FDA hasn't authorized a two-minute test for coronavirus A California company falsely claimed cargo planes were ready to ship millions of blood tests that could detect the new coronavirus in just two minutes and had won emergency authorization from the federal government By AMANDA SEITZ Associated Press April 1, 2020, 6:57 PM 4 min read
CHICAGO -- A California company falsely claimed cargo planes were ready to ship millions of blood tests that could detect the new coronavirus in just two minutes and had won emergency authorization from the federal government.
The Food and Drug Administration confirmed Wednesday, however, that it has not authorized any such test to be used for diagnosing coronavirus. The federal agency has warned of people peddling fraudulent coronavirus tests, vaccines, drugs and medical devices.
Media outlets around the world picked up the false news after an entity calling itself Bodysphere Inc. distributed a press release claiming it got such approval.
California state business filings do not show any record of Bodysphere Inc. A phone number listed on Bodysphere's website was disconnected and later removed from the site by Wednesday afternoon. A publicist for Bodysphere did not return repeated requests for comment.
In its press release Tuesday, Bodysphere claimed its test had already been “used successfully in several states.” It was published a day after President Donald Trump touted the FDA's approval last week of a swab test that can detect the illness in five minutes.
it actively spreads, said Northwestern University’s Institute for Global Health director Robert L. Murphy.
“I would be very wary of anybody trying to sell an antibody tests,” Murphy said.
In an email, the FDA said it is not authorizing any blood tests for detection of coronavirus.
https://www.mpo-mag.com/contents/view_breaking-news/2020-03-31/bodyspheres-two-minute-serological-test-kit-to-detect-novel-coronavirus/
https://abcnews.go.com/US/wireStory/fda-authorized-minute-test-coronavirus-69926105
FDA hasn't authorized a two-minute test for coronavirus
A California company falsely claimed cargo planes were ready to ship millions of blood tests that could detect the new coronavirus in just two minutes and had won emergency authorization from the federal government
By
AMANDA SEITZ Associated Press
April 1, 2020, 6:57 PM
4 min read
CHICAGO -- A California company falsely claimed cargo planes were ready to ship millions of blood tests that could detect the new coronavirus in just two minutes and had won emergency authorization from the federal government.
The Food and Drug Administration confirmed Wednesday, however, that it has not authorized any such test to be used for diagnosing coronavirus. The federal agency has warned of people peddling fraudulent coronavirus tests, vaccines, drugs and medical devices.
Media outlets around the world picked up the false news after an entity calling itself Bodysphere Inc. distributed a press release claiming it got such approval.
California state business filings do not show any record of Bodysphere Inc. A phone number listed on Bodysphere's website was disconnected and later removed from the site by Wednesday afternoon. A publicist for Bodysphere did not return repeated requests for comment.
In its press release Tuesday, Bodysphere claimed its test had already been “used successfully in several states.” It was published a day after President Donald Trump touted the FDA's approval last week of a swab test that can detect the illness in five minutes.
it actively spreads, said Northwestern University’s Institute for Global Health director Robert L. Murphy.
“I would be very wary of anybody trying to sell an antibody tests,” Murphy said.
In an email, the FDA said it is not authorizing any blood tests for detection of coronavirus.
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2 什么叫美国FDA没有批准“任何”这类检测产品？ ---美国FDA当然有批准某些公司的检测产品，但不是你所指这家二分钟检测产品，更不可能特异性和灵敏度达99%，好不好。
这下搞明白没？