Initial CDC Coronavirus Tests Failed Because of Contamination Inside the Labs

When the CDC tests failed, the U.S. lost valuable weeks early in the COVID-19 outbreak that kept the country from slowing the disease's spread

Photo: Jane Barlow - WPA Pool/Gett

The lack of available and speedy coronavirus testing kits has been an issue for the last two months as COVID-19 spreads throughout the U.S., and it all started when the initial tests, created by the Centers for Disease Control, failed.

Now, federal health officials have confirmed that those tests failed due to contamination and poor hygiene practices within the CDC’s labs, The New York Times reported.

The Food and Drug Administration, which oversees and regulates the CDC’s labs, said Saturday that two of the three CDC labs that were manufacturing the COVID-19 tests were in violation of their own standards for test development.

“CDC did not manufacture its test consistent with its own protocol,” an FDA spokesperson, Stephanie Caccomo, said, The Washington Post reported.

The FDA sent Dr. Timothy Stenzel, chief of in vitro diagnostics and radiological health to CDC headquarters in Atlanta in late February, after the errors with the test were identified, and found that there was no one running the test production, researchers were going in and out of the lab without changing their coats and positive coronavirus samples were mixed in with other equipment. These issues contaminated the space and led to the faulty tests, the FDA said.

The CDC has since corrected the issues in the lab, the agency told the Times, and the tests they have in production work correctly, but the lab is now under a formal investigation by the Department of Health and Human Services.

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The issues with the test also led to a major delay in testing. The FDA initially only allowed the CDC to create COVID-19 tests, and would not allow private labs, hospitals or academic institutions to make their own. Once the CDC test was shown to be faulty, the FDA removed that restriction but that put private manufacturers weeks behind, and the U.S. was unable to catch up as the virus spread around the country.

“It’s a race, and the virus is way ahead of us,” Dr. Emily Gurley, an infectious disease epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told PEOPLE.

Now, testing is available but in limited quantities. With the shortage in tests, hospitals and labs are mostly restricting testing to Americans who have COVID-19 symptoms or frontline health care workers.

As of April 20, there have been at least 753,317 confirmed cases of COVID-19 in the U.S. and 36,109 deaths. But only about 1 percent of the country has been tested for the virus, according to The Atlantic.

Experts say that for the U.S. to reopen, testing needs to be widely available to get a better understanding of who is infected, lest we risk a resurgence in cases.

“If we have quick testing, maybe that’s our way out,” Gurley said.

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