FDA Issues Safety Communication Warning of Potential False Negatives with Curative SARS-Cov-2 Test
Curative SARS-Cov-2 diagnosis test providing high number of false negatives, FDA warns.
FDA Issues Alert to Clinical Laboratories About the Effects of New SARS-CoV-2 Variant on Testing
A new SARS-CoV-2 variant, B.1.1.7, was identified late last year in the UK, prompting the FDA to monitor existing tests, such as TaqPath, Linea, and Accula.
HHS Announces $22 Billion for COVID-19 Testing and Monitoring
HHS details state-level support for COVID-19 testing and monitoring, with the more than $19 billion to be allocated through the existing CDC ELC cooperative agreement.
One Clinical Laboratory Now Offering Its COVID-19 Diagnostic Test On Amazon
While diagnostic testing for COVID-19 slowly shifts away from clinical laboratories, these changes can be beneficial.
CDC Announces New COVID-19 Testing Requirement for Travelers Arriving from the UK
US Centers for Disease Control and Prevention orders airlines to verify and confirm documentation for COVID-19 negative testing for certain travelers.
Two COVID-19 Testing Trends for Clinical Laboratories to Consider as New Year Begins
Two key trends are explained as potential opportunities for clinical laboratories in the year ahead.
FDA Enhances Medical Device Shortage Resources to Better Reflect the Needs of Clinical Laboratories
Six questions pertaining to the US Food and Drug Administration’s updated medical Device Shortage List, and the primary testing supplies that were added.
2020 in Review: Three Changes and Trends in COVID-19 Testing That Impacted Clinical Laboratories
How SARS-CoV-2 (COVID-19) testing evolved from diagnostic testing only in clinical laboratories to three categories of primary diagnostic and secondary testing.
FDA Issues EUA for Second COVID-19 Vaccine
“Through the FDA’s open and transparent scientific review process, …” : FDA Commissioner Stephen M. Hahn, MD, about the second EUA to cover a COVID-19 vaccine.
CMS Allows Clinical Laboratories to Perform Testing While Awaiting CLIA Certificate of Waiver Approval
The guidance explains when clinical laboratories can begin testing for SARS-CoV-2 after submitting the CMS-116 application for a CLIA Certificate of Waiver.