Common Technical Specifications Research Articles

Comparing private and public approaches to state megaproject implementation: The R100-R101 airship development case study

State support is critical to enhancing a country’s capacity for innovation and for delivering large-scale complex projects where significant upfront investment is required. These megaprojects are high risk due to their size, investment level, time duration and the type of innovation required. Their complexity means that context affects decision-making, innovation approach taken and project implementation. We utilise the 1921 Great Britain Imperial Airship Scheme to examine the impact of environment on the delivery by a State/government firm and a Private firm of a megaproject bound by common technical specifications. Edquist’s System of Innovation (2006) was used to examine the context; Flyvbjerg’s four sublimes (2012, 2014) to examine shifting stakeholder motivations, and Morris and Geraldi (2011) project management levels to critically examine how the megaproject unfolded. We argue the value of using select contemporary theory to deepen understanding of past historical megaproject implementation and perceptions of success.

Performance of the SAMBA I and II HIV-1 Semi-Q Tests for viral load monitoring at the point-of-care

Although access to antiretroviral therapy for HIV infection is increasing in resource-poor countries, viral load testing for monitoring of treatment efficacy remains limited, expensive, and confined to centralized laboratories. The SAMBA HIV-1 Semi-Q Test is a nucleic acid–based amplification assay developed for viral load monitoring performed on either the semi-automated SAMBA I system for laboratory use or the fully automated SAMBA II system for point-of care use. We have assessed the performance characteristics of the SAMBA HIV-1 Semi-Q Test on SAMBA I and SAMBA II systems according to the Common Technical Specifications of the European Community's 98/79 In Vitro Diagnostic Medical Devices Directive. The sensitivity, specificity, reproducibility, and viral subtype coverage of the test were similar on the SAMBA I and SAMBA II platforms. The clinical performance on the SAMBA I system was compared with the Roche CAP/CTM assay and evaluated in-house with 130 patient specimens from London as well as in the field with 390 specimens in Kenya and Zimbabwe. The overall concordance between the SAMBA and CAP/CTM assays was 98.1%. The clinical performance of the test on the SAMBA II platform in comparison with the Abbott HIV-1 RealTime Assay was evaluated in-house with 150 specimens from Ukraine, yielding a concordance of 98.0%. The results thus show that the SAMBA HIV-1 Semi-Q Test performs equivalently on SAMBA I and SAMBA II, and they suggest that the test is suitable for implementation at the point-of-care in resource-poor regions where viral load testing is desperately needed but often unavailable.

Revision of the Regulatory Framework for Medical Devices in the European Union: The Legal Challenges

This special edition of the European Journal of Risk Regulation deals with a highly topical, complex and controversial subject matter – the reform of the regulation of medical devices in the European Union.At first sight, and as further detailed in the following articles, there appears to be a general consensus about the need to improve the EU (and indeed the US) regulatory framework on medical devices, especially for high-risk categories of devices. Stakeholders including representatives of the industry, patient and consumer organizations, national authorities, healthcare professionals, agree that there is a need for change. However, opinions differ on what needs to be changed and how. Three alternatives for reform of the current EU systemof regulation have been debated over the past years: the adoption of a pharmastyle system of pre-market authorisation; maintaining the status quo but strengthening implementation and supervision in the Member States; or finally, introducing common technical specifications together with specific guidelines for certain high-risk devices.

Straight vegetable oil use in Micro-Gas Turbines: System adaptation and testing

The aim of this research work is to investigate the use of straight vegetable sunflower oil (SFO), a liquid biofuel, in a Micro-Gas Turbine (MGT). Compared to conventional diesel engines, micro-gas turbines represent a very reliable, clean and performing small scale cogeneration technology. Commercial gas turbines have already been tested with unconventional fuels, such as biomass derived fuels; however, research work on using Straight Vegetable Oil (SVO) as fuel in MGTs are really scarce.The chemical and physical characteristics of SVO are different from fossil diesel oil and rather far from the common technical specifications for gas turbine liquid fuels, not only in terms of kinematic viscosity and Lower Heating Value, but also as regards other issues as contaminant levels and composition, fuel cold properties, ignition properties, etc. Therefore, particular attention has to be given to the atomization and evaporation phases, as these are the most critical steps to achieve stable and efficient long term operation.An analysis based on numerical correlations available from literature was initially adopted for the analysis of the atomization process, supported by CFD modeling to qualitatively investigate the flow pattern. Control parameters were revised and set so to produce a sunflower oil spray having evaporation time comparable to diesel, and minor adaptations to the fuel line were designed and installed on the MGT.Tests with blends and straight vegetable oil were carried out to assess the difference between the standard and the modified machine, fed by diesel, in terms of exhaust emissions, power output and performances, that were similar to the standard diesel-fed MGT. Measured exhaust emissions were as expected well below those typical of diesel engines of the same size fed with VO. The experimental campaign confirmed that it is possible to operate a MGT fed with SVO through the adoption of minor modifications and by adjusting control parameters.

Analytical sensitivity of four HIV combined antigen/antibody assays using the p24 WHO standard

Background The Common Technical Specifications for HIV-1 p24 assays published in 2009 fixed the lower limit of detection for obtaining C.E. approval at 2 IU/ml against the WHO standard (first international reference, code NIBSC 90/636); it was previously 50 pg/ml. Some recent fourth generation HIV assays that simultaneously detect antigen and antibody are equivalent to p24 assays, but they were mainly evaluated using p24 antigen standards in pg/ml and little is known of their performance with the IU/ml standard. Objectives To evaluate four of the combined serological assays most commonly used for HIV diagnosis in France against the WHO standard in IU/ml. Study design The analytical sensitivity of four combined p24 antigen and antibody assays (ARCHITECT HIV Ag/Ab Combo, AxSYM HIV Ag/Ab Combo, VIDAS HIV DUO Quick and VIDAS HIV DUO Ultra) and of one p24 assay (VIDAS HIV p24 II) were determined using dilutions of the WHO standard. Results Four of the five assays had a lower limit of detection below 2 IU/ml: 1.24 for ARCHITECT Combo, 0.66 for VIDAS DUO Ultra, 0.43 for VIDAS DUO Quick and 0.73 to 1.15 for VIDAS p24, while that of AxSYM was close to 2 (1.94–2.25). Conclusions We have provided the first data on the lower limit of detection of HIV combined assays using the IU/ml WHO standard and demonstrated the need for a single international standard for comparing assays. We recommend the use of this approach in medical laboratory to validate on site their methods.

The National Blood Service (England) Approach to Evaluation of Kits for Detecting Infectious Agents

Blood services test their donations for a range of infectious agents before release for transfusion. To ensure that the assays used have appropriate sensitivity, subtype detection range, and specificity, and meet operational requirements (timeliness, automation, and process control), some form of selection is needed. The approach of the English National Blood Service (NBS) to the evaluation of commercial kits to assess their suitability is presented. As a centrally coordinated national service the NBS has the "critical mass" and can generate the economies of scale, to support a national kit evaluation group (KEG). Because England is within the European Union, KEG has no "licensing" function for manufacturers' kits which must be "Communautés Européennes marked" before they can be sold within the Union. The European Union's in vitro diagnostics directive sets out common technical specifications which manufacturers must meet. There are also UK ethical constraints on the use of patient/donor blood or tissue samples which must be complied with. In this context, KEG assesses the specificity of assays in collaboration with the blood center donation testing departments. The sensitivity of assays is determined in collaboration with the Health Protection Agency and the NBS National Transfusion Microbiology Reference Laboratory using performance panels, seroconversion panels, and a large range of divergent strains to assess detection range.

Derivation Of Common Safety TargetsFor The European Railways

Revitalizing the railways is a top priority of the European Union’s common transport policy. A declared objective is to aim towards the creation of a homogeneous European Railway that should help increase the share of railway traffic throughout Europe. At the moment the technical and operational fragmentation between the different Member States are seen as main obstacles to the competitiveness of railway transport, not only for cross-border operations, but also with Member states as it may hinder competition for the provision of railway services. Such considerations have led recently to the development of common solutions (i.e. ERTMS/ETCS for signaling) as well as to common technical specifications to allow interoperability (i.e. TSIs for high-speed and conventional railways). It is recognized that his drive towards interoperability also needs to be accompanied by some convergence in safety practices across Member States. This is meant on the one hand to maintain a high level of safety on the whole European railway network, and on the other hand to facilitate access to new entrants wishing to offer services in any country. The so-called Safety Directive has recently been adopted by the European Parliament and is intended to provide a common framework for achieving such a convergence. Among other provisions, the Safety Directive requires the gradual introduction of Common Safety targets. These will have to eventually be proposed for adoption by the new European Railway Agency. Common Safety Targets is a sensitive issue, hence the need for a large consensus building currently ongoing. This paper will present some aspects of the discussion that took place on this subject in the European Research project SAMRAIL. Emphasis is placed upon the various ways the Common Safety Targets could be defined and set.

The new European directive on in vitro diagnostics.

The Directive on in vitro Diagnostic Medical Devices (IVDD 98/79/EC) was officially adopted by the European Union (EU) on December 7, 1998. The IVDD aims to supplement the legal framework of the European Community, which governs the conditions for the placing on the market of medical devices, by extending the already implemented legislation to the category of in vitro diagnostic medical devices (IVDs). They consist of those devices, including reagents and reagent products, calibrator materials or instruments, as well as specimen receptacles, intended by the manufacturer for the in vitro analysis of specimens derived from the human body. This directive has introduced at the European level common regulatory requirements across Europe for the safety, quality and performance of in vitro diagnostics (IVDs), incorporating them into medical device legislation. It harmonizes the conformity assessment procedures to be applied by manufacturers before they place IVDs on the market. For certain products expressly specified in the directive, of which the most important are used for the evaluation of the safety of blood supply and patient testing, the manufacturer will have to take into account in their performance evaluation the so-called "Common Technical Specifications" (CTS). These are needed to establish the performance characteristics of the IVDs in evaluation and have the same status as harmonized standards. In the meantime, the IVD directive has been transposed into national law in all EU countries. During a transitional period ending in December 2003, manufacturers will have the option of following pre-existing national regulatory processes or taking their IVDs through the new procedures as specified in the directive. Following this, starting from 7th December 2003, adherence to the directive regulations will become mandatory, and only IVDs bearing the "Communautés Européennes (CE) mark" can then be sold in the EU.

Deployment status and common technical specifications for a B-PON system

Broadband passive optical networks (B-PONs) have entered the commercial deployment phase in North America, Japan, and Europe. Nippon Telegraph and Telephone, BellSouth, France Telecom, British Telecommunications p.l.c., and SBC have developed a set of common technical specifications (CTS) for a B-PON system based on ITU-T Recommendations G.983.1, G.983.2 and G.983.3. They have deployed or plan to deploy B-PON systems based on this CTS. This article describes B-PON interface features, the outline of the CTS, and the deployment status of the B-PON systems around the world.