Dr. Robert R. Redfield, director of the C.D.C., and other health experts have long suggested that contamination in laboratories may be the culprit. But even if several officials of the F.D.A. At the weekend cited the contamination as the cause, a C.D.C. spokesman, Benjamin Haynes, said that it was still only a possibility and that the agency was still awaiting formal conclusions from H.H.S.
In a statement, however, he acknowledged that the agency’s quality control measures were insufficient during the development of the coronavirus test. Since then, he said: “C.D.C. implemented improved quality control to resolve the problem and will assess the problem in the future. “
Initially, the C.D.C. was responsible for creating a coronavirus test that national and local public health agencies could use to diagnose Covid-19 in people and then isolate them to prevent the spread of the disease.
“It was just tragic,” said Scott Becker, executive director of the Association of Public Health Laboratories. “All the while we were sitting around waiting, I really felt like we were here at one of the most critical moments in the history of public health, and the greatest tool in our box. tools were missing. “
Becker said public health labs have started receiving the C.D.C. kits on February 7, and the next day, members were already calling to report that the test was not working properly. He alerted the C.D.C. and the F.D.A., which regulates medical devices, including laboratory tests.
“It fits what we said was plausible when we found the problem at the start,” said Becker. “When we found the problem, it seemed to our community that it was a contamination problem that would cause a problem of this magnitude.”
The F.D.A. concluded that C.D.C. manufacturing issues were to blame and prompted the agency to move production to an outside company. This company, I.D.T., accelerated the production of C.D.C. test and indicates that no other problems have been reported.