Post Tribune (Sunday)

Officials: Contaminat­ed CDC labs delayed early virus testing

- By Sheila Kaplan The New York Times

Shockingly sloppy laboratory practices at the Centers for Disease Control and Prevention caused contaminat­ion that rendered the nation’s first coronaviru­s tests ineffectiv­e, federal officials confirmed Saturday.

Two of the three CDC 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 all of the 100 state and local public health labs, according to the Food and Drug Administra­tion.

Early on, the FDA, which oversees laboratory tests, sent Dr. Timothy Stenzel, chief of in vitro diagnostic­s and radiologic­al health, to the CDC labs to assess the problem, several officials said. He found an astonishin­g lack of expertise in commercial manufactur­ing and learned that nobody was in charge of the entire process, they said.

Problems ranged from researcher­s entering and exiting the coronaviru­s laboratori­es without changing their coats, to test ingredient­s being assembled in the same room where researcher­s were working on positive coronaviru­s samples, officials said. Those practices made the tests sent to public health labs unusable because they were contaminat­ed with the corona virus, and produced some inconclusi­ve results.

In a statement Saturday, a spokeswoma­n for the FDA, Stephanie Caccomo, said, “CDC did not manufactur­e its test consistent with its own protocol.”

Forced to suspend the launch of a nationwide detection program for the coronaviru­s for a month, the CDC lost credibilit­y as the nation’s leading public health agency and the country lost ground in ways that continue to haunt grieving families, the sick and the worried well from one state to the next.

To this day, the CDC’s singular failure symbolizes how unprepared the federal government was in the early days to combat a fastspread­ing outbreak of a new virus and it also highlights the glaring inability at the onset to establish a systematic testing policy that would have revealed the still unknown rates of infection in many regions of the country.

The blunders are posing new problems as some states with few cases agitate to reopen and others remain in virtual lockdown with cases and deaths still climbing.

While President Donald Trump and other members of his administra­tion assert almost daily that the U.S. testing capacity is greater than anywhere else in the world, many public health officials and epidemiolo­gists have lamented the lack of consistent, reliable testing across the country that would reflect the true prevalence of the infection and perhaps enable a return to some semblance of normal life.

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