CDC publishes new interim guidance for use of pooling procedures for SARS-CoV-2 diagnostic, screening, and surveillance testing

Acute Care Hospital Program, Clinical Laboratory Program, Critical Access Hospital Program

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboratory Services View the guidance here. Online resources: Frequently Asked Questions about Coronavirus for Laboratories Clinical Laboratory COVID-19 Response Weekly Calls CDC’s Laboratory Outreach Communication System (LOCS) COVID-19 Information for Laboratories CDC COVID-19 website Register for CDC Health Alert…

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FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

Acute Care Hospital Program, Clinical Laboratory Program, Critical Access Hospital Program

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Manager(s), Laboaratory Services The US Food and Drug Administration (FDA) recently granted an Emergency Use Authorization (EUA) amendment, authorizing an update to the Instructions for Use (IFU) of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This update includes the addition of…

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CDC health advisory regarding the detection of Ciprofloxacin-resistant, β-lactamase-producing Neisseria meningitidis

Acute Care Hospital Program, Clinical Laboratory Program, Critical Access Hospital Program

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Managers, Laboratory Services On June 18, 2020, the CDC issued an official health advisory regarding the detection of Ciprofloxacin-resistant, β-lactamase-producing Neisseria meningitidis Key Points: Neisseria meningitidis isolates in the United States have been largely susceptible to the antibiotics recommended for…

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FDA Updates Website, Issues Warning Letters, and Revokes Chembio EUA

Acute Care Hospital Program, Clinical Laboratory Program, Critical Access Hospital Program

Attention: Clinical Laboratories Please share this announcement with: Medical Director, Laboratory Services Administrative Director and Managers, Laboratory Services Key points: The U.S. Food and Drug Administration (FDA) recently updated its website to provide increased functionality. The new link leads directly to FDA-authorized tests for the SARS-CoV-2 virus and viral antibodies. As of June 19, 2020,…

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