Roche CEO Severin Schwan Questions the Ethics of Certain Companies Making COVID-19 Antibody Tests and Calls Some of These Clinical Laboratory Tests a ‘Disaster’

Schwan’s concerns about inaccurate or unreliable COVID-19 serology tests were supported when the FDA issued more restrictive rules for these medical laboratory tests on May 4 Last month, Roche Group CEO Severin Schwan characterized some COVID-19 antibody tests as a “disaster” and questioned the ethics of some manufacturers of these tests. During a conference call with investors about the company’s first-quarter results, Schwan said of the recently-launched COVID-19 antibody assays, “These...

Achieving High Confidence Levels in the Quality and Accuracy of Your Clinical Lab’s Chosen COVID-19 Serology Tests

Achieving High Confidence Levels in the Quality and Accuracy of Your Clinical Lab’s Chosen COVID-19 Serology Tests, featuring James Westgard, PhD Dark Daily and COVID-19 STAT Intelligence Briefings is offering this FREE webinar as a service to our clinical lab and pathology colleagues   Thursday, June 11 at 1:00 PM EDT   Register Now As medical labs across the nation validate new, untried COVID-19 serology tests that often incorporate new methodologies, correct use of Westgard Rules...

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...

Where Are the Patients? Hospitals and Clinical Laboratories Wonder When Routine Surgeries, Procedures, and Testing Can Be Restarted Once the COVID-19 Outbreak Eases

Even as some states lift stay-at-home orders, clinical laboratories and pathology groups face uncertainty about how quickly routine daily test referrals will return to normal, pre-pandemic levels Although strokes and heart attacks do not take vacations, a large and growing number of patients with serious health issues who—in normal times—would require immediate attention are not contacting providers to get needed care. Instead, they are avoiding hospital emergency rooms and clinical...

US Works with Clinical Laboratories to Launch Several Large-Scale COVID-19 Serological Surveys to Track Undetected COVID-19 in the Nation’s Population

Though some experts claim widespread antibody testing is key to effective public health safety, the WHO warns positive serological tests may not indicate immunity from reinfection or transmission of SARS-CoV-2 It may be the largest program of clinical laboratory testing ever conducted in the United States. Health officials are preparing to undertake large-scale serological surveys (serosurveys) to detect and track previously undetected cases of SARS-CoV-2, the novel coronavirus, that causes...