TAL AXELROD - 04/18/20 THE HILL
The Centers for Disease Control and Prevention (CDC) was delayed in quickly producing a test kit for the coronavirus after contamination was found at some of its facilities, according to a new report from The Washington Post.
The CDC facilities that manufacture the kits reportedly violated manufacturing practices, resulting in a contamination of one of the three components used in the testing process.
The contamination is believed to have occurred after chemical mixtures were assembled into the kits in the same lab space that was handling synthetic coronavirus material. The proximity of the chemicals and the synthetic material violated working procedures.
CDC officials were forced to take more than a month to resolve the testing mix-up, which worsened national delays in the production and distribution of kits, according to the Post’s examination of federal documents and interviews with more than 30 present and former federal scientists and others familiar with the events.
The production and dissemination of the test kits are currently the subject of an investigation by the Department of Health and Human Services.
The CDC told the Post that its efforts “were not sufficient in this circumstance” and that the agency has “implemented enhanced quality control to address the issue.”
“As of March 23, more than 90 state and local public health labs in 50 states, the District of Columbia, Guam, and Puerto Rico verified they are successfully using [the] diagnostic kits,” it added.
The CDC did not immediately respond to a request for comment from The Hill.
Issues with the test were reportedly first noticed in January after the CDC distributed kits to 26 public health labs across the country. People with knowledge of the issue said false positives were reported at 24 of the 26 sites.
The false positives were reported during testing of “negative control’’ samples that contained highly purified water and no genetic material. That phase of testing is crucial in confirming if tests’ results are reliable.
“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. ... There is no other explanation for it,” a scientist said.
The delay in testing prevented public health labs from performing the initial surveillance necessary to try to predict and blunt the coronavirus’s spread in the U.S. before it became more widespread.
An examination of the CDC’s testing kit by the Food and Drug Administration found no issues with its design but faulted the agency’s manufacturing practices in explaining the delay in distribution.
“I was just saddened and embarrassed when this test didn’t work out,” James Le Duc, a virologist and former CDC official who now is director of the Galveston National Laboratory in Texas, told the Post. “It’s really a terrible black mark on the CDC, and the impact was devastating to the country.”
There have been more than 700,000 confirmed coronavirus cases in the U.S., and more than 37,000 people have died. There is still no vaccine for the disease.
The CDC facilities that manufacture the kits reportedly violated manufacturing practices, resulting in a contamination of one of the three components used in the testing process.
The contamination is believed to have occurred after chemical mixtures were assembled into the kits in the same lab space that was handling synthetic coronavirus material. The proximity of the chemicals and the synthetic material violated working procedures.
CDC officials were forced to take more than a month to resolve the testing mix-up, which worsened national delays in the production and distribution of kits, according to the Post’s examination of federal documents and interviews with more than 30 present and former federal scientists and others familiar with the events.
The production and dissemination of the test kits are currently the subject of an investigation by the Department of Health and Human Services.
The CDC told the Post that its efforts “were not sufficient in this circumstance” and that the agency has “implemented enhanced quality control to address the issue.”
“As of March 23, more than 90 state and local public health labs in 50 states, the District of Columbia, Guam, and Puerto Rico verified they are successfully using [the] diagnostic kits,” it added.
The CDC did not immediately respond to a request for comment from The Hill.
Issues with the test were reportedly first noticed in January after the CDC distributed kits to 26 public health labs across the country. People with knowledge of the issue said false positives were reported at 24 of the 26 sites.
The false positives were reported during testing of “negative control’’ samples that contained highly purified water and no genetic material. That phase of testing is crucial in confirming if tests’ results are reliable.
“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. ... There is no other explanation for it,” a scientist said.
The delay in testing prevented public health labs from performing the initial surveillance necessary to try to predict and blunt the coronavirus’s spread in the U.S. before it became more widespread.
An examination of the CDC’s testing kit by the Food and Drug Administration found no issues with its design but faulted the agency’s manufacturing practices in explaining the delay in distribution.
“I was just saddened and embarrassed when this test didn’t work out,” James Le Duc, a virologist and former CDC official who now is director of the Galveston National Laboratory in Texas, told the Post. “It’s really a terrible black mark on the CDC, and the impact was devastating to the country.”
There have been more than 700,000 confirmed coronavirus cases in the U.S., and more than 37,000 people have died. There is still no vaccine for the disease.
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