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…