Diagnostics of Plant Pests .pptVIP

Laboratory Diagnostics for Plant Pathogens of Regulatory Concern A National Laboratory Accreditation and Certification System Phil Berger National Science Program Leader - Molecular Diagnostics Biotechnology USDA APHIS PPQ Center for Plant Health Science Technology NPDN Linkages NPDN Critical System Requirements Validated Diagnostics Plant Diagnostic Information System Information Management (Alerts) Data Security, Analysis, and Flow Training Scenario Exercises Multidisciplinary Scientific Expertise Cross-ties to Other Networks Linkage with APHIS VS National Seed Health System (ASTA) FDA (ISO 17025) International Regulatory Agency Contacts EPPO, NAPPO, CFIA, DEFRA, IPPC Other (NBIS) Challenges to the NPDN Diversity and Numbers of Crops, Pests, Pathogens, Production Systems Over 1 billion Acres of crops, forage and forest Biology, Epidemiology Response and Recovery Threat Awareness Technology…“State of the Art” ID/Diagnostic Challenges Symptoms frequently not definitive Morphology of pathogens Immunology (ELISA) Molecular diagnostics (PCR) Biochemical analyses Culture Knowledge base (something new different) Meeting the Challenges Validated Diagnostics Laboratory Accreditation Certification, Proficiency Testing Permits Harnessing New Technology Roles Responsibilities (NPDN ? Regulatory Agencies) Offshore Pest Information Systems Information Technologies Working Definitions ? Accreditation: The determination that a laboratory is capable of performing competent diagnoses. ? Certification: The determination that a laboratory has undergone training, method validation, and quality assurance procedures for a specific diagnostic method. ? Assay: a quantitative or qualitative test of a substance (especially an ore or a drug) to determine its components; frequently used to test for the presence or concentration of infectious agents or antibodies etc. ? Proficiency: competence in something, or knowledge of it. . ? Validation: Assay validation is a p