FDA Updates Reporting Guidance, Authorizes Update to IFU for CDC Influenza SARS-CoV-2 Multiplex Assay, and CMS Updates CLIA Surveyor Guidance for SARS-CoV-2 Test Result Reporting

COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our COLA laboratories and affiliates. Below are links to the most recent messages about FDA updated reporting guidance, authorized updated Instructions for Use (IFU) for CDC Influenza SARS-CoV-2 Multiplex Assay, and updated CMS CLIA Surveyor Guidance for SARS-CoV-2 Test Result Reporting.

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.

CMS Updates CLIA Surveyor Guidance for SARS-CoV-2 Test Result Reporting

On January 8, 2021, the Centers for Medicare & Medicaid Services (CMS) updated the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting. Please refer to the updated guidance for details.