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The US Centers for Disease Control and Prevention violated its own manufacturing standards, which led to contamination of the country’s first coronavirus tests, rendering them ineffective, The Washington Post reported Saturday (April 18).
Problems with the tests were reported not long after the first case of COVID-19, the disease caused by SARS-CoV-2, was announced in late January in the US. The Food and Drug Administration (FDA) sent Timothy Stenzel, the agency’s director of in vitro diagnostics and radiological health, to the CDC headquarters in Atlanta to identify the source of the problem.
According to The New York Times, Stenzel found that no one was in charge of the entire test-manufacturing process, and those working on the tests didn’t have much expertise in commercial manufacturing. He also observed several opportunities for contamination, including test kit assembly in the same room with coronavirus material.
The CDC made its ...
