Transcript
Officials from the FDA are now explaining the lag in coronavirus testing in the US.
Multiple health officials say the problems stemmed from how the Centers for Disease Control and Prevention initially manufactured the test.
The FDA says it sent an official to the CDC in February when issues arose with the kits.
CDC officials thought the problem was with the test design.
Working together, the FDA and CDC determined the design of the test was fine.
But then it was discovered the problem stemmed from the fact the CDC made the test in one of its laboratories rather than its manufacturing facilities.
An FDA official said the CDC appeared to have violated its own manufacturing protocol and the tests had become contaminated.
The result was weeks of delays that slowed the US response to the coronavirus pandemic.
The CDC and FDA are now working with IDT, an outside manufacturing company to remanufacture tests that work properly.
Those tests are now being shipped to public health labs.
Posted – 4.19.20