01/13/2021: Lab Advisory: FDA Updates Reporting Guidance, Authorizes Update to IFU for CDC Influenza SARS-CoV-2 Multiplex Assay

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Clinical Laboratory Professionals

Level: Laboratory Advisory

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.

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

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)