New At-Home COVID-19 Test Available to Ship Now; CLIA Waiver Changes

department of education

November 30, 2021

Good morning, 

There are two important updates to the COVID-19 School Testing Program to share with you today. First, the State of Minnesota has secured 2.8 million BD Veritor At-Home rapid antigen COVID-19 tests for public, tribal and nonpublic schools. A large quantity of these tests are available now and ready to be shipped. Second, due to a change in the interpretation of federal regulations, schools that are administering Cue COVID-19 tests will be required to have a Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certificate of Waiver as of December 16, 2021 

BD Veritor At-Home COVID-19 Tests 

As COVID-19 cases remain at high levels, the State of Minnesota is providing additional rapid, antigen at-home COVID-19 tests for school staff and students. As you all know, testing is an important mitigation strategy that can keep students healthy and in their classrooms.  

Starting today, schools can order one test per student (using October 2020 enrollment data) and one test per each staff member, plus 20 percent (for contracted staff). The BD Veritor At-Home tests will arrive as soon as two weeks after the order is placed, depending on the volume of orders. Schools will have the opportunity to place additional orders for these tests in 2022. 

The BD Veritor At-Home test must be administered by families outside of the school building. Families need to download the Scanwell Health app on theiriPhoneSamsung Galaxy or Google Pixel smartphone. Once they create an account and are signed-in, the app will provide step-by-step video instructions in English. Families should ensure they have 20 minutes to take the test.  

To support schools in communicating with families about this test, the state has created a template email to send to families and a simple overview that should be printed and provided to families when they receive the test. 

Learn more about the BD Veritor At-Home test, including how to order tests.  

CLIA Certificate of Waiver Needed for Cue Tests 

The Minnesota Department of Health (MDH) recently learned that, even though the Cue tests are approved for over-the-counter use, organizations need to have a (CLIA) Certificate of Waiver when using them to test people in their facility. 

Starting on December 16, 2021, in order to receive Cue tests from MDH in the future, public and nonpublic school districts and school will need to have a CLIA Certificate of Waiver. Schools can apply for their own CLIA Certificate of Waiver using the CMS-116 form. Once the form is completed, it should be emailed to health.CLIA@state.mn.us. Schools with a CLIA waiver must pay a fee of $180 every two years. Quick Start Guide for Schools is available to guide the application process. 

Schools may need a CLIA waiver for more than just COVID testing, as CLIA applies to any testing on blood or other bodily fluids, including blood glucose and ketone tests completed by school staff.  

To reduce the barriers for schools to continue or begin administering Cue or BinaxNow Professional tests, the Minnesota Department of Health (MDH) is making a temporary statewide CLIA Certificate of Waiver available for COVID-19 testing only. You can learn more about this option at MDH Statewide Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver for COVID-19 Testing 

You can find more information about the Cue test on MDH’s website, including CLIA requirements and options, at Information for Organizations Requesting Cue Rapid Molecular Tests 

Upcoming Webinar 

School leaders and COVID Coordinators are invited to attend a COVID-19 School Testing Program Webinar that will provide information about these new options on December 8 at 10:30 a.m. There will be time for school staff to ask questions to MDE and MDH during this time.  

Additionally, we want to remind schools that the State of Minnesota has provided several other no-cost testing options for schools outlined on the MDH website. The state also recently contracted with 11 COVID-19 testing vendors. These vendors can provide schools with a variety of services including, but not limited to, creating and operating testing sites in schools, including providing trained staffing for these sites; providing options for bulk ordering COVID-19 tests; and, processing tests in labs and reporting test results. Read the full November 19 announcement regarding the new COVID-19 testing vendor options for schools.  

Thank you for your work keep our school communities healthy and safe. If you have any questions about school testing program options, email COVIDtesting.MDE@state.mn.us.