SARS-CoV-2 USA Changes

November 2023

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In 2024, some SARS-CoV-2 tests will change from CLIA Waived to Moderate complexity.

It is important that you confirm the status of your test method by contacting the manufacturer of your test kit, and/or checking the FDA medical device database

If your method is Moderate Complexity, you will need to be enrolled in a 5-challenge proficiency testing module. 

REPLY TO THIS EMAIL BY TUESDAY, NOVEMBER 21, 2023 to let us know if you need to enroll in one of these NEW 5-challenge modules for 2024:

  • 697 – SARS-CoV-2 Antigen (5-challenge) $522
  • 698 – SARS-CoV-2 Molecular (5-challenge) $531

If your kit is Waived Complexity, you do not need to change. The current 2-challenge modules, 688 and 689, will still be available for CLIA-waived methods and will be renamed as “Waived.”

Please contact us with any questions. Reply to this email, or call the Technical Support Group at 800.234.5315.

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