Contamination likely caused early delays

Contamination in manufacturing the Centers for Disease Control and Prevention test for the coronavirus caused weeks of delays that slowed the U.S. response to the pandemic, multiple health officials have told CNN, a problem that stemmed in part from the CDC not adhering to its own protocols, according to a U.S. Food and Drug Administration spokesperson.

“CDC made its test in one of its laboratories, rather than in its manufacturing facilities,” the FDA spokesperson told CNN on Saturday. “CDC did not manufacture its test consistent with its own protocol.”

The government has never fully explained what stalled the rollout of a crucial test needed to begin measuring the extent of the spread of COVID-19. It would take until the end of February to correct and the United States continues to lack extensive testing capability even as some states prepare ease up on restriction and reopen to a degree.

The Washington Post first reported details of the breakdown in the CDC’S manufacturing of the tests.

In mid-february, the CDC was uncertain whether its test was malfunctioning because of 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 have violated its own manufacturing protocols.

Within days the FDA and the CDC worked together to remanufacture the CDC test with the help of IDT, an outside manufacturer, according to administration officials. The remanufactured tests functioned correctly and were shipped to public health labs.

CDC spokesman Benjamin Haynes said that the matter is being investigated by the Department of Health and Human Services, and he acknowledged it “may be the result of a design and/ or manufacturing issue or possible contamination.”

The HHS inspector general said it expects to complete the review by 2021.