Helen Y. Chu, an infectious disease specialist in Seattle, knows that the US does not have much time to deal with Covid-19.

In late January, the US recorded the first case of nCoV as a 35-year-old man, returning to Seattle, Washington state from Wuhan, the center of the epidemic in China. The question at that time was: Has the man infected anyone yet? Is nCoV creeping into the community and spreading?

Zhou has a way to partially answer those questions. For months, she and a team of researchers collected nasal fluids from flu-symptomic residents across the Puget Sound area for the Seattle Flu Research Project.

To use these forms for the nCoV test, they need permission from state and federal officials. But officials have repeatedly rejected the idea, even as many weeks have passed since the outbreak in Wuhan and it has spread to many countries outside of China.

The early failure of the United States to allow the use of influenza research data for nCoV testing means that it has missed a "golden opportunity" to stop the epidemic earlier. Through interviews with email and correspondence data, NYTimes journalists Sheri Fink and Mike Baker built a picture of how regulations and bureaucracy have delayed the epidemic in the US how.

Immediately after the nCoV gene sequence was announced in January, the first work of the US Centers for Disease Control and Prevention (CDC) was to develop test kits. The agency also set criteria to determine individuals tested for nCoV: only those who have a fever, have breathing problems and have been to Wuhan.

Strict criteria caused the 35-year-old man to return to Seattle from Wuhan from his condition. However, state health officials have asked him to be tested and CDC agreed. The man was confirmed positive for nCoV on January 20.

Officials tracked 70 people who had come into contact with the man, 50 of whom agreed to take nasal fluid and none were positive for nCoV. But there is still a risk of missing the infected person, epidemiologist Scott Lindquist said.

Scott F. Dowell, former CDC official and deputy director of the Bill & Melinda Gates Foundation, the research sponsor, requested help from the CDC officials in charge of dealing with nCoV. "Hope for a solution," he wrote on February 10.

Lindquist epidemiologist in Washington writes to Alicia Fry, director of epidemiology and disease prevention at CDC for permission.

But the CDC declined, asking Lindquist to consult with the FDA. FDA does not approve it because the lab is not certified as a clinical laboratory and the licensing process can take months. Zhou and Lindquist tried many times to get approval, but the answer was always no.

"We feel like we are sitting still, waiting for a pandemic to appear," Zhou said. "We can help but we can't do anything".

While Washington State argues with federal officials, the CDC faces the difficult task of conducting more nCoV tests. CDC has developed its own test kits, similar to the way they deal with previous outbreaks. Some other countries also develop kits themselves.

But when CDC distributes test kits to laboratories across the country, some local health officials report that the devices are faulty. CDC promises to ship replacement products within a few days, but the problem lasts more than two weeks. Only 5 state-level laboratories can be tested during that period. Washington and New York are not among these.

By February 24, when a series of new nCoV infections were reported in the US, state laboratories began to worry. The Public Health Laboratory Association sent a letter to Stephen Hahn, FDA commissioner, asking him to allow state and local laboratories to create their own nCoV test kits.

Hahn answered two days later that "the wrong test result could have serious consequences for public health" and welcomed the laboratories to submit their own developed test kits for urgent approval.

But this approval process is quite cumbersome. Private and university clinical laboratories are disappointed with the speed of the FDA. Alex Greninger, from Washington University Medical Center in Seattle, said he was furious in mid-February when he urged the FDA. "nCoV is faster than FDA," he said.

To ensure the quality of the test kit, scientists need to try it with samples from patients who have confirmed positive for nCoV or a copy of the viral genome. But it is difficult to collect such samples because most hospitals laboratories do not have them. Karen Kaul, from NorthShore Hospital in Illinois, said it took a lot of effort to get a sample from a European laboratory.

Meanwhile, the FDA insists it is not acting slowly. The FDA says it has emergency approval for two test kits within 24 hours: one from the CDC, one from the Wadsworth lab in New York.

On the other side of the country, in Seattle, Zhou and his colleagues could not wait any longer. On February 25, they decided to test nCoV with the sample they had collected in the flu research project, despite the government's disagreement.

Technician Lea Starita was shocked to find a teenager who was positive for nCoV. He had been sampled only a few days earlier, not recently traveling abroad and unrelated to the confirmed cases. "At that time, I thought, 'My God, I just started a test and found a positive case for nCoV,' Starita said.

Project members discussed what they should do next and consider ethical considerations. "We are not allowed to disclose information outside. But we feel we need to say it," Zhou said. They decide the right thing to do is notify local health officials.

The state laboratory, then able to do the nCoV test, confirmed the results on the morning of February 28. The boy was notified right after he entered the school. He was taken home and the school was closed.

That evening, Seattle scientists and health officials met with representatives of the CDC and the FDA. The message from the federal government to the research project was very straightforward: "Stop testing," Lindquist said.

On February 29, officials changed their decision, allowing them to continue testing, but only with later samples. They should clearly mention to the sample giver that the samples are used for nCoV testing and that the results can be shared with local health authorities. They are not allowed to test thousands of previously collected samples.

On the same day, the FDA relaxed rules, allowing clinical laboratories to use kits developed by them, as long as they send evidence back to the agency.

On March 2, the evaluation committee of the Seattle Flu Research Project at the University of Washington concluded that scientists acted appropriately when testing and announcing the results because it was a medical emergency. public. The scientists then discovered more positive cases.

In addition to testing new samples, the scientists also tested old samples that had been in the freezer for weeks, though federal officials didn't allow them. They found more positive samples were collected from February 20 to 7 days before public health officials realized nCoV spread in the community.

But on the evening of 9/3, officials again asked them to stop testing until certified as a clinical laboratory.

Since the discovery of teens positive for nCoV, Seattle has been in crisis with dozens of people infected and at least 22 dead. nCoV seems to have been quietly spreading in the community for about 6 weeks. The US has so far recorded more than 1,700 cases, more than 40 deaths and more than 30 recovering.

When he looked back, Zhou understood why regulations restricting the scope of the project existed. "They are laid out for a reason. Officials want to protect the subjects of the study. Be ethical."

But she was disappointed that it took so long to overcome the bureaucratic barrier, when an outbreak was likely to erupt in Washington state and spread in many other areas. "I think others were not aware of this at the time," she said. "Now we know".