Laboratory Guidance: FDA has issued new Emergency Use Authorizations for high complexity tests

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…

Read more

COVID-19: Laboratory Updates on Collection, Handling and Testing Clinical Specimens

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…

Read more

COVID-19: Laboratory Updates – Biosafety Guidelines

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…

Read more

FDA FAQ on Diagnostic Testing for SARS-CoV-2

On March 10, 2020, the Food and Drug Administration (FDA) posted answers to frequently asked questions (FAQs) on Diagnostic Testing for SARS-CoV-2. This LOCS message is to raise awareness about these FDA FAQs among clinical laboratories that could potentially be asked to perform testing. Topics covered include information on Confirmatory testing for presumptive positive results…

Read more