COVID-19 Testing Updates: CMS Changes Regarding Point-of-Care Testing

Greetings Colleagues!

On September 26, 2022, CMS issued the memo, CMS Rescinds December 7, 2020, Enforcement Discretion for the Use of SARS-CoV-2 Tests on Asymptomatic Individuals Outside of the Test’s Instructions for Use, which impacts the ability of CLIA Certificate of Waiver labs and non-waived labs to use tests for SARS-CoV-2 on asymptomatic individuals outside of the test’s authorization. This means that effective immediately, facilities conducting point-of-care testing need to ensure they are following manufacturer’s instructions for each test as written, paying particular attention to whether or not the instructions allow for the test to be used on asymptomatic individuals. All programs who are currently conducting point-of-care testing or have plans to conduct this type of testing in the future should carefully review the instructions for each test type they are using to ensure they are in compliance with the intended use.

In summary:

• Facilities must follow point-of-care test instructions for use found on package inserts. Point-of-care test refers to any test conducted with the assistance of facility staff to administer, process, or read test results.
• Some point-of-care antigen tests are not authorized for testing individuals who do not have COVID-19 symptoms.
• If your facility orders antigen tests from MDH, please review Table 1 below to see if the tests you have are authorized for testing asymptomatic individuals.
• Review the MDH resource, COVID-19 Testing and Case Reporting Resources for Shelter and Correctional Settings for a list of testing options and order forms.

 

Table 1. COVID-19 point-of-care tests currently distributed by MDH and their intended uses. 

Point-of-care test	Links	Intended for testing symptomatic people?	Intended for testing asymptomatic people?
BinaxNOW Pro	Link to BinaxNow Pro Instructions for Use	Yes, within first seven days of symptom onset	No
QuickVue Pro	Link to QuickVue Pro Instructions for Use	Yes, within first five days of symptom onset	Yes, when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests
BD Veritor Pro	Link to BD Veritor Pro Instructions for Use	Yes, within the first five days of the symptom onset	Yes, when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests
Cue tests	Link to Cue Test Instructions for Use	Yes	Yes

 

Please contact the COVID-19 Highly Impacted Settings team at Health.R-congregate@state.mn.us if you have any questions.

 

Sincerely,  

COVID-19 Highly Impacted Settings Unit