CMS Releases FAQs for CLIA Certificates and University Laboratories
Three essential points pertaining to university laboratories planning for SARS-CoV-2 surveillance testing.
Diagnostics Expert Warns About the Downside of Pooled Testing Except for Limited Situations
Mayo Clinic Director of Clinical Virology Matthew J. Binnicker, PhD, explains when clinical laboratories should consider pooled testing for SARS-CoV-2.
Testing Donated Plasma: Clinical Laboratories Should Be Aware of Overlooked Requirement
To clear up any ambiguity, the EUA further clarifies that only one testing option is permitted under the initial EUA.
Notable Among CLIA-Certified COVID-19 Testing Laboratory Upstarts
If the COVID-19 pandemic continues into 2021, then clinical laboratories can expect many new competitors for SARS-CoV-2 testing.
CMS Releases New COVID-19 Testing and Reporting Requirements
Guidance released Sept. 8 provides simplified details on nursing home testing that should be performed, also identifies three circumstances related to COVID-19 testing triggers.
Abbott SARS-CoV-2 Antigen Test Receives EUA, Had $760 Million Deal Pending With Federal Government in Less Than 48 Hours
Federal collaboration with Abbott materializes into contract quickly after BinaxNOW COVID-19 Ag Card EUA announcement.
FDA Updates Convalescent Plasma Guidelines to Announce Temporary Enforcement Discretion for Testing
Four key points from the FDA’s September 2020 update to initial COVID-19 convalescent plasma guidelines.
Laboratory Expert Identifies Viral Load and Co-infections as Commonly Overlooked Tests for COVID-19 Patients
Pathologist Frederick (Fritz) Kiechle, MD, PhD, reviews two potential testing strategies associated with COVID-19 management.
CDC Updates SARS-CoV-2 Testing Guidelines, Reducing Recommendations for Testing Those Who Have Been Exposed
With another change to CDC COVID-19 testing guidance, clinical laboratories may begin to see more fluctuations in test volumes because of potentially conflicting federal, state, and local testing guidance.
FDA Issues New EUA for Multiplex SARS-CoV-2, Flu Test
Combination coronavirus flu tests readying for flu season.