Contamination at CDC lab delayed rollout of coronavirus tests

A major scientific breakdown at CDC's central laboratory complex in Atlanta led to the failure by the agency to quickly produce a test kit for detecting the novel coronavirus, according to a determination by federal regulators.

A major scientific breakdown at CDC's central laboratory complex in Atlanta led to the failure by the agency to quickly produce a test kit for detecting the novel coronavirus, according to a determination by federal regulators. The 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, scientists with knowledge of the matter 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. FDA officials reportedly separately concluded that CDC violated its own laboratory standards in making the kits. The substandard practices exposed the kits to contamination. 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. In testimony, CDC Director Robert Redfield described in general terms what may have caused the kits' failure. "The third control did not perform the way we wanted it to perform," he said, adding that the cause was either "a contamination" or an unspecified “biologic” factor that caused the test materials to malfunction.