FDA gives emergency authorization to most precise coronavirus-antibody test yet
NEW YORK — A new, next-level coronavirus-antibody test that measures not just antibodies’ presence but also how much protection they afford are on the way.The test, which on Wednesday received emergency-use authorization from the U.S. Food and Drug Administration, measures the number of neutralizing antibodies that the body’s immune system has produced after exposure, reported CNBC. While previous tests have measured antibody levels, this one zeroes in on the antibodies that attack two specific aspects of the novel coronavirus.This “new generation” of test, the COVID-SeroKlir, was developed by...
New York Daily News
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Abbott gets emergency FDA approval for antibody test that detects recent COVID-19 infectionsCHICAGO — Abbott’s latest antibody test — meant to show whether a person has recently had COVID-19 — has gained emergency use authorization from the U.S. Food and Drug Administration.The blood test detects a type of antibody, called IgM, that’s present after a person has been recently infected with COVID-19, Abbott said in a news release.It’s the second antibody test made by Illinois-based Abbott to gain emergency use authorization, in which the FDA allows the use of unapproved medical products to diagn...
Tribune News Service
Fauci to FDA: 'I got your back' on COVID-19 vaccine safety standards
ATLANTA — The federal government’s top infectious disease official attempted to reassure the public Thursday that he’ll support safety standards set by federal officials for any COVID-19 vaccines and their work won’t be swayed by politics.“If (U.S. Food and Drug Administration officials) come and say this is the way we should do it, I’ve got your back on that,” Dr. Anthony Fauci said in an online discussion organized by Emory University.The remarks came in response to a question from Dr. Sanjay Gupta, an associate Emory University professor and CNN medical correspondent who moderated the discu...
The Atlanta Journal-Constitution