A CDC lab in Atlanta is being investigated for potential contamination in its coronavirus test kits, meaning the virus could have spread in the US faster than we think
- US health authorities is investigating a Centers for Disease Control and Prevention (CDC) lab in Atlanta, Georgia, after it was found to have potentially produced faulty coronavirus test kits, Axios reported Sunday.
- A Food and Drug Administration official raised the alarm about possible contamination in the lab, Axios reported. The agency said there had been a "manufacturing issue."
- The tests were distributed to a number of state health departments, Axios reported, but the true scale of the problem is not yet clear. The test-kit production has now been moved to a different lab.
- It's not entirely clear whether the potential fault in the coronavirus test kits had wrongly diagnosed people or missed new diagnoses. But the snag in production is likely to slow the country's response to the outbreak.
- It also comes as an embarrassment to the CDC, which had rejected coronavirus test kits distributed by the World Health Organization in an attempt to make its own.
- Visit Business Insider's homepage for more stories.
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A Centers for Disease Control and Prevention (CDC) lab in Atlanta, Georgia, is being investigated for having produced potentially faulty coronavirus test kits, according to multiple reports.
A Food and Drug Administration (FDA) official raised the alarm about possible contamination in the lab, which produces the diagnostic tests for various states, Axios reported Sunday, containing unnamed sources.
The exact problem found at the lab is not yet clear. In a statement to Axios, FDA Commissioner Stephen Hahn noted that the "problems with certain test components were due to a manufacturing issue," without specifying further.
The tests produced at the lab had been distributed to state health departments and other unspecified locations, the Health and Human Services (HHS) told Axios in statement.
The Atlanta lab had manufactured "relatively small amounts" of the kits for labs around the country, Axios wrote, though the exact number remains unknown. Production of the kits has now been moved to a different lab, Axios said.
It's not entirely clear whether the potential fault in the coronavirus test kits had wrongly diagnosed people or missed new diagnoses. But the snag in production is likely to slow the country's response to the outbreak.
Timothy Stenzel, the FDA official who reported the faults, is the director of the Office of In Vitro Diagnostics and Radiological Health, but is not a lab inspector.
He had traveled to the Atlanta lab to troubleshoot technical issues in production, where he spotted inappropriate procedures and possible contaminants, according to Axios.
The issue prompted New York Governor Andrew Cuomo to apply for emergency permission to develop test kits at the state level, Reuters reported. New York confirmed its first case of the coronavirus on Sunday.
The snag in production comes at a time when the US is scrambling to catch up with testing for possible cases of the virus, and President Donald Trump's administration comes under scrutiny for its response to the crisis.
It is also an embarrassment for the CDC, which had refused to use the World Health Organization's test kits and opted to develop its own, according to a ProPublica investigation. By doing so, the CDC lost valuable weeks in attempting to devise its own test, ProPublica said.
Nonetheless Hahn, the FDA commissioner, told Axios that his agency "has confidence in the design and current manufacturing of the test that already have and are continuing to be distributed."
HHS Secretary Alex Azar told ABC News on Sunday that the US is "ramping up" testing, and said there are currently 75,000 tests available.
More than 3,600 people around the country have already been tested, Azar said. The US currently has 86 confirmed cases.
The Trump administration has been criticized for the way it's handled the public-health crisis.
Last week it barred all government health officials from speaking to the public about the outbreak without prior permission from the White House, The New York Times reported. One of those officials is Dr Anthony Fauci, one of the country's top experts in infectious diseases.
Fauci's previous statements had struck a markedly different tone to those by the president, who has been accused of downplaying the threat of the outbreak.
Trump has called criticism of his respnose to the virus a "hoax," in tactics that have been compared to those used by authoritarian regimes, Business Insider's Sonam Sheth and John Haltiwanger reported.
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