NEW YORK – Diagnostics nonprofit FIND said Thursday that human infections with H5N1 avian influenza may be going undetected in the absence of tests that are specific for the influenza subtype and public health authorities could miss the window to contain any outbreaks.
The organization noted that H5N1 influenza infections have proven to cause severe disease and death in humans, but there are no commercially available testing methods to distinguish it from other influenza subtypes. The virus has become widespread among wild birds and has caused outbreaks among poultry and US dairy cattle.
FIND Board Member Rick Bright, who was the director of the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority until 2020, said in a statement that quality diagnostics are the first line of defense against widespread disease transmission.
"Having just come out of the worst pandemic in a century, the lack of surveillance and investment into R&D of diagnostics, treatments, and vaccines is not only shocking but negligent," he said.
FIND and the World Health Organization said three weeks ago that they had formalized a partnership to hasten innovation and access to diagnostics, and FIND officials noted at the time that three US dairy workers had become infected with H5N1 avian influenza through spillover events in the prior month.
The WHO also reported in April that about 900 people in 23 countries have had confirmed H5N1 infections since 2003 and about half of those with confirmed infections had died. However, FIND officials said that the true case mortality rate may be lower since infections likely have been underreported and underdiagnosed in the absence of commercially available diagnostic tests that can distinguish H5N1 influenza from other subtypes.
FIND said that while the WHO has determined that the risk of human-to-human H5N1 transmission is low, the organizations are jointly monitoring the market for influenza tests and developing use cases and target product profiles for the tests that are needed. FIND also plans to soon begin evaluating the performance of existing tests for the identification of H5N1 infections.
FIND officials said that rapid antigen tests that can provide a result in about 10 to 15 minutes are a critical tool for outbreak containment, as was shown during the COVID-19 pandemic. However, the rapid tests that are available today do not distinguish influenza subtypes and cannot be used to identify H5N1 infections.
The nonprofit organization also said that it recommends enhanced global surveillance of bird and animal populations to detect H5N1 transmission and mutations, investments into accurate and accessible rapid tests for highly pathogenic avian influenza subtypes, global collaborations to ensure that manufacturing capabilities could meet global demand for tests, and regular updates to countries' pandemic preparation and response plans.
"Without comprehensive diagnostics for H5N1, we are pirouetting on the edge of a volcano that is about to erupt," FIND Board Chair Ayoade Alakija said in a statement. "The absence of surveillance means we're increasing the potential of missing the window to contain outbreaks like H5N1 before they escalate into full-blown pandemics."