Bird flu tests are hard to get. How will we know when to sound the alarm? – NBC News
                            June 16, 2024
                                Stanford University infectious disease doctor Abraar Karan has    seen a lot of patients with runny noses, fevers, and irritated    eyes lately. Such symptoms could signal allergies, Covid, or a    cold. This year, theres another suspect, bird flu  but    theres no way for most doctors to know.  
    If the government doesnt prepare to ramp up H5N1 bird flu testing, he and other    researchers warn, the United States could be caught off guard    again by a pandemic.  
    Were making the same mistakes today that we made with Covid,    Deborah Birx, who served as former President Donald Trumps    coronavirus response coordinator, said June 4 on CNN.  
    To become a pandemic, the H5N1 bird flu virus would need to    spread from person to person. The best way    to keep tabs on that possibility is by testing people.  
    Scientifically speaking, many diagnostic laboratories could    detect the virus. However, red tape, billing issues, and    minimal investment are barriers to quickly ramping up    widespread availability of testing. At the moment, the Food and    Drug Administration has authorized only the Centers for Disease    Control and Preventions bird flu test, which is used only for    people who work closely with livestock.  
    State and federal authorities have detected bird flu in dairy    cattle in 12 states. Three people who work on separate dairy    farms tested positive, and it is presumed they caught the virus    from cows. Yet researchers agree that number is an undercount    given the CDC has tested only about 40 people for the disease.  
    Its important to know if this is contained on farms, but we    have no information because we arent looking, said Helen Chu,    an infectious disease specialist at the University of    Washington in Seattle who alerted the country to Covids spread    in 2020 by testing people more broadly.  
    Reports of untested sick farmworkers  as well as    a maternity worker who had flu symptoms     in the areas with H5N1 outbreaks among cattle in Texas suggest    the numbers are higher. And the mild symptoms of those who    tested positive  a cough and eye inflammation, without a fever     are such that infected people might not bother seeking    medical care and, therefore, wouldnt be tested.  
    The CDC has asked farmworkers with flu symptoms to get tested,    but researchers are concerned about a lack of outreach and incentives to    encourage testing among people with limited job security and    access to health care. Further, by testing only on dairy farms,    the agency likely would miss evidence of wider spread.  
    Its hard to not compare this to Covid, where early on we only    tested people who had traveled, said Benjamin Pinsky, medical    director of the clinical virology laboratory at Stanford    University. That left us open to not immediately recognizing    that it was transmitting among the community.  
    In the early months of Covid, the rollout of testing in the    United States was catastrophically slow. Although the World Health    Organization had validated a test and other groups had    developed their own using basic molecular biology techniques,    the CDC at first insisted on creating and relying on its own    test. Adding to delays, the first version it shipped to state    health labs didnt work.  
    The FDA lagged, too. It didnt authorize tests from diagnostic    laboratories outside of the CDC until late February 2020.  
    On Feb. 27, 2020, Chus research lab detected Covid in a teenager who didnt meet the    CDCs narrow testing criteria. This case sounded an alarm that    Covid had spread below the radar. Scaling up to meet demand    took time: Months passed before anyone who needed a Covid test    could get one.  
    Chu notes this isnt 2020  not by a long shot. Hospitals    arent overflowing with bird flu patients. Also, the country    has the tools to do much better this time around, she said, if    theres political will.  
    For starters, tests that detect the broad category of    influenzas that H5N1 belongs to, called influenza A, are    FDA-approved and ubiquitous. These are routinely run in the    flu season, from November to February. An unusual number of    positives from these garden-variety flu tests this spring and    summer could alert researchers that something is awry.  
    Doctors, however, are unlikely to request influenza A tests for    patients with respiratory symptoms outside of flu season, in    part because health insurers may not cover them except in    limited circumstances, said Alex Greninger, assistant director    of the clinical virology laboratory at the University of    Washington.  
    Thats a solvable problem, he added. At the peak of the Covid    pandemic, the government overcame billing issues by mandating    that insurance companies cover tests, and set a lucrative price    to make it worthwhile for manufacturers. You ran into a    testing booth on every other block in Manhattan because    companies got $100 every time they stuck a swab in someones    nose, Greninger said.  
    Another obstacle is that the FDA has yet to allow companies to    run their influenza A tests using eye swabs, although the CDC    and public health labs are permitted to do so. Notably, the    bird flu virus was detected only in an eye swab from one    farmworker infected this year  and not in samples drawn from    the nose or throat.  
    Overcoming such barriers is essential, Chu said, to ramp up    influenza A testing in regions with livestock. The biggest    bang for the buck is making sure that these tests are routine    at clinics that serve farmworker communities, she said, and    suggested pop-up testing at state fairs, too.  
    In the meantime, novel tests that detect the H5N1 virus,    specifically, could be brought up to speed. The CDCs current    test isnt very sensitive or simple to use, researchers said.  
    Stanford, the University of Washington, the Mayo Clinic, and    other diagnostic laboratories that serve hospital systems have    developed alternatives to detecting the virus circulating now.    However, their reach is limited, and researchers stress a need    to jump-start additional capacity for testing before a crisis    is underway.  
    How can we make sure that if this becomes a public health    emergency we arent stuck in the early days of Covid, where    things couldnt move quickly? Pinsky said.  
    A recent rule that gives the FDA more    oversight of lab-developed tests may bog down authorization. In    a statement to KFF Health News, the FDA said that, for now, it    may allow tests to proceed without a full approval process. The    CDC did not respond to requests for comment.  
    But the American Clinical Laboratory Association has asked the    FDA and the CDC for clarity on the new rule. Its slowing    things down because its adding to the confusion about what is    allowable, said Susan Van Meter, president of the diagnostic    laboratory trade group.  
    Labcorp, Quest Diagnostics, and other major testing companies    are in the best position to manage a surge in testing demand    because they can process hundreds per day, rather than dozens.    But that would require adapting testing processes for their    specialized equipment, a process that consumes time and money,    said Matthew Binnicker, director of clinical virology at the    Mayo Clinic.  
    Theres only been a handful of H5N1 cases in humans the last    few years, he said, so its hard for them to invest millions    when we dont know the future.  
    The government could provide funding to underwrite its    research, or commit to buying tests in bulk, much as Operation    Warp Speed did to advance Covid vaccine development.  
    If we need to move to scale this, there would need to be an    infusion of money, said Kelly Wroblewski, director of    infectious disease programs at the Association of Public Health    Laboratories. Like an insurance policy, the upfront expense    would be slight compared with the economic blow of another    pandemic.  
    Other means of tracking the H5N1 virus are critical, too.    Detecting antibodies against the bird flu in farmworkers would    help reveal whether more people have been infected and    recovered. And analyzing wastewater for the virus could    indicate an uptick in infections in people, birds, or cattle.  
    As with all pandemic preparedness efforts, the difficulty lies    in stressing the need to act before a crisis strikes, Greninger    said.  
    We should absolutely get prepared, he said, but until the    government insures some of the risk here, its hard to make a    move in that direction.  
    KFF Health News is a national    newsroom that produces in-depth journalism about health issues    and is one of the core operating programs at KFF  the independent source for    health policy research, polling, and journalism.  
        Amy Maxmen | KFF Health        News      
        Amy Maxmen | KFF Health News      
        Arthur Allen | KFF Health        News      
        Arthur Allen | KFF Health News      
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Bird flu tests are hard to get. How will we know when to sound the alarm? - NBC News