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CDC coronavirus test-kit lab may have been contaminated; US lagging behind other countries in testing


There may be more cases than we know of

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The Trump administration has ordered an investigation of the Centers for Disease Control and Prevention after a Food and Drug Administration diagnostic scientist found possible contaminants during a visit to a CDC lab in Atlanta that produces coronavirus test kits, according to Axios.

Timothy Stenzel, the director of the FDA's Office of In Vitro Diagnostics and Radiological Health, visited the facility last week as pressure mounts on the government to meet growing demand for coronavirus test kits. While he was there, Axios reported he "happened to stumble upon the inappropriate procedures and possible contaminants."

Officials have not released the specific details of Stenzel's concerns, but the production of the test kits has been moved out of the Atlanta facility.

"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," FDA Commissioner Stephen Hahn told Axios. "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."

A statement from the Department of Health and Human Services did not shed more light on what exactly the problem is in the Atlanta lab. From Axios:

"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." (But the administration was not transparent about the senior FDA official's concerns about the conditions and procedures in the Atlanta laboratory.)

The United States is not testing at nearly the volume of other countries which have been hit harder by coronavirus, although an increasing number of cases in the U.S. has put pressure on government officials to ramp up testing.

About 3,600 people have been tested in the U.S. Testing has mostly been limited to people who have traveled to Wuhan, China, or to people known to have had contact with someone who traveled there. But in the past week, several cases with no apparent connection to Wuhan have been diagnosed in the U.S.

The U.S. has opted to produce its own test kits, rather than accept the test kits being distributed to other nations by the World Health Organization. Last month it was reported that labs have had issues validating the CDC tests.

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