The failure by the Centers for Disease Control and Prevention to quickly produce a test kit for detecting the novel coronavirus was triggered by a glaring scientific breakdown at the CDC’s central laboratory complex in Atlanta, according to scientists with knowledge of the matter and a determination by federal regulators.
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The CDC facilities that assembled the kits violated sound manufacturing practices, resulting in contamination of one of the three test components used in the highly sensitive detection process, the scientists said.
The cross contamination most likely occurred because chemical mixtures were assembled into the kits within a lab space that was also handling synthetic coronavirus material. The scientists also said the proximity deviated from accepted procedures and jeopardized testing for the virus.
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The Washington Post separately confirmed that Food and Drug Administration officials concluded that the CDC violated its own laboratory standards in making the kits. The substandard practices exposed the kits to contamination.
The troubled segment of the test was not critical to detecting the novel coronavirus, experts said. But after the difficulty emerged, CDC officials took more than a month to remove the unnecessary step from the kits, exacerbating nationwide delays in testing, according to an examination of federal documents and interviews with more than 30 present and former federal scientists and others familiar with the events. Many of them spoke on the condition of anonymity because they were not authorized to comment publicly.
This account confirms for the first time the contamination’s role in undermining the test and the CDC’s failure to meets its lab standards.
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People work at the Centers for Disease Control and Prevention in Atlanta last month.
The development and rollout of the original kits are subjects of an investigation led by the Department of Health and Human Services, federal officials said.
The CDC — America’s premier institution for combating the spread of catastrophic disease — declined to make available for interviews those involved in the test design or manufacturing. A spokesman, Benjamin N. Haynes, provided a statement Friday that acknowledged substandard “quality control” in its manufacturing of the test kits.
Those efforts “were not sufficient in this circumstance,” the statement said. The agency also said it has “implemented enhanced quality control to address the issue.”
The CDC said the problems with the test kits might have resulted from “a design and/or manufacturing issue or possible contamination.”
Haynes also defended the CDC’s work, saying that earlier troubles were eventually ironed out.
“As of March 23, more than 90 state and local public health labs in 50 states, the District of Columbia, Guam, and Puerto Rico verified they are successfully using [the] diagnostic kits,” Haynes said in the statement.
Shortcomings with the tests were first noticed in late January, after the CDC sent an initial batch to 26 public health labs across the country. According to those with knowledge of what unfolded, false-positive reactions emerged at 24 of the 26 labs that first tried out the kits in advance of analyzing samples gathered from patients.
“Only two of them got it right,’’ said a senior federal scientist who reviewed the development of the kits and internal test documentation, and who concluded that the false positives were caused by contamination that occurred at the CDC.
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