FDA offers strategies for conservation of PPE

The U.S. Food and Drug Administration (FDA) has released a letter addressing conservation strategies for use by health care organizations and personnel for personal protective equipment (PPE), such as medical gloves; the strategies are categorized for a range of needs and supply levels and are intended to assist health care organizations as they determine procedures…

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FDA Update: Policy for Diagnostic Tests for COVID-19 during the public health emergency

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…

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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…

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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…

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