.
.
.
From AXIOS
Test Kits May Have Been Contaminated
March 1, 2020
.
Behind the scenes: The FDA official who visited the Atlanta lab, Timothy Stenzel, is the director of the Office of In Vitro Diagnostics and Radiological Health.
.
-
About a week ago, when the Secretary of Health and Human Services Alex Azar was under extreme pressure over the delays in getting coronavirus testing kits to market, Stenzel traveled to Atlanta to help troubleshoot whatever technical problems might have been occurring with the tests.
-
Stenzel was alarmed by the procedures he witnessed in the Atlanta laboratory and raised concerns with multiple CDC officials, per a source familiar with the situation in Atlanta.
-
Stenzel is a highly-regarded scientist and diagnostics expert. He was on the ground in Atlanta to deal with technical issues and happened to stumble upon the inappropriate procedures and possible contaminants. He is not a laboratory inspector and thus was not charged with producing an inspection report on the lab conditions.
-
But he raised the concerns and they have been taken seriously and risen to the highest levels of the U.S. government.
.
On Thursday afternoon, the concerns about the Atlanta laboratory were raised in a conference call that included senior government officials from multiple agencies including the Department of Health and Human Services, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health.
.
-
The call’s purpose was to figure out ways to mass produce the testing kits and get them to market quickly.
-
The Trump administration says it’s now figured out how to get over those hurdles. An HHS spokesperson promised that by the end of this week, “we will have the capacity to test up to 75,000 individuals” for the coronavirus
.
What’s next: The FDA’s manufacturing concerns — which include the possible contamination of testing kits — have also resulted in the Trump administration ordering an independent investigation of the CDC’s Atlanta laboratory, according to senior officials.
.
-
“HHS 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,” said an HHS spokesperson.
-
“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.” (But the administration was not transparent about the senior FDA official’s concerns about the conditions and procedures in the Atlanta laboratory.)
-
A senior administration official added that the government also moved the manufacturing of the coronavirus tests out of the Atlanta laboratory of CDC.
-
The official said that the CDC engaged with a third party contractor on Feb. 20 to help manufacture the testing kits. The official added that the FDA regulator, Stenzel, visited the Atlanta laboratory on Feb. 22.
.
Between the lines: Until Thursday, the CDC’s guidance was to only test Americans for the coronavirus if they’d recently traveled to China — or had close contact with someone known to have the virus — and were symptomatic.
.
-
Under this policy, the CDC initially refused to test a California patient who didn’t fit this criteria but had the coronavirus, although the CDC disputes that it denied doctors’ testing request.
-
As of Friday, South Korea had tested 65,000 people for the coronavirus; the U.S. had tested only 459, per Science Magazine. China can reportedly conduct up to 1.6 million tests a week.
-
Although the World Health Organization has sent testing kits to 57 other countries, the U.S. decided to make its own.
.
Pain Management Specialist in San Diego & La Jolla 