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[July 30, 2020] Point-of-Care COVID-19 Antigen Test Kits - IHCA

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[July 30, 2020] Point-of-Care COVID-19 Antigen Test Kits

Posted Jul 30, 20202 min Read

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The Centers of Medicaid & Medicare Services announced that nursing homes will receive point-of-care COVID-19 antigen test kits and the first round of deliveries started in late July. Facilities across the US will receive one diagnostic test machine and enough test kits for a 6-week supply to test residents and employees.

  • CLIA Waiver is required
  • Tests must be ordered by a healthcare professional licensed under applicable state law or a pharmacist under HHS.
  • NHSN data will be used for subsequent deliveries of the equipment and test kits. Priority will be given but not limited to the following:
    • Providers with three or more COVID-19 positive cases
    • Number of positive cases in the greater community
  • Online training will be made available to providers by the manufacturer
  • Each test will cost around $25.00 and after the initial shipment, nursing homes will be responsible for procuring future supplies.
  • Reorder kits will be through a “Concierge” – one stop shop

There are two types of testing equipment:

  • Quidel Sofia 2
  • BD Veritor System
    • Both systems can complete 15-20 tests and results in an hour.
    • Sensitivity at 85-95%
    • Positive tests are 100% accurate
    • False positive tests results are possible

Recommendations: 

  • Ensure appropriate training is completed and documented for designated users for the specific model sent to your facility.
  • Ensure appropriate safety precautions are ongoing and fully implemented for those performing the tests and decontamination of the equipment is properly completed per the manufacturer’s recommendations.
  • Ensure tests are repeated when indicated.
  • Ensure materials are stored appropriately.
  • Designate a person or persons to inventory and reorder testing supplies.
  • Develop protocols with your medical staff and clinical leaders to ensure appropriate action is taken when a person with symptoms tests negative and there is reason to appropriately isolate and seek a diagnostic PCR test for COVID-19.
  • Review the AHCA FAQs and HHS FAQs

If you have question or need assistance with applying for a CLIA Waiver, email ldavenport@ihca.org

About the Author

Lori Davenport, Director of Regulatory and Clinical Affairs