The formulation of artificial reference standards for use within the ELISPOT assay

Whether to assess the functionality of equipment or as a determinate for the accuracy of assays, reference standards are essential for the purposes of standardisation and validation. The ELISPOT assay, developed over thirty years ago, has emerged as a leading immunological assay in the development of novel vaccines for the assessment of efficacy. However, with its widespread use, there is a growing demand for a greater level of standardisation across different laboratories. One of the major difficulties in achieving this goal has been the lack of definitive reference standards. This is partly due to the ex vivo nature of the assay, which relies on cells being placed directly into the wells. Thus, the aim of this thesis was to produce an artificial reference standard using liposomes, for use within the assay. Liposomes are spherical bilayer vesicles with an enclosed aqueous compartment and therefore are models for biological membranes. Initial work examined pre-design considerations in order to produce an optimal formulation that would closely mimic the action of the cells ordinarily placed on the assay. Recognition of the structural differences between liposomes and cells led to the formulation of liposomes with increased density. This was achieved by using a synthesised cholesterol analogue. By incorporating this cholesterol analogue in liposomes, increased sedimentation rates were observed within the first few hours. The optimal liposome formulation from these studies was composed of 2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), cholesterol (Chol) and brominated cholesterol (Brchol) at a 16:4:12 µMol ratio, based on a significantly higher (p<0.01) sedimentation (as determined by a percentage transmission of 59 ± 5.9 % compared to the control formulation at 29 ± 12 % after four hours). By considering a range of liposome formulations ‘proof of principle’ for using liposomes as ELISPOT reference standards was shown; recombinant IFN? cytokine was successfully entrapped within vesicles of different lipid compositions, which were able to promote spot formation within the ELISPOT assay. Using optimised liposome formulations composed of phosphatidylcholine with or without cholesterol (16 µMol total lipid) further development was undertaken to produce an optimised, scalable protocol for the production of liposomes as reference standards. A linear increase in spot number by the manipulation of cytokine concentration and/or lipid concentrations was not possible, potentially due to the saturation that occurred within the base of wells. Investigations into storage of the formulations demonstrated the feasibility of freezing and lyophilisation with disaccharide cryoprotectants, but also highlighted the need for further protocol optimisation to achieve a robust reference standard upon storage. Finally, the transfer of small-scale production to a medium lab-scale batch (40 mL) demonstrated this was feasible within the laboratory using the optimised protocol.

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

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 Studies—paratuberculosis (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-for-purpose. 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.

Education for all : providing curriculum for students with disabilities in a standards-based environment : implications for Queensland schools

This report investigates lessons learned by educators in the United States when providing a standards-based curriculum for all students including Students with Disabilities (SWD). Assumptions about implementation of these lessons are then made to the Queensland school system. Queensland mainstream schools currently provide a standards-based curriculum for over sixteen thousand-four hundred students with mild-moderate disabilities and appear to be challenged by this new educational reform and its implications to school and teacher practices, beliefs and attitudes. The analysis of US research, literature and educational policy for this report, has provided some implications for Queensland schools in the areas of student participation, achievement and curriculum planning to provide an “education for all”. The analysis and comparison of legislation and policy, which demonstrates some significant similarities, provides greater validity for the application of lessons learned in the United States to the Queensland context. The key findings about lessons learned provides Queensland schools with some assumptions as to why and how they need to refocus school leader and teachers’ practices, beliefs and attitudes to provide an “education for all”. These lessons infer that school leaders and teachers to explicitly focus on equity, expectation, accountability, performance, alignment and collaboration so that effective curriculum is provided for SWD, indeed all students, in the Queensland standards-based curriculum environment.

Enforcing minimum labour standards in Australia from 2010 : correcting or compounding problems

Fair Work Australia is to provide the institutional framework for the Australian industrial relations system from January 2010. Its creation provides the opportunity to improve minimum labour standards’ enforcement in Australia. However, the experience of the past must be appreciated and traditional assumptions about the operation of the Australian enforcement system discarded if the new institution is to be effective in its role. This paper focuses on the role of unions in enforcement as well as institutional location issues to expose a number of central enforcement problems that those seeking to establish new systems and processes should consider. A number of recommendations in respect of the structure of Fair Work Australia and the continuing role of unions are suggested.

How can preservice teachers be measured against advocated professional teaching standards?

Australia has had many inquiries into teaching and teacher education over the last decade. Standards for teaching have been produced by national education systems with many state systems following suit. The Queensland College of Teachers (QCT) advocates ten professional teaching standards for teachers and preservice teachers. How can preservice teachers be measured against advocated professional standards? This study investigated 106 second-year preservice teachers’ perceptions of their development against the QCT standards. A pretest-posttest survey instrument was developed based on the QCT standards and administered to these preservice teachers before and after their science education coursework. Percentages, ANOVAs and t-tests were generated to analyse the results. Findings indicated that 22 of the 24 paired pretest-posttest items were highly significant (p<.001). Percentage increases ranged from as low as 27% in the pretest to as high as 97% in the posttest, yet, there were two items with lower significance (i.e., working in professional science education teams and supporting students’ participation in society). Understanding preservice teachers’ perceptions of their abilities to implement these standards may be a step towards the process of determining the achievement of teaching standards; however, more rigorous measurements will need to be developed for both teachers and preservice teachers. University coursework and related assessments can provide an indication of achieving these standards, especially authentic assessment of preservice teachers’ practices.

Innovative cartography standards for Web-GIS portals : case study of the 'Survey of Israel's' Web-GIS Portal

Maps have been published on the world wide web since its inception (Cartwright, 1999) and are still accessed and viewed by millions of users today (Peterson, 2003). While early webbased GIS products lacked a complete set of cartographic capabilities, the functionality within such systems has significantly increased over recent years. Functionalities once found only in desktop GIS products are now available in web-based GIS applications, for example, data entry, basic editing, and analysis. Applications based on web-GIS are becoming more widespread and the web-based GIS environment is replacing the traditional desktop GIS platforms in many organizations. Therefore, development of a new cartographic method for web-based GIS is vital. The broad aim of this project is to examine and discuss the challenges and opportunities of innovative cartography methods for web-based GIS platforms. The work introduces a recently developed cartographic methodology, which is based on a web-based GIS portal by the Survey of Israel (SOI). The work discusses the prospects and constraints of such methods in improving web-GIS interfaces and usability for the end user. The work also tables the preliminary findings of the initial implementation of the web-based GIS cartographic method within the portal of the Survey of Israel, as well as the applicability of those methods elsewhere.

Interoperable Standards Development : Final Report

Since 1995 the buildingSMART International Alliance for Interoperability (buildingSMART)has developed a robust standard called the Industry Foundation Classes (IFC). IFC is an object oriented data model with related file format that has facilitated the efficient exchange of data in the development of building information models (BIM). The Cooperative Research Centre for Construction Innovation has contributed to the international effort in the development of the IFC standard and specifically the reinforced concrete part of the latest IFC 2x3 release. Industry Foundation Classes have been endorsed by the International Standards Organisation as a Publicly Available Specification (PAS) under the ISO label ISO/PAS 16739. For more details, go to http://www.tc184- sc4.org/About_TC184-SC4/About_SC4_Standards/ The current IFC model covers the building itself to a useful level of detail. The next stage of development for the IFC standard is where the building meets the ground (terrain) and with civil and external works like pavements, retaining walls, bridges, tunnels etc. With the current focus in Australia on infrastructure projects over the next 20 years a logical extension to this standard was in the area of site and civil works. This proposal recognises that there is an existing body of work on the specification of road representation data. In particular, LandXML is recognised as also is TransXML in the broader context of transportation and CityGML in the common interfacing of city maps, buildings and roads. Examination of interfaces between IFC and these specifications is therefore within the scope of this project. That such interfaces can be developed has already been demonstrated in principle within the IFC for Geographic Information Systems (GIS) project. National road standards that are already in use should be carefully analysed and contacts established in order to gain from this knowledge. The Object Catalogue for the Road Transport Sector (OKSTRA) should be noted as an example. It is also noted that buildingSMART Norway has submitted a proposal

Interview with Dr. Young-Ki Paik, President of the Human Proteome Organization (HUPO): Pharmacoproteomics and the approaching wave of “Proteomics Diagnostics”

Dr. Young-Ki Paik directs the Yonsei Proteome Research Center in Seoul, Korea and was elected as the President of the Human Proteome Organization (HUPO) in 2009. In the December 2009 issue of the Current Pharmacogenomics and Personalized Medicine (CPPM), Dr. Paik explains the new field of pharmacoproteomics and the approaching wave of “proteomics diagnostics” in relation to personalized medicine, HUPO’s role in advancing proteomics technology applications, the HUPO Proteomics Standards Initiative, and the future impact of proteomics on medicine, science, and society. Additionally, he comments that (1) there is a need for launching a Gene-Centric Human Proteome Project (GCHPP) through which all representative proteins encoded by the genes can be identified and quantified in a specific cell and tissue and, (2) that the innovation frameworks within the diagnostics industry hitherto borrowed from the genetics age may require reevaluation in the case of proteomics, in order to facilitate the uptake of pharmacoproteomics innovations. He stresses the importance of biological/clinical plausibility driving the evolution of biotechnologies such as proteomics,instead of an isolated singular focus on the technology per se. Dr. Paik earned his Ph.D. in biochemistry from the University of Missouri-Columbia and carried out postdoctoral work at the Gladstone Foundation Laboratories of Cardiovascular Disease, University of California at San Francisco. In 2005, his research team at Yonsei University first identified and characterized the chemical structure of C. elegans dauer pheromone (daumone) which controls the aging process of this nematode. He is interviewed by a multidisciplinary team specializing in knowledge translation, technology regulation, health systems governance, and innovation analysis.

Addressing Challenges for Internationalisation and Mobility in Engineering Through CDIO Standards

There is a growing need for international transparency of engineering qualifications, and mechanisms to support and facilitate student mobility. In response, there are a number of global initiatives attempting to address these needs, particularly in Europe, North America and Australia. The Conceive-Design-Implement-Operate (CDIO) Initiative has a set of standards, competencies, and proficiency levels developed through a global community of practice. It is a well-structured framework in which best-practice internationalisation and student mobility can be embedded. However, the current 12 CDIO Standards do not address international qualifications or student mobility. Based on an environmental scan of global activities, the underpinning principles of best practice are identified and form the basis of the proposed 13th CDIO Standard — “Internationalization and Mobility”.

Creating an asset registry for railway electrical traction equipment with open standards

An asset registry arguably forms the core system that needs to be in place before other systems can operate or interoperate. Most systems have rudimentary asset registry functionality that store assets, relationships, or characteristics, and this leads to different asset management systems storing similar sets of data in multiple locations in an organisation. As organisations have been slowly moving their information architecture toward a service-oriented architecture, they have also been consolidating their multiple data stores, to form a “single point of truth”. As part of a strategy to integrate several asset management systems in an Australian railway organisation, a case study for developing a consolidated asset registry was conducted. A decision was made to use the MIMOSA OSA-EAI CRIS data model as well as the OSA-EAI Reference Data in building the platform due to the standard’s relative maturity and completeness. A pilot study of electrical traction equipment was selected, and the data sources feeding into the asset registry were primarily diagrammatic based. This paper presents the pitfalls encountered, approaches taken, and lessons learned during the development of the asset registry.

A comparison of international occupational therapy competencies : implications for Australian standards in the new millennium

Background/aim: A timely evaluation of the Australian Competency Standards for Entry-Level Occupational Therapists© (1994) was conducted. This thorough investigation comprised a literature review exploring the concept of competence and the applications of competency standards; systematic benchmarking of the Australian Occupational Therapy Competency Standards (OT AUSTRALIA, 1994) against other national and international competency standards and other affiliated documents, from occupational therapy and other cognate disciplines; and extensive nationwide consultation with the professional community. This paper explores and examines the similarities and disparities between occupational therapy competency standards documents available in English from Australia and other countries.----- Methods: An online search for national occupational therapy competency standards located 10 documents, including the Australian competencies.----- Results: Four 'frameworks' were created to categorise the documents according to their conceptual underpinnings: Technical-Prescriptive, Enabling, Educational and Meta-Cognitive. Other characteristics that appeared to impact the design, content and implementation of competency standards, including definitions of key concepts, authorship, national and cultural priorities, scope of services, intended use and review mechanisms, were revealed.----- Conclusion: The proposed 'frameworks' and identification of influential characteristics provided a 'lens' through which to understand and evaluate competency standards. While consistent application of and attention to some of these characteristics appear to consolidate and affirm the authority of competency standards, it is suggested that the national context should be a critical determinant of the design and content of the final document. The Australian Occupational Therapy Competency Standards (OT AUSTRALIA, 1994) are critiqued accordingly, and preliminary recommendations for revision are proposed.

Moving towards open standards

Standards are designed to promote the interoperability of products and systems by enabling different parties to develop technologies that can be used together. There is an increasing expectation in many technical communities, including open source communities, that standards will be ‘open’. However, standards are subject to legal rights which impact upon, not only their development, but also their implementation. Of central importance are intellectual property rights: technical standards may incorporate patented technologies, while the specification documents of standards are protected by copyright. This article provides an overview of the processes by which standards are developed and considers the concept of ‘interoperability’, the meaning of the term ‘open standard’ and how open standards contribute to interoperability. It explains how intellectual property rights operate in relation to standards and how they can be managed to create standards that are open, not only during their development, but also in implementation.

International labour standards and Queensland

Queensland’s legal labour disputes history does not exhibit the current trend seen in Canada and Switzerland (Gravel & Delpech, 2008) where cases citing International Labour Standards (ILS) are often successful (which is not presently the case in Queensland either). The two Queensland cases (Kuhler v. Inghams Enterprises P/L & Anor, 1997 and Bale v. Seltsam Pty Ltd, 1996) that have used ILSs were lost. Australia is a member state of the International Labour Organization (ILO) and a signatory of many ILSs. Yet, ILSs are not used in their legal capacity when compared to other international standards in other areas of law. It is important to recognize that ILSs are uniquely underutilized in labour law. Australian environmental, criminal, and industrial disputes consistently draw on international standards. Why not for the plight of workers? ILSs draw their power from supranational influence in that when a case cites an ILS the barrister or solicitor is going beyond legal precedence and into international peer pressure. An ILS can be appropriately used to highlight that Australian or Queensland legislation does not conform to a Convention or Recommendation. However, should the case deal with a breach of existing law based or modified by an ILS, citing the ILS is a good way to remind the court of its origin. It’s a new legal paradigm critically lacking in Queensland’s labour law practice. The following discusses the research methodology used in this paper. It is followed by a comparative discussion of results between the prevalence of ILSs and other international standards in Queensland case history. Finally, evidence showing the international trend of labour disputes using ILSs for victory is discussed.