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