CDC LOCS Lab Advisory: FDA Updates Reporting Guidance, Authorizes Update to IFU for CDC Influenza SARS-CoV-2 Multiplex Assay

On January 8, 2021, the U.S. Food and Drug Administration (FDA) authorized an amendment to the Instructions for Use (IFU) of the CDC Influenza SARS-CoV-2 Multiplex Assay. This amendment includes the addition of two extraction instrument options and revised language for intended use. The revised language states that all SARS-CoV-2 test results – not just positive results – must be reported to public health.

Please refer to the IFU for more comprehensive information about these amendments. 

Online resources:

• Interim Guidance for Antigen Testing for SARS-CoV-2
• How to Report COVID-19 Laboratory Data
• Frequently Asked Questions about Coronavirus for Laboratories
• COVID-19 Information for Laboratories
• CDC COVID-19 website
• Clinical Laboratory COVID-19 Response Calls
• CDC Laboratory Outreach Communication System (LOCS)
• Register for CDC Health Alert Network (HAN) notifications, including updates about COVID-19. Enter your email address, search for HAN, and sign up

If you have any questions, please contact LOCS@cdc.gov.

This Lab Advisory was originally published by the CDC Laboratory Outreach Communication System (LOCS).