With So Many New COVID-19 Serology Tests Obtaining EUAs from the FDA, How Can Clinical Laboratories Identify Tests That Should Perform Reliably?

As federal and state officials ease many regulatory requirements to speed new COVID-19 serology tests to market with minimum data about performance, labs are left with important questions to answer on their own Every day, elected officials at all levels of government call for a huge expansion of COVID-19 serology testing. But, as most clinical laboratory managers and pathologists know, it is a complex undertaking for a lab to select any serological test, validate it, then run it daily in...

Woman Who Can Smell Parkinson’s Disease in Patients Even Before Symptoms Appear May Help Researchers Develop New Clinical Laboratory Test

She worked with researchers at the University of Manchester in England to identify volatile biomarkers for Parkinson’s disease that may lead to first noninvasive screening Clinical pathologists and medical laboratories are used to working with certain biological indicators that drive diagnostics and clinical laboratory testing. Mostly, those biomarkers are contained within various liquid samples, such as blood and urine. But what if a person’s odor could accurately predict risk for certain...

COVID-19 Pandemic Triggers Decline in Anatomic Pathology Testing and Shows How Digital Pathology, Remote Sign-Out Can Increase Pathology Services

Because of ‘shelter in place’ orders, many anatomic pathologists are reviewing digital images from home during the COVID-19 outbreak and demonstrating the value of whole slide imaging, digital pathology, and CMS’ recent amended remote sign-out policy COVID-19 is already triggering many permanent changes in the way healthcare is organized and delivered in the United States. However, not until the SARS-CoV-2 pandemic eases will the full extent of these changes become visible. This will be...

UC Berkeley Creates COVID-19 Robotic Testing Laboratory in Record Time by Reallocating Equipment and Training Researchers to Do Clinical Analysis

Medical laboratory leaders may be inspired by this rapid start-up and its outreach to students and the Bay area In what could take a typical clinical laboratory months or even years to launch, the Innovative Genomics Institute (IGI) at the University of California, Berkeley managed to make a COVID-19 diagnostic testing laboratory operational in just a few weeks.  Even more impressive is that the automated testing lab can reportedly process (with results in four hours) up to 3,000 patient...

COVID-19 Disruptions of Supply Chains Are One More Challenge for Clinical Laboratories to Bring Value to Hospitals and Healthcare Networks

Supply chain experts can explain ways clinical laboratories should evaluate their suppliers and sources Suddenly, supply chain management has become a critical success factor as hospitals, health systems, and clinical laboratories throughout the United States respond to the COVID-19 pandemic. Demand for essential supplies has left many health network medical laboratories vulnerable and understocked. One supply chain expert has several recommendations on how hospitals and clinical laboratories...

FDA Issues First Approval for At-Home COVID-19 Test to LabCorp’s Pixel; Other Clinical Laboratory-Developed At-Home Test Kits May Soon Be Available to General Public

Though the potential is high for false positives and false negatives, some experts believe at-home COVID-19 testing still holds promise for slowing the spread of the coronavirus Laboratory Corporation of America (LabCorp) is the first diagnostic test developer to receive approval from the US Food and Drug Administration (FDA) to market an at-home specimen collection kit for COVID-19. In an April 21 FDA news release, the federal agency announced it had “re-issued the emergency use authorization...