The production of coronavirus test kits by the CDC was delayed for almost a month, as the laboratories developing the kits had violated manufacturing practices that led to contamination of one of the three testing components, the Washington Post reported Saturday.
"The test manufactured by IDT was distributed and has encountered no issues, thus supporting the conclusion that it was a manufacturing issue", the FDA spokesperson said in the statement provided to CNN on Saturday. The mistake was "destroying the country" and "absolutely awful black mark at the CDC", James Le Duc, a former officer of CDC, told The Post.
As a result of damaged CDC test kits, a local doctor must send a sample of individuals into public health laboratory or directly to the CDC in Atlanta for testing, delay testing and the results for Americans who think they are infected.
The Food and Drug Administration also concluded the CDC violated its own laboratory standards, according to the paper. In the early weeks of March, the CDC's stumbles to provide test kits in Washington and New York City allowed the virus to spread quickly and silently. The email, sent from a CDC official to state public-health-lab officials, said some labs found "sporadic reactivity in the negative control of one of the three assay components". Testing is not yet widespread enough to reopen the country, health experts tell the Times.
Within days - by February 27 - the FDA and the CDC worked together to shift the manufacturing of the CDC test kits to IDT, an outside manufacturer, two FDA officials said. Now we have made more than 4 million and we believe we will have made more than 5 million by the end of this month, "Pence said". However, with a population of over 300 million people, those tested represent just one percent of the population. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases said last week that he expected a large number of tests to become available within the next week.
