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

Publication Date: Jan 13, 2021

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).

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