Recommended reporting standards for test accuracy studies of infectious diseases of finfish, amphibians, molluscs and crustaceans: the STRADAS-aquatic checklist

Abstract

Complete and transparent reporting of key elements of diagnostic accuracy studies for infectious diseases in cultured and wild aquatic animals benefits end-users of these tests, enabling the rational design of surveillance programs, the assessment of test results from clinical cases and comparisons of diagnostic test performance. Based on deficiencies in the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines identified in a prior finfish study (Gardner et al. 2014), we adapted the Standards for Reporting of Animal Diagnostic Accuracy Studiesparatuberculosis (STRADAS-paraTB) checklist of 25 reporting items to increase their relevance to finfish, amphibians, molluscs, and crustaceans and provided examples and explanations for each item. The checklist, known as STRADAS-aquatic, was developed and refined by an expert group of 14 transdisciplinary scientists with experience in test evaluation studies using field and experimental samples, in operation of reference laboratories for aquatic animal pathogens, and in development of international aquatic animal health policy. The main changes to the STRADAS-paraTB checklist were to nomenclature related to the species, the addition of guidelines for experimental challenge studies, and the designation of some items as relevant only to experimental studies and ante-mortem tests. We believe that adoption of these guidelines will improve reporting of primary studies of test accuracy for aquatic animal diseases and facilitate assessment of their fitness-forpurpose. Given the importance of diagnostic tests to underpin the Sanitary and Phytosanitary agreement of the World Trade Organization, the principles outlined in this paper should be applied to other World Organisation for Animal Health (OIE)-relevant species.

To pool or not to pool? Guidelines for pooling samples for use in surveillance testing of infectious diseases in aquatic animals

“…Both Gardner et al () and Laurin et al () discuss some of these factors in more detail at the DSe level. In the following subsections, we discuss the broad categories of these guidelines in more detail and provide examples of impacts on interpretation of DSe for pooled versus individual samples, highlighting areas that could lead to biased or incomplete interpretation of diagnostic accuracy estimates, and suggesting either mitigation strategies, statistical adjustments or the direction of any inherent bias that might affect interpretation and reporting of PSe results.…”

“…DFO, ; Tavornpanich et al, ). Therefore, transparent reporting (see Gardner et al, , and Laurin et al, ) of standard operating procedures (SOP) for pooling will help facilitate meta‐analyses and comparative studies.…”

“…Figure 2, it is critical that researchers clearly answer the following questions (in italics) prior to using pooled samples, as PSe will be affected by variations in these factors. Both Gardner et al (2016) and Laurin et al (2018) discuss some of these factors in more detail at the DSe level. In the following subsections, we discuss the broad categories of these guidelines in more detail and provide examples of impacts on interpretation of DSe for pooled versus individual samples, highlighting areas that could lead to biased or incomplete interpretation of diagnostic accuracy estimates, and suggesting either mitigation strategies, statistical F I G U R E 2 Decision tree of recommended guidelines for using pooling techniques for diagnostic test evaluation and surveillance studies of infectious diseases in aquatic animals.…”

Diagnostic validation of three test methods for detection of cyprinid herpesvirus 3 (CyHV-3)

“…All items from the STRADAS-aquatic checklist (Gardner et al 2016) applied to this study except for STRADAS items 7, 17, 19, 20 and 23 Participating laboratories Three laboratories participated in the precision study ( Fig. 1).…”

“…diagnostic sensitivity [DSe] and diagnostic specificity [DSp]) were generated in subsequent phases. The results are reported according to the Standards for Reporting of Animal Diagnostic Accuracy (STRA -DAS)-aquatic (Gardner et al 2016). …”