Shockingly sloppy laboratory practices at the US Centres for Disease Control and Prevention (CDC) caused contamination that rendered the United States' first coronavirus tests ineffective, officials confirmed last Saturday.
Two of the three CDC labs 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 the 100 state and local public health labs, the Food and Drug Administration (FDA) said.
Early on, the FDA, which oversees lab tests, sent Dr Timothy Stenzel, chief of in-vitro diagnostics and radiological health, to the CDC labs to assess the problem, officials said. He found an astonishing lack of expertise in commercial manufacturing and learnt that no one was in charge of the entire process.
Problems ranged from researchers entering and exiting the labs without changing their coats, to test ingredients being assembled in the same room where positive samples were being worked on, officials said.
Those practices made the tests unusable because they were contaminated with the coronavirus, and produced inconclusive results.
In a statement last Saturday, FDA spokesman Stephanie Caccomo, said: "CDC did not manufacture its test consistent with its own protocol."
The FDA confirmed its conclusions late last week after media outlets requested public disclosure of its inquiry, which is part of a larger federal investigation into the CDC lab irregularities by the Department of Health and Human Services.
Forced to suspend the launch of a nationwide coronavirus detection programme for a month, the CDC lost credibility as the US' leading public health agency, and the country lost ground in ways that continue to haunt the nation.
The failure symbolises how unprepared the federal government was to combat a fast-spreading outbreak of a new virus, and highlights its inability to establish a systematic testing policy. The blunders are posing new problems as some states with few cases agitate to reopen and others remain in lockdown with cases and deaths still climbing.
While US President Donald Trump and his administration assert almost daily that the US testing capacity is greater than anywhere else in the world, many public health officials have lamented the lack of consistent, reliable testing that would reflect the true prevalence of the infection.
CDC director Robert R. Redfield and other experts have long suggested that lab contamination might have been the culprit. But even until last week, CDC spokesman Benjamin Haynes asserted that it was still just a possibility. In a statement, however, he acknowledged that its quality control measures were insufficient during the test development.
Initially, the CDC was responsible for creating a coronavirus test that could be used to diagnose Covid-19 in people, and then isolate them to prevent the spread of the disease.
"It was just tragic," said Mr Scott Becker, executive director of the Association of Public Health Laboratories. "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."
Mr Becker said public health labs started receiving the CDC kits on Feb 7, and by the next day members were already calling him to report that the test was not working accurately. He alerted both the CDC and the FDA, which regulates medical devices, including lab tests.
"This is consistent with what we said was plausible when we found the problem at the beginning," Mr Becker said. "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 FDA concluded that CDC manufacturing issues were to blame and pushed the agency to move production to an outside firm. That company, IDT, accelerated production of the CDC test and says no more issues were reported.
Meanwhile, the FDA also came under fire for not initially allowing commercial labs like Quest and LabCorp and others to begin ramping up production of their own tests.
More than two months later, more than 730,000 Americans have become infected and nearly 40,000 have died. Testing is still rationed in some states and uneven in others, and it can take days before doctors and patients receive results. Many health experts say testing is nowhere near widespread enough to reopen the country or even return to some semblance of normalcy.
NYTIMES