The US Centers for Disease Control and Prevention (CDC) says a glitch in its bird flu testing didn’t affect the agency's response to the outbreak. But the error has sparked criticism of its unilateral approach to testing for emerging pathogens.
The agency has been working quietly since April to resolve a persistent problem with the test it developed, whilst the virus ravaged dairy farms and chicken coops across the country, infecting not less than 13 farmworkers this 12 months.
At a congressional hearing on July 23, Republican Rep. Brett Guthrie of Kentucky was asked in regards to the issue. “Man, this is reminiscent of 2020,” he said, referring to the time when the nation was caught completely off guard by the COVID-19 pandemic, partially due to the CDC's flawed testing. Demetre Daskalakis, director of the CDC's National Center for Immunization and Respiratory Diseases, responded that the agency quickly developed an answer that made its bird flu test reliable.
“The tests are 100% usable,” he later told KFF Health News, adding that the FDA had investigated the tests and reached the identical conclusion. The imperfect tests, which have a faulty element that sometimes requires a sample to be retested, will soon get replaced. He added, “We have made sure that we are offering a high-quality product.”
Still, some researchers were alarmed by the news, which got here 4 months after the federal government declared a worrisome outbreak of bird flu in cattle. The CDC's test is the just one available for clinical use. Some researchers say its shortcomings, while manageable, underscore the chance of counting on a single site for testing.
The problem got here to light in April because the agency was preparing to distribute its test to about 100 public health labs across the country. CDC officials discovered the issue through a top quality control system put in place after the 2020 COVID testing disaster.
Daskalakis said the CDC's original test design was superb, but a mistake arose when an organization hired by the agency manufactured the tests in bulk. In those tests, certainly one of the 2 components that detect proteins called H5 within the H5N1 bird flu virus was unreliable, eliminating a key preventive measure. By targeting the identical protein twice, the tests have a built-in backup in case one part fails.
The agency developed an answer to make sure a reliable result: If only certainly one of the 2 parts detected H5, the test was considered inconclusive and repeated. With the FDA's blessing, the CDC distributed the tests – with instructions on easy methods to bypass them – to public health laboratories.
Kelly Wroblewski, director of infectious diseases on the Association of Public Health Laboratories, said the test results were clear and there was no reason to discard the tests.
Still, the agency has hired one other manufacturer to duplicate the faulty component, so 1.2 million improved tests will soon be available, Daskalakis said. Some of the updated tests are already in stock on the CDC, however the FDA has not yet approved their use. Daskalakis declined to call the manufacturers.
The outbreak has now spread. Farm employees still lack information in regards to the virus and Equipment for defense Rural clinics may miss cases in the event that they fail to acknowledge an individual's connection to a farm and notify health authorities somewhat than their usual diagnostic laboratories.
These clinical laboratories are still not authorized to check for bird flu. Several of those laboratories have spent months Analyses and bureaucracy in order that they will perform the CDC's tests. As a part of the licensing process, the CDC also made them aware of the workaround with the present test.
But outside select circles, the news has been largely ignored. “I'm completely surprised by this,” Alex Greninger, deputy director of the University of Washington's Clinical Virology Laboratory, told KFF Health News. Greninger's lab is developing its own test and is attempting to obtain test kits from the CDC for evaluation.
“It's not a red flag,” he said, but he worries that while the CDC and FDA spend months developing and evaluating an updated test, the one test available is predicated on a single component. If the genetic code underlying that fragment of the H5 protein mutates, the test could produce false results.
It is just not unusual for educational and industrial diagnostic labs to make mistakes and discover them during quality control, as was the case with the CDC. Yet this is just not the agency’s first mishap. In 2016, long before the COVID debacle, CDC officials spent months instructing public health labs to Zika test This failed in a couple of third of the cases.
The CDC was much quicker and more practical in identifying and attempting to deal with the situation on this case. Still, the incident is a cause for concern. Michael Mina, chief scientific officer at telemedicine company eMed.com, said diagnostic firms could also be higher suited to the duty.
“It's a reminder that the CDC is not a reliable manufacturer of tests” and doesn’t have the resources that industry can muster to provide them, Mina said. “We are not asking the CDC to make vaccines and medicines, and we are not asking the Pentagon to make missiles.”
The CDC has licensed its updated test design to not less than seven clinical diagnostic laboratories. These labs form the idea for testing within the United States, but none have FDA approval to make use of it.
Diagnostic laboratories are also developing their very own tests. But progress is slow. One reason for that is the Lack of guaranteed salesAnother reason is regulatory uncertainty. FDA Guidance could make it tougher for non-governmental laboratories to offer latest tests within the early stages of pandemics, said Susan Van Meter, president of the American Clinical Laboratory Association, in a Letter dated July 1 to the FDA.
Transparency can be crucial, scientists said. Benjamin Pinsky, medical director of the Laboratory of Clinical Virology at Stanford University, said as a public agency, the CDC must make its protocol – its prescription for conducting the test – easily accessible online.
The World Health Organization is doing this for its Bird flu testsand with that information in hand, Pinsky's lab has developed an H5 bird flu test tailored to the strain circulating within the U.S. this 12 months. Laboratory published It will probably be launched this month, however the FDA has not approved it for widespread use.
The CDC's test recipe is accessible in a printed patent, Daskalakis said.
“We have made sure that tests exist and that they work,” he added.
When the CDC got here under fire on the July 23 congressional hearing, Daniel Jernigan, director of the CDC's National Center for Emerging and Zoonotic Infectious Diseases, identified that testing is only one tool. The agency needs money for an additional promising area – on the lookout for the virus in wastewater. Additional funding could be used for its current program, he said: “It is not included in the current budget and will go away without additional funding.”
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