Technical evaluation of the potential for streamlining of equipment validation for fermentation applications

The purpose of this article is to provide a few concrete examples of the potential to acceptably reduce the scope of validation and qualification testing based on scientific justification for the specific area of microbial fermentation. The key areas explored include: autoclave operational qualification (OQ) testing, autoclave load pattern testing, vessel sterilize-in-place testing, spore strip use and failure investigation, grouping of D-values for media and concentrated nutrients, influence of temperature on D-values, and equipment clean-in-place cleaning agent/recovery studies. Suggestions are offered based on technical data and engineering analysis of the procedures involved. Methodologies are described for how to evaluate the systems being tested relative to processing requirements to determine which testing might be minimized and which testing might warrant expansion. The ultimate risk to quality then must be evaluated by the designated quality control groups within the organization for the specific process and equipment in use.     

Survey of equipment in general practice.

Partners in general practice have to buy any equipment they want themselves. As a result partners in high investing practices have lower net incomes. Of the 297 practices in Devon and Cornwall, 265 responded to a questionnaire listing 115 possible items of practice equipment. Overall, practices seemed to be fairly well equipped. Key findings were that 193 of those who responded had an electrocardiograph, 206 had a kit for minor operations, 119 owned a computer, and less than one third owned a microscope. Most of these practices were high investors. There seems to be a shift away from some traditional instruments towards expensive information technology. Government policies are encouraging the use of computers and such equipment, though funds are not necessarily being made available for this purpose.     

Plasma-based organism evaluation equipment using atmospheric-pressure plasma jets: Efficacy for controlling insect pests

Alternative insect pest control methods are necessary for efficient pest management with reduced dependency on pesticides. Here, we report the biological responses of several insect species to, and the insecticidal efficacy of, reactive oxygen species (ROS) generated using atmospheric-pressure plasma jets. Plasma-based organism evaluation equipment (PBOEE) consisting of a plasma-generating acrylic chamber, plasma-maintaining acrylic chamber, and plasma efficacy evaluation container was developed. The PBOEE system enabled determination of the insecticidal efficacy of ROS free from the adverse effects of high temperature; moreover, four different exposures could be achieved within one run. The biological responses of five major insect pests (Aphis gossypii, Bemisia tabaci, Helicoverpa armigera, Tetranychus kanzawai, and Thrips palmi) were assessed, with a focus on knockdown time, recovery time, and median lethal time (LT₅₀). With short-term exposure (< 3 min), B. tabaci showed the fastest knockdown time (38.4 ± 2.7 s) and the slowest recovery time (699 ± 133 s), and no mortality was noted in any of the five species. On the other hand, with long-term exposure (< 21 min), insecticidal efficacy was observed in B. tabaci and T. palmi, which showed LT₅₀ values of 6.3 and 9.6 min, respectively. The PBOEE system can be used to determine the optimal exposure time for evaluating the insecticidal efficacy of plasma against insect pests, and plasma can be used for future control of some insect pests.     

Soft networks for bridging the gap between research and practice: illuminative evaluation of CHAIN

Objectives To explore the process of knowledge exchange in an informal email network for evidence based health care, to illuminate the value of the service and its critical success factors, and to identify areas for improvement.Design Illuminative evaluation.Setting Targeted email and networking service for UK healthcare practitioners and researchers.Participants 2800 members of a networking service.Main outcome measures Tracking of email messages, interviews with core staff, and a qualitative analysis of messages, postings from focus groups, and invited and unsolicited feedback to the service.Results The informal email network helped to bridge the gap between research and practice by serving as a rich source of information, providing access to members'' experiences, suggestions, and ideas, facilitating cross boundary collaboration, and enabling participation in networking at a variety of levels. Ad hoc groupings and communities of practice emerged spontaneously as members discovered common areas of interest.Conclusion This study illuminated how knowledge for evidence based health care can be targeted, personalised, and made meaningful through informal social processes. Critical success factors include a broad based membership from both the research and service communities; a loose and fluid network structure; tight targeting of messages based on members'' interests; the presence of a strong network identity and culture of reciprocity; and the opportunity for new members to learn through passive participation.     

Ultrasensitive profiling and sequencing of N-linked oligosaccharides using standard DNA-sequencing equipment

The analysis of protein-linked glycans is of increasing importance, both in basic glycobiological research and during the production process of glycoprotein pharmaceuticals. In many cases, the amount of glycoprotein available for typing the glycans is very low. This, combined with the high branching complexity typical for this class of compounds, makes glycan typing a challenging task. We present here methodology allowing the medium-throughput analysis of N-glycans derived from low picomole amounts of glycoproteins using the standard DNA-sequencing equipment available in any life sciences laboratory. The high sensitivity of the overall analytical process (from glycoprotein to results) is obtained using state-of-the-art deglycosylation procedures combined with a highly efficient and reproducible novel postderivatization cleanup step involving Sephadex G10 packed 96-well filterplates. All sample preparation steps (enzymatic deglycosylation with PNGase F, desalting, derivatization with 8-amino-1,3,6-pyrenetrisulfonic acid, and postderivatization cleanup) are performed using 96-well-based plates. This integrated sample preparation scheme is also compatible with capillary electrophoresis and MALDI-TOF-MS platforms already in use in some glycobiology labs and anticipates the higher throughput that will be offered by the capillary-array-based DNA sequencers currently penetrating the market. The described technology should bring high-performance glycosylation analysis within reach of each life sciences lab and thus help expedite the pace of discovery in the field of glycobiology.     

Performance evaluation of Baermann techniques: The quest for developing a microscopy reference standard for the diagnosis of Strongyloides stercoralis

BackgroundSoil-transmitted helminths (STH) are common in low and middle income countries where there is lack of access to clean water and sanitation. Effective diagnosis and treatment are essential for the control of STH infections. However, among STH parasites, Strongyloides stercoralis is the most neglected species, both in diagnostics and control strategies. Diagnostic methods cover different approaches, each with different sensitivities and specificities, such as serology, molecular techniques and microscopy based techniques. Of the later, the Baermann technique is the most commonly used procedure. In the literature, several ways have been described to perform the Baermann method, which illustrates the overall lack of a ‘(gold) reference standard’ method for the diagnosis of S. stercoralis infection. In this study we have evaluated the performance of three Baermann techniques in order to improve the reference standard for the microscopic diagnosis of S. stercoralis infection thereby facilitating individual case detection, mapping of the disease and proper evaluation of treatment responses.Methods/Principal findingsA community based cross sectional study was conducted at Zenzelima, Bahir Dar Zuria Ethiopia. A total of 437 stool samples were collected and analyzed by the following procedures: conventional Baermann (CB), modified Baermann (MB), and modified Baermann with charcoal pre-incubation (MBCI). The diagnostic sensitivity and Negative Predictive Value (NPV) of each technique was calculated using the combination of all the three techniques as a composite reference standard. Our result indicated that larvae of S. stercoralis were detected in 151 (34.6%) stool samples. The prevalence of S. stercoralis infection based on the three diagnostic methods was 9.6%, 8.0%, and 31.3% by CB, MB, and MBCI respectively. The sensitivity and NPV for CB, MB, and MBCI were 26.7% and 70.8%, 22.1% and 69.6%, and 87.0% and 93.2%, respectively. The MBCI showed significant difference (P- value = <0.001) in the sensitivity and NPV values when compared with CB and MB values. The agreement between CB, MB, and MBCI with the composite reference standard was 31.8%, 26.7%, 89.6%, respectively.Conclusion/SignificanceOur results suggest the superior performance of MBCI. It is relatively easy to implement, simple to perform and comparatively cheaper. The CB is by far the commonly used method in routine diagnostic although this technique significantly underestimates the true burden of the disease and thereby contributing to the exclusion of S. stercoralis from the control strategies. Therefore, MBCI is recommended as a routine microscopy-based diagnostic test for S. stercoralis infection, particularly in settings where molecular procedures are not available.     

《芒属种质资源描述规范和数据标准》的制定

目前芒属植物被视为最有前景的木质纤维素能源作物,在中国、美国、日本和欧洲国家得到了广泛研究和利用。但截至目前依然没有统一的芒属植物种质资源描述规范,一定程度上阻碍了其信息的共享与交流。鉴于此,本研究通过开展芒属植物种质资源描述和数据制定技术标准研究,旨在为芒属能源作物品种的选育、审定与推广提供科学规范的依据。本文论述了芒属种质资源描述规范、数据标准与数据质量控制规范的制定原则、方法与内容,对于促进整合全国芒属种质资源,规范芒属种质资源的收集、保存、评价具有指导作用。     

Thermal performance and emission characteristics of unvented biomass-burning cookstoves: A proposed standard method for evaluation

A method is proposed to measure emissions of air pollutants from unvented biomass-burning cookstoves and to incorporate a measure of these emissions in the existing way of rating cookstoves by thermal efficiency. Emission factors for the three metal stoves tested burning Acacia nilotica were found to range between 13 and 68 g kg⁻¹ for carbon monoxide and between 1·1 and 3·9 g kg⁻¹ for total suspended particulates and to increase with increasing thermal efficiency both within a stove and across stoves. Emissions for a uniform standard task — the proposed performance index — were, however, lower for total suspended particulates for the more efficient stoves but higher for CO, indicating that the increases in efficiency were not able to offset the greatly increased CO emission factors.     

Synthesis and evaluation of L-cystathionine as a standard for amino acid analysis

L-Cystathionine is a key nonprotein amino acid related to metabolic conditions. The quantitative determination of L-cystathionine in physiological fluids by amino acid analysis is important for clinical diagnosis; however, certified reference material for L-cystathionine with satisfactory purity, content, and quantity has been unavailable until recently. Consequently, a practical and simple method for the preparation of L-cystathionine was examined, which involves thioalkylation of N-tert-butoxycarbonyl-L-cysteine tert-butyl ester, derived from L-cystine, with (2S)-2-(tert-butoxycarbonyl)amino-4-iodobutanoic acid tert-butyl ester, derived from L-aspartic acid, to obtain L-cystathionine with protecting groups, followed by single-step deprotection under mild conditions. This method produces L-cystathionine in high purity (99.4%) and having sufficient percentage content according to amino acid analysis, which could be used as a standard for the amino acid analysis of physiological fluids.     

Should biochemical markers of bone turnover be considered standard practice for safety pharmacology?

The success in biomedical sciences such as genomics and proteomics is not paralleled in the medical product development methods. The consequence of this is a lack of translation into improved drug safety and efficacy. Therefore the US Food and Drug Administration (FDA) introduced the Critical Path Initiative in 2004 to modernize drug development and safety pharmacology. Bone is that largest tissue by weight, and is continuously remodelled. Changes in bone turnover lead to complications such as osteoporosis and fracture, that is associated with an increased mortality. Recent findings have identified bone as a possible endocrine organ and the availability of valid biochemical bone markers suggests that assessing bone turnover should also play an important role in general safety pharmacology.     

Prospective evaluation of the safety and efficacy of laparoscopic jejunostomy.

We prospectively assessed the safety and efficacy of laparoscopic jejunostomy done by 11 surgeons in 8 medical centers using the T-fastener technique. In all, 23 men and 13 women aged 19 to 84 (mean, 59) years required enteral feeding, but could not undergo gastrostomy and had no contraindication to laparoscopy. Of these patients, 12 had head and neck cancer and 11 had neurologic swallowing dysfunction. The procedure took 25 to 180 minutes (mean, 75). Three (8%) early cases were converted to open jejunostomy because of accidental enterotomies caused by inappropriate techniques that were avoided in later cases. Minor technical problems, such as passing a needle through the back wall of the jejunum, occurred in 7 patients, but they were easily corrected and produced no complications. Feedings were routinely begun within 24 hours of the surgical procedure. All jejunostomy catheters functioned well. This is a safe and effective technique when done by experienced laparoscopic surgeons, and serious complications are rare.     

Physiological testing of basketball players: toward a standard evaluation of anaerobic fitness

The aim of this study was to examine whether the changes in the rules of the game instituted in 2000 have modified the physiological factors of success in basketball. The performances of 8 elite male players and 8 average-level players were compared in order to identify which components of fitness among agility, speed, anaerobic power, anaerobic capacity, and upper body strength were key determinants of performance in modern basketball. Each subject performed 7 tests, including vertical jump (VJ), 20-m sprint, agility T test, suicide sprint, 30-second Wingate anaerobic test (WAnT), isokinetic testing of the knee extensors, and 1 repetition maximum (1RM) bench press test. The statistical difference in the anaerobic performances was assessed by Student's t test. The main results showed that, compared to average-level players, elite-level players achieved significantly better performances in the agility T test (+6.2%), VJ test (+8.8%), peak torques developed by knee extensors (+20.2%), and 1RM bench press (+18.6%, p < 0.05). In contrast, no significant difference between groups was observed on 20-m sprint, suicide run, and parameters of the WAnT (p > 0.05). These results emphasized the importance of anaerobic power in modern basketball, whereas anaerobic capacity does not seem to be a key aspect to consider. In this context, coaches are advised to avoid using exercises lasting >/=30 seconds in their physical fitness programs, but instead to focus on short and intense tests such as VJ, agility T test, and sprints over very short distances (5 or 10 m).     

Methods, equipment and techniques for rural health care and their evaluation

It is obvious that any strategy for village health care must involve the people actively--something that is more easily said than done. There is hardly any technology for rural health that does not have a significant software component. Why is it that so much that is known cannot be applied? What factors may be important in the diffusion of technology in a rural society? Technology must address itself to the needs as perceived by the people (in addition to what is perceived as their needs by the health care system). It must be compatible with the knowledge and skill levels of the community. Benefits must be visible to the community through appropriate assessment and feedback procedures so as to secure greater and greater involvement.     

Reference material for the evaluation of a standard method for the detection of salmonellas in foods and feeding stuffs

To evaluate a standard salmonella isolation method a reference material consisting of 0.2 g spray-dried milk inoculated with Salmonella typhimurium and contained in gelatin capsules was prepared. The organisms were distributed homogeneously between capsules, and their numbers were stable for 120 d when the capsules were stored in dry conditions at 4 degrees C. Addition of these capsules with or without food samples to pre-enrichment broth gave low and reproducible levels of Salm. typhimurium contamination without altering the pre-enrichment and without influencing the other bacterial flora present. As a result of an interlaboratory trial, the reference material indicated that the food and/or its competitive flora may have a negative influence on the detection of salmonellas.     

Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units

Background

There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials.

Methods

A collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis.

Results

Our recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP.

Conclusion

We argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.