CDC LOCS Lab Advisory: FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

The US Food and Drug Administration (FDA) recently granted an Emergency Use Authorization (EUA) amendment, authorizing an update to the Instructions for Use (IFU) of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This update includes the addition of the Promega Maxwell RSC 48 as an authorized extraction option for use with the test and an update of the in silico inclusivity analysis.

Review the updated IFU here.

This Lab Advisory was originally published by the CDC Laboratory Outreach Communication System (LOCS) here. Check out the CDC LOCS website and Coronavirus Disease 2019 (COVID-19) Information for Laboratories website for the latest information.