening and testing of asymptomatic individuals where ordered by a healthcare provider.

FDA’s FAQs on Testing for SARS-CoV-2 indicates that “Most EUA-authorized SARS-CoV-2 diagnostic tests have been authorized for use in individuals suspected of COVID-19 by their healthcare providers. Individuals suspected of COVID-19 infection or exposure can be symptomatic, pre-symptomatic, or asymptomatic.

During the August 5th FDA Town Hall on COVID-19 Testing, FDA clarified screening or testing of asymptomatic persons. FDA indicated that for molecular diagnostic tests with an EUA, the test can be used in screening/testing of asymptomatic populations when there is a healthcare provider order. There is no required change to the EUA for that test unless the test wants to claim a certain level of performance in the screening population.

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

Cue has not conducted a formal study, but we are aware that the Cue COVID-19 Test has been performed on asymptomatic patients as determined by the healthcare provider.

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 more 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 Cue COVID-19 Test Instructions For Use (IFU).

Was Cue granted an EUA from the FDA? If so, what are the parameters?

Cue was granted EUA from the FDA in June 2020 for the detection of nucleic acid from SARS-CoV-2. The Cue COVID-19 Test may be used to test individuals as ordered or directed by a healthcare provider. 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.

What is pool testing?

Pooling describes combining multiple swabs in one VTM sample. It can save time and resources but if the pool result is Positive, individuals included in the pool need to return for repeat testing. At this time, the Cue COVID-19 Test is not authorized for pool testing.

Reporting Test Results & Cue Health App

How are test results reported on the Cue Health App?

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

Can I use another type of iOS device for testing with the Cue Health Monitoring System?

Only the iPhone 8 Plus or later with iOS 13 or later have been validated and are approved for use. Use of earlier or other iOS devices (including iPads) have not been validated and are considered “Off Label Use.”

Is an application available for Android?

Cue expects to release an Android application in Q4 2020.

Does the Cue System report results to relevant governmental authorities?

The Cue system does not do any automatic reporting. All reporting is the responsibility of the Authorized Laboratory that administers the tests. The Authorized Laboratory can print the results and can manually enter them into its system; Cue is not involved in that process. All reporting is the responsibility of the Authorized Laboratory, the healthcare provider who orders the test, or the employer, as required by applicable law.

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 the test data go 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. We are planning to implement this later next year.

Privacy

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

The COVID-19 Tests are 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 Cartridge Reader analyzes the Cue COVID-19 Test Cartridge, the result is transmitted to Cue’s secure cloud-based database and is provided to the test operator on his or her business iPhone. Cue safeguards these test data in accordance with the HIPAA security standards when it is being transmitted and maintained in its database. The security of the iPhone and the operators 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.

Is an account with Cue required to use the product?

Yes. Before an operator or administrator of a test uses the Cue Health App, he or she 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 Health Reader collect and store data?

Once a test result is transferred from the Cue Cartridge Reader to the Cue Health App on the mobile smart device, the test result is deleted from the Cartridge Reader memory. Therefore, the Cue Cartridge 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.

If you still need assistance, contact customer support.

support@cuehealth.com833.cue.test (833.283.8378)

Coming soon