Contamination in manufacturing the Centers for Disease Control and Prevention’s test for coronavirus caused weeks of delays that slowed the US response to the pandemic, multiple health officials told CNN.
The problem stemmed in part from the CDC not adhering to its own protocols, a Food and Drug Administration spokesperson said on Saturday.
“[The] CDC made its test in one of its laboratories, rather than in its manufacturing facilities. CDC did not manufacture its test consistent with its own protocol,” the spokesperson said.
Some background: In mid-February, the CDC was uncertain whether its test was malfunctioning due to a design issue or a manufacturing issue, two FDA officials said.
That was concerning to the FDA. On Feb. 22, an FDA official traveled to Atlanta and spent the following days visiting CDC labs to try to sort out the testing problem.
According to an administration official, the FDA determined contamination was most likely occurring during the manufacturing process and that the CDC had appeared to violate its own manufacturing protocols.
By Feb. 27 the FDA and the CDC worked together to shift the manufacturing of the CDC test kits to IDT, an outside manufacturer, two FDA officials said. Those test kits functioned correctly and were shipped to public health labs.
“The test manufactured by IDT was distributed and has encountered no issues, thus supporting the conclusion that it was a manufacturing issue,” the FDA spokesperson said in the statement.
The inspector general also announced that it is doing its own investigation of the test creation and expects to complete the review by 2021.
The Washington Post was first to report the issue of contamination.
