DNA Based Molecular Diagnostic Techniques : Research Needs for Standardization and Validation

Contents: 1. Background. 2. Expert workshop. 3. Pathogen focus group reports. 4. Issues relating to the adoption of international standards for disease diagnosis and health certification. 5. Key outcomes and recommendations. 6. References. 7. Contributed papers and reviews: i. Technological constraints to disease prevention and control in aquatic animals with special reference to pathogen detection/Sharon MCGladdery. ii. The absolute requirement for predictive validation of non-culture based detection techniques/Maura Hiney. iii. Evaluation of diagnostic tests: the epidemiological approach/Daniel F. Fegan. iv. DNA-based diagnostic and detection methods for penaeid shrimp viral diseases/Donald V. Lightner. v. Practical problems with PCR detection in Asia: the importance of Standardization/M. Shariff, S. Soon, K.L. Lee and L.T. Tan. vi. Application of polymerase chain reaction for detection of shrimp pathogens in India/Indrani Karunasagar. vii. Viral genetic variation: implications for disease diagnosis and detection of shrimp pathogens/Peter J. Walker and Jeff A. Cowley. viii. The need for molecular tools in the study of mollusc pathogens/P.M. Hine. ix. Development and validation of DNA-based diagnostic techniques with particular reference to Bivalve Mollusc pathogens/Franck C.J. Berthe. x. Molecular diagnostics for the Oyster Pathogens Haplosporidium Nelsoni (Msx disease) and Perkinsus marinus (Dermo disease) in Chesapeakebay, Virginia, USA/Eugene M. Burreson. xi. Rapid detection and identification of fish pathogens/Alexandra Adams. xii. DNA-based studies on Aphanomyces Invadans, the fungal pathogen of Epizootic Ulcerative Syndrome (EUS)/James H. Lilley and Supranee Chinabut. xiii. Importance of standardisation and validation of molecular diagnostic techniques for aquatic animal pathogens and diseases for international trade and trans-boundary movement of aquatic animals and animal products/Barry J. Hill. Annex-1 - list of participants.

"In efforts to limit transboundary movement of pathogens and reduce the economic and socioeconomic impact of disease in aquaculture, there is considerable scope for more effective use of DNA-based methods of pathogen detection. These technologies offer rapid results with potentially high sensitivity and specificity, at relatively low cost. However, few, if any, of the available tests have been assessed appropriately against other diagnostic methods or standardized and validated for specified applications. Implementation of standardized practices that produce reliable, useful and comparable data will require a significant investment in research, training and infrastructure development. This review recommends the development of programmes of managed cooperative research to assist more effective use of DNA-based detection tests, focusing on improving the knowledge base by identification of new and emerging pathogens, relating pathogens in the Asia region to those described elsewhere, and defining the extent of genetic variation between related pathogens. The review also recommends the development of a laboratory accreditation programme in order to achieve standardization of sampling methods and test procedures complementary to the activities of the International Office of Epizootics (OIE) in obtaining internationally agreed test standards for molecular diagnostic technologies."