According to Axios, the first round of coronavirus testing kits were made in an unidentified Atlanta lab that may have been contaminated. An HHS official also told Politico that there were issues with the lab’s cleanliness that may have affected components of the coronavirus test kits. The official stated that the issue has been resolved but did not provide any more details.
In a statement to Axios, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said that government agencies worked to resolve the manufacturing issue.
“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.
“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 added.
The issues with the kits have delayed widespread testing of the virus across the US, even though it has already been more than two weeks since the FDA permitted the widespread distribution of the CDC test kits.
According to former FDA Commissioner Scott Gottlieb, the delay could prevent the government from containing a coronavirus outbreak.
“By that point, it may be harder to contain spread, and we'll be forced to rely on mitigation tactics to just limit the impact of the virus," Gottlieb told Politico.
However, HHS Secretary Alex Azar said Friday that testing capabilities for the COVID-19 virus would "rapidly expand" nationwide over the next few days. In addition, he noted that the FDA and the CDC are releasing guidance for labs on how to conduct tests without relying on the CDC kits, ABC News reported.
As of Friday, the US had processed more than 3,600 coronavirus tests, according to HHS. By comparison, according to the Korean National Health and Human Services Department, South Korea has already tested more than 78,000 people, including around 10,000 in one day.
According to the Johns Hopkins Center for System Science and Engineering, there are almost 90,000 cases of the coronavirus worldwide, and over 3,000 deaths have resulted from the disease. There are currently 86 cases in the US, and there have been two coronavirus-related deaths in the country, both of which occurred in King County, Washington.
