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Quads experience towards international harmonisation of methods development and validation procedures for regulatory purposes


<div><span lang="EN-AU"><span face="Calibri" style="font-family:Calibri;" size="3">The Quadrilateral Scientific Collaboration in Plant Biosecurity (Quads) Molecular Diagnostics Working Group is part of a scientific collaboration in plant biosecurity between the Australia, Canada, New Zealand and USA focused on the development of diagnostic protocols, and associated laboratory requirements and processes. This Collaboration provides a framework for scientific cooperation regarding plant protection, including: phytosanitary issues; identifying and sharing diagnostic tools and technologies; quality assurance and control methods; and developing common language and best practices not covered by other organisations. To facilitate harmonisation of diagnostic standards the working group has generated guidelines for method acceptance, a compendium of diagnostic methods from the four participating countries, and a guidance paper on proficiency testing. These items developed and shared between the countries highlight the importance of Quads activities. The application of Next Generation Sequencing (NGS) as a diagnostic tool is identified as both an opportunity and a challenge for diagnostic laboratories. A framework for the application of NGS as a diagnostic tool has been generated by the working group. It has been recognized that the absence of guidelines for the interpretation of NGS data sets by researchers, diagnosticians and regulators required to inform policy makers could adversely impact biosecurity. Activities in this space at a global level will be discussed. </span></span></div>