Federal officials have now confirmed that the Centers for Disease Control and Prevention (CDC) sent faulty coronavirus tests to states throughout the country that were actually tainted by the highly infectious disease.
The contamination made the tests uninterpretable, and—because testing is crucial for containment efforts—it lost the country invaluable time to get ahead of the advancing pandemic.
The CDC is blaming “a problem in the manufacturing of one of the reagents” on the colossal public safety failure. They even admitted in a statement to the New York Times that they “did not manufacture its test consistent with its own protocol,” but now claim that they have “implemented enhanced quality control to address the issue and will be assessing the issue moving forward.”
According to the New York Times, there was a lack of coordination and inexperience in commercial manufacturing.
Careless laboratory practices at the Centers for Disease Control and Prevention caused contamination that rendered the nation’s first coronavirus tests ineffective, federal officials confirmed on Saturday.
According to the Food and Drug Administration, two of the three C.D.C. laboratories in Atlanta that created the coronavirus test kits violated their own manufacturing standards, resulting in the agency sending tests that did not work to nearly 100 state and local public health labs.
Officials said lab problems consisted of researchers entering and exiting the coronavirus laboratories without changing their coats, test ingredients being assembled in the same room where researchers were working on positive coronavirus samples. Those sloppy practices made the tests sent to public health labs unusable because they were contaminated with the coronavirus, and produced some inconclusive results.
According to reports, public health laboratories started receiving the C.D.C. kits on Feb. 7, and by the next day members were already calling to report that the test was not working accurately. Alerts, which regulates medical devices, including laboratory tests were sent to both the C.D.C. and the F.D.A.
“This is consistent with what we said was plausible when we found the problem at the beginning,” said Scott Becker, Executive Director of the Association of Public Health Laboratories. “When we found the problem, it seemed to our community that it was a contamination issue that would cause a problem to this extent.”
The F.D.A. concluded that C.D.C. manufacturing issues were to blame and pushed the agency to shift production to an outside firm. That company, I.D.T., accelerated production of the C.D.C. test and says no more issues were reported.
However, the damage was done because it took the CDC a month to fix the problem. Over the crucial period between February and March, these faulty tests were distributed across the country. The incompetence from the experts prevented states from preventing the coronavirus outbreak, which led to the total lockdown of society.
While Trump and his administration have commented that the U.S. testing capacity is greater than anywhere else in the world, many public health officials have commented about the lack of consistent, reliable testing in the country.
Dr. Robert R. Redfield, the director of the C.D.C., and other health experts have alluded that contamination in the labs have been the culprit.
“It was just tragic,” said Becker. “All that time when we were sitting there waiting, I really felt like, here we were at one of the most critical junctures in public health history, and the biggest tool in our toolbox was missing.”
In a statement, however, he acknowledged that the agency’s quality control measures were insufficient during the coronavirus test development. Since then, he said, “C.D.C. implemented enhanced quality control to address the issue and will be assessing the issue moving forward.”
The CDC said in a statement that the agency “did not manufacture its test consistent with its own protocol.” Though the CDC appeared reluctant to admit contamination was at the root of the problem, the New York Times noted that in a separate statement the CDC seemed to acknowledge such problems, saying the agency has since “implemented enhanced quality control to address the issue and will be assessing the issue moving forward.”
During this time, the F.D.A. also came under fire for not initially allowing commercial labs such as Quest and LabCorp to begin ramping up production of their own tests to increase the testing abilities across the nation.
More than two months later, over 800,000 Americans have become infected with COVID19 and nearly 45,000 have died. Currently, testing is still not available to everyone and in some states it can take days before doctors and patients receive results. Many infectious disease and public health experts have reported that testing is nowhere near widespread enough to reopen the country or return to any sense of normalcy at this point.
