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BCA - National diagnostic tests for the detection of Epizootic haematopoietic necrosis virus (EHNV) and certification of EHNV-free fish

Project number: 1992-066.80
Project Status:
Completed
Budget expenditure: $4,394.73
Principal Investigator: Gerry Geen
Organisation: CSIRO Australian Animal Health Laboratory
Project start/end date: 30 Oct 2000 - 1 Jan 2009
Contact:
FRDC

Objectives

1. Select optimum EHNV detection protocols and establish these as national tests
2. Investigate the use of inactivated antigen in antigen capture ELISAs which would facilitate the distribution of the diagnostic tests
3. Use diagnostic tests to determine the minimum sampling sizes and types of samples required for disease-free certification of commercial stocks
4. Optimise immunological tests that detect EHNV and anti-EHNV antibodies, from field animals
5. Identify tissues/organs within host organisms where the virus replicates
6. Differentiate the major strains of Australian iridoviruses

National diagnostic tests for the detection of Epizootic haematopoietic necrosis virus (EHNV) and certification of EHNV-free fish

Project number: 1992-066
Project Status:
Completed
Budget expenditure: $367,578.00
Principal Investigator: Alex Hyatt
Organisation: CSIRO Australian Animal Health Laboratory
Project start/end date: 8 Feb 1993 - 20 Nov 1996
Contact:
FRDC

Objectives

1. Select optimum EHNV detection protocols and establish these as national tests
2. Investigate the use of inactivated antigen in antigen capture ELISAs which would facilitate the distribution of the diagnostic tests
3. Use diagnostic tests to determine the minimum sampling sizes and types of samples required for disease-free certification of commercial stocks
4. Optimise immunological tests that detect EHNV and anti-EHNV antibodies, from field animals
5. Identify tissues/organs within host organisms where the virus replicates
6. Differentiate the major strains of Australian iridoviruses
Environment
PROJECT NUMBER • 2004-217
PROJECT STATUS:
COMPLETED

Aquafin CRC - Atlantic Salmon Aquaculture Subprogram: development of an AGD vaccine: phase II

Amoebic gill disease (AGD) is considered to be the most significant health problem for farmed Atlantic salmon in Tasmania, costing the industry an estimated $15-20 million pa. It is caused by the presence of Neoparamoeba spp. on the gills and if untreated can lead to death. Although some control of...
ORGANISATION:
CSIRO Australian Animal Health Laboratory

Design standards for experimental and field studies to evaluate diagnostic accuracy of tests for infectious diseases in aquatic animals

Project number: 2015-045
Project Status:
Completed
Budget expenditure: $24,000.00
Principal Investigator: Mark S. Crane
Organisation: CSIRO Australian Animal Health Laboratory
Project start/end date: 31 May 2016 - 30 Mar 2017
Contact:
FRDC

Need

In aquatic animals, experimental studies are often used to study the pathogenicity of an etiologic agent; to study interactions between the host, pathogen, and environment; and to evaluate the comparative performance of existing and novel diagnostics. In the latter case, specimens are sometimes collected from animals at different stages of infection post-challenge to demonstrate temporal changes in diagnostic sensitivity post-challenge. Diagnostic accuracy studies should be designed to assess a test’s fitness for a designated purpose, and the design should also inform reporting in peer-reviewed journals. Reported studies should include clear descriptions of purpose and intended application, and authors should discuss the limitations of their results in the context of other available or currently-used tests to facilitate informed decisions by end-users. In human medical research, standards exist for various aspects of diagnostic test research, including guidelines for accurate and transparent reporting and for quality assessment of methodologies in systematic reviews of diagnostic-accuracy studies. Similar standards are required for animal, including aquatic animal, research. It is anticipated that the established criteria, from human clinical research for evaluating diagnostic accuracy studies, can be adapted to develop a standardized set of criteria for the design of field and experimental studies to assess diagnostic accuracy for infectious diseases in aquatic animals.

Objectives

1. Evaluate (a) design criteria reported for diagnostic studies of OIE-listed diseases of finfish, molluscs and crustaceans and (b) test design and accuracy recommendations from OIE, peer-reviewed literature in aquatic animal health and other sources (e.g. aquatic animal health experts).
2. Develop a list of gaps or inconsistencies in current design criteria and reporting for OIE-listed diseases in aquatic species, based on collected recommendations from Objective 1.
3. Compile consensus-based standards in an applicable format for diagnostic studies in finfish, molluscs and crustaceans for use by research journals and laboratories.

Final report

ISBN: 978-1-4863-1280-1
Authors: Mark St. J. Crane Peter G. Mohr Nick J. G. Moody
Final Report • 2019-06-01 • 433.17 KB
2015-045-DLD.pdf

Summary

Design and reporting quality are important parameters for assessing aquatic animal studies on diagnostic test sensitivity and specificity however standards for experimental design are lacking. As part of this study, design guidelines to improve the quality of published studies on test specificity and sensitivity on natural disease events well as experimental infectivity trials.

Thus important metrics for consideration at the design phase of diagnostic accuracy studies (DAS) include study purpose, targeted disease state (clinically diseased vs infected but apparently healthy), selection of appropriate samples and specimens, laboratory analytical methods, statistical methods and data interpretation. Implementing standards for designing DAS will assist in appropriate test selection for specific testing purposes and minimize the risk of reporting biased estimates of diagnostic sensitivity and specificity. In addition, with respect to pool-level sensitivity, using the developed protocols in DAS will ensure that the effect of pooling samples for the specified disease agents and hosts on diagnostic sensitivity will be clearly defined.
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