Mon. Sep 26th, 2022
Barricades will stand outside the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia, on Saturday, March 14, 2020.  As the novel coronavirus has spread across the US, the CDC is under mounting heat over a shaky rollout of crucial test kits.
enlarge Barricades will stand outside the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia, on Saturday, March 14, 2020. As the novel coronavirus has spread across the US, the CDC is under mounting heat over a shaky rollout of crucial test kits.

As the novel coronavirus took root across America, the U.S. Centers for Disease Control and Prevention sent tainted lab test kits to states self-seeded with the virus in early February, federal officials have confirmed.

The contamination did not spread the virus to humans, but it made test results uninterpretable and — because testing is critical to containment efforts — the country lost invaluable time to stay ahead of the advancing pandemic.

The CDC had been vague about what went wrong with the tests, initially saying only that “a problem in the manufacture of one of the reagents” led to the failure. Subsequent reporting suggested the issue was related to a negative control – that is, a portion of the test intended to be free of any trace of the coronavirus as a critical reference to confirm that the test was generally working well. .

Now, according to research findings reported by The New York Times, federal officials confirm that shoddy lab practices at two of the three CDC labs involved in creating the tests led to contamination of the tests and their uninterpretable results.

“Just tragic”

Shortly after the issues came to light in early February, the Food and Drug Administration sent Timothy Stenzel, chief of in vitro diagnostics and radiologic health, to the CDC to investigate what went wrong. According to the Times, he found a lack of coordination and inexperience in commercial production.

Issues leading to the contamination included researchers coming and going out of labs working on the test kits without changing their coats, and researchers sharing lab space to both assemble test components and process samples containing the coronavirus.

The CDC said in a statement to the Times on Saturday that the agency “did not manufacture its test in accordance with its own protocol.” While the CDC seemed reluctant to admit contamination was the root of the problem, the Times noted that the CDC appeared to acknowledge such issues in a separate statement, saying that the agency has since implemented “improved quality control to address the issue.” address and will assess the matter ahead.”

After the CDC first sent its test kit to the states in early February, it took the agency about a month to resolve the issue. By this time, the virus had invaded many communities unchecked and any chance the US had to contain its spread had all but gone. In mid-March, many states turned to mitigation efforts, such as social distancing, to try to mitigate — rather than prevent — the life-threatening, health-care-overwhelming effects of COVID-19.

“It was just tragic,” Scott Becker, executive director of the Association of Public Health Laboratories, told the Times. “All the time we sat there waiting, I really felt like we were here at one of the most critical crossroads in public health history, and the largest tool in our toolbox was missing.”

As of the morning of April 20, the US has confirmed more than 760,000 cases of COVID-19 and more than 40,700 deaths. The figures are expected to be underestimated due to the slow and still limited amount of testing.

By akfire1

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