Lab for coronavirus test kits may have been contaminated

A top federal scientist sounded the alarm about what he feared was contamination in an Atlanta lab where the government made test kits for the coronavirus, sources familiar with the situation in Atlanta tell me and Axios' Caitlin Owens.

The Trump administration has ordered an independent investigation of the Centers for Disease Control and Prevention lab, and the manufacture of the virus test kids has been moved, the sources said.

Why it matters: At a time when the administration is under scrutiny for its early preparations for the virus, the potential problems at the lab became a top internal priority for some officials. But the Trump administration did not talk publicly about the Food and Drug Administration’s specific concerns about the Atlanta lab.

Senior officials are still not saying exactly what the FDA regulator found at the Atlanta lab.
The CDC lab in Atlanta developed the testing formula for the coronavirus test — which the government says works — and was manufacturing smaller quantities of the testing kits for laboratories around the country. This is where the lab ran into problems, per sources familiar with the situation.

FDA commissioner Stephen Hahn said, in a statement to Axios, that government agencies have already worked together to resolve the problems with the coronavirus tests.

"Upon learning about the test issue from CDC, FDA worked with CDC to determine that problems with certain test components were due to a manufacturing issue," he said.

"We worked hand in hand with CDC to resolve the issues with manufacturing. FDA has confidence in the design and current manufacturing of the test that already have and are continuing to be distributed. These tests have passed extensive quality control procedures and will provide the high level of diagnostic accuracy we need during this coronavirus outbreak."



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