The Diagnostics Development Hub (DxD Hub), a national platform hosted by the Agency for Science, Technology and Research (A*STAR), Singapore, in collaboration with the National Institute of Environmental Studies (NIES), Japan and A*STAR The Institute of Bioinformatics (A*STAR BII), successfully developed Steadfast, an advanced diagnostic kit for the detection of the highly pathogenic H5N1 avian influenza virus (AIV). This development marks a major advance in bird flu surveillance, bolstering global pandemic preparedness efforts.
Steadfast not only offers rapid detection of H5N1 highly pathogenic avian influenza virus (AIV), but also distinguishes between highly pathogenic avian influenza (HPAI) and low pathogenic avian influenza (LPAI) strains, which are both critical to effective control measures. Unlike conventional sequencing methods, which take two to three days for results, this kit can detect HPAI H5 strains (H5N1, H5N5, H5N6) in just three hours. This rapid detection is vital to monitor migratory birds, provide early warnings and enhance biosecurity in poultry facilities.
HPAI strains, which are highly lethal and spread throughout the poultry body, require immediate culling of affected flocks to prevent serious outbreaks. In contrast, LPAI strains are confined to the respiratory and gastrointestinal tract and cause mild symptoms, allowing for less aggressive measures such as enhanced surveillance and biosecurity. By enabling faster identification of the specific strain, the kit enables more accurate and timely responses, significantly reducing the risks of transmission and helping to prevent potentially devastating outbreaks.
Highly pathogenic H5N1 AIV is widely transmitted by birds, especially poultry, through direct contact, contaminated surfaces, or contaminated feces. Migratory wild birds often carry the virus long distances, spreading it to domestic poultry populations, where it can cause serious outbreaks. Once infected, poultry act as reservoirs, potentially transmitting the virus to other birds and, in rare cases, to humans in close contact. Despite limited human transmission, H5N1 remains a critical global concern due to its high mortality rate and potential for mutation.
DxD Hub played a key role in the development of the prototype multiplex assay test kits, including the design and development of avian clinical trial protocols, data analysis and assay optimization. Validated by NIES, Japan’s main laboratory for avian influenza testing in wild birds, the kit accurately classified avian influenza viruses detected in wild birds in Japan between 2022 and 2024 as high or low pathogenicity . A*STAR BII provided bioinformatics expertise in the analysis of virus sequence, structure and evolution, supporting the integration of PCR diagnostics as a timely, cost-effective adjunct to genomic surveillance. This allowed for more effective detection and monitoring of ongoing H5N1 outbreaks. This close collaboration between the DxD Hub, NIES and A*STAR BII has been instrumental in improving the functionality of the diagnostic kit and ensuring its effectiveness in detecting HPAI and LPAI strains in real-world clinical and field applications. This highlights the success of joint efforts to improve detection and control measures for avian influenza, helping to limit the spread of the virus and protect public health.
“DxD Hub is pleased to have collaborated with global ecosystem partners such as NIES and A*STAR BII to develop the H5N1 Avian Influenza Diagnostic Kit. This achievement reflects our shared commitment to strengthening of zoonotic disease surveillance and pandemic preparedness,” said Dr. Weng Ruifen. , CEO of DxD Hub.
“The highly pathogenic avian influenza virus has caused mass mortality in chickens and wild birds not only in Japan but worldwide. Recently, infections have been confirmed in seals, cats, cattle, and even from cattle to humans, drawing attention as a possible next pandemic Such events highlight the rapid mutation of the virus, emphasizing the importance of establishing an effective surveillance system and detection methods that can be directly adapted to the mutation of the virus to prevent the spread of infection The kit developed in our joint project meets this demand and its widespread use is expected to alleviate public anxiety and allow a more flexible response to the spread of contamination,” said Dr ONUMA Manabu, Head of the NIES Biodiversity Resource Conservation Office.
A*STAR BII is pleased to be part of this joint effort and support the development of this advanced AIV diagnostic kit by lending our expertise in viral bioinformatics. Viral genomes evolve extremely rapidly and often silently, resulting in rapid and accurate -? through more demanding surveillance and rapid detection – critical to containing potential infectious disease outbreaks and minimizing zoonotic spills. With this kit, we can better protect food security, public health and economic stability in Singapore and around the world.”
Dr. Sebastian Maurer-Stroh, Executive Director of A*STAR BII
