Slapdash lab practices at the CDC in Atlanta contaminated first coroanvirus test kits and caused delay of WEEKS to US pandemic response because they did not WORK
Contamination in the CDC lab caused a month-long delay of the coronavirus test kits getting to labs.
An investigation carried out by the The Washington Post found that the lab at the Centers for Disease Control and Prevention in Atlanta 'violated sound manufacturing practices, resulting in contamination of one of the three test components used in the highly sensitive detection process.'
Scientists with knowledge of the matter told the Post that cross contamination likely occurred because 'chemical mixtures were assembled into the kits within a lab space that was also handling synthetic coronavirus material.'
Issues with the COVID-19 testing kits were first reported in January when the CDC's initial batch of tests produced false-positive results.
The scientists said the cross contamination broke the CDC's own protocols and jeopardized testing for the virus which has killed over 37,000 people.
The CDC sent an initial batch of kits to 26 public health labs across the US and 24 of those tests produce false-positive results.
After the contamination was uncovered, it took CDC officials more than a month to remove the faulty kits from the public health labs.
'The bottom line is, if you have a negative sample, and it's coming up positive, the only way for that to happen is cross contamination,' a scientist who spoke to the Post on condition of anonymity said. 'There is no other explanation for it.'
Food and Drug Administration officials concluded that the CDC violated its own lab standards in its production process, exposing them to contamination, the Post reported.
'CDC made its test in one of its laboratories, rather than in its manufacturing facilities,' an FDA spokesperson told CNN. 'CDC did not manufacture its test consistent with its own protocol.'
'It's critical that the tests used work, because false results can also contribute to the spread of COVID-19,' the FDA told the Post.
Federal officials said the Department of Health and Human Services are investigating the rollout of the initial testing kits.
In a statement Friday, CDC spokesman Benjamin N Haynes said their efforts 'were not sufficient in this circumstance,' adding that the CDC has 'implemented enhanced quality control to address the issue.'
The CDC said the problems with the kits may have resulted from 'a design and/or manufacturing issue or possible contamination.'
Slapdash lab practices at the CDC in Atlanta contaminated first coroanvirus test kits and caused delay of WEEKS to US pandemic response because they did not WORK
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April 19, 2020
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