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

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

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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FDA posts Independent Evaluations of COVID-19 Serological Tests

Attention: Clinical Laboratories Please share this announcement with the following:              Medical Director, Laboratory Services              Administrative Director and Managers, Laboratory Services On Thursday, June 4, 2020, the U.S. Food and Drug Administration (FDA) posted Independent Evaluations of COVID-19 Serological Tests. Key points: The document includes performance data for COVID-19 serology tests that have been…

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COVID-19 Update: FDA Provides Promised Transparency for Antibody Tests

Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests (from CDC, updated May 22, 2020) Key points: On May 21, 2020, the U.S. Food and Drug Administration (FDA) announced that it has removed a number of antibody tests from the “notification list” of tests offered under the Policy for Coronavirus Disease-2019 Tests During the…

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