During the coronavirus pandemic, testing shortages have led to backlogs. Experts worry that the United States has not learned from these mistakes and will not be prepared for a large-scale bird flu outbreak.
Rebecca Blackwell/AP/Associated Press
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Rebecca Blackwell/AP/Associated Press
It’s been nearly three months since the U.S. government declared an outbreak of avian influenza on a dairy farm. The World Health Organization considers the virus a public health concern because of its potential to cause a pandemic, but the United States has only tested about 45 people nationwide.
“We are flying blind,” said Jennifer Nuzzo, director of the Epidemiology Center at Brown University School of Public Health. She said because so few tests have been conducted, it’s impossible to know how many farmworkers have been infected or how severe the disease is. A lack of testing means the country may not notice if the virus starts spreading between people — another gateway to the pandemic.
“We want more testing. There’s no question about it,” said Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention. The CDC’s avian influenza test is the only test currently authorized for use by the U.S. Food and Drug Administration.
Shah said the agency has distributed the tests to about 100 public health laboratories across states. “We have about 1 million available now,” he said, “and expect another 1.2 million in the next two months.”
But Nazo and other researchers are concerned because the CDC and public health labs are not typically where doctors order tests. This work is often done by major clinical laboratories run by companies and universities, which lack accreditation for avian influenza testing.
Clinical labs say they’re ‘stuck on the bench’
As the outbreak spreads—at least 114 cattle herds were infected in 12 states as of June 18—researchers say the CDC and FDA are not moving fast enough to remove barriers that prevent clinical labs from testing obstacles. In one case, diagnostics company Neelyx Labs was put on hold for more than a month over an inquiry.
“Clinical laboratories are part of the nation’s public health system,” said Alex Greninger, assistant director of the Clinical Virology Laboratory at Washington University Medicine. “Pull us into the game. We’re stuck on the bench.
The CDC recognized the need for clinical laboratories in a June 10 memo. It called on industry to develop tests for the H5 avian influenza virus, which is circulating in dairy cows. “The limited availability and accessibility of diagnostic tests for influenza A (H5) creates several pain points,” the CDC writes. Those points include shortages of tests if demand surges.
Researchers, including former Centers for Disease Control and Prevention director Tom Frieden and Anthony Fauci, who is leading the U.S. response to the pandemic, see the testing failures as part of the U.S.’s poor performance on the pandemic. Key reasons. They say that had COVID-19 testing become widespread in early 2020, the U.S. could have caught many cases before they turned into outbreaks that shuttered businesses and killed people.
In an article published this month, Nuzzo and a group of colleagues argued that the problem is not the testing capability but the failure to deploy that capability quickly. The United States reports eight times the excess mortality rate than other countries with advanced laboratories and other technological advantages.
COVID-19 tests reviewed by the World Health Organization were launched in mid-January 2020. That is, the CDC develops its own tests and then sends them to local public health labs. Ultimately, the FDA authorizes testing by clinical diagnostic laboratories serving hospital systems, which then must scale up their operations. It takes time, and during outbreaks in nursing homes and prisons, people died while waiting for test results.
In contrast, South Korea immediately rolled out testing through private sector laboratories, allowing it to keep schools and businesses open. “They said, ‘Guys, get ready; we’re going to need a lot of testing,'” said Frieden, now president of the public health group Determined to Save Lives. “You need to put ads in the game.”
Nuzzo and her colleagues describe a step-by-step strategy for testing during health emergencies in response to apparent errors caused by COVID-19. But in this bird flu outbreak, the United States was weeks behind.
Adequate testing is critical for two reasons. First, Nuzzo said, people need to know if they are infected so they can get treatment quickly. Over the past two decades, about half of the approximately 900 people known to have been infected with bird flu worldwide have died from it.
While three farmworkers diagnosed with the disease in the U.S. this year had only mild symptoms, such as a runny nose and irritated eyes, others may not be so lucky. Flu treatment Tamiflu is effective only if taken immediately after symptoms appear.
The CDC and local health departments are trying to ramp up bird flu testing for farm workers, requiring them to get tested if they feel sick. Farmworker advocates cite several reasons why their outreach efforts have failed. For example, outreach may not be in the language farmworkers speak, and it may not address issues such as unemployment.
If people who live and work around farms or their children only go to the doctor when they get sick, those cases may be missed if the doctor sends the sample to their usual clinical laboratory. The CDC has asked doctors to send samples from people with flu symptoms who have been exposed to livestock or poultry to public health laboratories.
“If you work on a farm where there’s an outbreak and you’re worried about your welfare, you can get tested,” Shah said. But sending samples to public health requires knowledge, time and effort.
“I’m really concerned about the testing options that busy clinicians need to address this problem,” Nuzzo said.
Labs demand ‘rights of reference’, but federal agencies slow to respond
Another reason to get clinical labs involved is so the state can ramp up testing if bird flu is suddenly discovered in people who haven’t contracted it from cattle. There is no evidence that the virus has begun to spread from person to person, but this may change in the coming months as the virus develops.
Greninger said the quickest way to get clinical labs on board is to allow them to use a test the FDA has already authorized: the CDC’s avian flu test. On April 16, the U.S. Centers for Disease Control and Prevention (CDC) opened up this possibility by offering accredited laboratories a royalty-free license for avian influenza testing components.
Some commercial laboratories require a license. “We want to be ready before things get crazy,” said Shyam Saladi, CEO of diagnostics company Neelyx Labs, which has provided COVID-19 and MPOX tests during the outbreak. His experience over the past two months has revealed the types of obstacles that stand in the way of rapid growth in the lab.
In an email exchange with the CDC, shared with KFF Health NewsSaladi made it clear that the lab hopes to obtain a license related to CDC testing and the right to “cite” CDC data when applying for FDA authorization.
This “right of reference” makes it easier for one company to use a test developed by another company. It allows the new group to skip certain analyzes performed by the original manufacturer by telling the FDA to look at the data in the original FDA application. This was common in coronavirus testing during the peak of the pandemic.
At first, the CDC seemed eager to cooperate. “Data reference rights should be provided,” CDC patent expert Jonathan Motley wrote in an April 24 email to Saladi. Over the next few weeks, the CDC sent him Information about transferring a license to Saladi.
But Saladi has grown increasingly concerned about the company’s ability to cite CDC data in FDA applications. “Do you have an update on the rights of reference?” he asked the CDC on May 13.
Over the next few weeks, as the number of cattle infected with bird flu increased and more cases emerged among farm workers, he asked several more times. “Given that it is May 24th and the epidemic is still expanding, can CDC provide a date for a planned response?” Saladi wrote.
The CDC eventually signed a licensing agreement with Neelyx, but informed Saladi that it would not, in fact, provide a reference. Without that, Saladi said, he wouldn’t be able to move forward with testing at the CDC — at least not without more material from the agency. “It’s really frustrating,” he said. “We think they really intend to support the development of these tests in case they are needed.”
The CDC’s Shah said test manufacturers should produce their own data to prove they are using CDC tests correctly. “We don’t need to cut corners because of the shortage,” he said. “High Quality.”
The CDC has issued licenses for the tests to seven companies, including Neelyx, although the FDA has not yet approved any company to use them. Only one of the companies requested reference rights, Shah said. Labs may be able to get help from other materials currently being developed by the agency to allow them to complete their analyses—even without reference materials.
“This should have happened sooner,” Saladi told KFF Health News when told the CDC had not yet provided additional material. “There has been no communication about this.”
A look back at the early COVID-19 response
Greninger said the delays and confusion are reminiscent of the early months of the coronavirus outbreak, when federal agencies prioritized caution over speed. He said testing accuracy is important, but excessive scrutiny could cause harm in a fast-moving outbreak like this. “The CDC should try to open this up to labs with national reach and good reputations,” he said. “I’m in favor of getting labs ready — that’s a given.”
Clinical laboratories are also beginning to develop their own tests from scratch. But researchers say they are proceeding with caution because a recent FDA rule gives the agency more oversight of lab-developed tests, lengthening the path to approval. FDA press officer Janell Goodwin said in an email to KFF Health News that enforcement of the rule will occur gradually.
However, Susan Van Meter, president of the American Clinical Laboratory Association, a trade group whose members include the largest commercial diagnostic labs in the United States, said companies need a clearer message: “This will slow things down because it Adding to the confusion about what is allowed.
Testing for avian flu is already a risky bet because demand is uncertain. It’s unclear whether this outbreak in cattle will cause an epidemic or eventually disappear. In addition to issues with the CDC and Food and Drug Administration, clinical laboratories are trying to figure out whether health insurance companies or the government will pay for avian flu testing.
These wrinkles will eventually smooth out. Until then, the tiny number of people tested, combined with the lack of testing on cattle, is likely to draw criticism from the rest of the world.
“Think about our judgment about China’s transparency at the beginning of the COVID-19 outbreak,” Nuzzo said. “The current situation harms America’s standing in the world.”
KFF Health News is a national newsroom that produces in-depth journalism on health issues and is one of KFF’s core operating programs – an independent source of health policy research, polling and news.
