A new serological test can not only help humanity prepare for and respond to the next pandemic, but it also can be pivotal in the search for viral triggers of diseases like diabetes and celiac disease ...

A fascinating new preprint discusses the potential for customized serologic testing in individuals who have or have not been vaccinated against the severe acute respiratory syndrome coronavirus 2 ...

Against a backdrop of dynamic federal regulations and a quickly expanding commercial landscape, labs are facing unusual obstacles in validating serology testing for COVID-19. Issues with test accuracy ...

Please provide your email address to receive an email when new articles are posted on . In its recent guidance on serology and antibody testing for SARS-CoV-2, the American Association for Clinical ...

On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic. The Agency did this by updating (and superseding) previous ...

A novel coronavirus that was first reported in China in December 2019 quickly led to a global pandemic. Named COVID-19, the virus has had a devastating effect on economies and healthcare systems ...

MADISON, Wis.--(BUSINESS WIRE)--Promega Corporation today announced the launch of its new serological antibody test for COVID-19 to detect the presence of antibodies against the SARS-CoV-2 virus. A ...

MARCY L’ÉTOILE, France--(BUSINESS WIRE)-- Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced performance validation and the upcoming launch ...

WALTHAM, Mass.--(BUSINESS WIRE)-- PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has ...

The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization ...