Laboratory Alert: Safety letter about the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit

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 Posted 08.18.2020 by: Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS) Center for Surveillance, Epidemiology, and Laboratory Services (CSELS) Centers for Disease Control and Prevention (CDC) On August 17, 2020, the U.S. Food and Drug…

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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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No FDA pre-market review or review of EUA requests for LDTs for 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) The U.S. Department of Health and Human Services (HHS) recently announced that the U.S. Food and Drug Administration (FDA) will not require premarket review of Laboratory-Developed Tests (LDTs) for SARS-CoV-2. In alignment with this announcement, FDA will not review Emergency…

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