Tag Archives: regulatory update – COVID-19

On March 16, 2020, the FDA published notice for “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.” This document supersedes “Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under Clinical Laboratory Improvement Amendments (CLIA) prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency” issued…

The FDA has issued emergency use authorizations for two tests. Summary of Key Points: CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel The FDA has reauthorized the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.  In summary,  testing is now intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens collected from…

This LOCS message is to inform clinical laboratories that perform testing for SARS-CoV-2 (the agent of coronavirus disease 2019 [COVID-19])with the CDC Emergency Use Authorization (EUA) COVID-19 real-time PCR assay, CDC recommends collecting only the upper respiratory nasopharyngeal (NP) swab. Collection of an oropharyngeal (OP) specimen is a lower priority, and, if collected, should be…

On March 13, 2020, CDC updated the Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) page on the Information for Laboratories website. The revisions include recommendations for: Following Standard Precautions when handling all clinical specimens Using automated instruments and analyzers Point-of-care testing (POCT) Using EPA-registered disinfectants with label…