The capacity to perform early coronavirus testing and detection in the United States was severely hindered by the Centers for Disease Control (CDC), which released tests that were contaminated during the initial manufacturing process at the centers’ lab.
The Washington Post, which first reported on the findings, has concluded that the CDC failed to fix the problem for nearly a month, and didn’t provide enough information for the FDA to determine that the problem was the centers’ failure to follow laboratory procedures, and not a flaw in the test design.
Regulators told the news agency that they have made a similar determination, with the FDA telling the Post in a statement that the “CDC did not manufacture its test consistent with its own protocol.”
The CDC has since outsourced test manufacturing to a private lab, and in a statement said that the agency has since “implemented enhanced quality control to address the issue.”
On January 11, Chinese scientists published the genetic sequence of the coronavirus – without permission from the communist government – allowing countries around the world to begin developing tests, reports The South China Morning Post. (China shut down the lab for “rectification” the following day, publicly released the genetic sequence themselves, and later claimed that there was no evidence of human-to-human transmission.)
But as other countries began to develop tests to detect the virus, the CDC embarked on a journey to develop its own test, one that was more sophisticated than the tests that were ultimately used in other countries, reports The Washington Post.
The tests used in other countries contained two portions, each to identify a separate region of the virus’ structure. On the other hand, the CDC developed a test with a third portion, seemingly with the goal of increasing the confidence in the results.
But the third portion ultimately slowed down the entire project. In interviews with the news agency, scientists and regulators indicated that the bad batch of tests likely experienced cross-contamination at the manufacturing lab, which assembled the tests in places where coronavirus material was handled.
Unknown to the CDC, they sent out the compromised test kits to 26 public health labs across the country, instructing them to perform controlled experiments with purified water. Twenty-four of the labs reported positive results, stemming from the third portion of the test, reports the news agency.
“My question is – where was the adult supervision?” a former CDC lab chief told the news agency, which interviewed more than 30 people. “A competent laboratory would not have that problem. I don’t really understand how the kits got out without detecting a problem.”
Not only did the third portion slow down the process, experts believe it was ultimately unnecessary.
“Either the CDC didn’t know it was a crisis or they should have pulled the plug on that faster,’’ Paul Keim, a geneticist at Northern Arizona University, told the Post. “They didn’t have a test that worked.”
The CDC first publicly acknowledged that there may be an issue with the tests at a press briefing on February 12, reports the news agency.
“We think that the issue at the states can be explained by one reagent that isn’t performing as it should consistently, and that’s why we are remanufacturing that reagent,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the CDC, at the press conference.
According to The New York Times, the CDC planned to perform surveillance testing during mid-February in five major cities, two days after the press conference, but the plans didn’t come to fruition in most places, seemingly due to a lack of testing kits.
“We would be in a far different place,” Dr. Jennifer Nuzzo, an epidemiologist at Johns Hopkins University, told the news agency with regard to the lack of early detection efforts.
The CDC continued to conduct tests at its lab in Atlanta, as those were not afflicted with the same manufacturing problem and had been successfully used to identify non-community spread patients.
Furthermore, the agency declined to adopt the tests being used in other countries, in part due to concerns that the other tests had not been approved by federal regulators for use in the United States.
Dr. Anne Schushat, the principal deputy director of the CDC, reportedly later said that the CDC didn’t believe it was necessary to adopt “somebody else’s test.”
According to The Washington Post, complicating the CDC’s manufacturing fiasco, some public labs believed that the tests could be conducted without the third portion, but didn’t, on account that the center’s emergency guidelines prohibited them. Some labs eventually started using the test kits anyway, and promised to confirm the results with additional testing at the CDC.
Ultimately, the FDA couldn’t determine that the CDC’s manufacturing process was the problem until the weekend of February 23, nearly a month after the problems with the initial batch of tests were noticed.
The New York Times reports that at an undisclosed point in time, Dr. Timothy Stenzel, the official who concluded that the manufacturing process was flawed, allegedly made troubling observations about the CDC.
Early on, the F.D.A., which oversees laboratory tests, sent Dr. Timothy Stenzel, chief of in vitro diagnostics and radiological health, to the C.D.C. 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 coronavirus, and produced some inconclusive results.
The timeline suggests that the CDC’s failure to properly manufacture tests adversely affected how quickly cases of community spread were identified by public labs across the country.
At the time the FDA determined the source of the flaw, the CDC was still operating under highly specific testing guidance and a criteria that didn’t account for the possibility of community spread cases, and instead focused on foreign travelers.
“Patients that have fever, symptoms of lower respiratory infection, requiring hospitalization, and a history of travel from mainland china meet the case definition for testing,” Dr. Messonnier said in a press conference February 21.
“We are regularly looking at the epidemiological situation globally, with our state and local health department partners, evaluating our case definition to make sure it is sensitive and specific enough,” said Dr. Messonnier. “We want to make sure that we’re targeting our efforts appropriately.”
The same weekend the FDA determined the manufacturing process was flawed, and not the design, the CDC authorized UC Davis Medical Center to conduct testing on a patient with no known travel history to China.
The medical center had previously requested coronavirus testing from the CDC, shortly after the patient arrived from a separate hospital four days earlier, but said that a test wasn’t immediately administered because the patient didn’t meet the CDC’s criteria.
According to the medical center’s press release, neither the county nor the state were conducting coronavirus tests at the time. It’s unclear why the CDC allowed the patient to be tested for coronavirus at the time that they did.
On February 26, after receiving the positive test results from the CDC, the UC Davis Medical Center announced that they were treating “possibly the first patient to have received the infection from exposure in the community.”
A study out of Washington in mid-March has since found that the coronavirus was likely introduced to the state between late January and early February, “before active community surveillance was implemented.”
We demonstrate that SARS-CoV-2 was circulating in Washington State for 4-6 weeks before the first community-acquired case was detected on 28 February, 2020. Refining the time and geographic origin of the introduction into Washington State will require a combination of earlier samples and samples from other geographic locations, including from elsewhere in the United States and from China.