Coronavirus test kits could be contaminated after FDA scientist found ‘alarming’ impurities in the lab where they were made as CDC officials launch investigation into ‘defects’ there
- An FDA scientist visited the CDC lab where coronavirus test kits were being manufactured last week to help troubleshoot technical delays
- He reportedly raised an alarm that the lab might be contaminated after seeing ‘inappropriate procedures and possible contaminants’
- The CDC has confirmed a ‘manufacturing issue’ with their initial tests, but did not elaborate any further
- So far, 89 cases have been confirmed in the US and two people in Washington state have died
A laboratory at the Centers for Disease Control and Prevention (CDC) that was producing coronavirus test kits may have been contaminated, a report claims.
According to Axios, an official at the Food and Drug Administration (FDA) who visited the lab last week found ‘alarming issues’ including improper practices and contaminants.
He then warned the agency that this could lead to potential impurities within the tests themselves.
On Sunday, the US Department of Health and Human Services (HHS) confirmed it was investigating the lab and the ‘manufacturing defect’ that led to the delay of kits being rolled out.
Although there has been no further elaboration on what those defects might be, the Axios report links these defects to the FDA scientist’s findings.
An FDA scientist allegedly came across ‘inappropriate procedures and possible contaminants’ when he visited a CDC lab where coronavirus test kits were being manufactured, a new report claims. Pictured: A CDC test kit for coronavirus
Axios reports that Dr Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, was sent to the CDC lab in Atlanta a week ago to help fix technical problems that delayed test kits being sent to state and local health departments.
Dr Stenzel was allegedly ‘alarmed’ by the ‘inappropriate procedures and possible contaminants’ he saw in the lab.
It’s currently unclear what procedures and contaminants he may have seen, or how big a role they played in the delay of rolling out test kits.
Dr Stenzel is not a lab inspector so, although he was not required to report on the lab, he allegedly raise his concerns with his higher-ups.
‘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 to Axios in a statement.
He said that government agencies – CDC, FDA, HHS and the National Institutes of Health – have already worked together to resolve the problems with the coronavirus tests.
‘FDA has confidence in the design and current manufacturing of the test that already have and are continuing to be distributed,’ Hahn continued in his statement.
‘These tests have passed extensive quality control procedures and will provide the high-level of diagnostic accuracy we need during this coronavirus outbreak.’
The news may have been what prompted New York Governor Andrew Cuomo to ask permission from the FDA to use its own coronavirus testing kits.
On Saturday, the first case was confirmed in New York City.
The CDC and other health officials have come under fire for how slowly Americans are being tested.
A recent ProPublica investigation found the CDC refused to use tests kits made by the World Health Organization because the federal agency wanted to make its own.
Worldwide, more than 89,000 people have been infected with coronavirus and more than 3,000 people have died.
Manufacturing issues and delays have led to just 3,600 people being tested in the US, By comparison, South Korea has tested more than 66,000 citizens.
But HHS Secretary Alex Azar told ABC’s This Week on Sunday that the US currently has at least 75,000 test kits available.
Worldwide, more than 89,000 people have been infected and more than 3,000 people have died.
Cases in the US spiked over the weekend by 43 percent, increasing from 62 to 89.
Two deaths have been confirmed, both in Washington state and both among people who had pre-existing conditions.