A lab for the Centers for Disease Control and Prevention in Atlanta tasked with producing coronavirus test kits may have been contaminated.
The Trump administration ordered an investigation into the manufacturing of test kits for the COVID-19 virus after a top federal scientist from the Food and Drug Administration expressed concern about possible contamination occurring from the manufacturing process, according to a report from Axios. The government moved test kit manufacturing to another location while the lab in Atlanta is under investigation for potential contamination.
“[Department of Health and Human Services] 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 agency representative said.
The representative added, “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.”
FDA refused to say what may have caused the contamination but noted the administration is confident in the design of the test kit as the coronavirus spreads within the United States.
“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 said.
He added, “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.”
The test kits produced by the CDC have been used on more than 3,600 patients within the U.S. to determine whether individuals have coronavirus, according to the Department of Health and Human Services.
The U.S. government acknowledged the original testing kits used were faulty but maintained that they have full confidence in the kits being produced now. Administrators did not reveal whether the contamination in the Atlanta lab was the root of the problem in the first batch of test kits or if the incidents were unrelated. They also declined to say if the contamination was an isolated problem or a systematic issue.
“We will have the capacity to test up to 75,000 individuals,” an HHS representative said.
The U.S. trails China in test kit production. China has the capacity to test 1.6 million patients per day, while the U.S. works to hammer out the issues with its test. The coronavirus outbreak began in Wuhan, China, and more than 89,000 people have since been infected.
