Manual of Diagnostic Tests for Aquatic Animals
The World Organisation for Animal Health (OIE) is an intergovernmentalorganisation that was established to promote world animal health.The main activities of the organisation, which was established in1924, and in 2015 comprised 180 Member Countries, are as follows:
To ensure transparency in the global terrestrialand aquatic animal disease situation.
To collect, analyse and disseminate veterinary scientificinformation.
To provide expertise and encourage international solidarityin the control of animal diseases.
Within its mandate under the WTO (World Trade Organization)Agreement on Sanitary and Phytosanitary Measures (SPS Agreement),to safeguard world trade by publishing health standards for internationaltrade in animals and animal products.
To improve the legal framework and resources of nationalVeterinary Services and relevant Competent Authorities
To provide a better guarantee of the safety of food of animalorigin and to promote terrestrial and aquatic animal welfare througha science-based approach.
Diagnostic procedures for some aquatic animal diseases used tobe included in the OIE International AnimalHealth Code (1986 edition), but it became clear that separatepublications specific to aquatic animal health were needed. The reasonsare that many aspects of the conditions, problems and requirementsin aquaculture environments are different from those encounteredin terrestrial animals. Also, as international production and tradein aquatic animals and their products is intensifying and increasingin importance, more diseases are being included in the OIE Aquatic Animal Health Code (Aquatic Code).
The purpose of this Manual of DiagnosticTests for Aquatic Animals (AquaticManual) is to provide a uniform approach to the detectionof the diseases listed in the OIE AquaticCode, so that the requirements for health certificationin connection with disease prevention and control programmes, andtrade in aquatic animals and aquatic animal products can be met.
Although many publications exist on the detection and controlof aquatic animal diseases, the AquaticManual is a key and unique document describing the methodsthat should be applied to the OIE-listed diseases in aquatic animalhealth laboratories all over the world, thus increasing efficiencyand promoting improvements in aquatic animal health world-wide.The requirements published in this AquaticManual are recognised as international standards by theWTO.
The task of compiling the Aquatic Manual wasassigned to the OIE Aquatic Animal Health Standards Commission (AquaticAnimals Commission) by the World Assembly of Delegates (of OIE MemberCountries). The Aquatic Animals Commission, elected every 3 yearsby the World Assembly, was greatly assisted by invited contributionsfrom leading experts in the field. All the draft chapters were circulatedto OIE Member Countries, together with selected expert reviewersfor comment and revision. The Aquatic Manual willbe continually revised and updated as new information on aquaticanimal diseases in general, and new emerging diseases in particular,becomes available. It is intended to publish a new edition every4 years from 2014; intermittent changes will be available as soonas possible following adoption on the OIE Web site.
Valid laboratory results are essential for Aquatic Animal HealthServices to implement a range of programmes for diagnosis, surveillanceand trade. This Manual of Diagnostic Testsfor Aquatic Animals (Aquatic Manual)supports Aquatic Animal Health Services to provide effective laboratorytesting for pathogenic agents that may adversely affect aquaticanimals.
Section 1 of the Aquatic Manual providesrecommendations on general provisions required to support effective laboratorytesting capability. Chapter 1.1 outlines the important issues andconsiderations a laboratory should address in the design and maintenanceof its quality management system, whether or not it has been formallyaccredited. The chapter's recommendations cover technical, managerialand operational elements of testing, and the interpretation of testresults. Chapter 1.2 provides recommendations on the principlesand methods for validating diagnostic assays. Validation is essentialto ensure an assay is fit for its intended purpose, such as demonstratingfreedom from disease, or confirming diagnosis of clinical casesor estimating patterns of infection in a population. The chapterpresents a staged approach to assay validation that includes guidanceon analytical performance, diagnostic performance, reproducibility, assaydeployment and ongoing monitoring.
Section 2 of the Aquatic Manual providesrecommendations for diagnosis of specific diseases of amphibians, crustaceans,fish and molluscs. The disease-specific chapters in Section 2 coverall OIE listed diseases of aquatic animals. Some additional chaptersare included for diseases that are no longer listed by the OIE.These chapters have been retained in the AquaticManual at the request of OIE Member Countries because oftheir importance for trade or productivity. Each disease-specificchapter follows a similar format with information provided on thedisease (agent factors, host factors, disease patterns, controland prevention), sampling, diagnostic methods, ratings of the recommendedtests against their purpose of use, recommended tests for surveillanceto declare freedom, and definitions of suspect and confirmed cases.
The general provisions and disease-specific recommendations ofthe Aquatic Manual together providetechnical information to support implementation of standards containedin the OIE Aquatic Animal Health Code (Aquatic Code). These standards includeMember Countries' obligations to report the occurrence of listeddiseases; requirements to demonstrate freedom for a country, zoneor compartment; requirements for responding to the occurrence ofa disease; and requirements to return to freedom following a diseaseoutbreak. The recommendations in the AquaticManual and the Aquatic Code areintended to be complementary and both documents should be used togetherwhen developing or undertaking surveillance activities in accordancewith OIE Standards.
Nucleic-acid-based detection methods are described for all diseasesincluded in the Aquatic Manual. Therehas been a rapid growth in the use of molecular methods for aquaticanimal diseases because, compared with many traditional methods,they are more rapid, sensitive, cost effective, and may not relyon highly specialised personnel. Molecular methods are particularlyimportant in circumstances where some traditional methods are notavailable; for example, virus isolation in cell culture is not availablefor molluscs and crustaceans because of the lack of suitable celllines. Despite the obvious importance of molecular methods, it isessential that their limitations are understood and that they areused appropriately as part of a complete diagnostic investigation.In this regard, the case definitions in Section 7 of each disease-specificchapter should be followed closely to ensure the diagnostic approachused is able to satisfy the definitions of a suspect or confirmedcase.
Commercial kits are becoming increasingly available for aquaticanimal disease diagnosis. The use of commercial kits is only acceptableif they have been validated as fit for their intended purpose. TheOIE provides guidance on the suitability of specific commercialkits through the Register of diagnostic kits certified by the OIEas validated as fit for purpose. Commercial kits included in theregister have been evaluated in accordance with the Procedure forOIE Registration of Diagnostic Kits. The register is available onlineat: https://www.oie.int/en/our-scientific-expertise/certification-of-diagnostic-tests/the-register-of-diagnostic-tests/
The information presented in the AquaticManual has been prepared under the guidance of the AquaticAnimal Health Standards Commission with expertise provided by OIEReference Laboratories and Collaborating Centres. All recommendationsof this Aquatic Manual have beenadopted by the World Assembly of Delegates of the OIE and, as such,represent internationally agreed standards. The final version ofeach adopted chapter is the product of extensive consultation andcomment by OIE Member Countries. A list of the primary contributorsfor each chapter can be found in the next section of this Aquatic Manual.
Methods for diagnosis of aquatic animal diseases are evolvingrapidly. Individual chapters of the AquaticManual are updated regularly to take account of the latestscientific findings and technological developments. Any revisedchapters are provided to the Assembly for adoption in May each yearand, if adopted, will be published on the OIE website soon after.Users of this manual are encouraged to check the OIE website forthe most recently adopted chapters. These are clearly marked bytheir year of adoption.
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Quality management in veterinary testing laboratories
Principles and methods of validation of diagnosticassays for infectious diseases
Recommandations applicable to specific diseases
Diseases of amphibians
Infection with Batrachochytriumdendrobatidis
Infection with ranavirus
Diseases of crustaceans
Crayfish plague (Aphanomyces astaci)
Infection with yellow head virus genotype 1
Infectious hypodermal and haematopoietic necrosis
White spot disease
White tail disease
Spherical baculovirosis (Penaeusmonodon-type baculovirus)
Tetrahedral baculovirosis (Baculoviruspenaei)
Diseases of fish
Epizootic haematopoietic necrosis
Infection withAphanomycesinvadans (epizootic ulcerative syndrome)
Infection with Gyrodactylussalaris
Infectious haematopoietic necrosis
Infection with infectious salmon anaemia virus
infection with salmonid alphavirus
Koi herpesvirus disease
Red sea bream iridoviral disease
Spring viraemia of carp
Viral haemorrhagic septicaemia
Oncorhynchus masou virusdisease
Viral encephalopathy and retinopathy
Diseases of molluscs
Infection with abalone herpesvirus
Infection with Bonamia exitiosa
Infection with Bonamia ostreae
Infection with Marteilia refringens
Infection with ostreid herpesvirus 1 microvariants
Infection with Perkinsus marinus
Infection with Perkinsus olseni
Infection with Mikrocytos mackini