News from the Biological Stain Commission No. 12

Abstract

In this 12^th issue of News from the Biological Stain Commission (BSC) under the heading of Regulatory affairs, the Biological Stain Commission’s International Affairs Committee presents information from the meetings of ISO/TC 212/WG 1 Quality and competence in the medical laboratory and ISO/TC 212/WG 3 In vitro diagnostic products both held on 2 – 3 June 2010, plus information on the second plenary meeting of ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems held on 4 June 2010. All meetings took place in Seoul, Republic of Korea. Finally, information is provided concerning the 25^th meeting of CEN/TC 140 In vitro diagnostic medical devices held on 23 June 2010 in Berlin, Germany.     

News from the BSC No. 8

Abstract

In the 8th and following issues of News from the Biological Stain Commission (BSC), under the heading of Regulatory affairs, the BSC's International Affairs Committee will present information from a meeting held in Ghent, Belgium on 15–18 June 2009 concerning the progress achieved by the International Standards Organization Committee ISO/TC 212 Clinical Laboratory Testing and in Vitro Diagnostic Test Systems since the last meeting held in Vancouver, Canada in 2008. A note on the meaning and significance of E numbers found on the labels of foodstuffs and beverages sold for human consumption concludes this edition of News from the Biological Stain Commission.     

Orcein,a traditional stain revealed: some introductory remarks

In the three earlier editions of News from the Biological Stain Commission (BSC), under the heading of “Regulatory affairs,” the BSC's International Affairs Committee reported on the work of Technical Committee 212, Clinical Laboratory Testing and in Vitro Diagnostic Test Systems of the International Standards Organization (ISO/TC 212) and its working groups, WG 1, WG 2 and WG 3. In this issue of News from the BSC, H.O. Lyon provides information from the annual meeting of ISO/TC 212 that took place June 2–4, 2008 in Vancouver, British Columbia, Canada. In addition, under the heading of “Certification,” J.A. Kiernan examines the certification procedure for thionine used by the BSC laboratory in Rochester, NY.     

News from the Biological Stain Commission No. 7

Abstract

In this issue of News from the Biological Stain Commission (BSC), under the heading of Regulatory affairs, the Biological Stain Commission's International Affairs Committee presents information from a meeting held in Berlin by the International Standards Organization ISO/TC 212/WG 1, “Quality and Competence in the Medical Laboratory,” on 11–12 December 2008. After this, we turn again to problems with impure dyes and find that solvent dyes are impure even for non-biological use.     

Galectin-1 attenuates cardiomyocyte hypertrophy through splice-variant specific modulation of CaV1.2 calcium channel

Pressure overload-induced cardiac hypertrophy occurs in response to chronic blood pressure increase, and dysfunction of Ca_V1.2 calcium channel involves in cardiac hypertrophic processes by perturbing intracellular calcium concentration ([Ca²⁺]_i) and calcium-dependent signaling. As a carbohydrate-binding protein, galectin-1 (Gal-1) is found to bind with Ca_V1.2 channel, which regulates vascular Ca_V1.2 channel functions and blood pressure. However, the potential roles of Gal-1 in cardiac Ca_V1.2 channel (Ca_V1.2_CM) and cardiomyocyte hypertrophy remain elusive. By whole-cell patch clamp, we find Gal-1 decreases the I_Ca,L with or without isoproterenol (ISO) application by reducing the channel membrane expression in neonatal rat ventricular myocytes (NRVMs). Moreover, Gal-1 could inhibit the current densities of Ca_V1.2_CM by an alternative exon 9*-dependent manner in heterologously expressed HEK293 cells. Of significance, overexpression of Gal-1 diminishes ISO or KCl-induced [Ca²⁺]_i elevation and attenuates ISO-induced hypertrophy in NRVMs. Mechanistically, Gal-1 decreases the ISO or Bay K8644-induced phosphorylation of intracellular calcium-dependent signaling proteins δCaMKII and HDAC4, and inhibits ISO-triggered translocation of HDAC4 in NRVMs. Pathologically, we observe that the expressions of Gal-1 and Ca_V1.2_E9* channels are synchronously increased in rat hypertrophic cardiomyocytes and hearts. Taken together, our study indicates that Gal-1 reduces the channel membrane expression to inhibit the currents of Ca_V1.2_CM in a splice-variant specific manner, which diminishes [Ca²⁺]_i elevation, and attenuates cardiomyocyte hypertrophy by inhibiting the phosphorylation of δCaMKII and HDAC4. Furthermore, our work suggests that dysregulated Gal-1 and Ca_V1.2 alternative exon 9* might be attributed to the pathological processes of cardiac hypertrophy, and provides a potential anti-hypertrophic target in the heart.     

How LCA studies deal with uncertainty

In recent years many workers have examined the implications of various sources of uncertainty for the reliability of Life Cycle Assessment (LCA). Indeed, the International Standardization Organization (ISO) has recognised the relevance of this work by including several cautionary statements in the ISO 14040 series of standards. However, in practice, there is a risk that the significance of these uncertainties for the results of an LCA could be overlooked as practitioners strive to complete studies on time and within budget. This paper presents the findings of a survey of LCA studies we made to determine the extent to which the problem of uncertainty had been dealt with in practice. This survey revealed that the significance of the limitations on the reliability of LCA results given in the standards has not been fully appreciated by practitioners. We conclude that the standards need to be revised to ensure that LCA studies include at least a qualitative discussion on all relevant aspects of uncertainty.     

Selective multinationality how environmental management helps high-tech SMES identify high-growth,low-risk markets

Background  Small and medium sized enterprises in developed regions, as well as larger ‘Southern’ firms are more exposed to risk in regards to allocation decisions. This includes expenditures on fixed assets, R&D and environmental management, as well as the choice of suitable markets for the product or service at hand. For either type of firm, the consequences of not selecting, or timing, suitable markets can lead to bankruptcy. Objectives  This paper examines means for SMEs to expand internationally given the current fiscal climate, and rapid advances in certain enabling technologies. The goal is to identify a set of criteria which smaller firms can use to globalize which reduce risk and increase access to capital. Methods  Case studies are presented of a European Start-Up as well as a century-old Latin American firm, both in the water-treatment sector. The similarities in the risk-reward profiles are used to identify some key strategic guidelines for enterprises wishing to be, selectively, multinational. Results and Discussion  Selective multinationality is an immediate plan for international expansion which identifies the most appropriate markets, independent of their proximity to the firm’s production base or headquarters. At the base of selective multinationality, is the goal to impose the firm’s product in regions of high growth, high selling price and low risk of price dumping. Therefore, this requires theto resist the temptation to expand to markets based on merely geographical proximity. The globalization strategy should be established, along with environmental management, from the outset of the creation of the firm. It will be shown, herein, to be a key driver in the valuation of High Tech industrial SMEs, in particular those with high risk-high reward tradeoffs. Selective multinationality can best be implemented if the firm in question has a technology which addresses unmet needs in niche markets, where there is an expanding customer base focusing on client relationships and cost effectiveness, and where the multinationals enter from outside the sector via resellers. It will be demonstrated to be effective for startups from developed regions, as well as SMEs from developing/emerging countries, to both of whom the consequences of sub-optimal resource allocation can risk the future of the firm itself. Therefore, SMEs can, with appropriate planning and the integration of marketing and environmental strategies, become, selectively, global firms, with better credit access and sales growth, concomitant with lower risks. The High Tech industrial SME will succeed better if, from the outset, they behave like the organization they want to become, with globalization a key element of strategy, from the business plan foreword. Two case studies are presented, one documenting the water sector and die other the cost savings possible by integrating environmental management into die firm’s strategy.     

Using LCA to examine greenhouse gas abatement policy

The site-generic approach currently adopted by the Life Cycle Assessment (LCA) methodology introduces uncertainties into the impact assessment phase of an LCA study. These uncertainties are greatest for localised and short-lived problems but are less significant for long lasting, cumulative environmental effects. Indeed, the reliability of LCA results is high for problems that manifest at a global scale. Nevertheless, even though these results are considered accurate, it is still often unclear as to their relevance in terms of policy development and decision-making. Therefore, this paper demonstrates how LCA can be used to determine the efficacy of policies aimed at reducing a product system’s contribution to global environmental problems. We accomplish this aim by presenting a case study that evaluates the greenhouse gas contributions of each stage in the life cycle of containerboard packaging and the potential impact on emissions of various policy options available to decision makers. Our analysis showed that in general the most useful strategy was to recycle the used packaging. However, our analysis also indicated that when measures are taken to eliminate sources of methane emissions and encourage the use of plantation timber then recycling is no longer beneficial from a greenhouse perspective. This is because the process energy required in the form of gas and electricity is substantially greater for containerboard manufactured from recycled material than it is for virgin fibre.     

Evaluation of the flow-dialysis technique for analysis of protein-ligand interactions: an experimental and a monte carlo study

Flow dialysis has found widespread use in determining the dissociation constant (KD) of a protein-ligand interaction or the amount of available binding sites (E0). This method has the potency to measure both these parameters in a single experiment and in this article a method to measure simultaneously the KD and E0 is presented, together with an extensive error analysis of the method. The flow-dialysis technique is experimentally simple to perform. However, a number of practical aspects of this method can have a large impact on the outcome of KD and E0. We have investigated all sources of significant systematic and random errors, using the interaction between mannitol and its transporter from Escherichia coli as a model. Monte Carlo simulations were found to be an excellent tool to assess the impact of these errors on the binding parameters and to define the experimental conditions that allow their most accurate estimation.     

Nonrecovery of varying proportions of viable bacteria during spread plating governed by the extent of spreader usage and proposal for an alternate spotting-spreading approach to maximize the CFU

Aims: To elucidate the cause of high variations and inconsistencies in bacterial CFU observed within and between different experiments while assessing viable bacterial counts through spread plating (SP). Methods and Results: Following the inconsistent results, CFU estimations were undertaken through conventional SP using the spreader, or a modified approach that did not use spreader employing four organisms. The latter approach involving spotting‐and‐tilt‐spreading of inoculum on agar surface [spotting spreading (SS)] yielded higher CFU by 11–120% over the weighted average depending on the organism and diluent. The adverse effect owing to the spreader was the most obvious in Escherichia coli followed by Staphylococcus epidermidis, Enterobacter cloacae and Bacillus pumilus. Plate attributes that determined the surface moisture levels of agar medium and the spreading practice adopted by the personnel formed two other major influencing factors. Plating for shorter periods (<60 s) using fresh 15/20 ml plates caused loss of 3–12% CFU owing to inoculum adhesion to spreader irrespective of glass or polypropylene make. On the other hand, prolonging the plating brought down the CFU significantly. Spreader movement on agar surface subsequent to the exhaustion of free moisture, which was marked by the experiencing of some friction to smooth spreader movement, was detrimental to vegetative cells, while Bacillus spores were less affected. Conclusions: The study brings out that the way SP is carried out exerts significant effects on CFU influenced by plate conditions. Prolonged use of spreader on dry agar surface could be highly detrimental to bacterial cells. A mild use of spreader accounting for spreader‐adhering inoculum or the practice of SS not involving the spreader is recommended. Significance and Impact of the Study: This study unravels the effects owing to the spreader on bacterial cells and the CFU and recommends an alternate approach of SS to minimize CFU inconsistencies and to maximize the viable bacterial counts.