Molecular diagnostics using the QIAstat-Dx syndromic device for covering avian influenza pandemic preparedness.

Introduction: A key factor in influenza pandemic preparedness is the ability to detect zoonotic influenza virus strains as they emerge in humans through spillover events, ideally before human-to-human transmission occurs. Design: In this study, the utility of the QIAstat-Dx syndromic device for influenza surveillance was evaluated. Bioinformatic analysis was performed on all WHO-recommended influenza Candidate Vaccine Viruses (CVVs), including the common strains recommended for the 2023-2024 influenza vaccine composition in the northern hemisphere, and 16 different H5 highly pathogenic avian influenza virus (HPAIV) and two H9N2 low pathogenic avian influenza virus (LPAIV) strains. For laboratory validation, engineered gene fragments and real HPAIV and LPAIV samples were tested using the QIAstat-Dx Respiratory SARS-CoV-2 Panel. Results: During the bioinformatic screening, common influenza strains were positive including influenza A subtypes, and all H5 HPAIV and LPAIV H9N2 were detected as Influenza A positive without subtype discrimination. In all cases, laboratory validation confirmed all bioinformatic results. Conclusion: QIAstat-Dx can detect all tested potentially zoonotic influenza A virus strains, and discriminate them from human sesonal influenza A viruses, ensuring a correct diagnosis. Any tool available for surveillance and pandemic preparedness is essential for a rapid response to reduce healthcare costs and severity of future influenza pandemics.