MINNESOTA DEPARTMENT OF HEALTHCue Testing Information8/5/2022Test descriptionCue Health offers a diagnostic, rapid molecular COVID-19 test that uses a nasal swab. Results are available within20 minutes. The Minnesota Department of Health (MDH) has received a limited supply of Cue tests through theU.S. Department of Health and Human Services. These tests will be made available to approved test sites at nocost.Cue has two tests: one sold over the counter (OTC) and a professional version. They are the same test but havedifferent packaging. The Cue COVID-19 test for over the counter (OTC) is authorized for nonprescription homeuse.Federal guidance indicates that any care facility, test site, or other setting assisting with the administration orinterpretation of a Cue professional or OTC test must operate under a CLIA certificate of waiver, certificate ofcompliance, or certificate of accreditation. MDH has two statewide CLIA certificates of waiver that may be usedfor certain test sites, as described below.Considerations for useTest sites must agree to and meet several core requirements to receive the Cue tests.General information Cue tests must be administered according to the requirements in the manufacturer instructions and in theapplicable FDA emergency use authorization (refer to the Vendor information section below for theseresources). Test sites should follow MDH and Centers for Disease Control and Prevention (CDC) guidance. Cue tests may be considered when rapid results are needed. Cue tests may be used on people with symptoms or without symptoms. Cue tests may be used on people 2 years of age or older. The person administering the test uses a Cue Reader (included with a test order) to process and read testresults, which are typically available within 20 minutes. The person administering the test must report the test result to the person being tested. Positive results must be reported to MDH. Refer to the Reporting results to MDH section below for moreinformation.1 of 7

CUE TESTING INFORMATION Test sites are strongly encouraged to advise people who test positive to follow MDH general isolationguidance or the relevant setting-specific guidance. General isolation guidance is at If you test positive or havesymptoms html#positive). Even if a test result is negative, additional measures (e.g., testing, isolation) may be recommended, dependingon the setting where the patient lives, works, or attends. Refer to setting-specific guidance for additionaldetails at Guidance Library: COVID-19 nce.html).TrainingTest sites must review and follow all applicable training standards in the test manufacturer instructions, availablebelow. For test sites using the MDH statewide CLIA waiver, a person administering the test must complete thetraining referenced in the MDH CLIA Waiver COVID-19 Testing ronavirus/hcp/cliawaiver.pdf). Training videos, product information, andfrequently asked questions are at Cue Health Help & Support ( requirements Test sites must operate under a Clinical Laboratory Improvement Amendment (CLIA) certificate of waiver,certificate of compliance, or certificate of accreditation to order and conduct the Cue test, including a Cueover the counter (OTC) test. Many organizations have two options to obtain CLIA certification. First, any organization may apply for and obtain a CLIA certificate of waiver from the Centers for Medicareand Medicaid Services (CMS). Second, eligible organizations may submit a request for MDH to use one of the statewide MDH CLIAcertificates of waiver. More detail about eligibility, requirements, and limitations, and about requests forthese statewide certifications is available below.Individual test site CLIA certificate of waiver Some organizations may have an existing CLIA waiver that can be used to administer the Cue test. Organizations that are not eligible for the statewide CLIA certifications must obtain their own CLIA certificateof waiver. Test sites can learn more about the CLIA certificate of waiver application process at MinnesotaClinical Laboratory Improvement Amendment n/clia/index.html). For questions about CLIA, contact [email protected] or call 651-201-4120. CLIA application forms may be submitted to [email protected]. Once the form is submitted, it takesMDH approximately three days to process the application. Once MDH processes the application, test sitesmay choose to receive instructions to pay online with a credit card ( 180 every two years), or to wait twoto three weeks to receive an invoice in the mail. While this entire process takes about four to six weeks,testing may begin as soon as the test site has been assigned a CLIA certificate of waiver number, which istypically issued approximately three days after MDH receives the application.Additional information about waived testing is in a booklet developed by CDC and CMS, Ready? Set? Test!Patient Testing is Important. Get the right results klet Dec-2019.pdf).MDH statewide CLIA certificate of waiver MDH has a statewide CLIA certificate of waiver that allows organizations to use either the Cue OTC orprofessional test. Eligible organizations include:2 of 7

CUE TESTING INFORMATION Correctional facilities (e.g., jails, juvenile detention centers) Local and tribal public health organizations Long-term care organizations, including group homes Shelters Eligible organizations are encouraged to assess their own needs to determine whether to use the statewidecertificate or to obtain their own CLIA waiver. More information for organizations that elect to use MDH CLIA certificates of waiver is at MDH StatewideClinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver for COVID-19 s/hcp/clia.html). In general, organizations must send an email to [email protected] to request approval to usethe statewide certifications. The request must include a completed MDH CLIA Waiver COVID-19 TestingAcknowledgment liawaiver.pdf).Ordering provider requirements An ordering provider is not required to order the Cue OTC test. Please check to ensure that test kits receivedare OTC tests. An ordering medical provider is required to perform the professional version of the Cue test.Preparing the test area The area chosen for testing should provide enough room to safely administer the test, offer privacy, and havesurfaces that can hold testing materials and it should include convenient methods to dispose of test material(use biohazard bags). Disinfect surfaces within 6 feet of the specimen collection and handling area at these times: before testingbegins each day; between each specimen collection; at least hourly during testing; when visibly soiled, in theevent of a specimen spill or splash; and at the end of every testing day. Refer to CDC: Guidance for SARS-CoV2 Rapid Testing Performed in Point-of-Care Settings retesting.html). For information about COVID-19 disinfectants, refer to EPA About List N: Disinfectants for Coronavirus(COVID-19) s-coronavirus-covid-19-0).Using personal protective equipment Test sites must follow any personal protective equipment (PPE) requirements in the manufacturer instructionsand the applicable FDA emergency use authorization. Test sites should ensure that adults administering the test understand and implement appropriate infectionprevention measures, including the proper use of PPE for the tasks they are performing. For example,personnel collecting specimens or working within 6 feet of someone suspected to be infected with SARS-CoV2 should maintain proper infection control and use recommended PPE, which could include an N95 respiratoror higher-level respirator (or face mask if a respirator is not available), eye protection, gloves, and a lab coator gown. For more detailed information on standard and transmission-based infection preventionprecautions, visit CDC: Interim Infection Prevention and Control Recommendations for Healthcare PersonnelDuring the Coronavirus Disease 2019 (COVID-19) Pandemic ction-control-recommendations.html).3 of 7

CUE TESTING INFORMATION Depending on the setting, federal or state law may also impose PPE requirements. For example, theOccupational Health and Safety Administration impose standards relating to the use of respirators, dependingon whether respirators are mandatory, voluntary, or employer distributed. For more information, refer to DLI: Voluntary Use of Filtering Facepiece Respirators (N95) for ct voluntry use filtering facepiece respirators for COVID19.pdf) and CDC: Types of Masks and Respirators sick/types-of-masks.html). You may also contact:Minnesota OSHA Workplace Safety Consultation651-284-5060 or 800-657-3776For information on standard and transmission-based infection prevention precautions, refer to CDC: COVID19 Overview and Infection Prevention and Control Priorities in non-U.S. Healthcare -us-settings/overview/).Technology needs and considerations The Cue test requires the administrator of the test to download the free Cue Health app and to connect to aCue Reader device, which is included with the test order. The free Cue Health app 1 must be installed on a compatible mobile device issued by the test site – personaldevices may not be used. Visit Cue Health App Compatible Devices & System mpatible-devices/). Test sites should ensure the most up-to-dateapp is installed. The app is available on commercial application platforms: Apple App Store - Cue Health ( Google Play - Cue Health( re/apps/details?id com.cuehealth.healthapp Up to six Cue Reader devices can be connected to each mobile device. The person administering the test, who may be a staff person or an outside provider, will be able to see thetest results. MDH recommends against storing health information in the app directly. Refer to the legal andconsent section below.Test performance and technical considerationsInformation on test accuracy and any risks or side effects is available in the manufacturer instructions, COVID-19Cue COVID-19 Test Instructions For Use ( and The Cue COVID-19 Testfor Home and Over The Counter (OTC) Use ( there are technical difficulties when using the Cue test, test sites should contact the vendor for furtherguidance.Reference to any specific commercial products, process, or service by trade name, trademark, manufacturer, orotherwise, does not constitute or imply its endorsement, recommendation, or favoring by the State.14 of 7

CUE TESTING INFORMATIONSpecimen collection Adults must test children 2 years of age or older. Information on training is in the Vendor information sectionbelow. MDH recommends that people administering tests be evaluated first by a registered nurse or health careprovider for competency in administering a test.Reporting results to MDH Reporting cases and test results relating to infectious diseases is a vital step in controlling and preventing thespread of communicable disease. Test sites have two different COVID-19 reporting obligations under federaland state law. Test sites operating under a CLIA certificate of waiver must report positive Cue test results through one ofthe methods identified at COVID-19 Test Reporting avirus/hcp/reportlab.html). All organizations that report through MDH RePortal must use the specific Cue spreadsheet templateavailable at MDH COVID-19 Lab Results Reporting File Template - for Cue s/hcp/labcue.xlsx). For templates and guidance specific to schools and child care, refer to COVID-19 Testing in K-12Schools and Child Care: rus/schools/testing.html#report).Cases: Minnesota law also requires reports of cases of infectious disease, including COVID-19, regardlessof whether the case was identified on-site or elsewhere (e.g., at home test, external test site, providerdiagnosis, etc.). Refer to Reportable Disease le/index.html) for more information.Facilities that do not report test results to MDH as required will not receive additional test kits until reportingissues are resolved.Legal and consent The State of Minnesota makes no representations or warranties, express or implied, regarding these tests,including the use, condition, and effectiveness of tests, or the accuracy of test results. The persons orderingand taking a test accept the test as-is and assume all risks associated with the test. The State of Minnesotaassumes no responsibility for actual, consequential, incidental, special, or exemplary damages resulting from,caused by, or associated with any test. The person administering the test must ensure that the person taking a test has given informed consent totake the test. The person should work with a parent or guardian, as necessary, to ensure they understand andfully complete any informed consent requirements. Test sites must determine how to manage consent. This includes ensuring each person being testedcompletes the necessary informed consent and may include consent to sharing information with the personadministering the test and, if applicable, test sites before the test is performed. Test sites may be subject to federal and state laws and are responsible for complying with all applicable legalobligations, including those that govern data privacy and health records.5 of 7

CUE TESTING INFORMATION Test sites are strongly encouraged to consult with legal counsel. The State of Minnesota cannot provide legaladvice to test sites and this document should not be relied on as legal advice.CostThe Minnesota Department of Health (MDH) has received a limited supply of Cue tests through a grant by the U.S.Department of Health and Human Services. These tests will be made available at no cost.Vendor informationFor any questions about the Cue test, please contact the Cue team at 833-283-8378 or [email protected] information is at Cue Health ( Information available includes: Cue’s COVID‑19 Diagnostic Test 19/) Cue Health Help & Support ( documentation, frequently asked questions, and training videos. Cue Health COVID-19 Training Webinar( QMOm36oxRVemyBdapAoTxQ)A Cue product demo webinar; register for webinar in advance. Cue Health COVID-19 Dashboard Webinar( WuvtX8OtR2Khf0ErTCTXvQ)Bi-weekly Friday dashboard webinar.Cue professional test resourcesBefore administering the Cue professional test, it is critical that test sites and all staff involved in administering thetest understand the following information: FDA emergency use authorization (EUA):DHHS Letterhead: Cue COVID‑19 Test ( FDA instructions for use:COVID-19 Cue COVID-19 Test Instructions For Use ( FDA fact sheet for patients:Patient FS: Fact Sheet for Patients Cue COVID-19 Test ( OTC test resourcesBefore administering the Cue OTC test, it is critical that test sites and all staff involved in administering the testunderstand the following information: FDA emergency use authorization (EUA): Cue COVID-19 Test for Home and Over The Counter (OTC) Use Letter of Authorization ( of 7

CUE TESTING INFORMATION FDA instructions for use: Cue COVID-19 Test for Home and Over The Counter (OTC) Use - Instructions for Use( FDA FAQ: Cue COVID-19 Test for Home and Over The Counter (OTC) Use - FAQ( FDA fact sheet for individuals: Cue COVID-19 Test for Home and Over The Counter (OTC) Use - Fact Sheet forIndividuals ( to order tests A CLIA certificate of waiver number for each test site is required to place an order. Orders received without aCLIA certificate of waiver number will not be processed. Refer to the CLIA requirements section above forinformation on obtaining a CLIA waiver number. Ordering test kits requires a lead time of up to two weeks. Order Cue test materials at Information for Organizations Requesting Cue Rapid Molecular hcp/cue.html) (order form is near the bottom of the page). Test sites will need test cartridges, test readers, and test control swab packs. There will be: One test cartridge per test. One test reader per 200 test cartridges ordered. One test control swab kit per 100 tests for each test reader. Minnesota has a limited supply of free Cue tests and devices available for test sites. The Cue test cartridges and test control swab packs you receive may have a printed expiration date on the boxthat is past the current date (expired). These tests have had their expiration date extended by the FDA.Documentation will be sent with our order confirmation.For more informationFor more information on Cue tests, contact: [email protected] Department of Health 651-201-5000625 Robert Street North PO Box 64975, St. Paul, MN 55164-0975Contact health.[email protected] to request an alternate format.7 of 7

MINNESOTA DEPARTMENT OF HEALTH . 1 of 7 . Cue Testing Information . 8 / 5 /202 2 . Test description . Cue Health offers a diagnostic, rapid molecular COVID-19 test that uses a nasal swab. Results are available within 20 minutes. The Minnesota Department of Health (MDH) has received a limited supply of Cue tests through the