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.
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 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.
