Cue COVID-19 Test - Minnesota Dept. of Health

Cue COVID-19 Test
Description, Provider Instructions, and Priority Distribution

On this page:
What is the Cue COVID-19 test?
Why should we use this test?
Why is Minnesota distributing this test?
Distribution priorities and how tests will be distributed
Resources from Cue Health
MDH requirements of sites administering Cue tests
Reporting data to MDH
Frequently asked questions

What is the Cue COVID-19 test?

Cue is a point-of-care molecular test (isothermal nucleic acid amplification) that uses a device, test cartridge, and nasal swab to deliver COVID-19 test results to an iPhone or iPad in 19 minutes. Cue tests can be performed on asymptomatic or symptomatic patients and must be performed under at least a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, and all positive and negative individual test results must be reported to the Minnesota Department of Health. Cue Health has partnered with Impact Health to help with the implementation of Cue testing, including training on how to use the device and reporting test results to MDH.

Why should we use this test?

Cue provides a rapid test result for symptomatic or asymptomatic patients using nasal specimens. A quick positive test result allows for more rapid implementation of public health measures and may influence a person's compliance with isolation guidance.

Why is Minnesota distributing this test?

Minnesota is receiving Cue devices and test cartridges from the federal government. MDH is distributing Cue devices and test cartridges to facilities where there is high risk of COVID-19 spread and where traditional COVID testing has not fully met the needs of the population being served.

Distribution priorities and how tests will be distributed

MDH anticipates receiving approximately 1,500 Cue devices and 300,000 test cartridges from the federal government. Since demand may exceed supply, MDH will prioritize facilities that serve high positivity rate geographies, populations at disproportionate risk, and/or where access to COVID-19 testing is otherwise limited.

Resources from Cue Health

Impact Health Web Portal

  • The portal must be used to register patients and transmit data electronically to MDH. This application is paired to the Cue Health Mobile Application by the bar code on the specimen collection swab.
  • If the facility is already reporting test results to MDH using electronic lab reporting, the Cue test results can be included in the existing reporting to MDH.

Cue Health Mobile Application

  • The Cue Health app must be used to read test results from the Cue device. The app can be downloaded directly from the Apple Store to your iPhone or iPad.

MDH requirements of sites administering Cue tests

Sites must agree to and meet several core requirements in order to receive the Cue tests.

  • The facility agrees to use the tests in accordance with MDH guidance, including the priority populations referenced on this page, which may be updated based on evolving information.
  • The facility has either a valid Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
  • The facility is not currently receiving Cue tests directly from the federal government, and will let MDH know if it starts to receive them directly from the federal government.
  • The facility can appropriately manage biohazard waste disposal.
  • The facility has a provider able to order and administer Cue tests, per the emergency use authorization. The facility will administer the kits to patients in a manner consistent with all manufacturer guidance, MDH health alerts, and other relevant state and federal guidelines.
  • The facility must complete the Cue online training modules to ensure the test is used in a manner consistent with the manufacturer's instructions.
  • The facility must report Cue test results, both positive and negative at the individual level, and other required data to MDH. The facility must follow data reporting requirements and instructions, as provided by MDH.
  • The facility must follow all relevant data practices and privacy requirements under state and federal law, including but not limited to the Minnesota Health Records Act.

Reporting data to MDH

  • All COVID-19 test results performed using Cue inside your facility must be reported within 24 hours of results.
  • The facility must identify a contact for reporting results to MDH when requesting tests.
  • If the facility is already reporting test results to MDH using electronic lab reporting, the Cue test results can be included in the existing reporting to MDH.
  • Detailed reporting instructions will be sent via email with the approval of your test allocation request.
  • Facilities that are not reporting results to MDH as required will not receive additional test kits until reporting issues are resolved.

Frequently asked questions

How should results be reported to the patient?

Refer to the FDA: Cue COVID-19 Test - Instructions for Use (PDF) for proper reporting language.

What information can I give the patient?

See Cue Health: Product support & documentation for access to a fact sheet for patients.

What personal protective equipment is required?

Test administration requires the following personal protective equipment:

  • Personal protective equipment for health professionals using contact and droplet precautions. This includes gown, surgical mask, protective eyewear, and gloves as well as hand hygiene products.
  • A safe place is needed to complete the test. We recommend that all tests are completed in a setting that can be decontaminated between tests and when a positive test is detected, to reduce possibility of cross contamination.
  • When a test is complete, dispose of it in a biohazard bag.

Cue technical questions:

Reporting questions:

Ordering information:

Questions? Email: health.test.help@state.mn.us.

Updated Monday, 08-Feb-2021 15:08:34 CST