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APHL Applauds Revised FDA Policy on Serology Tests for COVID-19

Laboratory scientist performing serologic testing


Statement by Scott Becker, CEO, Association of Public Health Laboratories

Silver Spring, MD, May 4, 2020 — “The Food and Drug Administration made the right decision by walking back its policy on serology testing for COVID-19.

“We’ve long been concerned that allowing tests on the market that have not been approved and authorized for use is a recipe for disaster. This revised policy makes a lot of sense and should have been in place over the last six weeks.

“The changes announced today bring quality and transparency back into the picture on serology. In addition, it provides important guidance on performance criteria.

“We look forward continuing to work with our partners at FDA in responding to this ongoing pandemic and protecting the health of all of our communities.”

Contact: Michelle Forman, 240-485-2793 or


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The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the public’s health in the U.S. and globally. APHL’s member laboratories protect the public’s health by monitoring and detecting infectious and foodborne diseases, environmental contaminants, terrorist agents, genetic disorders in newborns and other diverse health threats. Learn more at

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