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."
A federal Food and Drug Administration spokesman, in a statement to CNBC that echoed what the agency told The Post, said, "CDC made its test in one of its laboratories, rather than in its manufacturing facilities."
"CDC did not manufacture its test consistent with its own protocol," the spokeswoman said.
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."
The FDA spokeswoman told CNBC that in February, her agency "was not able to determine from information provided by the CDC whether the test issues were due to a design or manufacturing issue."
"Knowing the underlying cause was important to determine whether the contract manufacturers could proceed to make the CDC's test for distribution and if the CDC could continue to manufacture its test. The FDA sent a renowned diagnostics expert to the CDC to help make that determination and to assist CDC," she said.
She added that the the FDA expert determined the problem was a manufacturing issue and "worked with CDC to facilitate the production and quality control processing of test kits made by one of its contract manufacturers to expedite test kit distribution to public health and non-public health laboratories."
"That company — IDT— manufactured the CDC test as the FDA had authorized it. The test manufactured by IDT was distributed and has encountered no issues, thus supporting the conclusion that it was a manufacturing issue," the spokeswoman said. "The CDC test design has been used to develop tests by other commercial manufacturers and academic laboratories without any problems."