FDA Reissues EUA for Convalescent Plasma to Permit the Use of Additional Antibody Test
Convalescent plasma titers can now be qualified using the Mount Sinai COVID-19 ELISA IgG Antibody Test.
Recent Study Concludes That No Routine Clinical Laboratory Test Reliably Serves as a Biomarker for COVID-19
More on a recent study of 67 routine clinical laboratory tests that sought to identify COVID-19 biomarkers.
FDA Releases Two New Serology Templates for Test Developers
New guidance on what should be submitted to the FDA in support of an EUA request or pre-EUA request for a SARS-CoV-2 antibody test.
University of Michigan Team Delivers Insights Into Hypercoagulopathy With COVID-19
The cause of hypercoagulopathy with COVID-19 may be due to autoantibodies, new study shows, creating potential for increased demand for autoantibody testing.
CDC Guidelines Include Laboratory Professionals Among First in Line to Receive COVID-19 Vaccine Once Authorized
The CDC’s Advisory Committee on Immunization Practices met Dec. 3, 2020, to determine COVID-19 vaccine allocation. Clinical laboratories may be among first to receive.
At-Home COVID-19 Testing Finally Arrives: Laboratory Expert Weighs in on the Implications for Clinical Laboratories
How at-home COVID-19 testing now authorized under FDA emergency use authorization and new tests coming to market may affect clinical laboratories.
More Confusion on Laboratory Developed Tests as HHS Directs FDA to Resume Reviewing LDT EUAs
New guidance positions FDA and now the NCI in process for those opting to use LDTs in their laboratories with or without FDA premarket review or authorization.
Second Monoclonal Antibody Treatment for COVID-19 Authorized for Treatment of Mild to Moderate Infections
Recent developments in emergency use authorizations for investigational therapies for use in the treatment of mild to moderate COVID-19.
HHS Launches Pilot Program Examining the Use of Integrating Rapid Molecular COVID-19 Test Into Existing Testing Strategies
HHS Cue pilot program creates hybrid COVID-19 testing strategy, potentially fast tracks Cue into institutions and communities outside of five-state rollout.
Clinical Laboratories May Benefit as Some Nursing Homes Hesitate to Implement Point of Care COVID-19 Antigen Testing
Nov. 2, 2020, marks the third and final wave of rapid COVID-19 testing device distribution (to about 1,360 nursing homes), according to CMS. Chilly nursing home response may create opportunities for clinical labs.