Avian Influenza Diagnostics Are Scarce: When Is It Time to Ring the Alarm?

At Stanford University, specialist in infectious diseases Abraar Karan has been encountering numerous patients presenting with symptoms such as nasal discharge, elevated body temperatures, and eye irritation. These indications might point to allergic reactions, Covid, a common cold, or the new contender, avian influenza. Regrettably, for most healthcare providers, distinguishing between these is not feasible.

Should the authorities fail to initiate enhancement of H5N1 avian influenza diagnostics, he and his peers caution, the country might again be taken by surprise by an epidemic.

“We are repeating the errors we committed with Covid at present,” declared Deborah Birx, who played the role of coronavirus response orchestrator for then-President Donald Trump, on a CNN broadcast dated June 4.

For H5N1 avian influenza to escalate to a pandemic status, it requires the ability to transmit among humans. Conducting tests amongst individuals is the optimal approach to stay vigilant of this threat.

In theory, numerous diagnostic centers are capable of detecting this virus. Nonetheless, bureaucratic obstacles, billing complications, and insufficient investment hinder the swift expansion of testing. Presently, the Food and Drug Administration has approved solely the bird flu diagnostic designed by the Centers for Disease Control and Prevention, reserved for individuals in close contact with poultry and livestock.

Local and national agencies have identified avian influenza in bovine populations across a dozen states. Three individuals, who worked on distinct bovine farms, contracted the infection, presumably from cattle. However, experts concur that these figures represent an underestimated count, given that the CDC has conducted testing on merely about 40 individuals for the illness.

“It’s crucial to ascertain whether this is confined to agricultural settings, but we lack data due to insufficient surveillance,” stated Helen Chu, a scholar in infectious diseases at the University of Washington in Seattle who, through widescale testing, brought attention to Covid’s proliferation in 2020.

Accounts of unexamined ailing agricultural laborers and a staff member in maternal care with flu-like symptoms within regions of bovine H5N1 outbreaks in Texas, suggest that the count may be greater. Furthermore, the subdued symptoms in those diagnosed—a cough and eye redness sans fever—are such that afflicted individuals may not seek medical aid and therefore remain undiagnosed.

The CDC has made an appeal for agricultural workers with flu symptoms to pursue testing. Nonetheless, there are concerns about an apparent deficiency in communications and the absence of drives to promote testing among individuals with precarious employment and limited healthcare accessibility. Moreover, limiting testing exclusively to bovine farms might result in oversight of more extensive contagion.

“It is difficult to refrain from drawing parallels with Covid, in which initially tests were restricted to those with a travel history,” mentioned Benjamin Pinsky, who helms the clinical virology laboratory at Stanford University, “This left us vulnerable to overlooking community transmission at the outset.”

In Covid’s nascent phases, the unveiling of diagnostics within the United States was debilitatingly sluggish. While the World Health Organization had sanctioned a test and other entities had concocted their own via rudimentary molecular biology techniques, the CDC initially resolved to devise and employ its unique test. Attributable to faults, the early iterations dispatched to state health departments malfunctioned.

Delays were also encountered by the FDA. It wasn’t until late February 2020 that the organization authorized tests from diagnostic labs independent of the CDC.

On Feb. 27, 2020, a lab operated by Chu’s research team detected Covid in a youth who did not fulfill the CDC’s restricted criteria for testing. This discovery served as a wake-up call that Covid was silently disseminating. Reaching a scale adequate to meet the demands took months: it was a considerable period before anyone requiring a Covid diagnostic could secure one.

Chu recalls that the current time is by no means comparable to 2020. Medical facilities are not swamped with cases of avian influenza. Moreover, the nation is equipped with the means to perform significantly better, she said, if only the political determination exists.

To begin with, diagnostics that are capable of detecting influenzas in the group to which H5N1 pertains, known as influenza A, have received FDA clearance and are widespread. These tests are typically conducted during the “flu season,” which ranges from November through February. An atypical surge of positives from these commonplace flu diagnostics during the spring and summer could serve as a cue for scientists that the situation may be unusual.

Nevertheless, physicians may not order tests for influenza A for patients exhibiting respiratory symptoms beyond flu season, partly because insurers may not compensate for them barring specific cases, according to Alex Greninger, assistant director of the clinical virology lab at the University of Washington.

Solving this dilemma is within reach, he suggested. Throughout the climax of the Covid pandemic, the government bypassed billing obstacles by mandating that insurance providers cover the tests, setting a profitable tariff to make production alluring for companies. “In Manhattan, you stumbled upon a diagnostic booth almost on every other corner because firms received $100 each time they conducted a nasal swab,” Greninger remarked.

Another stumbling block is the FDA’s hesitance to sanction the employment of influenza A diagnostics with samples from eye swabs, even though the CDC and public health laboratories are authorized to do so. It is noteworthy that this year, detection of the avian influenza virus in an agricultural worker stemmed exclusively from an eye swab, not from nasal or pharyngeal samples.

Eliminating such obstructions is crucial, Chu asserted, to extend influenza A diagnostics in regions heavily populated with livestock. “The most substantial gain can be achieved by normalizing these tests at clinics catering to communities of farm employees,” she asserted, and recommended transient diagnostic centers at state fairs as well.

Meanwhile, cutting-edge diagnostics that specifically recognize the H5N1 pathogen could be swiftly developed. The current CDC diagnostic lacks sensitivity and is not user-friendly, as noted by researchers.

Stanford, the University of Washington, the Mayo Clinic, and other diagnostic laboratories serving hospital networks have devised alternative methods for detecting the currently circulating virus. Yet, their influence is finite, and researchers underline the urgency to invigorate additional capacity for diagnostics before a calamity emerges.

“How do we ensure that if this turns into a public health urgency, we are not stranded in the initial stages of Covid, where prompt actions were hampered?” Pinsky queried.

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latest regulation granting the FDA expanded supervision over laboratory-crafted tests could impede the approval process. In a communication to KFF Health News, the FDA mentioned that, temporarily, it might permit the continuation of tests without undergoing the complete approval procedure. The CDC has yet to offer any remarks.

The American Clinical Laboratory Association has sought clarification on the updated regulation from both the FDA and the CDC. “The situation is being exacerbated by the additional uncertainty over permissible actions,” declared Susan Van Meter, the head of the medical laboratory organization.

Companies like Labcorp and Quest Diagnostics, alongside other prominent testing firms, are ideally suited to handle a spike in test demand as they have the capacity to analyze hundreds of samples daily, rather than just scores. Adapting test procedures to fit their sophisticated machinery is a process that requires both time and financial resources, asserted Matthew Binnicker, who directs clinical virology at the Mayo Clinic.

“The last few years have seen only a small number of H5N1 cases in humans,” he remarked, “which makes it challenging for them to invest heavily with the future being so uncertain.”

The government could endorse the necessary research through funding, or agree to acquire tests in large quantities, akin to the strategy used by Operation Warp Speed to promote the development of Covid vaccines.

“Scaling up would necessitate a significant financial commitment,” stated Kelly Wroblewski, who leads infectious disease initiatives at the Association of Public Health Laboratories. She views the upfront cost as a modest safeguard when measured against the potential fiscal havoc wrought by a fresh pandemic.

Alternate methods for monitoring the H5N1 strain are also vital. Observing antibodies to avian influenza in agricultural workers could unveil a greater number of past infections. Moreover, scouring wastewater for traces of the virus might signal a rising infection rate among humans, poultry, or livestock.

According to Greninger, the overarching problem within pandemic readiness is emphasizing the importance of preemptive action before an emergency emerges.

“It’s crucial to be prepared,” he advocated, “yet until the government mitigates some of the risks involved, it’s difficult to initiate such measures.”

KFF Health News is a premier national news outlet that creates thorough reporting on health topics and is one of the principal functions of KFF — a nonpartisan foundation for health policy study, surveys, and reporting.

Originally, this article appeared on NBCNews.com

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