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 laboratories and affiliates. Below is a link to the most message about a recent change to the interpretation of results for the CDC Emergency Use Authorization (EUA) Assay.
Change to Result Interpretation for CDC EUA Assay
This message is to inform clinical laboratories using the CDC 2019-nCoV Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel Emergency Use Authorizationexternal icon (EUA) that the presumptive positive result interpretation has been revised. Positive results generated by any laboratory testing under the CDC EUA may be interpreted as positive instead of presumptive. No confirmation of positive results is required. Please review the CDC EUA Instructions for Useexternal icon and Letter of Authorizationexternal icon for other changes.