How contamination in CDC labs delayed US coronavirus response and rollout of test kits
The Centers for Disease Control and Prevention lab (CDC) may have produced some of its coronavirus testing kits in labs that were already contaminated. This explains why some of these kits — shipped across the US and other countries in February — turned out to be defective, leading to delays in testing and the country's response to the pandemic.
Now, the country is leading the world in the number of infections and deaths. The virus has sickened more than 735,086 Americans and killed 38,910 people, according to Johns Hopkins University's tracker.
Recently, the US Food and Drug Administration (FDA) issued out a statement saying that the problem can be partly attributed to two CDC laboratories in Atlanta violating their manufacturing standards. “CDC did not manufacture its test consistent with its protocol,” Stephanie Caccomo, a spokeswoman for the FDA, said in a statement on Saturday.
According to The Washington Post, the CDC labs violated "sound manufacturing practices, resulting in contamination of one of the three test components used in the highly sensitive detection process."
The source of contamination can be traced back to CDC researchers entering and exiting labs without changing their coats. Further, the health agency made another mistake by building test kits in a room where researchers were working on positive coronavirus samples, the FDA said.
In late January, the CDC had shipped these kits to 26 public health labs across the country, 24 of which received faulty test kits. At that time, many Americans were left without a diagnosis while the CDC was trying to investigate whether the faulty test kits were a result of poor design or contamination.
This prompted the Trump administration to order an independent investigation into the matter. The federal agency had carried out the inquiry at CDC's Atlanta lab, where scientists worked out the formula for their testing kits.
In early March, a top federal scientist, who was involved in the investigation, reportedly told Axios about the contamination issue. The FDA did not divulge the details of the investigation until now after media outlets requested the federal agency to do so.
The government emails accessed by the Wall Street Journal details how the agency bungled its testing and how quality control failed to catch the error. Their tests incorrectly showed positive results in samples of laboratory-grade water. “It is unclear why quality control did not detect this issue before the kits were sent out to states,” said the email.
Fast forward to April, the US is still grappling with testing and experts have expressed their concerns over how the country is lagging. According to the COVID Tracking project, a website that keeps a tab on testing, the country has tested nearly 3.69 million people.
The US is only testing less than 150,000 a day. The country would need 10 to 20 times more tests than that, Tom Freiden, the former director of the US Centers for Disease Control and Preventionarvard researchers, told CNN.
Before the country reopens, Harvard researchers think that the US needs to conduct at least 500,000 tests a day, but it is only carrying out 150,000 tests a day currently.