Key Points: A delay by the federal Centers for Disease Control and Prevention in quickly making coronavirus test kits available was the result of "a glaring scientific breakdown" at the CDA central lab, The Washington Post reported.The Post reported that CDC facilities that assembled the testing kits "violated sound manufacturing practices, resulting in contamination of one of the three test components used in the highly sensitive detection process."James Le Duc, a virologist and former CDC officer who now heads the Galveston National Laboratory in Texas, told The Post that the situation was "really a terrible black mark on the CDC, and the impact was devastating to the country."The Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia.
A delay by the federal Centers for Disease Control and Prevention in quickly making coronavirus test kits available was the result of "a glaring scientific breakdown" at the CDC's central lab, The Washington Post reported Saturday, citing scientists and federal regulators.
The Post reported that CDC facilities which assembled the testing kits "violated sound manufacturing practices, resulting in contamination of one of the three test components used in the highly sensitive detection process."
And while the part of the test that was compromised was not critical to detecting the coronavirus, CDC officials took more than a month to remove it from the test kits, according to The Post.
That lag in action aggravated national delays in testing for the virus, and in turn hampered a battle to contain the virus's spread, the newspaper said.
James Le Duc, a virologist and former CDC officer who now heads the Galveston National Laboratory in Texas, told The Post that the situation was "really a terrible black mark on the CDC, and the impact was devastating to the country."
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The federal Food and Drug Administration told The Post that the "CDC did not manufacture its test consistent with its own protocol."
"It's critical that the tests used work, because false results can also contribute to the spread of Covid-19,'' the FDA said.
The FDA did not immediately respond to a request for comment from CNBC.
Benjamin Haynes, a spokesman for CDC, said in an email to CNBC, "CDC is aware of the Washington Post story regarding test kits."
"The issue with the N3 component of CDC's diagnostic test for COVID-19 may be the result of a design and/or manufacturing issue or possible contamination," Haynes wrote.
"This issue is being assessed by HHS [CDC's parent agency, the U.S. Health and Human Services Department].? We will share more when the results of the assessment are complete."
Read the full Washington Post story here.
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原文地址：https://www.cnbc.com/2020/04/18/coronavirus-tests-delayed-by-covid-19-contamination-at-cdc-lab.html