Letter to Editor, NY Times
sent Wed 06-May-20 12:04 PM
Thank you F.D.A.; Let’s take a deep breath
To the Editor:
Re “F.D.A. Orders Companies to Submit Antibody Test Data” (May 4):
The FDA deserves credit for its decision to require COVID-19 serological test developers to submit antibody test data before receiving an emergency use authorization to market and sell within the US.
Some scientists quickly realized that the initial batch of COVID-19 antibody test kits lacked independent evidence of their accuracy while over-eager researchers had skipped the vital first step, assessment of test kit performance. This led to a lot of noise in the initial studies, and national press coverage of these first studies generated undue optimism. The actions taken by the FDA Monday will guarantee increased rigor in antibody test measurements and interpretation.
In the coming weeks, we will have a better understanding of the extent of community infection as we characterize and monitor the extent of COVID-19 antibody response towards herd immunity. Let’s all wait for good clean data before discussing public policy and adjusting our own personal behaviors.
Adam J. Simon, PhD
Yardley, PA 19067