The Centers for Disease Control and Prevention (CDC) failed to follow appropriate manufacturing procedures while developing the United States’ coronavirus test, resulting in contamination that delayed making tests available nationwide, according to an investigation by the Washington Post’s David Willman.
News of the mishap comes as states are grappling with how and when to reopen their economies. That can’t be done safely until widespread testing is available, and experts say the US is woefully behind.
The CDC violated its own standards when developing the testing kits in a lab that was also working with synthetic coronavirus material, the Post reported. This led to contamination of one of the components used in the tests, which is believed to have caused false positives in the first batch of tests. The CDC took more than a month to correct the issue, hindering efforts to limit the early spread of the coronavirus in the US.
Federal officials told the Post the Department of Health and Human Services is investigating the development of the original kits, which was first flagged in January when 24 of 26 test kits sent out to public health departments showed false positives.
The error — and the delay in fixing it — likely contributed to a delay in testing that allowed the virus to spread undetected.
The genetic sequence for the coronavirus, which allowed scientists to begin developing a test to detect it, was made available worldwide on January 12. In countries like China, Germany, and South Korea, scientists used this information to make rapid, widespread testing available, which helped officials track the virus and develop containment strategies.
But in the US, scientists developed a more complex test aimed at distinguishing the novel coronavirus that causes Covid-19, SARS-CoV-2, from other coronaviruses — such as the one that causes SARS. The test component used to do so was likely the one that was contaminated, the Post reported. And even though distinguishing SARS-Cov-2 from other coronaviruses was eventually deemed unnecessary, there was a lengthy delay in jettisoning that component.
On February 28, nearly 50 days after the virus’s genetic sequence was made available, the Food and Drug Administration approved the CDC’s existing tests to be used in the US, and an outside contractor manufactured the rest of the tests the agency had planned to provide.
The next day, the first person in the US died from the virus. Now, there are more than 716,000 confirmed cases and more than 37,000 deaths as of April 18.
The CDC did not immediately respond to a request for comment from Vox, but spokesman Benjamin Haynes told the Post there was insufficient “quality control” in its test development and said that diagnostic kits were being used in every state by late March.
The United States’ sluggish testing rollout could have exacerbated the spread of the virus in the country
The US began testing slowly, and didn’t regularly hit more than 1,000 tests performed daily until nearly mid-March.
Prior to that point, the coronavirus was spreading throughout many communities without reliable detection. Many states also waited until mid-March to begin ratcheting up social distancing restrictions designed to slow the spread of the virus.
If testing had been available sooner, it may have made a difference in how quickly and how far the virus spread by allowing officials to track it, to isolate people confirmed to be infected, and to quarantine anyone those people came into contact with.
“If there’s enough testing around and people are willing to be tested, the brushfires can be identified and put out before the wildfire,” Jeffrey Martin, an epidemiologist at the University of California San Francisco, told Vox’s German Lopez. “The only way that a society can function is if the brushfires are identified and put out.”
Since mid-March, testing capacity in the US has surged. But experts say at least three times as many tests would need to be performed daily nationwide before social distancing restrictions could be safely eased. Without this sort of increase in testing, it will be impossible for officials to assess the decline of the disease with certainty.
“I want to be able to identify everybody who is even mildly symptomatic,” Ashish Jha, the director of the Harvard Global Health Institute, told Keith Collins of the New York Times. “So when I wake up one morning and have a sore throat and a fever, I should be able to go get tested. And then I want to be able to test all of my contacts if I turn out to be positive, so that I can do the test, trace, and isolate strategy that’s so critical to allowing us to open up and stay open.”
That’s bad news for state governors, who are stuck between protecting public health by continuing stringent statewide quarantines, and being pressured to reopen businesses under what’s shaping up to be a globally catastrophic economic downturn. Multiple state governors are choosing to ease some restrictions — such as allowing access to parks and golf courses — this week, and regional consortiums of governors say they’re working on plans to allow people to go back to work.
But epidemiologists say there’s a possibility that states reopening businesses and easing social distancing requirements too quickly could lead to a second wave of cases and deaths — in a worst-case scenario, that could mean up to 1.7 million Americans dead.
With more testing, it would be easier for scientists to determine whether it’s safe to return to some semblance of normalcy. But as state and local officials struggle to get the supplies they need to do widespread testing, it’s likely that any reopenings that do occur will carry more risk than they should, and that many Americans should prepare to spend yet more time at home.