In a major step toward improving disease surveillance, the European Union has developed two new digital RT-PCR tests capable of detecting highly pathogenic avian influenza A (H5N1) with exceptional precision. These tests, created by the European Commission’s Joint Research Centre (JRC) in collaboration with Sciensano (Belgium), Istituto Superiore di Sanità (Italy), and the EU Reference Laboratory for Avian Influenza, are designed to identify both specific clade 2.3.4.4b H5Nx viruses and a broader range of influenza A strains.
The digital RT-PCR assays offer a significant upgrade over conventional methods.
They can detect trace amounts of viral RNA and differentiate between seasonal flu and the dangerous H5Nx strains in a single test.
This is particularly valuable given the virus’s rapid spread among poultry and its recent detection in mammals such as cows and cats.
One of the most innovative features of these tests is their ability to analyze wastewater samples. This allows for early environmental detection, supporting the EU’s revised Urban Wastewater Treatment Directive, which now includes influenza viruses as surveillance targets.
The development of these assays was accelerated using a computational workflow previously applied to COVID-19 diagnostics. By analyzing thousands of viral sequences, researchers identified conserved genetic regions unique to the H5Nx clade, enabling fast and accurate detection.
These advancements come at a critical time.
The 2024–2025 epidemic season began earlier than expected, with outbreaks reported in migratory birds as early as September 2024.
The EU has responded with enhanced surveillance, strict biosecurity measures, and updated legislation, including Delegated Regulation (EU) 2020/689 and Regulation (EU) 2022/2371, which mandate comprehensive monitoring and rapid response to outbreaks.
Vaccination is also being considered as a preventive tool. Under Delegated Regulation (EU) 2023/361, Member States may implement vaccination plans, provided they meet strict monitoring and reporting requirements.
The new tests are now available to laboratories across the EU, reinforcing the bloc’s preparedness against cross-border health threats. By enabling faster and more accurate detection, these tools not only protect public health but also help stabilize the poultry industry, which has faced severe disruptions due to mass culling and rising egg prices.
