Bird flu tests are hard to get. How will we know when to sound the alarm?

Stanford University infectious disease specialist, Dr. Abraar Karan, has recently encountered numerous patients exhibiting symptoms such as runny noses, fevers, and irritated eyes. These symptoms could potentially indicate allergies, Covid-19, or a common cold. However, this year, there is a new concern: bird flu. Unfortunately, most doctors currently lack the means to determine whether patients are infected with H5N1 bird flu.

Experts and researchers, including Deborah Birx, who previously served as former President Donald Trump’s coronavirus response coordinator, are warning that if the government fails to prepare for increased testing of H5N1 bird flu, the United States could once again be caught off guard by a pandemic, just as it was with Covid-19.

For H5N1 bird flu to become a pandemic, it would need to spread from person to person. The most effective way to monitor and assess this possibility is through widespread testing of individuals.
From a scientific standpoint, many diagnostic laboratories have the capability to detect the virus. However, bureaucratic obstacles, billing complications, and insufficient investment hinder the swift expansion of testing availability. Currently, the Food and Drug Administration has only authorized the use of the Centers for Disease Control and Prevention’s bird flu test, which is solely utilized for individuals who have close contact with livestock.

Both state and federal authorities have identified instances of bird flu in dairy cattle across 12 states. Three individuals working on different dairy farms have tested positive for the virus, suggesting that they contracted it from the cows. However, researchers believe that this number is an underestimate, as the CDC has only conducted tests on approximately 40 individuals for the disease.
Helen Chu, an infectious disease specialist at the University of Washington in Seattle, emphasized the need for information regarding the containment of the virus on farms. However, currently, there is a lack of data due to the absence of active surveillance. Chu played a crucial role in raising awareness about the spread of Covid-19 in 2020 through widespread testing.

Recent reports indicate the presence of untested farmworkers who fell ill, as well as a maternity worker displaying flu-like symptoms, in areas with H5N1 outbreaks among cattle in Texas. These reports suggest that the number of cases may be higher than what has been officially reported. Additionally, the mild symptoms experienced by those who tested positive, such as a cough and eye inflammation without a fever, may discourage infected individuals from seeking medical care and consequently not getting tested.
The CDC has urged farmworkers experiencing flu symptoms to undergo testing. However, researchers are worried about a lack of outreach and incentives to motivate testing among individuals with unstable employment and limited healthcare access. Furthermore, focusing solely on testing dairy farms could potentially overlook signs of broader transmission.

Drawing parallels to the early stages of the Covid pandemic, Benjamin Pinsky, medical director of the clinical virology laboratory at Stanford University, noted, “It’s difficult not to compare this to Covid, where initially we only tested individuals who had traveled. This delayed our recognition of community transmission.”
During the initial months of the Covid pandemic, the testing process in the United States faced significant setbacks. Despite the availability of a validated test by the World Health Organization and other groups developing their own tests using basic molecular biology techniques, the CDC initially insisted on creating and relying on its own test. This decision, coupled with the fact that the first version of the test sent to state health labs did not work, led to further delays.

The FDA also contributed to the slow rollout of testing. It did not authorize tests from diagnostic laboratories outside of the CDC until late February 2020.

On February 27, 2020, a teenager who did not meet the CDC’s narrow testing criteria was found to have Covid in Chu’s research lab. This case served as a warning sign that the virus had spread undetected. However, it took several months to scale up testing capacity to meet the demand. As a result, it was not until later that individuals in need of a Covid test were able to access one.
Chu emphasizes that the current situation is not like 2020 at all. Hospitals are not overwhelmed with bird flu patients, and the country now has the necessary tools to handle the situation much better, if there is political will.

One important tool is the availability of FDA-approved tests that can detect influenza A, the broad category that H5N1 belongs to. These tests are widely used during the flu season, which typically runs from November to February. If there is an unusually high number of positive results from these tests during the spring and summer, it could serve as an early warning sign that something is not right.

However, outside of the flu season, doctors are unlikely to request influenza A tests for patients with respiratory symptoms. This is partly because health insurers may not cover these tests unless there are specific circumstances. Alex Greninger, the assistant director of the clinical virology laboratory at the University of Washington, explains this limitation.
He added that the problem is solvable. During the peak of the Covid pandemic, the government addressed billing issues by requiring insurance companies to cover tests and setting a profitable price for manufacturers. As a result, there were testing booths on almost every other block in Manhattan, with companies receiving $100 for every swab they administered, according to Greninger.

Another challenge is that the FDA has not yet authorized companies to conduct influenza A tests using eye swabs, although the CDC and public health labs are allowed to do so. It is worth noting that the bird flu virus was only detected in an eye swab from one infected farmworker this year, and not in samples taken from the nose or throat.
According to Chu, it is crucial to overcome these obstacles in order to increase influenza A testing in livestock regions. She emphasized the importance of making these tests a routine at clinics that cater to farmworker communities and even suggested pop-up testing at state fairs.

Meanwhile, there is a need to improve the current tests for detecting the H5N1 virus. Researchers have found that the CDC’s current test is not very sensitive or user-friendly.

Diagnostic laboratories such as Stanford, the University of Washington, and the Mayo Clinic have developed alternative methods for detecting the circulating virus. However, their reach is limited, and there is a pressing need to expand testing capacity before a crisis occurs.

Pinsky highlighted the importance of avoiding a situation similar to the early days of Covid, where things couldn’t move quickly. He questioned how we can ensure that we are prepared for a public health emergency without being hindered by slow testing.
The FDA’s increased oversight of lab-developed tests may cause delays in authorization, according to a statement from the FDA. They may allow tests to proceed without full approval for the time being. The American Clinical Laboratory Association has requested clarification from the FDA and CDC regarding the new rule, expressing concerns about the confusion it has caused. Labcorp, Quest Diagnostics, and other major testing companies are better equipped to handle a surge in testing demand due to their ability to process hundreds of tests per day. However, this would require them to adapt their testing processes for specialized equipment, which is a time-consuming and costly process, as noted by Matthew Binnicker, director of clinical virology at the Mayo Clinic.
“There have been only a few H5N1 cases in humans in recent years,” he explained. “This makes it difficult for them to invest millions without knowing what the future holds.”

To support its research, the government could offer funding or commit to purchasing tests in bulk, similar to Operation Warp Speed’s approach to advancing Covid vaccine development.

“If we want to expand our efforts, we would need a financial boost,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories. This upfront investment would be a small price to pay compared to the economic impact of another pandemic.

In addition, other methods of tracking the H5N1 virus are crucial. Identifying antibodies against the bird flu in farmworkers would help determine the number of people who have been infected and recovered. Furthermore, analyzing wastewater for the presence of the virus could indicate an increase in infections among people, birds, or cattle.
According to Greninger, the challenge in pandemic preparedness is emphasizing the importance of taking action before a crisis occurs.

He stated, “We should definitely make preparations, but without the government providing some assurance of the risks involved, it’s difficult to move in that direction.”

KFF Health News is a nationwide newsroom that specializes in producing comprehensive journalism on health issues. It is a key program within KFF, an independent organization that conducts health policy research, polling, and journalism.

This article was initially published on NBCNews.com.

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