Revue Scientifique Et Technique (International Office Of Epizootics)[JOURNAL]
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200 papers
Sustainable Development Goals and livestock systems.
Schneider F, Tarawali S
Rev Sci Tech · 2021 Aug · PMID 34542093 · Publisher ↗
Within the framework of the Sustainable Development Goals (SDGs) of the United Nations, particularly those that livestock impact most significantly (SDGs 1, 2, 3, 5, 8, 12, 13, 15 and 17), this paper provides an overview...
Within the framework of the Sustainable Development Goals (SDGs) of the United Nations, particularly those that livestock impact most significantly (SDGs 1, 2, 3, 5, 8, 12, 13, 15 and 17), this paper provides an overview of the livestock sector's impact on food system sustainability and opportunities for building solutions through sustainable livestock options that are supported by robust animal health services. The discourse is shaped by the experiences of the Global Agenda for Sustainable Livestock, a multi-stakeholder partnership which facilitates policy dialogue and action among diverse stakeholders to make livestock systems more sustainable. The Global Agenda for Sustainable Livestock adopted the aforementioned SDGs as the reference framework for its actions, which are organised under four domains (food and nutrition security, animal health and welfare, livelihoods and economic growth, and climate and natural resources). These domains are used to highlight the complexity and diversity of the livestock sector, its positive and negative relationships to development, the integral roles of animal health systems and the opportunities for livestock sector contributions towards a sustainable future.
Global Burden of Animal Diseases: a novel approach to understanding and managing disease in livestock and aquaculture.
Huntington B, Bernardo TM, Bondad-Reantaso M … +17 more , Bruce M, Devleesschauwer B, Gilbert W, Grace D, Havelaar A, Herrero M, Marsh TL, Mesenhowski S, Pendell D, Pigott D, Shaw AP, Stacey D, Stone M, Torgerson P, Watkins K, Wieland B, Rushton J
Rev Sci Tech · 2021 Aug · PMID 34542092 · Publisher ↗
Investments in animal health and Veterinary Services can have a measurable impact on the health of people and the environment. These investments require a baseline metric that describes the burden of animal health and we...
Investments in animal health and Veterinary Services can have a measurable impact on the health of people and the environment. These investments require a baseline metric that describes the burden of animal health and welfare in order to justify and prioritise resource allocation and from which to measure the impact of interventions. This paper is part of a process of scientific enquiry in which problems are identified and solutions sought in an inclusive way. It poses the broad question: what should a system to measure the animal disease burden on society look like and what value would it add? Moreover, it aims to do this in such a way as to be accessible by a wide audience, who are encouraged to engage in this debate. Given that farmed animals, including those raised by poor smallholders, are an economic entity, this system should be based on economic principles. These poor farmers are negatively impacted by disparities in animal health technology, which can be addressed through a mixture of supply-led and demand-driven interventions, reinforcing the relevance of targeted financial support from government and non-governmental organisations. The Global Burden of Animal Diseases (GBADs) Programme will glean existing data to measure animal health losses within carefully characterised production systems. Consistent and transparent attribution of animal health losses will enable meaningful comparisons of the animal disease burden to be made between diseases, production systems and countries, and will show how it is apportioned by people's socio-economic status and gender. The GBADs Programme will produce a cloud-based knowledge engine and data portal, through which users will access burden metrics and associated visualisations, support for decisionmaking in the form of future animal health scenarios, and the outputs of wider economic modelling. The vision of GBADs, strengthening the food system for the benefit of society and the environment, is an example of One Health thinking in action.
Livestock production systems, their responses to the demand for animal-source food, and the implications for animal health services.
Perry BD, Dijkman JT
Rev Sci Tech · 2021 Aug · PMID 34542091 · Publisher ↗
This paper reviews the rapidly changing global demands for animal-source foods, examines the agri-food systems behind these changes, and discusses the potential responses required by public-sector Veterinary Services to...
This paper reviews the rapidly changing global demands for animal-source foods, examines the agri-food systems behind these changes, and discusses the potential responses required by public-sector Veterinary Services to meet these new demands.
Examples of proper reporting for evaluation (Stage 2 validation) of diagnostic tests for diseases listed by the World Organisation for Animal Health.
Kostoulas P, Gardner IA, Elschner MC … +3 more , Denwood M J, Meletis L, Nielsen SS
Rev Sci Tech · 2021 Jun · PMID 34140743 · Publisher ↗
Reporting and design standards are key indicators of the quality of diagnostic accuracy (validation) studies but, with the exception of aquatic animal diseases and paratuberculosis in ruminants, there is limited guidance...
Reporting and design standards are key indicators of the quality of diagnostic accuracy (validation) studies but, with the exception of aquatic animal diseases and paratuberculosis in ruminants, there is limited guidance for designing these studies in animals. There is, therefore, a need for generic guidelines that are based on disease characteristics, such as mode of transmission, latent period and pathogenesis. Comprehensive, clear and transparent reporting of primary test accuracy studies for diseases listed by the World Organisation for Animal Health (OIE) has value for the end users of diagnostic tests and, ultimately, for decision-makers, who require systematic reviews and meta-analysis of multiple tests for specified diseases and testing purposes. The recent publication of reporting standards for Bayesian latent class models, to analyse test-accuracy data from naturally occurring disease events, fills an important gap as these methods are being increasingly used for OIE-listed diseases. Adherence to design and reporting standards, as well as to guidelines, helps to ensure that research funding for test validation studies is used appropriately and that the strengths and limitations of single tests or test combinations are made clear to test users. The authors provide a review of key points that are often overlooked or misinterpreted in test validation studies, as well as two concrete examples of good practice for use as a reference point for future studies.
Preface - Diagnostic test validation science.
Eloit M
Rev Sci Tech · 2021 Jun · PMID 34140742 · Publisher ↗
Abstract loading — click title to view on PubMed.
Introduction - Validation of tests for OIE-listed diseases as fit-for-purpose in a world of evolving diagnostic technologies.
Gardner IA, Colling A, Caraguel C … +4 more , Crowther JR, Jones G, Firestone SM, Heuer C
Rev Sci Tech · 2021 Jun · PMID 34140741 · Publisher ↗
The World Organisation for Animal Health (OIE) has made leading contributions to the discipline of test validation science by providing standards and guidelines that inform the test validation process in terrestrial and...
The World Organisation for Animal Health (OIE) has made leading contributions to the discipline of test validation science by providing standards and guidelines that inform the test validation process in terrestrial and aquatic animals. The OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, and the Manual of Diagnostic Tests for Aquatic Animals describe the test validation pathway in the context of fitness for purpose, elaborate on the importance of diagnostic sensitivity (DSe) and specificity (DSp) as measures of test accuracy, and designate additional factors (e.g. test cost, laboratory throughput capacity and rapidity of test results) that influence choices of a single test over others or the inclusion of a new test in a diagnostic process that includes multiple tests. This paper provides examples of each of the six main testing purposes listed in the Terrestrial Manual and describes additional metrics such as ruggedness and robustness that should be included in the validation of point-of-care tests. Challenges associated with new diagnostic technologies and platforms are described. Validated tests with estimates of DSe and DSp are needed to measure confidence in test results for OIE-listed diseases, to facilitate risk assessments related to animal movement, to estimate true prevalence, and for certification of disease freedom and use in epidemiological (risk factor) studies.
Review of critical factors affecting analytical characteristics of serological and molecular assays.
Bowden TR, Crowther JR, Wang J
Rev Sci Tech · 2021 Jun · PMID 34140740 · Publisher ↗
Analytical characteristics of diagnostic tests, encompassing estimates of repeatability, analytical specificity (ASp) and analytical sensitivity (ASe), are determined during Stage 1 of the OIE Assay Validation Pathway. R...
Analytical characteristics of diagnostic tests, encompassing estimates of repeatability, analytical specificity (ASp) and analytical sensitivity (ASe), are determined during Stage 1 of the OIE Assay Validation Pathway. Repeatability (an estimate of assay precision and robustness), ASp (measuring only what an assay is intended to measure) and ASe (synonymous with the lower limit of detection) are fundamental parameters that determine future test performance. Importantly, these parameters provide the basis for deciding whether a prototype assay progresses to the next stage of the OIE Assay Validation Pathway (determination of diagnostic characteristics) or is withdrawn in favour of alternate tests with better analytical performance characteristics. Implicit in the successful development and validation of any assay is a sound understanding of the target pathogen, the disease pathogenesis in susceptible hosts, the fundamental technical principles that underliey each test system, and its intended use. Factors that affect analytical characteristics of diagnostic assays are numerous and may vary according to each assay type. Using, as examples, development of an enzyme-linked immunosorbent assay for detection of antibodies to capripoxviruses, and the comparative assessment of three quantitative real-time polymerase chain reactions for detection of African swine fever virus DNA, the main factors affecting analytical characteristics of serological and molecular assays are considered. As reviewed within, comprehensive and well-designed experiments are required to develop and optimise assays with favourable analytical characteristics. The underlying principles are broadly applicable to all assay types and, when conducted with appropriate rigour, provide the foundations for high-quality diagnostic tests that are fit for their intended purpose(s).
Tour d'horizon des tests de diagnostic recommandés dans le Manuel des tests de diagnostic et des vaccins pour les animaux terrestres de l'Organisation mondiale de la santé animale.
Cullinane AA, Garvey M
Rev Sci Tech · 2021 Jun · PMID 34140739 · Publisher ↗
To provide a standardised approach to the diagnosis of diseases and to facilitate health certification for trade, the World Organisation for Animal Health (OIE) standards, described in the Manual of Diagnostic Tests and...
To provide a standardised approach to the diagnosis of diseases and to facilitate health certification for trade, the World Organisation for Animal Health (OIE) standards, described in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual), include internationally agreed laboratory diagnostic techniques. This review examines the type of tests recommended in the disease-specific chapters of the Terrestrial Manual for the six most common purposes of diagnostic techniques, including certification for movement, confirmation of clinical cases and disease surveillance. The most frequently recommended tests for all six purposes are enzyme-linked immunosorbent assay and/or polymerase chain reaction, for which there are detailed validation guidelines in the OIE Terrestrial Manual. This is true for all species and no species-specific barriers to validation related to test type were identified. Classical techniques continue to be well represented in the Terrestrial Manual recommendations whereas novel technologies are slow to gain acceptance. These classical tests can present challenges for validation as there may be a dearth of international standard reagents and harmonised protocols.
Diagnostic applications of molecular and serological assays for bluetongue and African horse sickness.
Mayo CE, Weyer CT, Carpenter MJ … +8 more , Reed KJ, Rodgers CP, Lovett KM, Guthrie AJ, Mullens BA, Barker CM, Reisen WK, MacLachlan NJ
Rev Sci Tech · 2021 Jun · PMID 34140738 · Publisher ↗
The availability of rapid, highly sensitive and specific molecular and serologic diagnostic assays, such as competitive enzyme-linked immunosorbent assay (cELISA), has expedited the diagnosis of emerging transboundary an...
The availability of rapid, highly sensitive and specific molecular and serologic diagnostic assays, such as competitive enzyme-linked immunosorbent assay (cELISA), has expedited the diagnosis of emerging transboundary animal diseases, including bluetongue (BT) and African horse sickness (AHS), and facilitated more thorough characterisation of their epidemiology. The development of assays based on real-time, reverse-transcription polymerase chain reaction (RT-PCR) to detect and identify the numerous serotypes of BT virus (BTV) and AHS virus (AHSV) has aided in-depth studies of the epidemiology of BTV infection in California and AHSV infection in South Africa. The subsequent evaluation of pan-serotype, real-time, RT-PCR-positive samples through the use of serotype-specific RT-PCR assays allows the rapid identification of virus serotypes, reducing the need for expensive and time-consuming conventional methods, such as virus isolation and serotype-specific virus neutralisation assays. These molecular assays and cELISA platforms provide tools that have enhanced epidemiologic surveillance strategies and improved our understanding of potentially altered Culicoides midge behaviour when infected with BTV. They have also supported the detection of subclinical AHSV infection of vaccinated horses in South Africa. Moreover, in conjunction with whole genome sequence analysis, these tests have clarified that the mechanism behind recent outbreaks of AHS in the AHS-controlled area of South Africa was the result of the reversion to virulence and/or genome reassortment of live attenuated vaccine viruses. This review focuses on the use of contemporary molecular diagnostic assays in the context of recent epidemiologic studies and explores their advantages over historic virus isolation and serologic techniques.
Pathogen detection and disease diagnosis in wildlife: challenges and opportunities.
Michel AL, Van Heerden H, Crossley BM … +3 more , Al Dahouk S, Prasse D, Rutten V
Rev Sci Tech · 2021 Jun · PMID 34140737 · Publisher ↗
The availability of rapid, highly sensitive and specific molecular and serologic diagnostic assays, such as competitive enzyme-linked immunosorbent assay (cELISA), has expedited the diagnosis of emerging transboundary an...
The availability of rapid, highly sensitive and specific molecular and serologic diagnostic assays, such as competitive enzyme-linked immunosorbent assay (cELISA), has expedited the diagnosis of emerging transboundary animal diseases, including bluetongue (BT) and African horse sickness (AHS), and facilitated more thorough characterisation of their epidemiology. The development of assays based on real-time, reverse-transcription polymerase chain reaction (RT-PCR) to detect and identify the numerous serotypes of BT virus (BTV) and AHS virus (AHSV) has aided in-depth studies of the epidemiology of BTV infection in California and AHSV infection in South Africa. The subsequent evaluation of pan-serotype, real-time, RT-PCR-positive samples through the use of serotype-specific RT-PCR assays allows the rapid identification of virus serotypes, reducing the need for expensive and time-consuming conventional methods, such as virus isolation and serotype-specific virus neutralisation assays. These molecular assays and cELISA platforms provide tools that have enhanced epidemiologic surveillance strategies and improved our understanding of potentially altered Culicoides midge behaviour when infected with BTV. They have also supported the detection of subclinical AHSV infection of vaccinated horses in South Africa. Moreover, in conjunction with whole genome sequence analysis, these tests have clarified that the mechanism behind recent outbreaks of AHS in the AHS-controlled area of South Africa was the result of the reversion to virulence and/or genome reassortment of live attenuated vaccine viruses. This review focuses on the use of contemporary molecular diagnostic assays in the context of recent epidemiologic studies and explores their advantages over historic virus isolation and serologic techniques.
Emerging and endemic zoonotic diseases: surveillance and diagnostics.
Stevenson M, Halpin K
Rev Sci Tech · 2021 Jun · PMID 34140736 · Publisher ↗
In this paper, the authors: (a) list methods used to diagnose zoonotic diseases in humans and animals; (b) identify between-species differences in diagnostic approaches, providing commentary on the benefits that might ar...
In this paper, the authors: (a) list methods used to diagnose zoonotic diseases in humans and animals; (b) identify between-species differences in diagnostic approaches, providing commentary on the benefits that might arise from simultaneous interpretation of data from human and animal health surveillance systems; and (c) reiterate the importance of using species-specific, validated diagnostic tests for surveillance and disease outbreak investigations. Emerging and endemic zoonotic diseases are likely to provide a continued threat to global health in the short- to medium-term future. A good deal of knowledge about the drivers of infectious disease emergence has been developed based on numerous examples from the recent past. Sharing of diagnostic resources across human and animal health sectors, sharing of human and animal health surveillance data, development of skills in the interpretation of that data and awareness of issues related to the validation and interpretation of diagnostic test data are necessary prerequisites for an effective endemic disease surveillance system. A good understanding of the epidemiological patterns of endemic disease will allow human and animal health professionals be able to more quickly detect the presence of emerging disease threats.
Factors affecting test reproducibility among laboratories.
Waugh C, Clark G
Rev Sci Tech · 2021 Jun · PMID 34140735 · Publisher ↗
Reproducibility is the ability of an assay to provide consistent results (when testing the same samples) in different laboratories. The validation of a new diagnostic assay should include specific assessment of assay rep...
Reproducibility is the ability of an assay to provide consistent results (when testing the same samples) in different laboratories. The validation of a new diagnostic assay should include specific assessment of assay reproducibility to determine the degree to which results are unaffected by minor changes in experimental conditions. Ideally, assessment of reproducibility involves the testing of identical samples in multiple laboratories by multiple analysts using the same method, reagents and controls, albeit with different equipment. Such an assessment will provide estimates of the precision and accuracy of an assay across laboratories. In reality, although the reproducibility of an assay is often assessed by multiple laboratories testing identical samples, the reagents, controls and testing platforms used, while similar, are usually not the same. Thus, reproducibility testing permits the assessment of variability resulting from different testing platforms, reagent supplies and operators. The determination of minor versus major variations in test conditions that may be anticipated in multi-laboratory use is part of the assessment at this stage of validation. Once validated, there are ongoing monitoring requirements to assess the performance characteristics and ensure they are consistently maintained. The use of quality assurance programmes is required, as this offers continued monitoring of assay performance by measuring the precision and accuracy of results for well-characterised samples and controls. Tests recommended by the World Organisation for Animal Health as fit for purpose are widely used internationally and need to have satisfactory reproducibility.
Perspectives and challenges in validating new diagnostic technologies.
Halpin K, Tribolet L, Hobbs E … +1 more , Singanallur NB
Rev Sci Tech · 2021 Jun · PMID 34140734 · Publisher ↗
This paper focuses on several new diagnostic technologies, which are set to dominate the testing landscape in the near future and have applications in animal health diagnostics, namely: next-generation sequencing, assays...
This paper focuses on several new diagnostic technologies, which are set to dominate the testing landscape in the near future and have applications in animal health diagnostics, namely: next-generation sequencing, assays to detect biomarkers, and point-of-care tests. An example of real-time loop-mediated isothermal amplification validation is also provided. Validating these new technologies presents several challenges, which are addressed in this paper.
The role of national and international veterinary laboratories.
Brown IH, Cassar CA, Slomka MJ … +2 more , McElhinney LM, Brouwer A
Rev Sci Tech · 2021 Jun · PMID 34140733 · Publisher ↗
In the field of diagnostic test validation, World Organisation for Animal Health (OIE) Reference Laboratories (RLs) have a pivotal role and provide the international community with impartial advice and support in the sel...
In the field of diagnostic test validation, World Organisation for Animal Health (OIE) Reference Laboratories (RLs) have a pivotal role and provide the international community with impartial advice and support in the selection, development and validation of diagnostic tests, which can be applied to the specialist diseases for which they are designated. National RLs provide an invaluable function in supporting the introduction, ongoing validation and application of validated diagnostic tests in line with international standards. Experienced staff with extensive knowledge of such systems and access to specialist facilities for conducting work are available to monitor changes or advancements in technology. They consider their relevance and value to evolving diagnostic test requirements. Reference Laboratories often have a broad mandate of activity linking research or development programmes and surveillance activities to benefit the continual assessment and, if necessary, improvement of diagnostic tools. Reference Laboratories maintain or have access to unique biological archives (known positive and negative sample populations) and produce international reference standards, both of which are vital in establishing the necessary and detailed validation of any diagnostic test. Reference Laboratories act either singularly or in collaborative partnerships with other RLs or science institutes, but also, when required, and with impartiality, with the commercial sector, to ensure new tests are validated according to OIE standards. They promote and apply formal programmes of quality assurance (including proficiency testing programmes) for newly validated tests, ensuring ongoing monitoring and compliance with standards, or as required set out any limitations or uncertainties. Reference Laboratories publish information on test validation in the scientific literature and on relevant websites, as well as disseminating information at workshops and international conferences. Furthermore, they can offer training in the processes and systems underpinning test validation.
Validation, certification and registration of veterinary diagnostic test kits by the World Organisation for Animal Health Secretariat for Registration of Diagnostic Kits.
Gifford G, Szabo M, Hibbard R … +4 more , Mateo D, Colling A, Gardner I, Erlacher Vindel E
Rev Sci Tech · 2021 Jun · PMID 34140732 · Publisher ↗
In the field of diagnostic test validation, World Organisation for Animal Health (OIE) Reference Laboratories (RLs) have a pivotal role and provide the international community with impartial advice and support in the sel...
In the field of diagnostic test validation, World Organisation for Animal Health (OIE) Reference Laboratories (RLs) have a pivotal role and provide the international community with impartial advice and support in the selection, development and validation of diagnostic tests, which can be applied to the specialist diseases for which they are designated. National RLs provide an invaluable function in supporting the introduction, ongoing validation and application of validated diagnostic tests in line with international standards. Experienced staff with extensive knowledge of such systems and access to specialist facilities for conducting work are available to monitor changes or advancements in technology. They consider their relevance and value to evolving diagnostic test requirements. Reference Laboratories often have a broad mandate of activity linking research or development programmes and surveillance activities to benefit the continual assessment and, if necessary, improvement of diagnostic tools. Reference Laboratories maintain or have access to unique biological archives (known positive and negative sample populations) and produce international reference standards, both of which are vital in establishing the necessary and detailed validation of any diagnostic test. Reference Laboratories act either singularly or in collaborative partnerships with other RLs or science institutes, but also, when required, and with impartiality, with the commercial sector, to ensure new tests are validated according to OIE standards. They promote and apply formal programmes of quality assurance (including proficiency testing programmes) for newly validated tests, ensuring ongoing monitoring and compliance with standards, or as required set out any limitations or uncertainties. Reference Laboratories publish information on test validation in the scientific literature and on relevant websites, as well as disseminating information at workshops and international conferences. Furthermore, they can offer training in the processes and systems underpinning test validation.
Proficiency testing and ring trials.
Johnson P, Cabuang L
Rev Sci Tech · 2021 Jun · PMID 34140731 · Publisher ↗
The validation of diagnostic methods (and the subsequent results generated by a laboratory) are improved through participation in inter-laboratory comparisons (IC), such as proficiency-testing (PT) programmes and other e...
The validation of diagnostic methods (and the subsequent results generated by a laboratory) are improved through participation in inter-laboratory comparisons (IC), such as proficiency-testing (PT) programmes and other exercises referred to as 'ring tests' or 'ring trials' (RTs). This is a requirement to comply with international quality standards. Validating a method is a continuous process and taking part in ongoing PT programmes supports the management of a method's life cycle, providing continuing assessment of fitness (sometimes referred to as the 'validation retention status'). Proficiency-testing panel designs ensure that the methods used, particularly diagnostic specificity and sensitivity, are suitably challenged. Appraising PT results over time can illustrate whether the laboratory's performance is stable, improving or worsening, and proficiency tests can also highlight variations in the performance of assays. The development of new proficiency tests can support the implementation of novel diagnostics technologies, such as whole genome sequencing and point-of-care testing, and assist in cross-sectoral partnerships focusing on One Health approaches, which are high on the agenda for infectious disease control. For example, the rapid design and distribution of emergency exempted assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) means that these assays were not as rigorously evaluated as assays for established infectious diseases. Therefore, participation in PT programmes for SARS-CoV-2 is essential to understand the performance of these assays. While other mechanisms help to underpin laboratory activities, PT has been, and should remain, an integral part of laboratory quality assurance. Resources must be directed towards increasing and improving the quality of PT (for example, availability and accessibility of suitable biological and reference materials are essential for a PT provider to execute its duties), to support established and novel methods such as genomic and point-of-care tests.
Your assay has changed - is it still 'fit for purpose'? What evaluation is required.
Kirkland PD, Newberry KM
Rev Sci Tech · 2021 Jun · PMID 34140730 · Publisher ↗
A reliable laboratory assay is an essential tool for the diagnosis or surveillance of most animal diseases. Before routine use, assays should be appropriately validated to ensure that they have performance characteristic...
A reliable laboratory assay is an essential tool for the diagnosis or surveillance of most animal diseases. Before routine use, assays should be appropriately validated to ensure that they have performance characteristics that provide reliable results and can be used for the intended purpose. It is inevitable that, over time, changes will need to be made to assay reagents, to the assay format, to test a different species or for implementation in a new laboratory. Whenever there is a change (whether it be components, application or location), it is essential to establish whether the new circumstances affect the biological basis and properties of the assay. If the modifications do not affect the biological basis of the assay, the changes might be considered minor and a verification study can be conducted to confirm that the performance characteristics have not been adversely affected. Major changes require a new validation to be carried out. A method comparability study, where original and modified assays are run concurrently to test the same sample panel, provides an extremely robust comparison. However, comparability studies are not always an option, especially for the introduction of a method to a new laboratory. Access to original validation data and suitable reference sample panels then becomes essential to provide evidence that the assay remains 'fit for the intended purpose'.
A review of guidelines for evaluating a minor modification to a validated assay.
Reising MM, Tong C, Harris B … +7 more , Toohey-Kurth KL, Crossley B, Mulrooney D, Tallmadge RL, Schumann KR, Lock AB, Loiacono CM
Rev Sci Tech · 2021 Jun · PMID 34140729 · Publisher ↗
Any modification to a validated assay must be evaluated in terms of the impact on the assay's performance characteristics and whether the assay remains fit for the intended purpose. The comparison is referred to as a 'me...
Any modification to a validated assay must be evaluated in terms of the impact on the assay's performance characteristics and whether the assay remains fit for the intended purpose. The comparison is referred to as a 'method comparison', 'method comparability', 'method change', or 'comparative validation'. This review presents recommendations and examples of studies found in the current literature as a means of assessing minor modifications. In addition, the authors discuss common statistical approaches used for these comparisons.
Quality standards and guidelines for test validation for infectious diseases in veterinary laboratories.
Newberry KM, Colling A
Rev Sci Tech · 2021 Jun · PMID 34140728 · Publisher ↗
The World Organisation for Animal Health Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Chapter 1.1.1. summarises the most relevant governance and managerial aspects of veterinary testing laboratories,...
The World Organisation for Animal Health Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Chapter 1.1.1. summarises the most relevant governance and managerial aspects of veterinary testing laboratories, and Chapter 1.1.5. introduces quality management. Both chapters are based on the International Organization for Standardization/International Electrotechnical Commission standard, ISO/IEC 17025:2005 'General requirements for the competence of testing and calibration laboratories'. This paper provides an update of standards and regulatory bodies relevant for accreditation of quality management systems (QMS), with a focus on ISO/IEC 17025:2017 for testing and calibration laboratories. Important issues and considerations that a laboratory should address in the design and maintenance of its QMS are highlighted and examples provided, in particular aspects of test validation and verification, including measurement uncertainty (MU). A QMS aims to address all aspects of the laboratory operation, including staff, organisational structure, processes, and procedures. Accreditation of a diagnostic laboratory requires three notable components: (a) independent or third-party assessment; (b) suitably validated tests performed by proficient laboratory operators in an adequately equipped laboratory; and (c) ongoing internal and external quality control. Together, these components ensure a test outcome is the result of a standardised process and structured peer review, and demonstrate both competency and ability to produce technically valid diagnostic results that will meet the needs of customers - veterinarians, animal owners, regulators, organisations and industry - as well as the needs of decision-makers involved in animal health and surveillance programmes.
Selection and use of reference panels: a case study highlighting current gaps in the materials available for foot and mouth disease.
Ludi AB, Mioulet V, Kassimi LB … +7 more , Lefebvre DJ, De Clercq K, Chitsungo E, Nwankpa N, Vosloo W, Paton DJ, King DP
Rev Sci Tech · 2021 Jun · PMID 34140727 · Publisher ↗
The World Organisation for Animal Health (OIE) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals describes a diverse array of assays that can be used to detect, characterise and monitor the presence of infe...
The World Organisation for Animal Health (OIE) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals describes a diverse array of assays that can be used to detect, characterise and monitor the presence of infectious agents of farmed livestock. These methods have been developed in different laboratories, at different times, and often include tests or kits provided by the commercial sector. Reference panels are essential tools that can be used during assay development and in validation exercises to compare the performance of these varied (and sometimes competing) diagnostic technologies. World Organisation for Animal Health Reference Laboratories already provide approved international standard reagents to help calibrate diagnostic tests for a range of diseases, but there remain important gaps in their availability for comparative purposes and the calibration of test results across different laboratories. Using foot and mouth disease (FMD) as an example, this review highlights four specific areas where new reference reagents are required. These are to: reduce bias in estimates of the diagnostic sensitivity and inter-serotypic specificity of tests used to detect diverse strains of FMD virus (FMDV), provide bio-safe positive controls for new point-of-care test formats that can be deployed outside high containment, harmonise FMDV antigens for post-vaccination serology, and address inter-laboratory differences in serological assays used to measure virus-specific FMD antibody responses. Since there are often limited resources to prepare and distribute these materials, sustainable progress in this arena will only be achievable if there is consensus and coordination of these activities among OIE Reference Laboratories.
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