CDC includes new information on cycle threshold values for RT-PCR tests for SARS-CoV-2 in Laboratory FAQ

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

Attention: Clinical Laboratory Professionals Please share this information with: Medical Director(s), Laboratory Services Lab Manager(s) The CDC recently updated the Frequently Asked Questions (FAQs) about COVID-19 for Laboratories to include new information on cycle threshold (Ct) values for reverse transcriptase – polymerase chain reaction (RT-PCR) tests for SARS-CoV-2. Click here to view the updated FAQs.…

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CMS Issues Statement Regarding Quality Control for Tests with FDA EUA

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

Attention: Clinical Laboratory Professionals Please share the following with: Medical Director, Laboratory Services Lab Manager(s) The Centers for Medicare & Medicaid Services (CMS) has issued a statement in response to recent confusion regarding quality control for tests with FDA emergency use authorization (EUA). See below for the statement from CMS: “The manufacturer’s instructions for all…

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FDA Safety Letter about Potential False Positives with Antigen Tests for Rapid Detection of SARS-CoV-2

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

Attention: Clinical Laboratory Professionals Please share the following with: Medical Director, Laboratory Services Lab Manager(s) On November 3, 2020, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff and Health Care Providers as an alert that false positive results can occur with antigen tests, including when users do not follow…

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