The Trump administration is investigating possible contamination in a Centers for Disease Control lab that has been producing coronavirus test kits.
The Department of Health and Human Services issued a statement regarding its efforts to address concerns about the virus testing kits, according to Axios.
“HHS has launched an investigation and is assembling a team of non-CDC scientists to better understand the nature and source of the manufacturing defect in the first batch of COVID-19 test kits that were distributed to state health departments and others,” an HHS spokesperson said.
“HHS/CDC have been transparent with the American people regarding the issue with the manufacturing of the diagnostic and will be transparent with the findings of this investigation.”
According to Axios, concerns about the lab emerged after a visit from Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health for the Food and Drug Administration.
Axios, quoting a source it did not name, said Stenzel was “alarmed by the procedures he witnessed in the Atlanta laboratory and raised concerns with multiple CDC officials.”
Politico reported that it was told by an unnamed HHS official that “there was an problem with lab test cleanliness that affected the rollout of the coronavirus tests.”
As a result of the concerns, an inter-agency discussion ensued. Since then, FDA Commissioner Stephen Hahn said the agencies are resolving the problems.
The HHS spokesperson said about 75,000 people will be able to be tested this week.
That compares against about 3,600 who have been tested overall since the outbreak of the virus.
“Upon learning about the test issue from CDC, FDA worked with CDC to determine that problems with certain test components were due to a manufacturing issue,” Hahn said in a statement.
“We worked hand in hand with CDC to resolve the issues with manufacturing. FDA has confidence in the design and current manufacturing of the test that already have and are continuing to be distributed. These tests have passed extensive quality control procedures and will provide the high-level of diagnostic accuracy we need during this coronavirus outbreak,” he said.
The kits are now being made by what Axios described as a “third party contractor.”
“The rollout of a CDC-designed test kit to state and local labs has become a fiasco because it contained a faulty reagent. Labs around the country eager to test more suspected cases—and test them faster—have been unable to do so,” the magazine reported.
According to Science, test kits started to flow to state and local public health labs in early February, but a week later, CDC learned that a problem with the kits led them to be unreliable.
The World Health Organization provides testing kits. CDC officials have not said why they did not choose to rely on those.
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