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Sample records for european reference laboratories

  1. The added value of a European Union tuberculosis reference laboratory network--analysis of the national reference laboratory activities.

    PubMed

    Drobniewski, F A; Nikolayevskyy, V; Hoffner, S; Pogoryelova, O; Manissero, D; Ozin, A J

    2008-03-18

    National reference laboratories (NRL) and other laboratories are the cornerstones of well-functioning tuberculosis programmes and surveillance activities. However, the scope and activity of NRL services for mycobacterial identification and drug susceptibility testing (DST) has not been examined in detail across the European Union (EU), nor has the added value of cooperation and networking at the European level been explored with regard to strengthening laboratory services. Therefore, the European Centre for Disease Prevention and Control (ECDC) has commissioned a survey to explore these issues and to identify areas of work that could bring added value by supporting networking activities of tuberculosis (TB) reference laboratories in the EU. Structured questionnaires were sent to TB reference laboratory experts in the EU and European Economic Area (EEA) countries, and in three additional countries selected on the basis of their networking activities with EU projects and other initiatives (Switzerland, Croatia and Israel). The compiled results describe the activities and structure of 32 NRLs (29 countries replied, a response rate of 91%). The analysis of the survey led to the following recommendations for strengthening TB laboratory services: (1) implementing of the published European standards for TB laboratory services with respect to infrastructure, national reference functions, biosafety, human resources, quality assurance, operational research (including evaluation of new medical diagnostics), accuracy and speed, appropriately trained staff; (2) ensuring that laboratories only perform activities for which they have demonstrated proficiency; (3) implement validated and standardised second-line drug susceptibility testing (DST), including drugs used to define extensively drug-resistant tuberculosis (XDR TB); (4) aiming to identify Mycobacterium tuberculosis complex (MTBC) and rifampicin (RIF) resistance in over 90% of cultures and cases from smear-positive sputum

  2. Evaluation of molecular typing of foodborne pathogens in European reference laboratories from 2012 to 2013.

    PubMed

    Schjørring, Susanne; Niskanen, Taina; Torpdahl, Mia; Björkman, Jonas T; Nielsen, Eva Møller

    2016-12-15

    In 2012, the European Centre for Disease Prevention and Control (ECDC) initiated external quality assessment (EQA) schemes for molecular typing including the National Public Health Reference Laboratories in Europe. The overall aim for these EQA schemes was to enhance the European surveillance of food-borne pathogens by evaluating and improving the quality and comparability of molecular typing. The EQAs were organised by Statens Serum Institut (SSI) and included Salmonella enterica subsp. enterica, verocytotoxin-producing Escherichia coli (VTEC) and Listeria monocytogenes. Inter-laboratory comparable pulsed-field gel electrophoresis (PFGE) images were obtained from 10 of 17 of the participating laboratories for Listeria, 15 of 25 for Salmonella, but only nine of 20 for VTEC. Most problems were related to PFGE running conditions and/or incorrect use of image acquisition. Analysis of the gels was done in good accordance with the provided guidelines. Furthermore, we assessed the multilocus variable-number tandem repeat analysis (MLVA) scheme for S. Typhimurium. Of 15 laboratories, nine submitted correct results for all analysed strains, and four had difficulties with one strain only. In conclusion, both PFGE and MLVA are prone to variation in quality, and there is therefore a continuous need for standardisation and validation of laboratory performance for molecular typing methods of food-borne pathogens in the human public health sector. This article is copyright of The Authors, 2016.

  3. Evaluation of molecular typing of foodborne pathogens in European reference laboratories from 2012 to 2013

    PubMed Central

    Schjørring, Susanne; Niskanen, Taina; Torpdahl, Mia; Björkman, Jonas T; Nielsen, Eva Møller

    2016-01-01

    In 2012, the European Centre for Disease Prevention and Control (ECDC) initiated external quality assessment (EQA) schemes for molecular typing including the National Public Health Reference Laboratories in Europe. The overall aim for these EQA schemes was to enhance the European surveillance of food-borne pathogens by evaluating and improving the quality and comparability of molecular typing. The EQAs were organised by Statens Serum Institut (SSI) and included Salmonella enterica subsp. enterica, verocytotoxin-producing Escherichia coli (VTEC) and Listeria monocytogenes. Inter-laboratory comparable pulsed-field gel electrophoresis (PFGE) images were obtained from 10 of 17 of the participating laboratories for Listeria, 15 of 25 for Salmonella, but only nine of 20 for VTEC. Most problems were related to PFGE running conditions and/or incorrect use of image acquisition. Analysis of the gels was done in good accordance with the provided guidelines. Furthermore, we assessed the multilocus variable-number tandem repeat analysis (MLVA) scheme for S. Typhimurium. Of 15 laboratories, nine submitted correct results for all analysed strains, and four had difficulties with one strain only. In conclusion, both PFGE and MLVA are prone to variation in quality, and there is therefore a continuous need for standardisation and validation of laboratory performance for molecular typing methods of food-borne pathogens in the human public health sector. PMID:28006653

  4. Spectroscopy applied to feed additives of the European Union Reference Laboratory: a valuable tool for traceability.

    PubMed

    Omar, Jone; Slowikowski, Boleslaw; Boix, Ana; von Holst, Christoph

    2017-08-01

    Feed additives need to be authorised to be placed on the market according to Regulation (EU) No. 1831/2003. Next to laying down the procedural requirements, the regulation creates the European Union Reference Laboratory for Feed Additives (EURL-FA) and requires that applicants send samples to the EURL-FA. Once authorised, the characteristics of the marketed feed additives should correspond to those deposited in the sample bank of the EURL-FA. For this purpose, the submitted samples were subjected to near-infrared (NIR) and Raman spectroscopy for spectral characterisation. These techniques have the valuable potential of characterising the feed additives in a non-destructive manner without any complicated sample preparation. This paper describes the capability of spectroscopy for a rapid characterisation of products to establish whether specific authorisation criteria are met. This study is based on the analysis of feed additive samples from different categories and functional groups, namely products containing (1) selenium, (2) zinc and manganese, (3) vitamins and (4) essential oils such as oregano and thyme oil. The use of chemometrics turned out to be crucial, especially in cases where the differentiation of spectra by visual inspection was very difficult.

  5. Role of Sample Processing Strategies at the European Union National Reference Laboratories (NRLs) Concerning the Analysis of Pesticide Residues.

    PubMed

    Hajeb, Parvaneh; Herrmann, Susan S; Poulsen, Mette E

    2017-07-19

    The guidance document SANTE 11945/2015 recommends that cereal samples be milled to a particle size preferably smaller than 1.0 mm and that extensive heating of the samples should be avoided. The aim of the present study was therefore to investigate the differences in milling procedures, obtained particle size distributions, and the resulting pesticide residue recovery when cereal samples were milled at the European Union National Reference Laboratories (NRLs) with their routine milling procedures. A total of 23 NRLs participated in the study. The oat and rye samples milled by each NRL were sent to the European Union Reference Laboratory on Cereals and Feedingstuff (EURL) for the determination of the particle size distribution and pesticide residue recovery. The results showed that the NRLs used several different brands and types of mills. Large variations in the particle size distributions and pesticide extraction efficiencies were observed even between samples milled by the same type of mill.

  6. External quality assessment for molecular typing of Salmonella 2013-2015: performance of the European national public health reference laboratories.

    PubMed

    Jensen, M B F; Schjørring, S; Björkman, J T; Torpdahl, M; Litrup, E; Nielsen, E M; Niskanen, T

    2017-06-01

    We report the results of three consecutive External Quality Assessments (EQAs) for molecular subtyping of Salmonella to assess the performance of the European national public health reference laboratories (NPHRLs). The EQA included the molecular typing methods used for European enhanced surveillance of human Salmonella infections: pulsed field gel electrophoresis (PFGE), including gel analysis by the use of the software BioNumerics, and 5-locus multiple locus variable number of tandem repeat analysis (MLVA) for serovar Typhimurium. The participation in the PFGE laboratory part was higher (27/35) than in the gel analysis (19/35) and MLVA (15/35), suggestive of the need for capacity building in methods requiring specialized equipment (MLVA) or software (gel analysis). The majority (25/27) of the participating NPHRLs produced inter-laboratory comparable PFGE gel(s). Two laboratories continued to produce low-quality gels and should have additional technical assistance in the future. In particular, two gel quality evaluation parameters, measuring "image acquisition and running conditions" and "bands", were identified to cause gel quality problems throughout the EQAs. Despite the high number of laboratories participating in the PFGE laboratory part, the participation in gel analysis was low, although increasing. In the MLVA part, the NPHRLs correctly assigned 96% (405/420) allelic profiles according to the nomenclature. In conclusion, the EQAs identified critical parameters for unsuccessful performance and helped to offer assistance to those laboratories that needed it most. The assessments supported the development of quality in molecular typing and promoted the harmonization of subtyping methods used for EU/EEA-wide surveillance of human Salmonella infections.

  7. The work of the European Union Reference Laboratory for Food Additives (EURL) and its support for the authorisation process of feed additives in the European Union: a review

    PubMed Central

    von Holst, Christoph; Robouch, Piotr; Bellorini, Stefano; de la Huebra, María José González; Ezerskis, Zigmas

    2016-01-01

    ABSTRACT This paper describes the operation of the European Union Reference Laboratory for Feed Additives (EURL) and its role in the authorisation procedure of feed additives in the European Union. Feed additives are authorised according to Regulation (EC) No. 1831/2003, which introduced a completely revised authorisation procedure and also established the EURL. The regulations authorising feed additives contain conditions of use such as legal limits of the feed additives, which require the availability of a suitable method of analysis for official control purposes under real world conditions. It is the task of the EURL to evaluate the suitability of analytical methods as proposed by the industry for this purpose. Moreover, the paper shows that one of the major challenges is the huge variety of the methodology applied in feed additive analysis, thus requiring expertise in quite different analytical areas. In order to cope with this challenge, the EURL is supported by a network of national reference laboratories (NRLs) and only the merged knowledge of all NRLs allows for a scientifically sound assessment of the analytical methods. PMID:26540604

  8. Microscopic diagnosis of sodium acetate-acetic acid-formalin-fixed stool samples for helminths and intestinal protozoa: a comparison among European reference laboratories.

    PubMed

    Utzinger, J; Botero-Kleiven, S; Castelli, F; Chiodini, P L; Edwards, H; Köhler, N; Gulletta, M; Lebbad, M; Manser, M; Matthys, B; N'Goran, E K; Tannich, E; Vounatsou, P; Marti, H

    2010-03-01

    The present study aimed to compare the diagnostic performance of different European reference laboratories in diagnosing helminths and intestinal protozoa, using an ether-concentration method applied to sodium acetate-acetic acid-formalin (SAF)-preserved faecal samples. In total, 102 stool specimens were analysed during a cross-sectional parasitological survey in urban farming communities in Côte d'Ivoire. Five SAF-preserved faecal samples were prepared from each specimen and forwarded to the participating reference laboratories, processed and examined under a microscope adhering to a standard operating procedure (SOP). Schistosoma mansoni (cumulative prevalence: 51.0%) and hookworm (cumulative prevalence: 39.2%) were the predominant helminths. There was excellent agreement (kappa > 0.8; p < 0.001) among the reference laboratories for the diagnosis of S. mansoni, hookworm, Trichuris trichiura and Ascaris lumbricoides. Moderate agreement (kappa = 0.54) was found for Hymenolepis nana, and lesser agreement was observed for other, less prevalent helminths. The predominant intestinal protozoa were Entamoeba coli (median prevalence: 67.6%), Blastocystis hominis (median prevalence: 55.9%) and Entamoeba histolytica/Entamoeba dispar (median prevalence: 47.1%). Substantial agreement among reference laboratories was found for E. coli (kappa = 0.69), but only fair or moderate agreement was found for other Entamoeba species, Giardia intestinalis and Chilomastix mesnili. There was only poor agreement for B. hominis, Isospora belli and Trichomonas intestinalis. In conclusion, although common helminths were reliably diagnosed by European reference laboratories, there was only moderate agreement between centres for pathogenic intestinal protozoa. Continued external quality assessment and the establishment of a formal network of reference laboratories is necessary to further enhance both accuracy and uniformity in parasite diagnosis.

  9. Health-based reference intervals for ALAT, ASAT and GT in serum, measured according to the recommendations of the European Committee for Clinical Laboratory Standards (ECCLS).

    PubMed

    Leino, A; Impivaara, O; Irjala, K; Mäki, J; Peltola, O; Järvisalo, J

    1995-05-01

    The reference intervals for the activities of L-alanine aminotransferase (EC 2.6.1.2, ALAT), L-aspartate aminotransferase (EC 2.6.1.1, ASAT) and gamma-glutamyltransferase (EC 2.3.2.2, GT) in serum were determined according to the recommendations of the European Committee for Clinical Laboratory Standards (ECCLS). Serum specimens from 954 subjects were analysed for ALAT and ASAT and from 794 subjects for GT. The subjects, aged 27-67 years, were participants in general health surveys. The reference population was formed by excluding subjects with any disease, or on any medication, affecting the liver, and also those consuming excessive amounts of alcohol. The 95% inner reference intervals for ALAT and ASAT were 9-50 (n = 189) and 15-36 U l-1 (n = 192) in men and 8-38 (n = 270) and 13-33 U l-1 (n = 270) in women. For GT the reference interval was 11-58 in men (n = 165) and 8-42 U l-1 in women (n = 220). Serum GT levels correlated clearly with alcohol consumption. Serum ALAT and ASAT were only slightly associated with alcohol consumption at levels less than 280 g per week in men and 190 g per week in women. There were modest positive associations between the three enzyme levels and body mass index. None of the enzymes correlated significantly with age.

  10. Requirements for Reference (Calibration) Laboratories in Laboratory Medicine

    PubMed Central

    Siekmann, Lothar

    2007-01-01

    In addition to reference measurement procedures and reference materials, reference or calibration laboratories play an integral role in the implementation of measurement traceability in routine laboratories. They provide results of measurements using higher-order methods, e.g. isotope dilution mass spectrometry and may assign values to materials to be used for external quality assessment programs and to secondary reference materials. The requirements for listing of laboratories that provide reference measurement services include a statement of the metrological level or principle of measurement, accreditation as a calibration laboratory according to ISO 15195 and the participation in a proficiency testing system (regular inter-laboratory comparisons) for reference laboratories. Ring trials are currently conducted for thirty well-defined measurands and the results are made available to all laboratories. Through the use of reference laboratory services that are listed by the Joint Committee for Traceability in Laboratory Medicine there is the opportunity to further promote traceability and standardisation of laboratory measurements. PMID:18392129

  11. European Vertical Reference System Influence in Latvia

    NASA Astrophysics Data System (ADS)

    Celms, A.; Reķe, I.; Ratkevičs, A.

    2015-11-01

    Till 1 December, 2014, in Latvia the heights were determined in Baltic Normal Height System 1977. The national height system is determined by the Cabinet of Ministers and internal laws. Now for the change of the national height system to reconcile it with the European Vertical Reference System, amendments to the laws and regulations have been developed, but so far only the amendment to the Geospatial Information Law is in force, the amendment to the regulation of the Cabinet of Ministers is still not approved. This amendment declares the Latvia Height System based on the European Vertical Reference System in Latvia as the national height system. For height transformation, there is a transformation formula for each European country. After calculations it is seen that height difference between Baltic Normal Height System 1977 and European Vertical Reference System depends on point location in the territory (coordinates). This unequal height difference between both height systems will cause unequal height values on border connection points between Baltic countries. The aim of the research is to evaluate the European Vertical Reference System in Latvia. To reach the aim the following tasks are set: 1) to evaluate the components of transformation formulas; 2) using the transformation formulas to calculate height differences between Baltic Normal Height System 1977 and the European Vertical Reference System realization EVRF2007 for the territory of Latvia and also between Baltic Normal Height System 1977 and the Latvia Normal Height System; 3) to get height differences in the European Vertical Reference System on the borderlines of Latvia - Estonia and Latvia - Lithuania.

  12. A European Humus Forms Reference Base

    NASA Astrophysics Data System (ADS)

    Zanella, A.; Englisch, M.; Ponge, J.-F.; Jabiol, B.; Sartori, G.; Gardi, C.

    2012-04-01

    From 2003 on, a panel of experts in humus and humus dynamics (Humus group) has been working about a standardisation and improvement of existing national humus classifications. Some important goals have been reached, in order to share data and experiences: a) definition of specific terms; b) description of 15 types of diagnostic horizons; c) of 10 basic humus forms references; d) subdivision of each main reference in 2-4 sub-unities; e) elaboration of a general European Humus Form Reference Base (http://hal-agroparistech.archives-ouvertes.fr/docs/00/56/17/95/PDF/Humus_Forms_ERB_31_01_2011.pdf); f) publication of the scientific significance of this base of classification as an article [A European morpho-functional classification of humus forms. Geoderma, 164 (3-4), 138-145]. The classification will be updated every 2 years and presently the Humus group is assessing biological (general: soil, vegetation, biome; specific: fungi, bacteria, pedofauna), physical (air temperature, rainfall) and chemical (pH, mineral elements, organic matter, quality and quantity of humic components…) factors which characterize basic humus forms and their varieties. The content of the new version of the classification is planned to be more "practical", like an ecological manual which lists associated humus forms and environmental data in the aim to contribute to a more precise environmental diagnosis of every analysed terrestrial and semiterrestrial European ecosystem. The Humus group is also involved in an endeavour to include humus forms in the World Reference Base for Soils (WRB-FAO) according to nomenclatural principles erected for soil profiles. Thirty basic references have been defined, complemented by a set of qualifiers (prefixes and suffixes), allowing to classify European humus forms and probably a large majority of humus forms known worldwide. The principles of the classification, the diagnostic horizons and humus forms main references are presented at the General Assembly of

  13. Establishing reference intervals in the coagulation laboratory.

    PubMed

    Castellone, D D

    2017-05-01

    Obtaining a reference interval (RI) is a challenge for any laboratory and becomes more complicated in the coagulation laboratory due to testing on samples with limited stability on reagents that are poorly standardized. Reference intervals are required to be able to evaluate results in relation to a patients' hemostatic disorder. This becomes one of the most important tasks conducted in the coagulation laboratory. However, many laboratories lack the time, finances and in many cases the expertise to conduct this study. Many RI are obtained from package inserts, or from publications written by experts in lieu of laboratories conducting their own studies. An overview of validating reference intervals and options for verifying or transference of reference intervals is discussed. Based on the confidence interval and the acceptability of risk laboratories are willing to accept, coagulation laboratories have options to conduct robust studies for their RI. Data mining or global reference studies may help to provide data for age specific ranges. Pre-analytical variables and selection of healthy subjects have the largest impact on coagulation testing outcomes and need to be well controlled during the establishment of reference intervals. Laboratories have options in lieu of conducting a full validation on how to verify RI based on smaller RI studies or transference of RI after determining compatibility of the original RI study. © 2017 John Wiley & Sons Ltd.

  14. The European network of Biosafety-Level-4 laboratories: enhancing European preparedness for new health threats.

    PubMed

    Nisii, C; Castilletti, C; Di Caro, A; Capobianchi, M R; Brown, D; Lloyd, G; Gunther, S; Lundkvist, A; Pletschette, M; Ippolito, G

    2009-08-01

    Emerging and re-emerging infections and possible bioterrorism acts will continue to challenge both the medical community and civilian populations worldwide, urging health authorities to respond rapidly and effectively. Established in 2005, the European Community (EC)-funded European Network of Biosafety-Level-4 laboratories (Euronet-P4), which brings together the laboratories in Porton Down, London, Hamburg, Marburg, Solna, Lyon and Rome, seeks to increase international collaboration in the areas of high containment laboratory biosafety and viral diagnostic capability, to strengthen Europe's capacity to respond to an infectious disease emergency, and to offer assistance to countries not equipped with such costly facilities. Network partners have agreed on a common strategy to fill the gaps identified in the field of risk group-4 agents' laboratory diagnosis, namely the lack of standardization and of reference samples. The network has received a further 3-year funding, to offer assistance to external laboratories, and to start the planning of field activities.

  15. Laboratory medicine in the European Union.

    PubMed

    Oosterhuis, Wytze P; Zerah, Simone

    2015-01-01

    The profession of laboratory medicine differs between countries within the European Union (EU) in many respects. The objective of professional organizations of the promotion of mutual recognition of specialists within the EU is closely related to the free movement of people. This policy translates to equivalence of standards and harmonization of the training curriculum. The aim of the present study is the description of the organization and practice of laboratory medicine within the countries that constitute the EU. A questionnaire covering many aspects of the profession was sent to delegates of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and Union Européenne de Médecins Spécialistes (UEMS) of the 28 EU countries. Results were sent to the delegates for confirmation. Many differences between countries were identified: predominantly medical or scientific professionals; a broad or limited professional field of interest; inclusion of patient treatment; formal or absent recognition; a regulated or absent formal training program; general or minor application of a quality system based on ISO Norms. The harmonization of the postgraduate training of both clinical chemists and of laboratory physicians has been a goal for many years. Differences in the organization of the laboratory professions still exist in the respective countries which all have a long historical development with their own rationality. It is an important challenge to harmonize our profession, and difficult choices will need to be made. Recent developments with respect to the directive on Recognition of Professional Qualifications call for new initiatives to harmonize laboratory medicine both across national borders, and across the borders of scientific and medical professions.

  16. [The National Reference Centres and Reference Laboratories. Importance and tasks].

    PubMed

    Laude, G; Ammon, A

    2005-09-01

    Since 1995, the German Federal Ministry for Health and Social Security funds National Reference Centres (NRC) for the laboratory surveillance of important pathogens and syndromes. Which pathogens or syndromes are selected to be covered by a NRC depends on their epidemiological relevance, the special diagnostic tools, problems with antimicrobial resistance and necessary infection control measures. Currently, there are 15 NRC, which are appointed for a period of 3 years (currently from January 2005 through December 2007). Towards the end of their appointment all NRC are evaluated by a group of specialists. The assessment of their achievements is guided by a catalogue of tasks for the NRC. In addition to the NRC, a total of 50 laboratories are appointed which provide specialist expertise for additional pathogens in order to have a broad range of pathogens for which specialist laboratories are available. Their predominant task is to give advice and support for special diagnostic problems. Both NRC and the specialist laboratories are important parts of the network for infectious disease epidemiology.

  17. The role of leptospirosis reference laboratories.

    PubMed

    Hartskeerl, Rudy A; Smythe, Lee D

    2015-01-01

    The general goal of reference centres is to support the community, from diagnostic laboratories to research institutions, in the execution of their work by providing reference strains and reagents and giving instructions and recommendations to individual colleagues and national and international organisations on a wide variety of issues. There are different levels of reference centres, from local to international, with an increasing package of tasks and responsibilities. Local reference centres might limit activities to diagnostic confirmation by applying standard testing, while international reference centres cover a wider range of activities from design, validation and harmonisation of diagnostic and reference technologies to international monitoring associated with recommendations on the global burden and distribution of leptospirosis and its prevention and control to national and international health decision makers. This chapter focusses on four major pillars constituting reference tasks in addition to the obvious provision of reference substances, i.e. Research and training, Diagnosis, Identification of Leptospira and Surveillance. Due to financial and organisational constraints, reference centres are restricted in their capacity for basic research and consequently focus on applied research into various aspects of leptospirosis. They offer training, either individually or groupwise, that might vary from standard technologies to novel sophisticated methodologies, depending on the need and requests of the trainee. Most reference centres are involved in the confirmation of preliminary diagnosis obtained at peripheral levels, such as local hospitals and health centres, while other major activities involve the design and validation of diagnostics, their international harmonisation and quality assurance. Identification of causative Leptospira strains (or serovars) is key to the identification of infection sources and is critical for surveillance. Hence, reference

  18. Public health microbiology in Germany: 20 years of national reference centers and consultant laboratories.

    PubMed

    Beermann, Sandra; Allerberger, Franz; Wirtz, Angela; Burger, Reinhard; Hamouda, Osamah

    2015-10-01

    In 1995, in agreement with the German Federal Ministry of Health, the Robert Koch Institute established a public health microbiology system consisting of national reference centers (NRCs) and consultant laboratories (CLs). The goal was to improve the efficiency of infection protection by advising the authorities on possible measures and to supplement infectious disease surveillance by monitoring selected pathogens that have high public health relevance. Currently, there are 19 NRCs and 40 CLs, each appointed for three years. In 2009, an additional system of national networks of NRCs and CLs was set up in order to enhance effectiveness and cooperation within the national reference laboratory system. The aim of these networks was to advance exchange in diagnostic methods and prevention concepts among reference laboratories and to develop geographic coverage of services. In the last two decades, the German public health laboratory reference system coped with all major infectious disease challenges. The European Union and the European Centre for Disease Prevention and Control (ECDC) are considering implementing a European public health microbiology reference laboratory system. The German reference laboratory system should be well prepared to participate actively in this upcoming endeavor.

  19. Towards European urinalysis guidelines. Introduction of a project under European Confederation of Laboratory Medicine.

    PubMed

    Kouri, T T; Gant, V A; Fogazzi, G B; Hofmann, W; Hallander, H O; Guder, W G

    2000-07-01

    Improved standardized performance is needed because urinalysis continues to be one of the most frequently requested laboratory tests. Since 1997, the European Confederation of Laboratory Medicine (ECLM) has been supporting an interdisciplinary project aiming to produce European urinalysis guidelines. More than seventy clinical chemists, microbiologists and ward-based clinicians, as well as representatives of manufacturers are taking part. These guidelines aim to improve the quality and consistency of chemical urinalysis, particle counting and bacterial culture by suggesting optimal investigative processes that could be applied in Europe. The approach is based on medical needs for urinalysis. The importance of the pre-analytical stage for total quality is stressed by detailed illustrative advice for specimen collection. Attention is also given to emerging automated technology. For cost containment reasons, both optimum (ideal) procedures and minimum analytical approaches are suggested. Since urinalysis mostly lacks genuine reference methods (primary reference measurement procedures; Level 4), a novel classification of the methods is proposed: comparison measurement procedures (Level 3), quantitative routine procedures (Level 2), and ordinal scale examinations (Level 1). Stepwise strategies are suggested to save costs, applying different rules for general and specific patient populations. New analytical quality specifications have been created. After a consultation period, the final written text will be published in full as a separate document.

  20. Cost-containment and the use of reference laboratories.

    PubMed

    Shaw, S T; Miller, J M

    1985-12-01

    Hospital laboratories and hospital-independent reference laboratories will need to change in order to provide comprehensive, medically appropriate, and reasonably priced laboratory services in the cost-containment age we are entering. The change must be economically and technologically innovative and relevant to society's next generation of health care needs. Hospital laboratories and commercial laboratories may become weaker or stronger relative to one another, but our guess is that they will ultimately become more like one another or even may join forces to provide optimal patient care in the future. Until that time comes, hospital laboratories must decide whether to employ reference laboratory services more or less, enter a joint venture with a reference laboratory, or become a reference laboratory. Some of the items that could be considered in arriving at this decision are listed in Table 2. Some items favor hospital laboratories; some favor reference laboratories; some are a toss-up; and some suggest there are advantages in a team approach. For the present, we believe there are many arguments favoring a continuation and possibly even an expansion of hospital laboratory services, but this will likely be most feasible in financially sound and progressive hospitals having forward-looking administrators and imaginative but fiscally minded laboratory directors and managers. If decisions are made to send more tests to reference laboratories, each hospital or user laboratory must seek the best and most cost-effective services available. Various financial, technical, and medical considerations are described that should aid in the evaluation of where to have tests performed. We have provided suggestions on how agreements with reference laboratories can be established in either a formal (contractual) or an informal (verbal) way. Additionally, we have described methods for evaluating (or monitoring) the quality and quantity of services received from a reference

  1. Pharmacogenomics Implementation: Considerations for Selecting a Reference Laboratory.

    PubMed

    Vo, Teresa T; Bell, Gillian C; Owusu Obeng, Aniwaa; Hicks, J Kevin; Dunnenberger, Henry M

    2017-09-01

    One of the initial steps for implementing pharmacogenomics into routine patient care is selecting an appropriate clinical laboratory to perform the testing. With the rapid advances in genotyping technologies, many clinical laboratories are now performing pharmacogenomic testing. Selection of a reference laboratory depends on whether a particular genotype assay is already performed by an internal health care organization laboratory or only available externally. Other factors for consideration are coverage of genomic variants important for the patient population, technical support, and cost. In some instances, the decision to select a particular reference laboratory may be the responsibility of the clinician who is recommending genomic interrogation. Only limited guidance is available that describes the laboratory characteristics to consider when selecting a reference laboratory. We provide practical considerations for selecting a clinical laboratory for pharmacogenomic testing broadly categorized into four domains: pharmacogene and variant selection; logistics; reporting of results; and test costs along with reimbursement. © 2017 Pharmacotherapy Publications, Inc.

  2. Physical fitness reference standards in European children: the IDEFICS study.

    PubMed

    De Miguel-Etayo, P; Gracia-Marco, L; Ortega, F B; Intemann, T; Foraita, R; Lissner, L; Oja, L; Barba, G; Michels, N; Tornaritis, M; Molnár, D; Pitsiladis, Y; Ahrens, W; Moreno, L A

    2014-09-01

    A low fitness status during childhood and adolescence is associated with important health-related outcomes, such as increased future risk for obesity and cardiovascular diseases, impaired skeletal health, reduced quality of life and poor mental health. Fitness reference values for adolescents from different countries have been published, but there is a scarcity of reference values for pre-pubertal children in Europe, using harmonised measures of fitness in the literature. The IDEFICS study offers a good opportunity to establish normative values of a large set of fitness components from eight European countries using common and well-standardised methods in a large sample of children. Therefore, the aim of this study is to report sex- and age-specific fitness reference standards in European children. Children (10,302) aged 6-10.9 years (50.7% girls) were examined. The test battery included: the flamingo balance test, back-saver sit-and-reach test (flexibility), handgrip strength test, standing long jump test (lower-limb explosive strength) and 40-m sprint test (speed). Moreover, cardiorespiratory fitness was assessed by a 20-m shuttle run test. Percentile curves for the 1st, 3rd, 10th, 25th, 50th, 75th, 90th, 97th and 99th percentiles were calculated using the General Additive Model for Location Scale and Shape (GAMLSS). Our results show that boys performed better than girls in speed, lower- and upper-limb strength and cardiorespiratory fitness, and girls performed better in balance and flexibility. Older children performed better than younger children, except for cardiorespiratory fitness in boys and flexibility in girls. Our results provide for the first time sex- and age-specific physical fitness reference standards in European children aged 6-10.9 years.

  3. Defining Chlorophyll-a Reference Conditions in European Lakes

    PubMed Central

    Alves, Maria Helena; Argillier, Christine; van den Berg, Marcel; Buzzi, Fabio; Hoehn, Eberhard; de Hoyos, Caridad; Karottki, Ivan; Laplace-Treyture, Christophe; Solheim, Anne Lyche; Ortiz-Casas, José; Ott, Ingmar; Phillips, Geoff; Pilke, Ansa; Pádua, João; Remec-Rekar, Spela; Riedmüller, Ursula; Schaumburg, Jochen; Serrano, Maria Luisa; Soszka, Hanna; Tierney, Deirdre; Urbanič, Gorazd; Wolfram, Georg

    2010-01-01

    The concept of “reference conditions” describes the benchmark against which current conditions are compared when assessing the status of water bodies. In this paper we focus on the establishment of reference conditions for European lakes according to a phytoplankton biomass indicator—the concentration of chlorophyll-a. A mostly spatial approach (selection of existing lakes with no or minor human impact) was used to set the reference conditions for chlorophyll-a values, supplemented by historical data, paleolimnological investigations and modelling. The work resulted in definition of reference conditions and the boundary between “high” and “good” status for 15 main lake types and five ecoregions of Europe: Alpine, Atlantic, Central/Baltic, Mediterranean, and Northern. Additionally, empirical models were developed for estimating site-specific reference chlorophyll-a concentrations from a set of potential predictor variables. The results were recently formulated into the EU legislation, marking the first attempt in international water policy to move from chemical quality standards to ecological quality targets. PMID:20401659

  4. Quality control for diagnostic oral microbiology laboratories in European countries.

    PubMed

    Rautemaa-Richardson, Riina; der Reijden Wa, Wil A Van; Dahlen, Gunnar; Smith, Andrew J

    2011-01-01

    Participation in diagnostic microbiology internal and external quality control (QC) processes is good laboratory practice and an essential component of a quality management system. However, no QC scheme for diagnostic oral microbiology existed until 2009 when the Clinical Oral Microbiology (COMB) Network was created. At the European Oral Microbiology Workshop in 2008, 12 laboratories processing clinical oral microbiological samples were identified. All these were recruited to participate into the study and six laboratories from six European countries completed both the online survey and the first QC round. Three additional laboratories participated in the second round. Based on the survey, European oral microbiology laboratories process a significant (mean per laboratory 4,135) number of diagnostic samples from the oral cavity annually. A majority of the laboratories did not participate in any internal or external QC programme and nearly half of the laboratories did not have standard operating procedures for the tests they performed. In both QC rounds, there was a large variation in the results, interpretation and reporting of antibiotic susceptibility testing among the laboratories. In conclusion, the results of this study demonstrate the need for harmonisation of laboratory processing methods and interpretation of results for oral microbiology specimens. The QC rounds highlighted the value of external QC in evaluating the efficacy and safety of processes, materials and methods used in the laboratory. The use of standardised methods is also a prerequisite for multi-centre epidemiological studies that can provide important information on emerging microbes and trends in anti-microbial susceptibility for empirical prescribing in oro-facial infections.

  5. Measurement comparisons of radioactivity among European monitoring laboratories for the environment and food stuff.

    PubMed

    Wätjen, U; Spasova, Y; Altzitzoglou, T

    2008-01-01

    For more than 15 years, European Union (EU) laboratories monitoring environmental radioactivity have been obliged to participate in measurement comparisons organised by the European Commission. After a short review of comparisons conducted during the 1990s, the approach of IRMM organising these comparisons since 2003 is presented. It relies on the provision of comparison samples with reference values traceable to the International Reference System for radionuclides (SIR). The results of the most recent comparison, the determination of (40)K, (90)Sr and (137)Cs in milk powder, are presented. The influence of repetitive participation in measurement comparisons on laboratory performance is studied on the basis of data from more than 20 laboratories having participated in several exercises during the last 15 years.

  6. Wide variability in laboratory reference values for serum testosterone.

    PubMed

    Lazarou, Stephen; Reyes-Vallejo, Luis; Morgentaler, Abraham

    2006-11-01

    The laboratory determination of testosterone levels consistent with a diagnosis of hypogonadism is complicated by the availability of multiple testosterone assays and varying reference ranges. To assess current laboratory practices regarding availability of testosterone assays and use of reference values. A telephone survey of 12 academic, 12 community medical laboratories, and one national laboratory. Types of androgen assays offered and determination of reference values. All of the academic and eight of the community centers performed total testosterone testing. Free testosterone was performed in-house by six of the 12 academic and one community center. Testing for bioavailable testosterone, free androgen index, and percent free testosterone was performed in-house by no more than two centers. There were eight and four different assays used for total and free testosterone, respectively. One national laboratory offered equilibrium dialysis measurement of free testosterone. Of the 25 labs, there were 17 and 13 different sets of reference values for total and free testosterone, respectively. The low reference value for total testosterone ranged from 130 to 450 ng/dL (350% difference), and the upper value ranged from 486 to 1,593 ng/dL (325% difference). Age-adjusted reference values were applied in four centers for total testosterone and in seven labs for free testosterone. All reference values were based on a standard statistical model without regard for clinical aspects of hypogonadism. Twenty-three of the 25 lab directors responded that clinically relevant testosterone reference ranges would be preferable to current standards. Laboratory reference values for testosterone vary widely, and are established without clinical considerations.

  7. Establishing an enteric bacteria reference laboratory in Sierra Leone.

    PubMed

    Chattaway, Marie Anne; Kamara, Abdul; Rhodes, Fay; Kaffeta, Konneh; Jambai, Amara; Alemu, Wondimagegnehu; Islam, Mohammed Sirajul; Freeman, Molly M; Welfare, William; Harding, Doris; Samba, Ahmed F; Abu, Musu; Kamanda, Sylvester; Grant, Kathie; Jenkins, Claire; Nair, Satheesh; Connell, Steve; Siorvanes, Lisa; Desai, Sarika; Allen, Collette; Frost, Margaret; Hughes, Daniel; Jeffrey, Zonya; Gill, Noel; Salter, Mark

    2014-06-09

    In 2012, Sierra Leone experienced its worst cholera outbreak in over 15 years affecting 12 of the country's 13 districts. With limited diagnostic capability, particularly in bacterial culture, the cholera outbreak was initially confirmed by microbiological testing of clinical specimens outside of Sierra Leone. During 2012 - 2013, in direct response to the lack of diagnostic microbiology facilities, and to assist in investigating and monitoring the cholera outbreak, diagnostic and reference services were established in Sierra Leone at the Central Public Health Reference Laboratory focusing specifically on isolating and identifying Vibrio cholerae and other enteric bacterial pathogens. Sierra Leone is now capable of confirming cholera cases by reference laboratory testing.

  8. Comparison of the Vitek 2 Antifungal Susceptibility System with the Clinical and Laboratory Standards Institute (CLSI) and European Committee on Antimicrobial Susceptibility Testing (EUCAST) Broth Microdilution Reference Methods and with the Sensititre YeastOne and Etest Techniques for In Vitro Detection of Antifungal Resistance in Yeast Isolates ▿ ‖

    PubMed Central

    Cuenca-Estrella, Manuel; Gomez-Lopez, Alicia; Alastruey-Izquierdo, Ana; Bernal-Martinez, Leticia; Cuesta, Isabel; Buitrago, Maria J.; Rodriguez-Tudela, Juan L.

    2010-01-01

    The commercial technique Vitek 2 system for antifungal susceptibility testing of yeast species was evaluated. A collection of 154 clinical yeast isolates, including amphotericin B- and azole-resistant organisms, was tested. Results were compared with those obtained by the reference procedures of both the CLSI and the European Committee on Antimicrobial Susceptibility Testing (EUCAST). Two other commercial techniques approved for clinical use, the Etest and the Sensititre YeastOne, were included in the comparative exercise as well. The average essential agreement (EA) between the Vitek 2 system and the reference procedures was >95%, comparable with the average EAs observed between the reference procedures and the Sensititre YeastOne and Etest. The EA values were >97% for Candida spp. and stood at 92% for Cryptococcus neoformans. Intraclass correlation coefficients (ICC) between the commercial techniques and the reference procedures were statistically significant (P < 0.01). Percentages of very major errors were 2.6% between Vitek 2 and the EUCAST technique and 1.6% between Vitek 2 and the CLSI technique. The Vitek 2 MIC results were available after 14 to 18 h of incubation for all Candida spp. (average time to reading, 15.5 h). The Vitek 2 system was shown to be a reliable technique to determine antifungal susceptibility testing of yeast species and a more rapid and easier alternative for clinical laboratories than the procedures developed by either the CLSI or EUCAST. PMID:20220169

  9. Comparison of the Vitek 2 antifungal susceptibility system with the clinical and laboratory standards institute (CLSI) and European Committee on Antimicrobial Susceptibility Testing (EUCAST) Broth Microdilution Reference Methods and with the Sensititre YeastOne and Etest techniques for in vitro detection of antifungal resistance in yeast isolates.

    PubMed

    Cuenca-Estrella, Manuel; Gomez-Lopez, Alicia; Alastruey-Izquierdo, Ana; Bernal-Martinez, Leticia; Cuesta, Isabel; Buitrago, Maria J; Rodriguez-Tudela, Juan L

    2010-05-01

    The commercial technique Vitek 2 system for antifungal susceptibility testing of yeast species was evaluated. A collection of 154 clinical yeast isolates, including amphotericin B- and azole-resistant organisms, was tested. Results were compared with those obtained by the reference procedures of both the CLSI and the European Committee on Antimicrobial Susceptibility Testing (EUCAST). Two other commercial techniques approved for clinical use, the Etest and the Sensititre YeastOne, were included in the comparative exercise as well. The average essential agreement (EA) between the Vitek 2 system and the reference procedures was >95%, comparable with the average EAs observed between the reference procedures and the Sensititre YeastOne and Etest. The EA values were >97% for Candida spp. and stood at 92% for Cryptococcus neoformans. Intraclass correlation coefficients (ICC) between the commercial techniques and the reference procedures were statistically significant (P<0.01). Percentages of very major errors were 2.6% between Vitek 2 and the EUCAST technique and 1.6% between Vitek 2 and the CLSI technique. The Vitek 2 MIC results were available after 14 to 18 h of incubation for all Candida spp. (average time to reading, 15.5 h). The Vitek 2 system was shown to be a reliable technique to determine antifungal susceptibility testing of yeast species and a more rapid and easier alternative for clinical laboratories than the procedures developed by either the CLSI or EUCAST.

  10. Interlaboratory ring trial to evaluate CFT proficiency of European laboratories for diagnosis of glanders in equids.

    PubMed

    Laroucau, K; Colaneri, C; Jaÿ, M; Corde, Y; Drapeau, A; Durand, B; Zientara, S; Beck, C

    2016-06-18

    To evaluate the routine complement fixation test (CFT) used to detect Burkholderia mallei antibodies in equine sera, an interlaboratory proficiency test was held with 24 European laboratories, including 22 National Reference Laboratories for glanders. The panels sent to participants were composed of sera with or without B mallei antibodies. This study confirmed the reliability of CFT and highlighted its intralaboratory reproducibility. However, the sensitivity of glanders serodiagnosis and laboratory proficiency may be improved by standardising critical reagents, including antigens, and by developing a standard B mallei serum. British Veterinary Association.

  11. Transport equations of electrodiffusion processes in the laboratory reference frame.

    PubMed

    Garrido, Javier

    2006-02-23

    The transport equations of electrodiffusion processes use three reference frames for defining the fluxes: Fick's reference in diffusion, solvent-fixed reference in transference numbers, and laboratory fluxes in electric conductivity. The convenience of using only one reference frame is analyzed here from the point of view of the thermodynamics of irreversible processes. A relation between the fluxes of ions and solvent and the electric current density is deduced first from a mass and volume balance. This is then used to show that (i) the laboratory and Fick's diffusion coefficients are identical and (ii) the transference numbers of both the solvent and the ion in the laboratory reference frame are related. Finally, four experimental methods for the measurement of ion transference numbers are analyzed critically. New expressions for evaluating transference numbers for the moving boundary method and the chronopotentiometry technique are deduced. It is concluded that the ion transport equation in the laboratory reference frame plays a key role in the description of electrodiffusion processes.

  12. The European Micropaleontological Reference Centre in Kraków

    NASA Astrophysics Data System (ADS)

    Kaminski, Michael; Waskowska, Anna; Bebenek, Slawomir; Pilarz, Monika

    2016-04-01

    We are pleased to announce the establishment of the European Micropaleontological Reference Centre, housed in the offices of Micropress Europe at the AGH University of Science & Technology in Krakow, Poland. The new European Micropaleontological Reference Centre is an initiative of the Grzybowski Foundation and Micropress Europe. The centre is designed to serve the micropaleontological community by providing a permanent repository or "museum" for published microfossil collections. The centre houses a growing collection of microfossils picked into faunal slides, as well as a well-stocked library of micropaleontological books, journals, and reprints. We have the only up-to-date paper copy of the Ellis & Messina Catalogue of Foraminifera in Central Europe. Currently, the slide collections include: - Type slides of benthic foraminifera from Poland (the collection of I. Heller from the Polish oil company GEONAFTA), - Carboniferous foraminifera from Germany and Poland (collections of G. Eickhoff and Z. Alexandrowicz), - IODP sites in the Arctic, Atlantic, and Indian Oceans (collections of M. Kaminski, E. Setoyama, A. Holborn), - Exploration wells in the Boreal seas: North Sea, Norwegian Sea, Western Barents Sea, Labrador Sea, Bering Sea, Spitsbergen, Western Siberia (collections of M. Kaminski, J. Nagy, T. Van Den Akker, V. Podobina, and others), - Paratethyan Foraminifera (collections of E. Luczkowska, C. Beldean, F. Szekely), - Mesozoic-Paleogene Foraminifera from Gubbio, Italy (collections of M. Kaminski, C. Cetean, and students) and the Polish Carpathians (collection of A. Waskowska), - Caribbean (collection of M. Kaminski, R. Preece), West Africa (collection of R. Preece, S. Kender, C. Cetean), - We have a separate collection of type specimens of species (paratypes). Slides are housed in cabinet drawers together with the relevant publication. Researchers are welcome to visit the offices of Micropress Europe to view the archived microfossil collections. The center

  13. [On the way to national reference system of laboratory medicine].

    PubMed

    Muravskaia, N P; Men'shikov, V V

    2014-10-01

    The application of standard samples and reference techniques of implementation of measurements is needed for a valid support of reliability of analyses applied in clinical diagnostic laboratories. They play role of landmarks under metrologic monitoring, calibration of devices and control of quality of results. The article presents analysis of shortcomings interfering with formation of national reference system in Russia harmonized with possibilities provided by international organizations. Among them are the joint Committee on metrologic monitoring in laboratory medicine under the auspices of the International Bureau of Weights and Measures, the International Federation of clinical chemistry and laboratory medicine, etc. The results of the recent development of national normative documents, standard samples and techniques assisted by the authors of article are considered. They are the first steps to organization of national reference system which would comprise all range of modern analytical technologies of laboratory medicine. The national and international measures are proposed to enhance the promptest resolving of task of organization of national reference system for laboratory medicine in the interests of increasing of effectiveness of medical care to citizen of Russia.

  14. DNA-Based Methods in the Immunohematology Reference Laboratory

    PubMed Central

    Denomme, Gregory A

    2010-01-01

    Although hemagglutination serves the immunohematology reference laboratory well, when used alone, it has limited capability to resolve complex problems. This overview discusses how molecular approaches can be used in the immunohematology reference laboratory. In order to apply molecular approaches to immunohematology, knowledge of genes, DNA-based methods, and the molecular bases of blood groups are required. When applied correctly, DNA-based methods can predict blood groups to resolve ABO/Rh discrepancies, identify variant alleles, and screen donors for antigen-negative units. DNA-based testing in immunohematology is a valuable tool used to resolve blood group incompatibilities and to support patients in their transfusion needs. PMID:21257350

  15. [Determining and verifying reference intervals in clinical laboratories].

    PubMed

    Henny, Joseph

    2011-01-01

    Based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC-LM), updated guidelines were recently published under the auspices of the IFCC-LM and the Clinical and Laboratory Standards Institute (CLSI). This article summarises these new proposals: (1) defining more precisely the terminology, which is often confusing, noticeably concerning the terms of reference limits and decision limits; (2) showing the different steps for determining reference limits according to the original procedure and the conditions which should be respected and (3) proposing a simple methodology allowing to the Clinical Laboratories to satisfy the needs of the Regulation and Standards. The updated document proposes to verify if published reference limits are applicable to the Laboratory involved. Finally the strengths and limits of the revised recommendations (noticeably the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical methodology, etc.) will be briefly discussed.

  16. Automated production of an on-line laboratory reference manual from a laboratory information system.

    PubMed

    Bennett, Sterling T; Kern, Dale A

    2002-04-01

    Laboratories provide information beyond test results, including information related to patient preparation, specimen collection and handling, test methodology, test availability, and interpretation of results. Most laboratories publish reference manuals to distribute this information to clients, while relying on the laboratory information system to provide this information to laboratory staff. Maintaining duplicate sources of information is expensive and error-prone, and printed materials become rapidly outdated. We developed a process to automate the production of a web-based reference manual directly from the laboratory information system, using a combination of MUMPS programs and HTML templates. We now focus our resources to assure that the laboratory information system database is accurate and complete, and then with minimal additional effort or expense produce an up-to-date on-line reference manual. We are therefore able to provide better sources of information in a sustainable manner.

  17. European registration process for Clinical Laboratory Geneticists in genetic healthcare.

    PubMed

    Liehr, Thomas; Carreira, Isabel M; Aktas, Dilek; Bakker, Egbert; Rodríguez de Alba, Marta; Coviello, Domenico A; Florentin, Lina; Scheffer, Hans; Rincic, Martina

    2017-03-08

    Tremendous progress in genetics and genomics led to a wide range of healthcare providers, genetic tests, and more patients who can benefit from these developments. To guarantee and improve the quality of genetic testing, a unified European-based registration for individuals qualified in biomedicine was realized. Therefore a Europe-wide recognition of the profession 'European registered Clinical Laboratory Geneticist (ErCLG)' based on a syllabus of core competences was established which allows for harmonization in professional education. The 'European Board of Medical Genetics division - Clinical Laboratory Geneticist' provides now since 3 years the possibility to register as an ErCLG. Applicants may be from all European countries and since this year also from outside of Europe. Five subtitles reflect the exact specialty of each ErCLG, who can reregister every 5 years. A previously not possible statistics based on ~300 individuals from 19 countries as holders of an ErCLG title provides interesting insights into the professionals working in human genetics. It could be substantiated that there are around twice as many females than males and that a PhD title was achieved by 80% of registered ErCLGs. Also most ErCLGs are still trained as generalists (66%), followed by such ErCLGs with focus on molecular genetics (23%); the remaining are concentrated either on clinical (6%), tumor (4%) or biochemical genetics (1%). In conclusion, besides MDs and genetic counselors/nurses an EU-wide recognition system for Clinical Laboratory Geneticist has been established, which strengthens the status of specialists working in human genetic diagnostics in Europe and worldwide.European Journal of Human Genetics advance online publication, 8 March 2017; doi:10.1038/ejhg.2017.25.

  18. Reference levels at European level for cardiac interventional procedures.

    PubMed

    Padovani, R; Vano, E; Trianni, A; Bokou, C; Bosmans, H; Bor, D; Jankowski, J; Torbica, P; Kepler, K; Dowling, A; Milu, C; Tsapaki, V; Salat, D; Vassileva, J; Faulkner, K

    2008-01-01

    In interventional cardiology, a wide variation in patient dose for the same type of procedure has been recognised by different studies. Variation is almost due to procedure complexity, equipment performance, procedure protocol and operator skill. The SENTINEL consortium has performed a survey in nine european centres collecting information on near 2000 procedures, and a new set of reference levels (RLs) for coronary angiography and angioplasty and diagnostic electrophysiology has been assessed for air kerma-area product: 45, 85 and 35 Gy cm2, effective dose: 8, 15 and 6 mSv, cumulative dose at interventional reference point: 650 and 1500 mGy, fluoroscopy time: 6.5, 15.5 and 21 min and cine frames: 700 and 1000 images, respectively. Because equipment performance and set-up are the factors contributing to patient dose variability, entrance surface air kerma for fluoroscopy, 13 mGy min(-1), and image acquisition, 0.10 mGy per frame, have also been proposed in the set of RLs.

  19. Plasma creatinine in dogs: intra- and inter-laboratory variation in 10 European veterinary laboratories

    PubMed Central

    2011-01-01

    Background There is substantial variation in reported reference intervals for canine plasma creatinine among veterinary laboratories, thereby influencing the clinical assessment of analytical results. The aims of the study was to determine the inter- and intra-laboratory variation in plasma creatinine among 10 veterinary laboratories, and to compare results from each laboratory with the upper limit of its reference interval. Methods Samples were collected from 10 healthy dogs, 10 dogs with expected intermediate plasma creatinine concentrations, and 10 dogs with azotemia. Overlap was observed for the first two groups. The 30 samples were divided into 3 batches and shipped in random order by postal delivery for plasma creatinine determination. Statistical testing was performed in accordance with ISO standard methodology. Results Inter- and intra-laboratory variation was clinically acceptable as plasma creatinine values for most samples were usually of the same magnitude. A few extreme outliers caused three laboratories to fail statistical testing for consistency. Laboratory sample means above or below the overall sample mean, did not unequivocally reflect high or low reference intervals in that laboratory. Conclusions In spite of close analytical results, further standardization among laboratories is warranted. The discrepant reference intervals seem to largely reflect different populations used in establishing the reference intervals, rather than analytical variation due to different laboratory methods. PMID:21477356

  20. Effluent-Monitoring Procedures: Basic Laboratory Skills. Student Reference Manual.

    ERIC Educational Resources Information Center

    Engel, William T.; And Others

    This is one of several short-term courses developed to assist in the training of waste water treatment plant operational personnel in the tests, measurements, and report preparation required for compliance with their NPDES Permits. This Student Reference Manual provides a review of basic mathematics as it applies to the chemical laboratory. The…

  1. Laboratory diagnosis of paediatric tuberculosis in the European Union/European Economic Area: analysis of routine laboratory data, 2007 to 2011.

    PubMed

    Sanchini, A; Fiebig, L; Drobniewski, F; Haas, W; Richter, E; Katalinic-Jankovic, V; Pimkina, E; Skenders, G; Cirillo, D M; Balabanova, Y

    2014-03-20

    Laboratory confirmation of paediatric tuberculosis (TB) is frequently lacking. We reviewed the range of routine laboratory tests and their performance in different biological samples used to diagnose active TB in children. A questionnaire-based survey was conducted among the European Reference Laboratory Network for TB followed by collection of routine laboratory data on 10,549 paediatric samples tested in 2007 to 2011 at six reference laboratories (in Croatia, Germany, Italy, Latvia, Lithuania and the United Kingdom (UK)). The questionnaire showed that all laboratories used rapid assays. Non-respiratory samples were collected more often in Germany (135/275, 49.1%) and the UK (490/2,140, 22.9%) compared with Croatia (138/2,792, 4.9%), Latvia (222/2,401, 9.2%) and Lithuania (76/1,549, 4.9%). Overall laboratory positivity rates (isolation of Mycobacterium tuberculosis complex and/or identification of its nucleic acids in a sample) were higher in lymph node and gastric aspirate samples (14/203 (6.9%) and 43/1,231 (3.5%)) than in sputum samples (89/4,684 (1.9%)). Pooled sensitivity, specificity, positive and negative predictive values and accuracy of molecular assays assessed against solid or liquid culture were 79.2%, 93.6%, 67.1%, 96.5% and 91.6%, respectively. A more intensive approach in obtaining gastric aspirate and non-respiratory samples may increase laboratory confirmation of paediatric TB. Major effort is needed in optimisation and validation of molecular tests in these samples.

  2. Vocabulary for use in measurement procedures and description of reference materials in laboratory medicine.

    PubMed

    Dybkaer, R

    1997-02-01

    The preparation of written records of measurement procedures and descriptions of reference materials requires order, scientific and practical expertise, exactness, and completeness. Realizing the importance of adequate documentation in science, practice, and industrial development, the European Committee for Standardization (CEN) has drafted two European Standards on the two subjects, presenting the structure and contents of such documents. The standards, however, do not provide guidance to the proper use of quantities, units, equations, numerical values, and terminology. Laboratory workers writing procedures and descriptions of materials have various educational backgrounds, so that it may be difficult to achieve harmonization of presentation and language. The present text provides an overview of structure of such documents (with reference to the CEN standards), some principles of quantities and units, a common vocabulary (based on authoritative international standards and recommendations), 144 named and defined concepts, and an extensive bibliography.

  3. European medical laboratory accreditation. Present situation and steps to harmonisation.

    PubMed

    Huisman, Wim

    2012-07-01

    Accreditation of medical laboratories in Europe is primarily according to ISO15189. The percentage of accredited laboratories is still small. The time spent on an assessment is quite different between countries. More important is the way the assessment process is carried out. Harmonisation in accrediting medical laboratories is the main task of the Health Care Committee within EA (European cooperation of Accreditation). The EFCC Working Group on Accreditation strongly contributes as the representative of laboratory professionals. An important item is the use of flexible scope. The intention is that all tests within a medical discipline are offered for accreditation. This is not yet normal practice. Other items concern accreditation of point-of-care testing (POCT) - reliability of the pre-analytical phase, when the phlebotomy is not done by the laboratory, and practical use of uncertainty and verification. Also the diversity in time spent for an assessment is discussed. The added value of accreditation is strongly dependent upon the assessors who have an important task. Their training and calibration needs continuous input. The medical laboratory professionals should participate in all aspects concerning the quality system, starting with the standard, working on the guidelines, the assessment itself, and input in the accreditation bodies.

  4. GMOMETHODS: the European Union database of reference methods for GMO analysis.

    PubMed

    Bonfini, Laura; Van den Bulcke, Marc H; Mazzara, Marco; Ben, Enrico; Patak, Alexandre

    2012-01-01

    In order to provide reliable and harmonized information on methods for GMO (genetically modified organism) analysis we have published a database called "GMOMETHODS" that supplies information on PCR assays validated according to the principles and requirements of ISO 5725 and/or the International Union of Pure and Applied Chemistry protocol. In addition, the database contains methods that have been verified by the European Union Reference Laboratory for Genetically Modified Food and Feed in the context of compliance with an European Union legislative act. The web application provides search capabilities to retrieve primers and probes sequence information on the available methods. It further supplies core data required by analytical labs to carry out GM tests and comprises information on the applied reference material and plasmid standards. The GMOMETHODS database currently contains 118 different PCR methods allowing identification of 51 single GM events and 18 taxon-specific genes in a sample. It also provides screening assays for detection of eight different genetic elements commonly used for the development of GMOs. The application is referred to by the Biosafety Clearing House, a global mechanism set up by the Cartagena Protocol on Biosafety to facilitate the exchange of information on Living Modified Organisms. The publication of the GMOMETHODS database can be considered an important step toward worldwide standardization and harmonization in GMO analysis.

  5. Reference materials and reference measurement systems in laboratory medicine. Harmonization of nomenclature and definitions in reference measurement systems.

    PubMed

    Dybkaer, R

    1995-12-01

    Reliability of clinical laboratory results is obtained through quality assurance in both their production and transmission. The former involves a reference measurement system of reference materials and reference measurement procedures with metrological and statistical verification of results. The latter requires that sender and receiver have access to a common terminology. Thus, two data banks are required. A plurilingual systematic vocabulary related to the reference measurement system, giving concepts with terms and definitions concerning measurement standards, reference measurement procedures, internal quality control, external quality assessment, probability and statistics-mainly based on existing authoritative publications. The material should be processed by standard scientific terminological procedure and offered to pertinent organizations and specialists for comment before finalization and authorization. A multilingual collection of systematic names for properties examined by the branches of Laboratory Medicine, such as clinical chemistry, clinical immunology, clinical microbiology, clinical pharmacology, haematology and blood banking, and histochemistry and cytology. The database should function as a reference to consultation and as a link in the transmission of data between local laboratory "dialects". This should be based on the ongoing comprehensive IUPAC/IFCC project for forming names in collaboration with relevant scientific organisations and area specialists. The relational data base including "run-time" software would be accessed by e-mail (gopher or other storage medium).

  6. The" Common European Framework of Reference for Languages," the European Language Portfolio, and Language Learning in Higher Education

    ERIC Educational Resources Information Center

    Little, David

    2012-01-01

    This article explains the relevance of the "Common European Framework of Reference for Languages" (CEFR) and the European Language Portfolio (ELP) to language learning in higher education, especially as regards the definition of aims and learning outcomes and the promotion of students' capacity to manage their own learning. After…

  7. The" Common European Framework of Reference for Languages," the European Language Portfolio, and Language Learning in Higher Education

    ERIC Educational Resources Information Center

    Little, David

    2012-01-01

    This article explains the relevance of the "Common European Framework of Reference for Languages" (CEFR) and the European Language Portfolio (ELP) to language learning in higher education, especially as regards the definition of aims and learning outcomes and the promotion of students' capacity to manage their own learning. After…

  8. Severe Weather Research at the European Severe Storms Laboratory

    NASA Astrophysics Data System (ADS)

    Groenemeijer, Pieter

    2013-04-01

    The European Severe Storms Laboratory's (ESSL) aim is to increase understanding of high-impact weather, with a particular focus on phenomena with small spatial and temporal dimensions, such as large hail, convectively-driven severe wind gusts, tornadoes and extreme precipitation.The ESSL performs and supports research activities and contributes to enhancing forecasting and warning capabilities in several ways. First, ESSL supports research by providing quality-controlled point data on severe weather events in the European Severe Weather Database. These data are collected through collaborations with networks of voluntary observers, and National HydroMeteorological Institutes throughout Europe. Second, research carried out at ESSL includes modelling the present and future occurrence of severe weather phenomena. This is done by developing proxies for severe weather events for use with reanalysis and climate model data. Third, at the ESSL Testbed, new products to support forecasting and warning operations are tested and demonstrated. Among these tools are visualizations of NWP ensemble data as well as radar, satellite and lightning detection data. Testbed participants provide feedback to the products and receive training in forecasting severe convective weather. Last, every second year ESSL organizes or co-organizes the European Conferences on Severe Storms.

  9. Aligning ESP Courses with the "Common European Framework of Reference for Languages"

    ERIC Educational Resources Information Center

    Athanasiou, Androulla; Constantinou, Elis Kakoulli; Neophytou, Maro; Nicolaou, Anna; Papadima Sophocleous, Salomi; Yerou, Christina

    2016-01-01

    This article explains how the "Common European Framework of References for Languages" (CEFR; Council of Europe 2001, "Common European Framework of Reference for Languages: Learning, teaching, assessment." Cambridge: Cambridge University Press) has been applied in language courses at the Language Centre (LC) of the Cyprus…

  10. Aligning ESP Courses with the "Common European Framework of Reference for Languages"

    ERIC Educational Resources Information Center

    Athanasiou, Androulla; Constantinou, Elis Kakoulli; Neophytou, Maro; Nicolaou, Anna; Papadima Sophocleous, Salomi; Yerou, Christina

    2016-01-01

    This article explains how the "Common European Framework of References for Languages" (CEFR; Council of Europe 2001, "Common European Framework of Reference for Languages: Learning, teaching, assessment." Cambridge: Cambridge University Press) has been applied in language courses at the Language Centre (LC) of the Cyprus…

  11. Lawrence Livermore National Laboratory Working Reference Material Production Pla

    SciTech Connect

    Wong, Amy; Thronas, Denise; Marshall, Robert

    1998-11-04

    This Lawrence Livermore National Laboratory (LLNL) Working Reference Material Production Plan was written for LLNL by the Los Alamos National Laboratory to address key elements of producing seven Pu-diatomaceous earth NDA Working Reference Materials (WRMS). These WRMS contain low burnup Pu ranging in mass from 0.1 grams to 68 grams. The composite Pu mass of the seven WRMS was designed to approximate the maximum TRU allowable loading of 200 grams Pu. This document serves two purposes: first, it defines all the operations required to meet the LLNL Statement of Work quality objectives, and second, it provides a record of the production and certification of the WRMS. Guidance provided in ASTM Standard Guide C1128-89 was used to ensure that this Plan addressed all the required elements for producing and certifying Working Reference Materials. The Production Plan was written to provide a general description of the processes, steps, files, quality control, and certification measures that were taken to produce the WRMS. The Plan identifies the files where detailed procedures, data, quality control, and certification documentation and forms are retained. The Production Plan is organized into three parts: a) an initial section describing the preparation and characterization of the Pu02 and diatomaceous earth materials, b) middle sections describing the loading, encapsulation, and measurement on the encapsulated WRMS, and c) final sections describing the calculations of the Pu, Am, and alpha activity for the WRMS and the uncertainties associated with these quantities.

  12. The European Network of Analytical and Experimental Laboratories for Geosciences

    NASA Astrophysics Data System (ADS)

    Freda, Carmela; Funiciello, Francesca; Meredith, Phil; Sagnotti, Leonardo; Scarlato, Piergiorgio; Troll, Valentin R.; Willingshofer, Ernst

    2013-04-01

    Integrating Earth Sciences infrastructures in Europe is the mission of the European Plate Observing System (EPOS).The integration of European analytical, experimental, and analogue laboratories plays a key role in this context and is the task of the EPOS Working Group 6 (WG6). Despite the presence in Europe of high performance infrastructures dedicated to geosciences, there is still limited collaboration in sharing facilities and best practices. The EPOS WG6 aims to overcome this limitation by pushing towards national and trans-national coordination, efficient use of current laboratory infrastructures, and future aggregation of facilities not yet included. This will be attained through the creation of common access and interoperability policies to foster and simplify personnel mobility. The EPOS ambition is to orchestrate European laboratory infrastructures with diverse, complementary tasks and competences into a single, but geographically distributed, infrastructure for rock physics, palaeomagnetism, analytical and experimental petrology and volcanology, and tectonic modeling. The WG6 is presently organizing its thematic core services within the EPOS distributed research infrastructure with the goal of joining the other EPOS communities (geologists, seismologists, volcanologists, etc...) and stakeholders (engineers, risk managers and other geosciences investigators) to: 1) develop tools and services to enhance visitor programs that will mutually benefit visitors and hosts (transnational access); 2) improve support and training activities to make facilities equally accessible to students, young researchers, and experienced users (training and dissemination); 3) collaborate in sharing technological and scientific know-how (transfer of knowledge); 4) optimize interoperability of distributed instrumentation by standardizing data collection, archive, and quality control standards (data preservation and interoperability); 5) implement a unified e-Infrastructure for data

  13. Online reference database of European Y-chromosomal short tandem repeat (STR) haplotypes.

    PubMed

    Roewer, L; Krawczak, M; Willuweit, S; Nagy, M; Alves, C; Amorim, A; Anslinger, K; Augustin, C; Betz, A; Bosch, E; Cagliá, A; Carracedo, A; Corach, D; Dekairelle, A F; Dobosz, T; Dupuy, B M; Füredi, S; Gehrig, C; Gusmaõ, L; Henke, J; Henke, L; Hidding, M; Hohoff, C; Hoste, B; Jobling, M A; Kärgel, H J; de Knijff, P; Lessig, R; Liebeherr, E; Lorente, M; Martínez-Jarreta, B; Nievas, P; Nowak, M; Parson, W; Pascali, V L; Penacino, G; Ploski, R; Rolf, B; Sala, A; Schmidt, U; Schmitt, C; Schneider, P M; Szibor, R; Teifel-Greding, J; Kayser, M

    2001-05-15

    The reference database of highly informative Y-chromosomal short tandem repeat (STR) haplotypes (YHRD), available online at http://ystr.charite.de, represents the largest collection of male-specific genetic profiles currently available for European populations. By September 2000, YHRD contained 4688 9-locus (so-called "minimal") haplotypes, 40% of which have been extended further to include two additional loci. Establishment of YHRD has been facilitated by the joint efforts of 31 forensic and anthropological institutions. All contributing laboratories have agreed to standardize their Y-STR haplotyping protocols and to participate in a quality assurance exercise prior to the inclusion of any data. In view of its collaborative character, and in order to put YHRD to its intended use, viz. the support of forensic caseworkers in their routine decision-making process, the database has been made publicly available via the Internet in February 2000. Online searches for complete or partial Y-STR haplotypes from evidentiary or non-probative material can be performed on a non-commercial basis, and yield observed haplotype counts as well as extrapolated population frequency estimates. In addition, the YHRD website provides information about the quality control test, genotyping protocols, haplotype formats and informativity, population genetic analysis, literature references, and a list of contact addresses of the contributing laboratories.

  14. Annual report of the Australian National Enterovirus Reference Laboratory 2012.

    PubMed

    Roberts, Jason; Hobday, Linda; Ibrahim, Aishah; Aitken, Thomas; Thorley, Bruce

    2013-06-30

    In 2012 no cases of poliomyelitis were reported through clinical surveillance in Australia, and poliovirus was not detected through virological surveillance. Australia conducts surveillance for cases of acute flaccid paralysis (AFP) in children less than 15 years as the main mechanism to monitor its polio-free status in accordance with World Health Organization (WHO) recommendations. Cases of AFP in children are notified to the Australian Paediatric Surveillance Unit or the Paediatric Active Enhanced Disease Surveillance System. In 2012 Australia reported 1.2 non-polio AFP cases per 100,000 children, meeting the WHO performance criterion for a sensitive system for the fifth year in a row. However the faecal specimen collection rate from AFP cases was 29%, which was well below the WHO target of 80%. Virological surveillance for poliovirus consists of two components. Firstly, the Enterovirus Reference Laboratory Network of Australia (ERLNA) reports on the typing of enteroviruses detected in or isolated from clinical specimens. Secondly, environmental surveillance is conducted at sentinel sites. These surveillance systems are co-ordinated by the National Enterovirus Reference Laboratory (NERL).

  15. Diagnosing Malaria Cases Referred to the Malaria Reference Laboratory in Tehran University of Medical Science, Iran

    PubMed Central

    NATEGHPOUR, Mehdi; EDRISSIAN, Gholamhossein; MOTEVALLI HAGHI, Afsaneh; FARIVAR, Leila; KAZEMI-RAD, Elham

    2015-01-01

    Background: The number of malaria cases is declining worldwide; however, it remains as a serious health problem. Diagnosing unusual cases is the most important issue to manage the problem. This study designed to describe the number of falciparum and vivax malaria infected patients referred to Malaria Reference Laboratory in Tehran University of Medical Science from 2000 to 2012. Methods: A retrospective study was conducted based on the collected questionnaires from each patient referred to the laboratory. Diagnosing results and demographic information for positive cases were analyzed using SPSS software. Problematic cases were evaluated for any difficulties in diagnosis or in clinical signs. Scanning and molecular methods were performed whenever there was an atypical case referred to the laboratory. Some of the samples had various difficulties for diagnosing such as presence of fussed gametocytes and schizonts of Plasmodium falciparum in peripheral blood and CCHF like hemoragic disorders. Results: Plasmodium vivax caused a large proportion of the cases (76.1%) in contrast with P. falciparum that included smaller proportion (22.8%) and the rest (1.1) belonged to mixed infection. Most of the positive cases (69.6%) were belonged to Afghani people. Men (94.6%) showed more infection than women (5.4%), moreover the most infection (44.5%) was seen at a range of 21–30 yr. Conclusion: In the case of existing atypical issues to diagnose, it is needed to perform more precise microscopical examination beyond the current standard conditions. Sometimes molecular method is required to verify the exact agent of the disease. PMID:26811720

  16. Reference Intervals, Intraindividual and Interindividual Variability, and Reference Change Values for Hematologic Variables in Laboratory Beagles

    PubMed Central

    Bourgès-Abella, Nathalie H; Gury, Thierry D; Geffré, Anne; Concordet, Didier; Thibault-Duprey, Kevin C; Dauchy, Arnaud; Trumel, Catherine

    2015-01-01

    In research and development studies for human and veterinary medicine, relevant comparators for interpreting clinical pathology results are matched with concurrent control animals. However, reference intervals (RI) provide a comparator database and important aids for interpreting clinical pathology data, especially in laboratory beagle dogs. Furthermore, RI incorporate biologic variation, which includes analytical, intraindividual, and interindividual variation. No studies to date have established RI and studied the effect of biologic variation on hematologic variables in a large group of laboratory dogs. The purpose of this retrospective study was to establish hematologic RI for laboratory beagles according to international recommendations and estimate the effect of biologic variation in routinely measured hematologic analytes by using the databank at a pharmaceutical center. Blood specimens from 340 healthy beagles (age, 9 to 36 mo) were evaluated by using a flow-cytometry-based hematology analyzer. RI and their 90% confidence intervals were established by using a nonparametric method. Effects of sex, age, and weight were investigated. Weight had no effect on any analyte. RBC, Hgb, Hct, MCV, MCH, RBC distribution width, and platelet count increased with age, whereas WBC count decreased. The only clinically relevant effect of sex was observed for platelets, which were lower in male beagles than in female and warranted 2 different RI. The calculated index of individuality showed that population-based RI were appropriate for almost all hematologic analytes, as might be expected for a homogeneous group of laboratory beagles. PMID:25651086

  17. Laboratory testing of West Valley reference 6 glass

    SciTech Connect

    Ebert, W.L.

    1995-07-01

    A series of laboratory tests is being conducted to characterize the corrosion of West Valley reference 6 glass (WV6) and to provide parametric values for modeling its long-term durability. Models require measurement of the corrosion rate in the absence of corrosion products and in fluids that are {open_quotes}saturated{close_quotes} with corrosion products, and the identification of alteration phases. Corrosion rates in dilute and saturated conditions were measured using MCC-1 and PCT tests, respectively. Vapor hydration tests were performed to generate secondary phases. The PCT tests show the WV6 glass to be more durable than SRL EA, SRL 202, and HW-39-1 glasses. Vapor hydration tests show weeksite (a uranyl silicate), a potassium-bearing zeolite, analcime, potassium feldspar, a calcium silicate phase, and lithium phosphate to form as WV6 glass corrodes. Test results are presented and their relevance to long-term performance discussed.

  18. Language Educational Policy and Language Learning Quality Management: The "Common European Framework of Reference"

    ERIC Educational Resources Information Center

    Barenfanger, Olaf; Tschirner, Erwin

    2008-01-01

    The major goal of the Council of Europe to promote and facilitate communication and interaction among Europeans of different mother tongues has led to the development of the "Common European Framework of Reference for Languages: Learning, Teaching, Assessment" (CEFR). Among other things, the CEFR is intended to help language…

  19. Language Educational Policy and Language Learning Quality Management: The "Common European Framework of Reference"

    ERIC Educational Resources Information Center

    Barenfanger, Olaf; Tschirner, Erwin

    2008-01-01

    The major goal of the Council of Europe to promote and facilitate communication and interaction among Europeans of different mother tongues has led to the development of the "Common European Framework of Reference for Languages: Learning, Teaching, Assessment" (CEFR). Among other things, the CEFR is intended to help language…

  20. Learning to Learn in the European Reference Framework for Lifelong Learning

    ERIC Educational Resources Information Center

    Pirrie, Anne; Thoutenhoofd, Ernst D.

    2013-01-01

    This article explores the construction of learning to learn that is implicit in the document "Key Competences for Lifelong Learning--European Reference Framework" and related education policy from the European Commission. The authors argue that the hallmark of learning to learn is the development of a fluid sociality rather than the…

  1. Learning to Learn in the European Reference Framework for Lifelong Learning

    ERIC Educational Resources Information Center

    Pirrie, Anne; Thoutenhoofd, Ernst D.

    2013-01-01

    This article explores the construction of learning to learn that is implicit in the document "Key Competences for Lifelong Learning--European Reference Framework" and related education policy from the European Commission. The authors argue that the hallmark of learning to learn is the development of a fluid sociality rather than the…

  2. Australian National Enterovirus Reference Laboratory annual report, 2013.

    PubMed

    Roberts, Jason A; Hobday, Linda K; Ibrahim, Aishah; Aitkin, Thomas; Thorley, Bruce R

    2015-06-30

    Australia conducts surveillance for cases of acute flaccid paralysis (AFP) in children less than 15 years of age as the main method to monitor its polio-free status in accordance with the World Health Organization (WHO) recommendations. Cases of AFP in children are notified to the Australian Paediatric Surveillance Unit or the Paediatric Active Enhanced Disease Surveillance System and faecal specimens are referred for virological investigation to the National Enterovirus Reference Laboratory. In 2013, no cases of poliomyelitis were reported from clinical surveillance and Australia reported 1.4 non-polio AFP cases per 100,000 children, meeting the WHO performance criterion for a sensitive surveillance system. Non-polio enteroviruses can also be associated with AFP and enterovirus A71 was identified from nine of the 61 cases classified as non-polio AFP in 2013, which was part of a larger outbreak associated with this virus. A Sabin poliovirus was detected in an infant recently returned from Pakistan and who had been vaccinated while abroad. Globally, 416 cases of polio were reported in 2013, with the 3 endemic countries: Afghanistan; Nigeria; and Pakistan, accounting for 38% of the cases. To safeguard the progress made towards polio eradication, in May 2014, WHO recommended travellers from the 10 countries that are currently reporting wild poliovirus transmission have documented evidence of recent polio vaccination before departure.

  3. Calibration of European pharmacopoeia biological reference preparation for diphtheria vaccine (adsorbed) batch 4.

    PubMed

    Stickings, P; Rigsby, P; Buchheit, K-H; Sesardic, D

    2009-10-01

    A collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the National Institute for Biological Standards and Control (NIBSC) to establish replacement batches of the current World Health Organization (WHO) International Standard (IS) and European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Diphtheria Vaccine (Adsorbed). Two candidates were assayed against the current 3rd IS/BRP batch 3 for Diphtheria Vaccine (Adsorbed) with an assigned potency of 160 IU/ampoule using established WHO/Ph. Eur. challenge methods in guinea pigs as described in the Ph. Eur. general chapter 2.7.6. Assay of diphtheria vaccine (adsorbed). Twenty-one laboratories (regulatory organisations and manufacturers) from 17 countries participated in the study. Two freeze-dried, stabilised diphtheria vaccine (adsorbed) preparations were included in the study: Preparation A (07/218) and Preparation B (07/216). As stocks of the 3rd IS were very low, the Diphtheria vaccine (adsorbed) BRP batch 3, which is identical to the 3rd IS but which was kept at the EDQM, was used for the calibration (coded Preparation C). The majority of participants performed 2 independent challenge tests. Five laboratories performed the intradermal challenge test, 16 laboratories performed the systemic challenge test. For Preparation A, the unweighted geometric mean potency estimate (with 95 % confidence limits) for all laboratories that provided valid results (n = 17) was 97.2 (89.5-105.6) IU/ampoule. For systemic challenge assays (n = 14) the unweighted geometric mean potency was 97.0 (88.1-106.7) IU/ampoule. The between-laboratory GCV was 17.4 % for all assays and 18.0 % for systemic challenge assays. There was no significant difference in estimates for intradermal or systemic challenge (p = 0.45). For Preparation B the unweighted geometric mean potency estimate (with 95 % confidence limits) for all laboratories that provided valid results (n

  4. [Tasks and duties of veterinary reference laboratories for food borne zoonoses].

    PubMed

    Ellerbroek, Lüppo; Alter, T; Johne, R; Nöckler, K; Beutin, L; Helmuth, R

    2009-02-01

    Reference laboratories are of central importance for consumer protection. Field expertise and high scientific competence are basic requirements for the nomination of a national reference laboratory. To ensure a common approach in the analysis of zoonotic hazards, standards have been developed by the reference laboratories together with national official laboratories on the basis of Art. 33 of Directive (EG) No. 882/2004. Reference laboratories function as arbitrative boards in the case of ambivalent or debatable results. New methods for detection of zoonotic agents are developed and validated to provide tools for analysis, e. g., in legal cases, if results from different parties are disputed. Besides these tasks, national reference laboratories offer capacity building and advanced training courses and control the performance of ring trials to ensure consistency in the quality of analyses in official laboratories. All reference laboratories work according to the ISO standard 17025 which defines the grounds for strict laboratory quality rules and in cooperation with the respective Community Reference Laboratories (CRL). From the group of veterinary reference laboratories for food-borne zoonoses, the national reference laboratories are responsible for Listeria monocytogenes, for Campylobacter, for the surveillance and control of viral and bacterial contamination of bivalve molluscs, for E. coli, for the performance of analysis and tests on zoonoses (Salmonella), and from the group of parasitological zoonotic agents, the national reference laboratory for Trichinella.

  5. Annual report of the Australian National Poliovirus Reference Laboratory, 2008.

    PubMed

    Roberts, Jason A; Grant, Kristina A; Yoon, Yeon Kyung; Polychronopoulos, Sophie; Ibrahim, Aishah; Thorley, Bruce R

    2009-09-01

    The Australian National Poliovirus Reference Laboratory (NPRL) is accredited by the World Health Organization (WHO) for the testing of stool specimens from cases of acute flaccid paralysis (AFP), a major clinical presentation of poliovirus infection. The NPRL, in collaboration with the Australian Paediatric Surveillance Unit, co-ordinates surveillance for cases of AFP in children in Australia, according to criteria recommended by the WHO. Clinical specimens are referred from AFP cases in children and suspected case of poliomyelitis in persons of any age. The WHO AFP surveillance performance indicator for a polio-free country such as Australia, is 1 non-polio AFP case per 100,000 children less than 15 years of age. In 2008, the Polio Expert Committee (PEC) classified 62 cases as non-polio AFP, or 1.51 non-polio AFP cases per 100,000 children aged less than 15 years. Poliovirus infection is confirmed by virus culture of stool specimens from AFP cases as other conditions that present with acute paralysis can mimic polio. While no poliovirus was reported in Australia from any source in 2008, the non-polio enteroviruses echovirus 25, coxsackievirus B2 and echovirus 11 were isolated from stool specimens of AFP cases. The last report of a wild poliovirus in Australia was due to an importation from Pakistan in 2007. With 4 countries remaining endemic for poliomyelitis--Afghanistan, India, Nigeria and Pakistan--and more than 1,600 confirmed cases of wild poliovirus infection in 18 countries in 2008, Australia continues to be at risk of further importation events.

  6. Status, quality and specific needs of Zika virus (ZIKV) diagnostic capacity and capability in National Reference Laboratories for arboviruses in 30 EU/EEA countries, May 2016.

    PubMed

    Mögling, Ramona; Zeller, Hervé; Revez, Joana; Koopmans, Marion; Reusken, Chantal

    2017-09-07

    With international travel, Zika virus (ZIKV) is introduced to Europe regularly. A country's ability to robustly detect ZIKV introduction and local transmission is important to minimise the risk for a ZIKV outbreak. Therefore, sufficient expertise and diagnostic capacity and capability are required in European laboratories. To assess the capacity, quality, operational specifics (guidelines and algorithms), technical and interpretation issues and other possible difficulties that were related to ZIKV diagnostics in European countries, a questionnaire was conducted among national reference laboratories in 30 countries in the European Union/European Economic Area (EU/EEA) in May 2016. While the coverage and capacity of ZIKV diagnostics in the EU/EEA national reference laboratories were found to be adequate, the assessment of the quality and needs indicated several crucial points of improvement that will need support at national and EU/EEA level to improve ZIKV preparedness, response and EU/EEA ZIKV surveillance activities. This article is copyright of The Authors, 2017.

  7. Emissions of maritime transport: a European reference system.

    PubMed

    Schrooten, Liesbeth; De Vlieger, Ina; Panis, Luc Int; Chiffi, Cosimo; Pastori, Enrico

    2009-12-20

    Emissions from ships have recently received more attention since they have become a significant concern for air quality in harbours and port cities. This paper presents the methodology for a comprehensive maritime transport database of activity data, specific energy consumption, emission factors, and total emissions that have been developed within the European EX-TREMIS project. The model is built upon 3 modules: the fleet module, the transport activity module, and the emission module. The fleet module defines the ship categories, the loading capacities, and the engine characteristics of the different vessels by using EUROSTAT data, Sea Web Lloyd's database, and international literature. The transport activity module transforms total cargo handled (mainly based on EUROSTAT data and CEMT statistics) into ship-equivalents. These ship-equivalents are further transformed into ship-hours. The emission module calculates energy uses and CO(2), NO(X), SO(2), CO, HC, CH(4), NMHC, PM emissions from the resulting maritime activities. We have used technology based emission factors to take into account the technological evolution of vessels. To illustrate this new methodology, we present some results (emissions, fuel consumption and emission factors) for different countries. The overall methodology as well as the results and the country specific energy consumption and emission factors per ship type and size class can be extracted from the EX-TREMIS website (www.ex-tremis.eu). Our results contribute to more accurate estimates of emissions and air quality assessments in coastal cities and ports.

  8. Empirical Learner Language and the Levels of the "Common European Framework of Reference"

    ERIC Educational Resources Information Center

    Wisniewski, Katrin

    2017-01-01

    The "Common European Framework of Reference" (CEFR) is the most widespread reference tool for linking language tests, curricula, and national educational standards to levels of foreign language proficiency in Europe. In spite of this, little is known about how the CEFR levels (A1-C2) relate to empirical learner language(s). This article…

  9. Hematologic reference intervals and age effect in European Strigiformes.

    PubMed

    Agusti Montolio, Susana; Molina López, Rafael; Cray, Carolyn; Lavín González, Santiago; Nicolás Francisco, Olga; Marco Sánchez, Ignasi; Casas-Díaz, Encarna; Cuenca Valera, Rafaela

    2017-09-01

    The clinical importance of hematologic testing in avian veterinary medicine is reflected in the increasing number of studies for the establishment of hematologic RIs of Strigiformes and other species. Age is an important physiologic factor in birds and the effect on hematology variable should be understood. The objective of this study was to determine baseline data of hematologic variables in 5 species of Iberian Strigiformes in different age classes. Nocturnal birds of prey were sampled at Wildlife Health Centers. Packed cell volume was determined by the microhematocrit centrifugation method, and RBC and WBC counts were determined using the direct hemocytometer count method with Natt and Herrick solution. Hemoglobin concentration was measured spectrophotometrically. The MCV, MCHC, and MHC were calculated using the standard formulas. The differential WBC count was performed by the routine microscopic evaluation of 200 cells on a blood smear manually stained with Wright stain. Thrombocyte blood count estimate was obtained from the blood film. No differences were observed between juveniles and adults for any variable evaluated in Tawny owl, Little owl, Scops owl, Long-eared owl, and Barn owl. In addition, PCV, RBC, and HGB of chicks were statistically significantly lower than in juveniles and adults, and total WBC was significantly higher in Tawny owl, Little owl, Scops owl, and Long-eared owl. Our findings provide evidence that laboratory data from chicks of Strigiformes are different compared to juveniles and adults; therefore, separate RIs were defined. © 2017 American Society for Veterinary Clinical Pathology.

  10. Groove depth measurements on roughness reference standards of the Croatian National Laboratory for Length (LFSB)

    NASA Astrophysics Data System (ADS)

    Baršić, Gorana; Mahović, Sanjin; Bartolo Picotto, Gian; Amer, Mohamed A.; Runje, Biserka

    2011-09-01

    In the Laboratory for Precise Measurements of Length, LFSB, which is now the Croatian National Laboratory for Length, unique roughness reference standards were developed in the year 1986. Because of the world-class quality of those standards and their measuring features, the same were sold in several European countries, and today they, among others, are used as roughness reference standards in Italy, Slovenia and Croatia. However, especially in the last decade, there was significant progress in the field of nanotechnology that led to the development of new measuring equipment. The above-mentioned standards due to their size, production technology and measuring features cannot fully meet metrological requirements in the field of nanometrology, i.e. they are not compatible with scanning probe microscopes. Therefore, it was decided to search for possible limitations in the procedure of groove depth measurements on the LFSB standards. In order to include as many measuring devices as possible, i.e. measurement methods, in this research, in 2008 the LFSB launched EURAMET Project 1012 'Limitations of methods for measuring the depth of the groove' in collaboration with national metrology institutes of Italy and Egypt. In this paper the results of measurements performed within the project are presented, and based on the obtained results, the advantages and limitations of the LFSB standards have been discussed, with recommendations for their improvement.

  11. Laboratory Reference Spectroscopy of Icy Satellite Candidate Surface Materials (Invited)

    NASA Astrophysics Data System (ADS)

    Dalton, J. B.; Jamieson, C. S.; Shirley, J. H.; Pitman, K. M.; Kariya, M.; Crandall, P.

    2013-12-01

    The bulk of our knowledge of icy satellite composition continues to be derived from ultraviolet, visible and infrared remote sensing observations. Interpretation of remote sensing observations relies on availability of laboratory reference spectra of candidate surface materials. These are compared directly to observations, or incorporated into models to generate synthetic spectra representing mixtures of the candidate materials. Spectral measurements for the study of icy satellites must be taken under appropriate conditions (cf. Dalton, 2010; also http://mos.seti.org/icyworldspectra.html for a database of compounds) of temperature (typically 50 to 150 K), pressure (from 10-9 to 10-3 Torr), viewing geometry, (i.e., reflectance), and optical depth (must manifest near infrared bands but avoid saturation in the mid-infrared fundamentals). The Planetary Ice Characterization Laboratory (PICL) is being developed at JPL to provide robust reference spectra for icy satellite surface materials. These include sulfate hydrates, hydrated and hydroxylated minerals, and both organic and inorganic volatile ices. Spectral measurements are performed using an Analytical Spectral Devices FR3 portable grating spectrometer from .35 to 2.5 microns, and a Thermo-Nicolet 6500 Fourier-Transform InfraRed (FTIR) spectrometer from 1.25 to 20 microns. These are interfaced with the Basic Extraterrestrial Environment Simulation Testbed (BEEST), a vacuum chamber capable of pressures below 10-9 Torr with a closed loop liquid helium cryostat with custom heating element capable of temperatures from 30-800 Kelvins. To generate optical constants (real and imaginary index of refraction) for use in nonlinear mixing models (i.e., Hapke, 1981 and Shkuratov, 1999), samples are ground and sieved to six different size fractions or deposited at varying rates to provide a range of grain sizes for optical constants calculations based on subtractive Kramers-Kronig combined with Hapke forward modeling (Dalton and

  12. The Common European Framework of Reference (CEFR) in Canada: A Research Agenda

    ERIC Educational Resources Information Center

    Arnott, Stephanie; Brogden, Lace Marie; Faez, Farahnaz; Péguret, Muriel; Piccardo, Enrica; Rehner, Katherine; Taylor, Shelley K.; Wernicke, Meike

    2017-01-01

    This article proposes a research agenda for future inquiry into the use of the Common European Framework of Reference (CEFR) in the plurilingual Canadian context. Drawing on data collected from a research forum hosted by the Canadian Association of Second Language Teachers in 2014, as well as a detailed analysis of Canadian empirical studies and…

  13. European specialist porphyria laboratories: diagnostic strategies, analytical quality, clinical interpretation, and reporting as assessed by an external quality assurance program.

    PubMed

    Aarsand, Aasne K; Villanger, Jørild H; Støle, Egil; Deybach, Jean-Charles; Marsden, Joanne; To-Figueras, Jordi; Badminton, Mike; Elder, George H; Sandberg, Sverre

    2011-11-01

    The porphyrias are a group of rare metabolic disorders whose diagnosis depends on identification of specific patterns of porphyrin precursor and porphyrin accumulation in urine, blood, and feces. Diagnostic tests for porphyria are performed by specialized laboratories in many countries. Data regarding the analytical and diagnostic performance of these laboratories are scarce. We distributed 5 sets of multispecimen samples from different porphyria patients accompanied by clinical case histories to 18-21 European specialist porphyria laboratories/centers as part of a European Porphyria Network organized external analytical and postanalytical quality assessment (EQA) program. The laboratories stated which analyses they would normally have performed given the case histories and reported results of all porphyria-related analyses available, interpretative comments, and diagnoses. Reported diagnostic strategies initially showed considerable diversity, but the number of laboratories applying adequate diagnostic strategies increased during the study period. We found an average interlaboratory CV of 50% (range 12%-152%) for analytes in absolute concentrations. Result normalization by forming ratios to the upper reference limits did not reduce this variation. Sixty-five percent of reported results were within biological variation-based analytical quality specifications. Clinical interpretation of the obtained analytical results was accurate, and most laboratories established the correct diagnosis in all distributions. Based on a case-based EQA scheme, variations were apparent in analytical and diagnostic performance between European specialist porphyria laboratories. Our findings reinforce the use of EQA schemes as an essential tool to assess both analytical and diagnostic processes and thereby to improve patient care in rare diseases.

  14. High heterogeneity in methods used for the laboratory confirmation of pertussis diagnosis among European countries, 2010: integration of epidemiological and laboratory surveillance must include standardisation of methodologies and quality assurance.

    PubMed

    He, Q; Barkoff, A M; Mertsola, J; Glismann, S; Bacci, S

    2012-08-09

    Despite extensive childhood immunisation, pertussis remains one of the world’s leading causes of vaccine preventable deaths. The current methods used for laboratory diagnosis of pertussis include bacterial culture, polymerase chain reaction (PCR) and enzyme linked immunosorbent assay (ELISA) serology. We conducted a questionnaire survey to identify variations in the laboratory methods and protocols used among participating countries included in the European surveillance network for vaccine-preventable diseases(EUVAC.NET). In February 2010, we performed the survey using a web-based questionnaire and sent it to the country experts of 25 European Union countries,and two European Economic Area (EEA) countries,Norway and Iceland. The questionnaire consisted of 37 questions which covered both general information on surveillance methods and detailed laboratory methods used. A descriptive analysis was performed.Questionnaires were answered by all 27 contacted countries. Nineteen countries had pertussis reference laboratories at the national level; their functions varied from performing diagnosis to providing technical advice for routine microbiology laboratories. Culture,PCR and serology were used in 17, 18 and 20 countries,respectively. For PCR, nine laboratories used insertion sequence IS481 as the target gene, which is present in multiple copies in the Bordetella pertussis genome and thus has a greater sensitivity over single copy targets, but has been proved not to be specific for B.pertussis. Antibodies directed against pertussis toxin(PT) are specific for B. pertussis infections. For ELISA serology, only 13 countries’ laboratories used purified PT as coating antigen and 10 included World Health Organization (WHO) or Food and Drug Administration (FDA) reference sera in their tests. This present survey shows that methods used for laboratory confirmation of pertussis differ widely among European countries and that there is a great heterogeneity of the reference

  15. European Fiber Optics. USAF Laboratory Experts’ Visit,

    DTIC Science & Technology

    1979-12-01

    emitting at 480 ma. AE-Telefunken Telecomunications and Cable Systems Division Postfach 1120 7150 Backnang, Germany Principal Contact: Dr. K. D. 4chenkel...alignment purposes. Standard Telecomunication Laboratories, Inc. (STL) London Road Harlow, Essex 017 9NA, England Principal Contact: Dr. M. Chown - Manager

  16. An improved auto-generation system to obtain reference intervals for laboratory medicine.

    PubMed

    Kim, Hyung Hoi; Hong, Hae Sook; Kim, Shine Young; Tran, Tung; Lee, Ji Min; Kim, Hwa Sun; Cho, Hune

    2010-03-01

    Reference values are highly required parameters for all tests in the clinical laboratory, and the supplementary provision of reliable reference intervals is an important task for both clinical laboratories and diagnostic test manufacturers. Despite the progress that has been made in the conceptual aspects of reference intervals, in practice their use is still not completely satisfactory. Most of the laboratories have used various methods to calculate statistic-based reference intervals, and they have mainly focused on extracted data, yet its use is considerably limited. We had to deal with the inconvenience of using a number of programs (SPSS or SAS, MS Excel) in order to calculate the results of reference intervals. In order to obtain standardized reference intervals, we developed an integrated program that can calculate, by a nonparametric method, reference intervals with using the Clinical and Laboratory Standards Institute (CLSI) processes as its guideline. We also developed a grouping interface that enables users to customize classification of each group (age, gender, blood group, race, etc) when calculating reference intervals. To verify the developed program, we compared the reference intervals of the current data on 281 persons for 8 total areas, and the reference intervals were was already calculated beforehand with by using this new program. As a result, both results perfectly matched. This integrated program will be convenience for calculating reasonable values through continual datainspection at an inspection lab for calculating reference intervals. The newly developed program will improve the consistency and reliability of the statistics on reference intervals.

  17. U.S. Geological Survey Standard Reference Sample Project: Performance Evaluation of Analytical Laboratories

    USGS Publications Warehouse

    Long, H. Keith; Daddow, Richard L.; Farrar, Jerry W.

    1998-01-01

    Since 1962, the U.S. Geological Survey (USGS) has operated the Standard Reference Sample Project to evaluate the performance of USGS, cooperator, and contractor analytical laboratories that analyze chemical constituents of environmental samples. The laboratories are evaluated by using performance evaluation samples, called Standard Reference Samples (SRSs). SRSs are submitted to laboratories semi-annually for round-robin laboratory performance comparison purposes. Currently, approximately 100 laboratories are evaluated for their analytical performance on six SRSs for inorganic and nutrient constituents. As part of the SRS Project, a surplus of homogeneous, stable SRSs is maintained for purchase by USGS offices and participating laboratories for use in continuing quality-assurance and quality-control activities. Statistical evaluation of the laboratories results provides information to compare the analytical performance of the laboratories and to determine possible analytical deficiences and problems. SRS results also provide information on the bias and variability of different analytical methods used in the SRS analyses.

  18. Programme of the Community Network of Reference Laboratories for Human Influenza to improve Influenza Surveillance in Europe.

    PubMed

    Meijer, Adam; Brown, Caroline; Hungnes, Olav; Schweiger, Brunhilde; Valette, Martine; van der Werf, Sylvie; Zambon, Maria

    2006-11-10

    All laboratories participating in the Community Network of Reference Laboratories for Human Influenza in Europe (CNRL) co-ordinated by the European Influenza Surveillance Scheme (EISS) should be able to perform a range of influenza diagnostics. This includes direct detection, culture, typing, subtyping and strain characterisation of influenza viruses, diagnostic serology and the creation of archives for clinical specimens and virus isolates. To improve the capacity and quality of the laboratories of the CNRL and to increase the consistency in performance among all 25 European Union countries plus Norway, Romania, and Switzerland, five task groups were set up in February 2005. These task groups developed work programmes in the areas of virus isolation, antibodies, molecular virology, quality control assessment and antiviral susceptibility testing. This report outlines the programmes and the results achieved in the first half-year of operation of the task groups. The action plans are challenging and it is expected that these efforts will lead to considerable improvements in the performance of the laboratories and in the standardisation of methods employed in Europe with regard to routine influenza surveillance and early warning for emerging viruses.

  19. Reference percentiles for FEV1 and BMI in European children and adults with cystic fibrosis

    PubMed Central

    2012-01-01

    Background The clinical course of Cystic Fibrosis (CF) is usually measured using the percent predicted FEV1 and BMI Z-score referenced against a healthy population, since achieving normality is the ultimate goal of CF care. Referencing against age and sex matched CF peers may provide valuable information for patients and for comparison between CF centers or populations. Here, we used a large database of European CF patients to compute CF specific reference equations for FEV1 and BMI, derived CF-specific percentile charts and compared these European data to their nearest international equivalents. Methods 34859 FEV1 and 40947 BMI observations were used to compute European CF specific percentiles. Quantile regression was applied to raw measurements as a function of sex, age and height. Results were compared with the North American equivalent for FEV1 and with the WHO 2007 normative values for BMI. Results FEV1 and BMI percentiles illustrated the large variability between CF patients receiving the best current care. The European CF specific percentiles for FEV1 were significantly different from those in the USA from an earlier era, with higher lung function in Europe. The CF specific percentiles for BMI declined relative to the WHO standard in older children. Lung function and BMI were similar in the two largest contributing European Countries (France and Germany). Conclusion The CF specific percentile approach applied to FEV1 and BMI allows referencing patients with respect to their peers. These data allow peer to peer and population comparisons in CF patients. PMID:22958330

  20. The space laboratory: A European-American cooperative effort

    NASA Technical Reports Server (NTRS)

    Hoffmann, H. E. W.

    1981-01-01

    A review of the history of the European participation in the American space shuttle project is presented. Some early work carried out in West Germany on the rocket-powered second state of a reusable launch vehicle system is cited, in particular wind tunnel studies of the aerodynamic and flight-mechanical behavior of various lifting body configurations in the subsonic range. The offer made by the U.S. to Europe of participating in the space shuttle program by developing a reusable launch vehicle is discussed, noting West Germany's good preparation in this area, as well as the ultimate decision of the U.S. to exclude Europe from participation in the design of the Orbiter and the booster stage of the shuttle.

  1. Recommendation for the review of biological reference intervals in medical laboratories.

    PubMed

    Henny, Joseph; Vassault, Anne; Boursier, Guilaine; Vukasovic, Ines; Mesko Brguljan, Pika; Lohmander, Maria; Ghita, Irina; Andreu, Francisco A Bernabeu; Kroupis, Christos; Sprongl, Ludek; Thelen, Marc H M; Vanstapel, Florent J L A; Vodnik, Tatjana; Huisman, Willem; Vaubourdolle, Michel

    2016-12-01

    This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), updated guidelines were recently published under the auspices of the IFCC and the Clinical and Laboratory Standards Institute (CLSI). This document summarizes proposals for recommendations on: (i) The terminology, which is often confusing, noticeably concerning the terms of reference limits and decision limits. (ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.

  2. The "Common European Framework of Reference for Languages," the European Language Portfolio, and Language Teaching/Learning at University: An Argument and Some Proposals

    ERIC Educational Resources Information Center

    Little, David

    2016-01-01

    I begin this article by briefly explaining why I think CercleS should encourage university language centres to align their courses and assessment with the proficiency levels of the "Common European Framework of Reference for Languages" (CEFR) and why they should use a version of the European Language Portfolio (ELP) to support the…

  3. The "Common European Framework of Reference for Languages," the European Language Portfolio, and Language Teaching/Learning at University: An Argument and Some Proposals

    ERIC Educational Resources Information Center

    Little, David

    2016-01-01

    I begin this article by briefly explaining why I think CercleS should encourage university language centres to align their courses and assessment with the proficiency levels of the "Common European Framework of Reference for Languages" (CEFR) and why they should use a version of the European Language Portfolio (ELP) to support the…

  4. Updated standards and processes for accreditation of echocardiographic laboratories from The European Association of Cardiovascular Imaging.

    PubMed

    Popescu, Bogdan A; Stefanidis, Alexandros; Nihoyannopoulos, Petros; Fox, Kevin F; Ray, Simon; Cardim, Nuno; Rigo, Fausto; Badano, Luigi P; Fraser, Alan G; Pinto, Fausto; Zamorano, Jose Luis; Habib, Gilbert; Maurer, Gerald; Lancellotti, Patrizio; Andrade, Maria Joao; Donal, Erwan; Edvardsen, Thor; Varga, Albert

    2014-07-01

    Standards for echocardiographic laboratories were proposed by the European Association of Echocardiography (now the European Association of Cardiovascular Imaging) 7 years ago in order to raise standards of practice and improve the quality of care. Criteria and requirements were published at that time for transthoracic, transoesophageal, and stress echocardiography. This paper reassesses and updates the quality standards to take account of experience and the technical developments of modern echocardiographic practice. It also discusses quality control, the incentives for laboratories to apply for accreditation, the reaccreditation criteria, and the current status and future prospects of the laboratory accreditation process. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  5. Establishment of Traceability of Reference Grade Hydrometers at National Physical Laboratory, India (npli)

    NASA Astrophysics Data System (ADS)

    Kumar, Anil; Kumar, Harish; Mandal, Goutam; Das, M. B.; Sharma, D. C.

    The present paper discusses the establishment of traceability of reference grade hydrometers at National Physical Laboratory, India (NPLI). The reference grade hydrometers are calibrated and traceable to the primary solid density standard. The calibration has been done according to standard procedure based on Cuckow's Method and the reference grade hydrometers calibrated covers a wide range. The uncertainty of the reference grade hydrometers has been computed and corrections are also calculated for the scale readings, at which observations are taken.

  6. External Quality Assessment Scheme for reference laboratories - review of 8 years' experience.

    PubMed

    Kessler, Anja; Siekmann, Lothar; Weykamp, Cas; Geilenkeuser, Wolf Jochen; Dreazen, Orna; Middle, Jonathan; Schumann, Gerhard

    2013-05-01

    We describe an External Quality Assessment Scheme (EQAS) intended for reference (calibration) laboratories in laboratory medicine and supervised by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine and the responsible Committee on Traceability in Laboratory Medicine. The official EQAS website, RELA (www.dgkl-rfb.de:81), is open to interested parties. Information on all requirements for participation and results of surveys are published annually. As an additional feature, the identity of every participant in relation to the respective results is disclosed. The results of various groups of measurands (metabolites and substrates, enzymes, electrolytes, glycated hemoglobins, proteins, hormones, thyroid hormones, therapeutic drugs) are discussed in detail. The RELA system supports reference measurement laboratories preparing for accreditation according to ISO 17025 and ISO 15195. Participation in a scheme such as RELA is one of the requirements for listing of the services of a calibration laboratory by the Joint Committee on Traceability in Laboratory Medicine.

  7. Laboratory breeding of the European rabbit flea, Spilopsyllus cuniculi (Dale).

    PubMed Central

    Vaughan, J. A.; Coombs, M. E.

    1979-01-01

    A method is described for the laboratory breeding of the rabbit flea in which the immature stages are reared at constant temperature and humidity. Eggs are obtained by confining fleas taken from a rabbit and her nest shortly after parturition with two of her nestlings in an incubator for 24 h. The eggs are transferred to an artificial diet medium on which the immature stages are reared. On average a female flea produces 50 eggs during the first six days post-partum. At 25 degrees C, 95% of eggs hatched at 79% RH and 98% at 84% RH. Most eggs hatched on the third day after laying and hatching was completed by the fourth day. Significantly more fleas of both sexes were obtained when larvae were reared at 25 degrees C on a medium containing powdered 41B rodent diet than on one containing terrier meal. Both diets also contained yeast and dried rabbit blood. There was no significant difference between the numbers of fleas obtained at 79% RH and 84% RH. Significantly more fleas were also obtained when larvae were reared at 27 degrees C, 84% RH, than at 25 degrees C. Female fleas emerged sooner than males at both 27 degrees C and 25 degrees C. Fleas from the laboratory culture were heavier than those from wild nests. Female fleas were heavier than male fleas in both cases. PMID:512357

  8. A plea for intra-laboratory reference limits. Part 1. General considerations and concepts for determination.

    PubMed

    Haeckel, Rainer; Wosniok, Werner; Arzideh, Farhad

    2007-01-01

    Accurate results for quantitative procedures can be useless if the reference limits for the interpretation of laboratory results are unreliable. Recent concepts for quality management systems require that laboratories pay more attention to identification and verification of reference limits. Scientific recommendations often claim that each laboratory should determine intra-laboratory reference limits, which should be reviewed periodically. This recommendation is currently neglected by most laboratories; instead they use reference limits from external sources, despite various problems of transference. Prospective and retrospective methods either using or neglecting disease prevalences (polymodal or unimodal concepts, respectively) and applying different statistical approaches for determining reference limits have been described. The various procedures are reviewed with regard to their diagnostic sensitivity, specificity and (non-)efficiency. The present gold standard is the reference limit concept according to IFCC recommendations (a unimodal prospective approach). This concept, together with trueness-based standardization, is the most useful basis for harmonization of the decision-making process with laboratory results, despite complex problems of traceability and transference. This harmonization is at present only achieved for a limited number of analytes for which SI units and traceability can be technically realized. For the majority of measurands in laboratory medicine, much research is still required and results cannot be expected in the near future. For these measurands, a need remains for internal, efficient and simple identification of population-based reference limits. Therefore, newer retrospective concepts were developed that use large data sets from laboratory information systems to derive intra-laboratory reference limits. These approaches appear promising and should be further developed.

  9. The quality of veterinary in-clinic and reference laboratory biochemical testing.

    PubMed

    Rishniw, Mark; Pion, Paul D; Maher, Tammy

    2012-03-01

    Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

  10. Quality management in European screening laboratories in blood establishments: A view of current approaches and trends.

    PubMed

    Pereira, Paulo; Westgard, James O; Encarnação, Pedro; Seghatchian, Jerard; de Sousa, Gracinda

    2015-04-01

    The screening laboratory has a critical role in the post-transfusion safety. The success of its targets and efficiency depends on the management system used. Even though the European Union directive 2002/98/EC requires a quality management system in blood establishments, its requirements for screening laboratories are generic. Complementary approaches are needed to implement a quality management system focused on screening laboratories. This article briefly discusses the current good manufacturing practices and good laboratory practices, as well as the trends in quality management system standards. ISO 9001 is widely accepted in some European Union blood establishments as the quality management standard, however this is not synonymous of its successful application. The ISO "risk-based thinking" is interrelated with the quality risk-management process of the EuBIS "Standards and criteria for the inspection of blood establishments". ISO 15189 should be the next step on the quality assurance of a screening laboratory, since it is focused on medical laboratory. To standardize the quality management systems in blood establishments' screening laboratories, new national and European claims focused on technical requirements following ISO 15189 is needed.

  11. MODS accreditation process for regional reference laboratories in Peru: validation by GenoType® MTBDRplus.

    PubMed

    Coronel, J; Roper, M; Mitchell, S; Castillo, E; Gamarra, N; Drobniewski, F; Luna, G; Mendoza, A; Moore, D A J

    2010-11-01

    Although considerable effort has been put into the development and evaluation of new diagnostics for tuberculosis (TB) and multidrug-resistant TB (MDR-TB), little attention has thus far been paid to the technical aspects of initiating quality-assured routine service use. For implementation of the microscopic-observation drug susceptibility (MODS) methodology in the Peruvian reference laboratory network, a laboratory accreditation process was devised; MODS results from an expert reference laboratory (Universidad Peruana Cayetano Heredia [UPCH]) were used as the standard against which implementing laboratory MODS results were judged to ensure that, prior to use for patient care, implementing laboratories achieved the same high performance with MODS as previously demonstrated in the research laboratory. To evaluate the validity of MODS-based accreditation and the concordance of MODS drug susceptibility testing (DST) with molecular testing. Head-to-head comparison of MODS DST results from implementing Peruvian regional reference laboratories and the accrediting expert MODS laboratory (UPCH) with GenoType® MTBDRplus DST. The concordance of phenotypic MODS rifampicin (RMP) DST with GenoType MTBDRplus was respectively 97.4%, 97.9% and 97.1% for the two implementing regional laboratories and UPCH, and respectively 94.7%, 95.7% and 94.6% for isoniazid (INH) DST. High and consistent levels of MODS/MTBDRplus concordance for INH and RMP DST confirm the validity of the use of rapid methods as reference standards for accreditation.

  12. MODS accreditation process for regional reference laboratories in Peru: validation by GenoType® MTBDRplus

    PubMed Central

    Coronel, J.; Roper, M.; Mitchell, S.; Castillo, E.; Gamarra, N.; Drobniewski, F.; Luna, G.; Mendoza, A.; Moore, D. A. J.

    2011-01-01

    SUMMARY SETTING Although considerable effort has been put into the development and evaluation of new diagnostics for tuberculosis (TB) and multidrug-resistant TB (MDR-TB), little attention has thus far been paid to the technical aspects of initiating quality-assured routine service use. For implementation of the microscopic-observation drug susceptibility (MODS) methodology in the Peruvian reference laboratory network, a laboratory accreditation process was devised; MODS results from an expert reference laboratory (Universidad Peruana Cayetano Heredia [UPCH]) were used as the standard against which implementing laboratory MODS results were judged to ensure that, prior to use for patient care, implementing laboratories achieved the same high performance with MODS as previously demonstrated in the research laboratory. OBJECTIVE To evaluate the validity of MODS-based accreditation and the concordance of MODS drug susceptibility testing (DST) with molecular testing. DESIGN Head-to-head comparison of MODS DST results from implementing Peruvian regional reference laboratories and the accrediting expert MODS laboratory (UPCH) with GenoType® MTBDRplus DST. RESULTS The concordance of phenotypic MODS rifampicin (RMP) DST with GenoType MTBDRplus was respectively 97.4%, 97.9% and 97.1% for the two implementing regional laboratories and UPCH, and respectively 94.7%, 95.7% and 94.6% for isoniazid (INH) DST. CONCLUSION High and consistent levels of MODS/MTBDRplus concordance for INH and RMP DST confirm the validity of the use of rapid methods as reference standards for accreditation. PMID:20937190

  13. European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated): collaborative study for the establishment of batch No. 3.

    PubMed

    Martin, J; Daas, A; Milne, C

    2016-01-01

    Inactivated poliomyelitis vaccines are an important part of the World Health Organization (WHO) control strategy to eradicate poliomyelitis. Requirements for the quality control of poliomyelitis vaccines (inactivated) include the use of an in vitro D antigen quantification assay for potency determination on the final lot as outlined in the European Pharmacopoeia (Ph. Eur.) monograph 0214. Performance of this assay requires a reference preparation calibrated in International Units (IU). A Ph. Eur. biological reference preparation (BRP) for poliomyelitis vaccine (inactivated) calibrated in IU has been established for this purpose. Due to the dwindling stocks of batch 2 of the BRP a collaborative study was run as part of the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme to establish BRP batch 3 (BRP3). Twelve laboratories including Official Medicines Control Laboratories (OMCLs) and manufacturers participated. The candidate BRP3 (cBRP3) was from the same source and had the same characteristics as BRP batch 2 (BRP2). During the study the candidate was calibrated against the 3(rd) International Standard for inactivated poliomyelitis vaccine using in-house D antigen ELISA assays in line with the Ph. Eur. monograph 0214. The candidate was also compared to BRP2 to evaluate the continuity. Based on the results of the study, values of 320 DU/mL, 78 DU/mL and 288 DU/mL (D antigen units/mL) (IU) for poliovirus type 1, 2 and 3 respectively were assigned to the candidate. In June 2016, the Ph. Eur. Commission adopted the material as Ph. Eur. BRP for poliomyelitis vaccine (inactivated) batch 3.

  14. Implementing a network for electronic surveillance reporting from public health reference laboratories: an international perspective.

    PubMed Central

    Bean, N. H.; Martin, S. M.

    2001-01-01

    Electronic data reporting from public health laboratories to a central site provides a mechanism for public health officials to rapidly identify problems and take action to prevent further spread of disease. However, implementation of reference laboratory systems is much more complex than simply adopting new technology, especially in international settings. We describe three major areas to be considered by international organizations for successful implementation of electronic reporting systems from public health reference laboratories: benefits of electronic reporting, planning for system implementation (e.g., support, resources, data analysis, country sovereignty), and components of system initiation (e.g., authority, disease definition, feedback, site selection, assessing readiness, problem resolution). Our experience with implementation of electronic public health laboratory data management and reporting systems in the United States and working with international organizations to initiate similar efforts demonstrates that successful reference laboratory reporting can be implemented if surveillance issues and components are planned. PMID:11747687

  15. Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

    PubMed Central

    Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

    2016-01-01

    Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients’ care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine. PMID:27019800

  16. An approach to establish the uncertainty budget of catalytic activity concentration measurements in a reference laboratory.

    PubMed

    Rami, Laura; Canalias, Francesca

    2015-04-01

    Reference laboratories providing reference services recognized by the Joint Committee for Traceability in Laboratory Medicine (JCTLM) must be accredited as calibration laboratories according to ISO 17025 and ISO 15195. These standards require laboratories to establish an uncertainty budget, in which the uncertainty contributions of the relevant uncertainty components are specified. We present a model to estimate the measurement uncertainty of creatine kinase catalytic activity concentration results obtained by IFCC primary reference measurement procedure. The measurement uncertainty has been estimated by following the next steps: 1) specification of the measurand; 2) identification of the most relevant uncertainty sources; 3) estimation of standard uncertainties by either type A or type B evaluation; 4) estimation of combined uncertainty while taking into account sensitivity coefficients, as well as existence of correlated uncertainty sources; and 5) estimation of expanded uncertainty with a defined coverage probability. The estimated expanded uncertainty was 2.2% (k=2). Uncertainty sources with a significant contribution to the measurement uncertainty were the following: pH adjustment (0.68%), absorbance accuracy (0.48%), wavelength adjustment (0.20%), reaction temperature (0.19%), volume fraction of sample (0.15%) and absorbance linearity (0.06%). The present model is an approach to establish the uncertainty budget of primary reference procedures for the measurement of the catalytic activity concentration of enzymes, and aims at being an example to be followed by other reference laboratories, as well as by laboratories that carry out primary reference measurement procedures.

  17. Reference materials and intercomparison samples available from the Environmental Monitoring Systems Laboratory - Las Vegas

    SciTech Connect

    Kantor, E.J.; Laska, P.R.

    1985-06-01

    Reference materials and intercomparison samples may be obtained by laboratories involved in the analysis of environmental samples containing radioactivity, pesticides, toxic inorganic species, or toxic organic species. These reference materials and intercomparison samples are available from the US Environmental Protection Agency's Quality Assurance Division located at the Environmental Monitoring Systems Laboratory in Las Vegas (EMSL-LV). These materials are useful for incorporation into a laboratory's quality control program for the evaluation of the precision and accuracy of analytical work. Media used for radiation reference materials are pitchblende, Monazite ore, uranium mill tailings, Mancos shale, fly ash, and water spiked with radionuclides. Radioactivity intercomparison samples consist of water, milk, air, urine, and a simulated diet slurry spiked with radionuclides. Media available for toxic organic reference materials are sludge, shale oil, and rag oil, and for intercomparison samples are soil and water. Characterized fly ash, foundry sludge, and river sediment serve as reference materials for toxic inorganics, while spiked soil and water serve as intercomparison samples. Finally, spiked adipose tissue, blood plasma, urine, and water comprise the pesticide intercomparison samples, and, after the disclosure of the true pesticide compositions and concentrations of these samples, the laboratory can use the samples as reference materials. The reference materials are generally available continuously, but the intercomparison samples are distributed on a scheduled basis and in some cases only to certain laboratories. 9 tables.

  18. Laboratory Medicine Specialization Teaching and Training in Italy with a Glance to Some European and Non-European Countries

    PubMed Central

    2010-01-01

    The Italian Ministry of Education, University and Research has recently reformed the medical schools of specialization in accordance with a series of EC Directives. Four different curricula have been defined into the class of “Diagnostics and Laboratory Medicine”, respectively: Anatomic Pathology, Clinical Biochemistry, Clinical Pathology, and Microbiology & Virology. Each curriculum is based on a scheme of 300 credits, that includes formal educational activities) and practical activities distributed on a five years’ period. The four curricula share a common course of either formal or practical activities. Main training and professional objectives are in favour of: a) the principles of appropriateness and of evidence based medicine, b) the acquisition of either on-the-bench experience and practice, or skills in organizing and managing the laboratory activities and personnel c) the understanding of data and phenomena relevant to the patients in a clinically oriented vision, d) the ability to translate research results into diagnostic advantages, e) the values of humanism and ethics. When comparing the Italian curriculum with some European and non-European curricula in Laboratory Medicine, many similarities are apparent: above all, the medical pertinence of the profession is increasingly affirmed in favour of a consultancy role to be played by the specialist in Laboratory Medicine at the clinical level. Main conclusions: a) the education, skill and expertise required for laboratory specialists regard now a broad variety of issues, b) these embrace not only technical, scientific and organizational aspects, but even the ability to develop consultative capacities in different diagnostic areas, c) moreover the implicit translational aspects in the profession require the adoption of innovative and multifaceted curricula. PMID:27683357

  19. The Monitoring of Triphenylmethane Dyes in Aquaculture Products Through the European Union Network of Official Control Laboratories.

    PubMed

    Verdon, Eric; Bessiral, Melaine; Chotard, Marie-Pierre; Couëdor, Pierrick; Fourmond, Marie-Pierre; Fuselier, Régine; Gaugain, Murielle; Gautier, Sophie; Hurtaud-Pessel, Dominique; Laurentie, Michel; Pirotais, Yvette; Roudaut, Brigitte; Sanders, Pascal

    2015-01-01

    Aquaculture has been the fastest growing animal production industry for the past four decades, and almost half of the fish eaten in the world are now farmed fish. To prevent diseases in this more intensive aquaculture farming, use of therapeutic chemicals has become a basic choice. The monitoring of malachite green, a triphenylmethane dye and one of the oldest and widely used chemicals in fish production, has gained more interest since the mid 1990s when this substance was finally proven to be toxic enough to be prohibited in seafood products destined for human consumption. The enforcement of the European Union (EU) regulation of this banned substance along with some other triphenylmethane dye congeners and their metabolites in its domestic production and in seafood imports was undertaken through the National Residue Monitoring Plans implemented in nearly all of the 28 EU member states. The reliability of the overall European monitoring of this dye contamination in aquaculture products was assessed by using the results of proficiency testing (PT) studies provided by the EU Reference Laboratory (EU-RL) in charge of the network of the EU National Reference Laboratories (NRLs). The proficiency of each NRL providing analytical support services for regulating dye residues was carefully checked during three PT rounds. In the process, the analytical methods developed and validated for this purpose have gradually been improved and extended over the last two decades.

  20. National Survey of Adult and Pediatric Reference Intervals in Clinical Laboratories across Canada: A Report of the CSCC Working Group on Reference Interval Harmonization.

    PubMed

    Adeli, Khosrow; Higgins, Victoria; Seccombe, David; Collier, Christine P; Balion, Cynthia M; Cembrowski, George; Venner, Allison A; Shaw, Julie

    2017-06-21

    Reference intervals are widely used decision-making tools in laboratory medicine, serving as health-associated standards to interpret laboratory test results. Numerous studies have shown wide variation in reference intervals, even between laboratories using assays from the same manufacturer. Lack of consistency in either sample measurement or reference intervals across laboratories challenges the expectation of standardized patient care regardless of testing location. Here, we present data from a national survey conducted by the Canadian Society of Clinical Chemists (CSCC) Reference Interval Harmonization (hRI) Working Group that examines variation in laboratory reference sample measurements, as well as pediatric and adult reference intervals currently used in clinical practice across Canada. Data on reference intervals currently used by 37 laboratories were collected through a national survey to examine the variation in reference intervals for seven common laboratory tests. Additionally, 40 clinical laboratories participated in a baseline assessment by measuring six analytes in a reference sample. Of the seven analytes examined, alanine aminotransferase (ALT), alkaline phosphatase (ALP), and creatinine reference intervals were most variable. As expected, reference interval variation was more substantial in the pediatric population and varied between laboratories using the same instrumentation. Reference sample results differed between laboratories, particularly for ALT and free thyroxine (FT4). Reference interval variation was greater than test result variation for the majority of analytes. It is evident that there is a critical lack of harmonization in laboratory reference intervals, particularly for the pediatric population. Furthermore, the observed variation in reference intervals across instruments cannot be explained by the bias between the results obtained on instruments by different manufacturers. Copyright © 2017 The Canadian Society of Clinical Chemists

  1. Report of the Australian National Polio Reference Laboratory. 1 July to 31 December 1999.

    PubMed

    Kennett, M; Stambos, V; Turnbull, A; Ibrahim, A; Kelly, H

    2000-05-01

    Since 1994, as part of the global eradication of poliomyelitis, the Australian National Polio Reference Laboratory (NPRL) at the Victorian Infectious Diseases Reference Laboratory (VIDRL) has been responsible for virological testing to confirm the absence of poliomyelitis in Australia. Samples from patients with acute flaccid paralysis are transported to VIDRL for viral culture. Polio and enteroviruses are referred for intratypic differentiation as wild or Sabin (vaccine) strains. A total of 23 faecal specimens from 17 patients were processed for enterovirus culture in the period 1 July to 31 December 1999. Since 1995, 1,078 enterovirus isolates from six states have been tested for the presence of wild poliovirus. To date, 562 strains were confirmed as Sabin vaccine-like, one non Sabin-like strain was identical with a laboratory control virus and the other strains were non-polio enteroviruses or other viruses. A World Health Organization (WHO) workshop in diagnostic polio polymerase chain reaction techniques was held at VIDRL in November 1999. The laboratory was reaccredited as a regional polio reference laboratory for the WHO Western Pacific region and a national laboratory for Australia, the Pacific Island countries and Brunei Darussalam. Planning is proceeding for the polio-free certification and containment of laboratory stocks of wild poliovirus infectious materials in Australia.

  2. A European Network of Analytical and Experimental Laboratories for Geosciences: Challenges and Perspectives

    NASA Astrophysics Data System (ADS)

    Freda, C.; Funiciello, F.; Meredith, P.; Sagnotti, L.; Scarlato, P.; Troll, V. R.; Willingshofer, E.; EPOS-WG6

    2012-04-01

    The EU policy for scientific research in the third millennium is that of a coordinated approach to support and develop continent-scale research infrastructures. The vision is to integrate the existing research infrastructures in order to increase the accessibility and usability of multidisciplinary data, enhancing worldwide interoperability by establishing a leading integrated European infrastructure and services. Integrating Earth Sciences infrastructures in Europe is the mission of the European Plate Observing System (EPOS), a research infrastructure and e-science for data and observatories on earthquakes, volcanoes, surface dynamics and tectonics. Within the existing core elements to be integrated in the EPOS cyber-infrastructure are: geographical distributed observational infrastructures (seismic and geodetic networks), observatories for multidisciplinary local data acquisition (e.g., volcanoes, active fault-zone, geothermal and deep drilling experiments), and analytical facilities for data repositories and integration. The integration of European analytical, experimental, and analogue laboratories plays a key role in this context and is the task of EPOS Working Group 6 (WG6). The Analytical and Experimental LaboratoriesGroup thus aims to link experimental, analytical, and analogue laboratories into a single, but geographically distributed, infrastructure for rock physics, including palaeomagnetism, analytical and experimental petrology and volcanology, and tectonic modeling.The WG6 has set a short term goal that has now been achieved, being a review of operational laboratory facilities in the community and the creation of a database from that information. Currently 12 countries (Germany, Greece, Ireland, Italy, Portugal, Romania, Slovenia, Spain, Sweden, Switzerland, The Netherlands, United Kingdom) are included in the database. As long-term goals, the WG6 aims to create mechanisms and procedures for easy access to laboratory facilities, turning small

  3. Implementation of a national reference laboratory for Buruli ulcer disease in Togo.

    PubMed

    Beissner, Marcus; Huber, Kristina Lydia; Badziklou, Kossi; Halatoko, Wemboo Afiwa; Maman, Issaka; Vogel, Felix; Bidjada, Bawimodom; Awoussi, Koffi Somenou; Piten, Ebekalisai; Helfrich, Kerstin; Mengele, Carolin; Nitschke, Jörg; Amekuse, Komi; Wiedemann, Franz Xaver; Diefenhardt, Adolf; Kobara, Basile; Herbinger, Karl-Heinz; Kere, Abiba Banla; Prince-David, Mireille; Löscher, Thomas; Bretzel, Gisela

    2013-01-01

    In a previous study PCR analysis of clinical samples from suspected cases of Buruli ulcer disease (BUD) from Togo and external quality assurance (EQA) for local microscopy were conducted at an external reference laboratory in Germany. The relatively poor performance of local microscopy as well as effort and time associated with shipment of PCR samples necessitated the implementation of stringent EQA measures and availability of local laboratory capacity. This study describes the approach to implementation of a national BUD reference laboratory in Togo. Large scale outreach activities accompanied by regular training programs for health care professionals were conducted in the regions "Maritime" and "Central," standard operating procedures defined all processes in participating laboratories (regional, national and external reference laboratories) as well as the interaction between laboratories and partners in the field. Microscopy was conducted at regional level and slides were subjected to EQA at national and external reference laboratories. For PCR analysis, sample pairs were collected and subjected to a dry-reagent-based IS2404-PCR (DRB-PCR) at national level and standard IS2404 PCR followed by IS2404 qPCR analysis of negative samples at the external reference laboratory. The inter-laboratory concordance rates for microscopy ranged from 89% to 94%; overall, microscopy confirmed 50% of all suspected BUD cases. The inter-laboratory concordance rate for PCR was 96% with an overall PCR case confirmation rate of 78%. Compared to a previous study, the rate of BUD patients with non-ulcerative lesions increased from 37% to 50%, the mean duration of disease before clinical diagnosis decreased significantly from 182.6 to 82.1 days among patients with ulcerative lesions, and the percentage of category III lesions decreased from 30.3% to 19.2%. High inter-laboratory concordance rates as well as case confirmation rates of 50% (microscopy), 71% (PCR at national level), and 78

  4. Implementation of a National Reference Laboratory for Buruli Ulcer Disease in Togo

    PubMed Central

    Badziklou, Kossi; Halatoko, Wemboo Afiwa; Maman, Issaka; Vogel, Felix; Bidjada, Bawimodom; Awoussi, Koffi Somenou; Piten, Ebekalisai; Helfrich, Kerstin; Mengele, Carolin; Nitschke, Jörg; Amekuse, Komi; Wiedemann, Franz Xaver; Diefenhardt, Adolf; Kobara, Basile; Herbinger, Karl–Heinz; Kere, Abiba Banla; Prince-David, Mireille; Löscher, Thomas; Bretzel, Gisela

    2013-01-01

    Background In a previous study PCR analysis of clinical samples from suspected cases of Buruli ulcer disease (BUD) from Togo and external quality assurance (EQA) for local microscopy were conducted at an external reference laboratory in Germany. The relatively poor performance of local microscopy as well as effort and time associated with shipment of PCR samples necessitated the implementation of stringent EQA measures and availability of local laboratory capacity. This study describes the approach to implementation of a national BUD reference laboratory in Togo. Methodology Large scale outreach activities accompanied by regular training programs for health care professionals were conducted in the regions “Maritime” and “Central,” standard operating procedures defined all processes in participating laboratories (regional, national and external reference laboratories) as well as the interaction between laboratories and partners in the field. Microscopy was conducted at regional level and slides were subjected to EQA at national and external reference laboratories. For PCR analysis, sample pairs were collected and subjected to a dry-reagent-based IS2404-PCR (DRB-PCR) at national level and standard IS2404 PCR followed by IS2404 qPCR analysis of negative samples at the external reference laboratory. Principal Findings The inter-laboratory concordance rates for microscopy ranged from 89% to 94%; overall, microscopy confirmed 50% of all suspected BUD cases. The inter-laboratory concordance rate for PCR was 96% with an overall PCR case confirmation rate of 78%. Compared to a previous study, the rate of BUD patients with non-ulcerative lesions increased from 37% to 50%, the mean duration of disease before clinical diagnosis decreased significantly from 182.6 to 82.1 days among patients with ulcerative lesions, and the percentage of category III lesions decreased from 30.3% to 19.2%. Conclusions High inter-laboratory concordance rates as well as case confirmation

  5. Assembling and auditing a comprehensive DNA barcode reference library for European marine fishes.

    PubMed

    Oliveira, L M; Knebelsberger, T; Landi, M; Soares, P; Raupach, M J; Costa, F O

    2016-12-01

    A large-scale comprehensive reference library of DNA barcodes for European marine fishes was assembled, allowing the evaluation of taxonomic uncertainties and species genetic diversity that were otherwise hidden in geographically restricted studies. A total of 4118 DNA barcodes were assigned to 358 species generating 366 Barcode Index Numbers (BIN). Initial examination revealed as much as 141 BIN discordances (more than one species in each BIN). After implementing an auditing and five-grade (A-E) annotation protocol, the number of discordant species BINs was reduced to 44 (13% grade E), while concordant species BINs amounted to 271 (78% grades A and B) and 14 other had insufficient data (grade D). Fifteen species displayed comparatively high intraspecific divergences ranging from 2·6 to 18·5% (grade C), which is biologically paramount information to be considered in fish species monitoring and stock assessment. On balance, this compilation contributed to the detection of 59 European fish species probably in need of taxonomic clarification or re-evaluation. The generalized implementation of an auditing and annotation protocol for reference libraries of DNA barcodes is recommended.

  6. Reference intervals of bone turnover markers in healthy premenopausal women: results from a cross-sectional European study.

    PubMed

    Eastell, Richard; Garnero, Patrick; Audebert, Christine; Cahall, David L

    2012-05-01

    Robust validated reference intervals for bone turnover markers (BTMs) are required to assess fracture risk and effectiveness of therapy. However, there are currently limited reference intervals for BTMs in premenopausal women, especially comparing manual and automated assays. This study determined the BTM reference intervals using automated and manual assays, compared the results obtained from two different assays, and evaluated the factors that may affect BTM levels. This was a cross-sectional registry study in 194 healthy, premenopausal, European Caucasian women aged 35 to 39years from France (n=98) and Denmark (n=96). Two independent specialized laboratories, one in France (Synarc) and the other in Denmark (Nordic Bioscience), analyzed blood and urine samples from each woman for BTM levels. The type of assay used in this study significantly affected the reference intervals obtained for serum cross-linked C-terminal telopeptide of type I collagen (sCTX) and urinary cross-linked N-terminal telopeptides of type I collagen (uNTX/Cr; both P<0.001), but not for serum procollagen type I amino-terminal propeptide (PINP; P=0.28). The Serum Crosslaps® ELISA; Microtitre-plate based ELISA; Metra BAP EIA; and UniQ® PINP RIA assays yielded higher BTM reference values. The reference intervals for the BTMs, as measured with Serum β-Crosslaps, Elecsys® 2010 Systems; VITROS® ECI System; Ostase®, Access® Immunoassay System; and Total PINP, Elecsys® 2010 Systems assays, were 0.111-0.791ng/mL for sCTX, 12.3-59.7nmol BCE/mmol creatinine for uNTX/Cr, 5.8-17.5ng/mL for bone alkaline phosphatase (ALP), and 17.3-83.4ng/mL for PINP, respectively. When measured with Serum Crosslaps® ELISA, Microtitre-plate based ELISA, Metra BAP EIA, and UniQ® PINP RIA, the reference intervals were 0.177-0.862ng/mL for sCTX, 22.6-95.7nmol BCE/mmol creatinine for uNTX/Cr, 14.8-38.8U/L for bone ALP, and 19.5-75.2ng/mL for PINP, respectively. The clinical interpretation of the BTMs of a subject

  7. An overview of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM)

    PubMed Central

    Stavelin, Anne; Albe, Xavier; Meijer, Piet; Sarkany, Erika; MacKenzie, Finlay

    2017-01-01

    The European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM) was founded in 1996 and currently has members from 29 European countries and 6 countries from outside Europe. EQALM provides a forum for co-operation and exchange of knowledge on quality-related matters in laboratory medicine, especially with regard to external quality assessment (EQA) programs in Europe. In addition, EQALM represent the EQA providers in laboratory medicine at European level vis-ŕ-vis political, professional, scientific and other bodies, including patients’ organisations. To this end EQALM promotes activities such as organizing meetings with scientific and practical themes for members and other interested parties, issuing scientific publications, developing EQA projects and representing laboratory medicine EQA activities within other organisations and networks. EQALM is active in scientific and educational activity in different fields such as survey frequency, haematology, haemostasis, microbiology, nomenclature, virtual microscopy, traceability, accreditation, and quality assurance of the total testing process. The aim of this paper is to give an overview of the EQALM organisation. PMID:28392724

  8. The "Common European Framework of Reference" Down Under: A Survey of Its Use and Non-Use in Australian Universities

    ERIC Educational Resources Information Center

    Normand-Marconnet, Nadine; Lo Bianco, Joseph

    2015-01-01

    Today, the "Common European Framework of Reference for Languages" (CEFR; Council of Europe 2001) is widely recognised as emblematic of globalization in education, both in the realms of policy and in educational practice (Byram et al. 2012a). In Europe the CEFR is regularly cited as a reference point for curriculum planning, and is often…

  9. The "Common European Framework of Reference" Down Under: A Survey of Its Use and Non-Use in Australian Universities

    ERIC Educational Resources Information Center

    Normand-Marconnet, Nadine; Lo Bianco, Joseph

    2015-01-01

    Today, the "Common European Framework of Reference for Languages" (CEFR; Council of Europe 2001) is widely recognised as emblematic of globalization in education, both in the realms of policy and in educational practice (Byram et al. 2012a). In Europe the CEFR is regularly cited as a reference point for curriculum planning, and is often…

  10. SENIORLAB: a prospective observational study investigating laboratory parameters and their reference intervals in the elderly

    PubMed Central

    Risch, Martin; Nydegger, Urs; Risch, Lorenz

    2017-01-01

    Abstract Background: In clinical practice, laboratory results are often important for making diagnostic, therapeutic, and prognostic decisions. Interpreting individual results relies on accurate reference intervals and decision limits. Despite the considerable amount of resources in clinical medicine spent on elderly patients, accurate reference intervals for the elderly are rarely available. The SENIORLAB study set out to determine reference intervals in the elderly by investigating a large variety of laboratory parameters in clinical chemistry, hematology, and immunology. Methods/design: The SENIORLAB study is an observational, prospective cohort study. Subjectively healthy residents of Switzerland aged 60 years and older were included for baseline examination (n = 1467), where anthropometric measurements were taken, medical history was reviewed, and a fasting blood sample was drawn under optimal preanalytical conditions. More than 110 laboratory parameters were measured, and a biobank was set up. The study participants are followed up every 3 to 5 years for quality of life, morbidity, and mortality. The primary aim is to evaluate different laboratory parameters at age-related reference intervals. The secondary aims of this study include the following: identify associations between different parameters, identify diagnostic characteristics to diagnose different circumstances, identify the prevalence of occult disease in subjectively healthy individuals, and identify the prognostic factors for the investigated outcomes, including mortality. Discussion: To obtain better grounds to justify clinical decisions, specific reference intervals for laboratory parameters of the elderly are needed. Reference intervals are obtained from healthy individuals. A major obstacle when obtaining reference intervals in the elderly is the definition of health in seniors because individuals without any medical condition and any medication are rare in older adulthood. Reference

  11. Criteria for Centers of Reference for pediatric diabetes--a European perspective.

    PubMed

    Danne, Thomas; Lion, Sylvia; Madaczy, Lazlo; Veeze, Henk; Raposo, Fillipe; Rurik, Imre; Aschemeier, Bärbel; Kordonouri, Olga

    2012-09-01

    'SWEET' is an acronym standing for 'Better control in pediatric and adolescent diabeteS: Working to crEate CEnTers of Reference (CORs)' and is based on a partnership of established national and European diabetes organizations such as International Diabetes Federation, Federation of European Nurses in Diabetes, and Primary Care Diabetes Europe (PCDE, www.sweet-project.eu). A three-level classification of centers has been put forward. In addition to centers for local care, SWEET collaborating centers on their way to being a COR have been defined. Peer-audited CORs with a continuous electronic documentation of at least 150 pediatric patients with diabetes treated by a multidisciplinary team based on the International Society for Pediatric and Adolescent Diabetes (ISPAD) Clinical Practice recommendations have been created in 12 European countries. In 2011, they cared for between 150 to more than 700 youth with diabetes with an average hemoglobin A1c between 7.6 and 9.2%. Although these clinics should not be regarded as representative for the whole country, the acknowledgment as COR includes a common objective of targets and guidelines as well as recognition of expertise in treatment and education at the center. In a first step, the SWEET Online platform allows 12 countries using 11 languages to connect to one unified diabetes database. Aggregate data are de-identified and exported for longitudinal health and economic data analysis. Through their network, the CORs wish to obtain political influence on a national and international level and to facilitate dissemination of new approaches and techniques. The SWEET project hopes to extend from the initial group of centers within countries, throughout Europe, and beyond with the help of the ISPAD network.

  12. Consortium For Central European GPS Geodynamic Reference Network (cegrn): Organization and Objectives

    NASA Astrophysics Data System (ADS)

    Fejes, I.

    After many years of informal collaboration 13 institutes from 13 Central European countries decided to formalize their organization for long term maintenance of CEGRN. The CEGRN Consortium was established on 4th of Sepember 2001 in Budapest by signing a Memorandum of Agreement. The participants recognized the importance of international collaboration in the field of Space Geodesy, Geodynamics and Earth Sciences. There is a need for a coherent, high accuracy and high quality reference network in Central Europe for geodynamic investigations. The maintenance of the network includes coordinated programme of measurements, technical developments and international access to monitoring results for a long period of time. The Consortium fosters coordinated maintenance and upgrade of existing CEGRN sites, establishment of new ones, coordinated monitoring measurements, the operation and development of CEGRN Data Centre and Processing Centres.

  13. The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: Code of Conduct, Version 2--2008.

    PubMed

    McMurray, Janet; Zerah, Simone; Hallworth, Michael; Koeller, Ursula; Blaton, Victor; Tzatchev, Kamen; Charilaou, Charis; Racek, Jaroslav; Johnsen, Anders; Tomberg, Karel; Harmoinen, Aimo; Baum, Hannsjörg; Rizos, Demetrios; Kappelmayer, Janos; O'Mullane, John; Nubile, Giuseppe; Pupure, Silvija; Kucinskiene, Zita; Opp, Matthias; Huisman, Wim; Solnica, Bogdan; Reguengo, Henrique; Grigore, Camelia; Spanár, Július; Strakl, Greta; Queralto, Josep; Wallinder, Hans; Schuff-Werner, Peter

    2009-01-01

    In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 10 years, more than 2000 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Federation of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). A Code of Conduct was adopted in 2003 and a revised and updated version, taking account particularly of the guidelines of the Conseil Européen des Professions Libérales (CEPLIS) of which EFCC is a member, is presented in this article. The revised version was approved by the EC4 Register Commission and by the EFCC Executive Board in Paris on 6 November, 2008.

  14. The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: guide to the Register, version 3-2010.

    PubMed

    McMurray, Janet; Zérah, Simone; Hallworth, Michael; Schuff-Werner, Peter; Haushofer, Alexander; Szekeres, Thomas; Wallemacq, Pierre; Tzatchev, Kamen; Charilaou, Charis; Racek, Jaroslav; Johnsen, Anders; Tomberg, Karel; Harmoinen, Aimo; Baum, Hannsjörg; Rizos, Demetrios; Kappelmayer, Janos; O'Mullane, John; Nubile, Giuseppe; Pupure, Silvija; Kucinskiene, Zita; Opp, Matthias; Jansen, Rob; Solnica, Bogdan; Reguengo, Henrique; Grigore, Camelia; Spanár, Július; Strakl, Greta; Queralto, Josep; Wallinder, Hans; Wieringa, Gijsbert

    2010-07-01

    In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 12 years, more than 2200 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). Two previous Guides to the Register have been published, one in 1997 and another in 2003. The third version of the Guide is presented in this article and is based on the experience gained and development of the profession since the last revision. Registration is valid for 5 years and the procedure and criteria for re-registration are presented as an Appendix at the end of the article.

  15. GCR Simulator Reference Field and a Spectral Approach for Laboratory Simulation

    NASA Technical Reports Server (NTRS)

    Slaba, Tony C.; Blattnig, Steve R.; Norbury, John W.; Rusek, Adam; La Tessa, Chiara; Walker, Steven A.

    2015-01-01

    The galactic cosmic ray (GCR) simulator at the NASA Space Radiation Laboratory (NSRL) is intended to deliver the broad spectrum of particles and energies encountered in deep space to biological targets in a controlled laboratory setting. In this work, certain aspects of simulating the GCR environment in the laboratory are discussed. Reference field specification and beam selection strategies at NSRL are the main focus, but the analysis presented herein may be modified for other facilities. First, comparisons are made between direct simulation of the external, free space GCR field and simulation of the induced tissue field behind shielding. It is found that upper energy constraints at NSRL limit the ability to simulate the external, free space field directly (i.e. shielding placed in the beam line in front of a biological target and exposed to a free space spectrum). Second, variation in the induced tissue field associated with shielding configuration and solar activity is addressed. It is found that the observed variation is likely within the uncertainty associated with representing any GCR reference field with discrete ion beams in the laboratory, given current facility constraints. A single reference field for deep space missions is subsequently identified. Third, an approach for selecting beams at NSRL to simulate the designated reference field is presented. Drawbacks of the proposed methodology are discussed and weighed against alternative simulation strategies. The neutron component and track structure characteristics of the simulated field are discussed in this context.

  16. Progress in photovoltaic module calibration: results of a worldwide intercomparison between four reference laboratories

    NASA Astrophysics Data System (ADS)

    Dirnberger, D.; Kräling, U.; Müllejans, H.; Salis, E.; Emery, K.; Hishikawa, Y.; Kiefer, K.

    2014-10-01

    Measurement results from a worldwide intercomparison of photovoltaic module calibrations are presented. Four photovoltaic reference laboratories in the USA, Japan and Europe with different traceability chains, measurement equipment and procedures, and uncertainty estimation concepts, participated. Seven photovoltaic modules of different technologies were measured (standard and high-efficiency crystalline silicon, cadmium telluride, single and double-junction amorphous and micromorph silicon). The measurement results from all laboratories and for all devices agreed well. Maximum power for the crystalline silicon samples was within ±1.3% for all thin-film modules roughly within ±3%, which is an improvement compared to past intercomparisons. The agreement between the results was evaluated using a weighted mean as a reference value, which considers results-specific uncertainty, instead of the widely used unweighted arithmetic mean. A further statistical analysis of all deviations between results and the corresponding reference mean showed that the uncertainties estimated by the participating laboratories were realistic, with a slight tendency towards being too conservative. The observed deviations of results from the reference mean concerned mainly short-circuit current and fill factor. Module stability was monitored through repeated measurements at Fraunhofer ISE before and after measurements at each of the other participating laboratories. Based on these re-measurements, stability problems that occurred for some thin-film modules and influenced the results were analyzed and explained in detail.

  17. Clinical isolates and laboratory reference Candida species and strains have varying abilities to form biofilms.

    PubMed

    Alnuaimi, Ali D; O'Brien-Simpson, Neil M; Reynolds, Eric C; McCullough, Michael J

    2013-11-01

    Candida biofilms are a major virulence trait for this yeast. In this study, the biofilm-forming ability of the major medically important clinical and laboratory reference strains was compared. Biofilms were quantified using traditional methods, that is, crystal violet (CV), tetrazolium (XTT) reduction and colony-forming unit assays (CFU), and two new methods: an automated cell counter (ACC) and biofilm suspension turbidity (BST) method. Biofilms could be categorized based on biofilm biomass (high, medium and low) and growth state (high and low). Candida albicans genotypes, A, B and C, showed medium biofilm mass and low growth rate, and only one C. albicans laboratory strain, ATCC MYA-2719, matched this biofilm category. Of all non-albicans Candida species tested, only Candida dubliniensis and Candida glabrata laboratory and clinical isolates had similar biofilm development. The ACC and BST methods for measuring biofilm significantly correlated with CV and CFU biofilm mass measurements. Thus, biofilm mass can be rapidly assessed using biofilm disruptive/cellular nondestructive methods allowing yeast biofilm cells to be used for further analysis. In conclusion, Candida laboratory reference strains and clinical isolates have been shown to form biofilms at different rates; hence for validity, the selection of laboratory reference strains in biofilm studies may be critical for virulence assessment.

  18. Defining laboratory reference values and decision limits: populations, intervals, and interpretations.

    PubMed

    Boyd, James C

    2010-01-01

    This article provides a brief overview of various approaches that may be utilized for the analysis of human semen test results. Reference intervals are the most widely used tool for the interpretation of clinical laboratory results. Reference interval development has classically relied on concepts elaborated by the International Federation of Clinical Chemistry Expert Panel on Reference Values during the 1980s. These guidelines involve obtaining and classifying samples from a healthy population of at least 120 individuals and then identifying the outermost 5% of observations to use in defining limits for two-sided or one-sided reference intervals. More recently, decision limits based on epidemiological outcome analysis have also been introduced to aid in test interpretation. The reference population must be carefully defined on the basis of the intended clinical use of the underlying test. To determine appropriate reference intervals for use in male fertility assessment, a reference population of men with documented time to pregnancy of < 12 months would be most suitable. However, for epidemiological assessment of semen testing results, a reference population made up of unselected healthy men would be preferred. Although reference and decision limits derived for individual semen analysis test results will undoubtedly be the interpretational tools of choice in the near future, in the long term, multivariate methods for the interpretation of semen analysis alone or in combination with information from the female partner seem to represent better means for assessing the likelihood of achieving a successful pregnancy in a subfertile couple.

  19. Defining laboratory reference values and decision limits: populations, intervals, and interpretations

    PubMed Central

    Boyd, James C.

    2010-01-01

    This article provides a brief overview of various approaches that may be utilized for the analysis of human semen test results. Reference intervals are the most widely used tool for the interpretation of clinical laboratory results. Reference interval development has classically relied on concepts elaborated by the International Federation of Clinical Chemistry Expert Panel on Reference Values during the 1980s. These guidelines involve obtaining and classifying samples from a healthy population of at least 120 individuals and then identifying the outermost 5% of observations to use in defining limits for two-sided or one-sided reference intervals. More recently, decision limits based on epidemiological outcome analysis have also been introduced to aid in test interpretation. The reference population must be carefully defined on the basis of the intended clinical use of the underlying test. To determine appropriate reference intervals for use in male fertility assessment, a reference population of men with documented time to pregnancy of < 12 months would be most suitable. However, for epidemiological assessment of semen testing results, a reference population made up of unselected healthy men would be preferred. Although reference and decision limits derived for individual semen analysis test results will undoubtedly be the interpretational tools of choice in the near future, in the long term, multivariate methods for the interpretation of semen analysis alone or in combination with information from the female partner seem to represent better means for assessing the likelihood of achieving a successful pregnancy in a subfertile couple. PMID:20111086

  20. Adult Hematology and Clinical Chemistry Laboratory Reference Ranges in a Zimbabwean Population

    PubMed Central

    Mandozana, Gibson; Tinago, Willard; Nhando, Nehemiah; Mgodi, Nyaradzo M.; Bwakura-Dangarembizi, Mutsawashe F.

    2016-01-01

    Background Laboratory reference ranges used for clinical care and clinical trials in various laboratories in Zimbabwe were derived from textbooks and research studies conducted more than ten years ago. Periodic verification of these ranges is essential to track changes over time. The purpose of this study was to establish hematology and chemistry laboratory reference ranges using more rigorous methods. Methods A community-based cross-sectional study was carried out in Harare, Chitungwiza, and Mutoko. A multistage sampling technique was used. Samples were transported from the field for analysis at the ISO15189 certified University of Zimbabwe-University of California San Francisco Central Research Laboratory. Hematology and clinical chemistry reference ranges lower and upper reference limits were estimated at the 2.5th and 97.5th percentiles respectively. Results A total of 769 adults (54% males) aged 18 to 55 years were included in the analysis. Median age was 28 [IQR: 23–35] years. Males had significantly higher red cell counts, hemoglobin, hematocrit, and mean corpuscular hemoglobin compared to females. Females had higher white cell counts, platelets, absolute neutrophil counts, and absolute lymphocyte counts compared to males. There were no gender differences in eosinophils, monocytes, and absolute basophil count. Males had significantly higher levels of urea, sodium, potassium, calcium, creatinine, amylase, total protein, albumin and liver enzymes levels compared to females. Females had higher cholesterol and lipase compared with males. There are notable differences in the white cell counts, neutrophils, cholesterol, and creatinine kinase when compared with the currently used reference ranges. Conclusion Data from this study provides new country specific reference ranges which should be immediately adopted for routine clinical care and accurate monitoring of adverse events in research studies. PMID:27812172

  1. Adult Hematology and Clinical Chemistry Laboratory Reference Ranges in a Zimbabwean Population.

    PubMed

    Samaneka, Wadzanai P; Mandozana, Gibson; Tinago, Willard; Nhando, Nehemiah; Mgodi, Nyaradzo M; Bwakura-Dangarembizi, Mutsawashe F; Munjoma, Marshall W; Gomo, Zvenyika A R; Chirenje, Zvavahera M; Hakim, James G

    2016-01-01

    Laboratory reference ranges used for clinical care and clinical trials in various laboratories in Zimbabwe were derived from textbooks and research studies conducted more than ten years ago. Periodic verification of these ranges is essential to track changes over time. The purpose of this study was to establish hematology and chemistry laboratory reference ranges using more rigorous methods. A community-based cross-sectional study was carried out in Harare, Chitungwiza, and Mutoko. A multistage sampling technique was used. Samples were transported from the field for analysis at the ISO15189 certified University of Zimbabwe-University of California San Francisco Central Research Laboratory. Hematology and clinical chemistry reference ranges lower and upper reference limits were estimated at the 2.5th and 97.5th percentiles respectively. A total of 769 adults (54% males) aged 18 to 55 years were included in the analysis. Median age was 28 [IQR: 23-35] years. Males had significantly higher red cell counts, hemoglobin, hematocrit, and mean corpuscular hemoglobin compared to females. Females had higher white cell counts, platelets, absolute neutrophil counts, and absolute lymphocyte counts compared to males. There were no gender differences in eosinophils, monocytes, and absolute basophil count. Males had significantly higher levels of urea, sodium, potassium, calcium, creatinine, amylase, total protein, albumin and liver enzymes levels compared to females. Females had higher cholesterol and lipase compared with males. There are notable differences in the white cell counts, neutrophils, cholesterol, and creatinine kinase when compared with the currently used reference ranges. Data from this study provides new country specific reference ranges which should be immediately adopted for routine clinical care and accurate monitoring of adverse events in research studies.

  2. Data Services and Transnational Access for European Geosciences Multi-Scale Laboratories

    NASA Astrophysics Data System (ADS)

    Funiciello, Francesca; Rosenau, Matthias; Sagnotti, Leonardo; Scarlato, Piergiorgio; Tesei, Telemaco; Trippanera, Daniele; Spires, Chris; Drury, Martyn; Kan-Parker, Mirjam; Lange, Otto; Willingshofer, Ernst

    2016-04-01

    The EC policy for research in the new millennium supports the development of european-scale research infrastructures. In this perspective, the existing research infrastructures are going to be integrated with the objective to increase their accessibility and to enhance the usability of their multidisciplinary data. Building up integrating Earth Sciences infrastructures in Europe is the mission of the Implementation Phase (IP) of the European Plate Observing System (EPOS) project (2015-2019). The integration of european multiscale laboratories - analytical, experimental petrology and volcanology, magnetic and analogue laboratories - plays a key role in this context and represents a specific task of EPOS IP. In the frame of the WP16 of EPOS IP working package 16, European geosciences multiscale laboratories aims to be linked, merging local infrastructures into a coherent and collaborative network. In particular, the EPOS IP WP16-task 4 "Data services" aims at standardize data and data products, already existing and newly produced by the participating laboratories, and made them available through a new digital platform. The following data and repositories have been selected for the purpose: 1) analytical and properties data a) on volcanic ash from explosive eruptions, of interest to the aviation industry, meteorological and government institutes, b) on magmas in the context of eruption and lava flow hazard evaluation, and c) on rock systems of key importance in mineral exploration and mining operations; 2) experimental data describing: a) rock and fault properties of importance for modelling and forecasting natural and induced subsidence, seismicity and associated hazards, b) rock and fault properties relevant for modelling the containment capacity of rock systems for CO2, energy sources and wastes, c) crustal and upper mantle rheology as needed for modelling sedimentary basin formation and crustal stress distributions, d) the composition, porosity, permeability, and

  3. Generation of daylight reference years for two European cities with different climate: Athens, Greece and Bratislava, Slovakia

    NASA Astrophysics Data System (ADS)

    Markou, M. T.; Kambezidis, H. D.; Bartzokas, A.; Darula, S.; Kittler, R.

    2007-12-01

    In this work, daylight reference years (DRYs), based on daylight and solar radiation measurements, are designed for two European cities, Athens, Greece and Bratislava, Slovakia, by using the Danish method, the Festa-Ratto technique and the Modified Sandia National Laboratories methodology. The data basis consists of 5-minute values of global and diffuse horizontal illuminance, global and diffuse horizontal irradiance, zenith luminance and solar altitude as well as of daily values of sunshine duration for 5 years for Athens and 8 years for Bratislava. Moreover, Linke's turbidity factor, luminous turbidity factor and relative sunshine duration are calculated and utilized. Then, for each DRY, the predominant sky-luminance distributions over Athens and Bratislava are identified, by using the methodology of Kittler et al., who corresponded the main sky conditions to 15 theoretical sky standards in diagrams of the ratio of zenith luminance to diffuse horizontal illuminance against solar altitude. For both cities the three aforementioned methods do not create identical DRYs. Despite the differences, the sky types defined for each of the two places seem not to depend on the choice of DRY. The predominant sky standard, for all of them, is a cloudless, polluted sky with a broad solar corona for Athens and an overcast sky with slight brightening towards the sun as well as very clear sky with low atmospheric turbidity for Bratislava. However, the selection of the DRY, which represents best the daylight conditions, is necessary for studies in saving energy in buildings. The DRY, which is created by the Modified Sandia National Laboratories method, is chosen for most cases, while the one created by the Danish method is also useful on certain occasions.

  4. Establishing a China malaria diagnosis reference laboratory network for malaria elimination.

    PubMed

    Yin, Jian-hai; Yan, He; Huang, Fang; Li, Mei; Xiao, Hui-hui; Zhou, Shui-sen; Xia, Zhi-gui

    2015-01-28

    In China, the prevalence of malaria has reduced dramatically due to the elimination programme. The continued success of the programme will depend upon the accurate diagnosis of the disease in the laboratory. The basic requirements for this are a reliable malaria diagnosis laboratory network and quality management system to support case verification and source tracking. The baseline information of provincial malaria laboratories in the China malaria diagnosis reference laboratory network was collected and analysed, and a quality-assurance activity was carried out to assess their accuracies in malaria diagnosis by microscopy using WHO standards and PCR. By the end of 2013, nineteen of 24 provincial laboratories have been included in the network. In the study, a total of 168 staff were registered and there was no bias in their age, gender, education level, and position. Generally Plasmodium species were identified with great accuracy by microscopy and PCR. However, Plasmodium ovale was likely to be misdiagnosed as Plasmodium vivax by microscopy. China has established a laboratory network for primary malaria diagnosis which will cover a larger area. Currently, Plasmodium species can be identified fairly accurately by microscopy and PCR. However, laboratory staff need additional trainings on accurate identification of P. ovale microscopically and good performance of PCR operations.

  5. Termite-Susceptible Species of Wood for Inclusion as a Reference in Indonesian Standardized Laboratory Testing.

    PubMed

    Arinana; Tsunoda, Kunio; Herliyana, Elis N; Hadi, Yusuf S

    2012-03-28

    Standardized laboratory testing of wood and wood-based products against subterranean termites in Indonesia (SNI 01.7207-2006) (SNI) has no requirement for the inclusion of a comparative reference species of wood (reference control). This is considered a weakness of the Indonesian standard. Consequently, a study was undertaken to identify a suitable Indonesian species of community wood that could be used as a reference control. Four candidate species of community woods: Acacia mangium, Hevea brasiliensis, Paraserianthes falcataria and Pinus merkusii were selected for testing their susceptibility to feeding by Coptotermes formosanus. Two testing methods (SNI and the Japanese standard method JIS K 1571-2004) were used to compare the susceptibility of each species of wood. Included in the study was Cryptomeria japonica, the reference control specified in the Japanese standard. The results of the study indicated that P. merkusii is a suitable reference species of wood for inclusion in laboratory tests against subterranean termites, conducted in accordance with the Indonesian standard (SNI 01.7207-2006).

  6. Reference ranges for the clinical laboratory derived from a rural population in Kericho, Kenya.

    PubMed

    Kibaya, Rukia S; Bautista, Christian T; Sawe, Frederick K; Shaffer, Douglas N; Sateren, Warren B; Scott, Paul T; Michael, Nelson L; Robb, Merlin L; Birx, Deborah L; de Souza, Mark S

    2008-10-03

    The conduct of Phase I/II HIV vaccine trials internationally necessitates the development of region-specific clinical reference ranges for trial enrollment and participant monitoring. A population based cohort of adults in Kericho, Kenya, a potential vaccine trial site, allowed development of clinical laboratory reference ranges. Lymphocyte immunophenotyping was performed on 1293 HIV seronegative study participants. Hematology and clinical chemistry were performed on up to 1541 cohort enrollees. The ratio of males to females was 1.9:1. Means, medians and 95% reference ranges were calculated and compared with those from other nations. The median CD4+ T cell count for the group was 810 cells/microl. There were significant gender differences for both red and white blood cell parameters. Kenyan subjects had lower median hemoglobin concentrations (9.5 g/dL; range 6.7-11.1) and neutrophil counts (1850 cells/microl; range 914-4715) compared to North Americans. Kenyan clinical chemistry reference ranges were comparable to those from the USA, with the exception of the upper limits for bilirubin and blood urea nitrogen, which were 2.3-fold higher and 1.5-fold lower, respectively. This study is the first to assess clinical reference ranges for a highland community in Kenya and highlights the need to define clinical laboratory ranges from the national community not only for clinical research but also care and treatment.

  7. Reference Ranges for the Clinical Laboratory Derived from a Rural Population in Kericho, Kenya

    PubMed Central

    Kibaya, Rukia S.; Bautista, Christian T.; Sawe, Frederick K.; Shaffer, Douglas N.; Sateren, Warren B.; Scott, Paul T.; Michael, Nelson L.; Robb, Merlin L.; Birx, Deborah L.; de Souza, Mark S.

    2008-01-01

    The conduct of Phase I/II HIV vaccine trials internationally necessitates the development of region-specific clinical reference ranges for trial enrolment and participant monitoring. A population based cohort of adults in Kericho, Kenya, a potential vaccine trial site, allowed development of clinical laboratory reference ranges. Lymphocyte immunophenotyping was performed on 1293 HIV seronegative study participants. Hematology and clinical chemistry were performed on up to 1541 cohort enrollees. The ratio of males to females was 1.9∶1. Means, medians and 95% reference ranges were calculated and compared with those from other nations. The median CD4+ T cell count for the group was 810 cells/µl. There were significant gender differences for both red and white blood cell parameters. Kenyan subjects had lower median hemoglobin concentrations (9.5 g/dL; range 6.7–11.1) and neutrophil counts (1850 cells/µl; range 914–4715) compared to North Americans. Kenyan clinical chemistry reference ranges were comparable to those from the USA, with the exception of the upper limits for bilirubin and blood urea nitrogen, which were 2.3-fold higher and 1.5-fold lower, respectively. This study is the first to assess clinical reference ranges for a highland community in Kenya and highlights the need to define clinical laboratory ranges from the national community not only for clinical research but also care and treatment. PMID:18833329

  8. An analysis of reference laboratory (send out) testing: an 8-year experience in a large academic medical center.

    PubMed

    MacMillan, Donna; Lewandrowski, Elizabeth; Lewandrowski, Kent

    2004-01-01

    Utilization of outside reference laboratories for selected laboratory testing is common in the United States. However, relatively little data exist in the literature describing the scope and impact of these services. In this study, we reviewed use of reference laboratory testing at the Massachusetts General Hospital, a large urban academic medical center in Boston, Massachusetts. A retrospective review of hospital and laboratory administrative records over an 8-year period from fiscal years (FY) 1995-2002. Over the 8 years studied, reference laboratory expenses increased 4.2-fold and totaled 12.4% of the total laboratory budget in FY 2002. Total reference laboratory test volume increased 4-fold to 68,328 tests in FY 2002 but represented only 1.06% of the total test volume in the hospital. The menu of reference laboratory tests comprised 946 tests (65.7% of the hospital test menu) compared to 494 (34.3%) of tests performed in house. The average unit cost of reference laboratory tests was essentially unchanged but was approximately 13 times greater than the average unit cost in the hospital laboratory. Much of the growth in reference laboratory cost can be attributed to the addition of new molecular, genetic, and microbiological assays. Four of the top 10 tests with the highest total cost in 2002 were molecular diagnostic tests that were recently added to the test menu. Reference laboratory testing comprises a major component of hospital clinical laboratory services. Although send out tests represent a small percentage of the total test volume, these services account for the majority of the hospital laboratory test menu and a disproportionate percentage of laboratory costs.

  9. Laboratory diagnosis of endophthalmitis: comparison of microbiology and molecular methods in the European Society of Cataract & Refractive Surgeons multicenter study and susceptibility testing.

    PubMed

    Seal, David; Reischl, Udo; Behr, Anke; Ferrer, Consuelo; Alió, Jorge; Koerner, Roland J; Barry, Peter

    2008-09-01

    To investigate and compare the use of molecular biology with the use of traditional Gram stain and organism culture for the laboratory diagnosis of postoperative endophthalmitis. Twenty-four ophthalmology units together with 9 microbiology laboratories and 2 European reference molecular biology laboratories. A prospective randomized partially masked multicenter cataract surgery study recruited 16 603 patients. This resulted in 29 cases of presumed postoperative endophthalmitis. Gram stain and culture were performed in the local laboratory according to agreed protocols. Samples of aqueous and/or vitreous were transported to the first referenced molecular biology laboratory (Regensburg, Germany) for polymerase chain reaction (PCR) testing, and an extracted aliquot of DNA was then referred to the second laboratory (Alicante, Spain) for PCR. Of the 29 who presented with presumed postoperative endophthalmitis, 20 were classified as proven infective endophthalmitis with positive Gram stain, culture, or PCR. Fourteen patients were culture-positive; all but 1 of these was also positive by PCR. Six patients were positive by PCR but negative by Gram stain or culture. Nine patients were negative by both microbiology and PCR testing. Use of molecular biology technique increased the laboratory rate of identifying the pathogen by 20%, confirming the technique is very useful for the endophthalmitis specimen. Samples of both aqueous and vitreous should be collected and stored at -20 degrees C for PCR at the time of the diagnostic taps.

  10. Collaborative study for the establishment of a European Phamacopoeia Biological reference preparation for Bordetella pertussis mouse antiserum for serological potency testing of acellular pertussis vaccines.

    PubMed

    Poirier, Bertrand; Bornstein, Nicole; Andre, Murielle; Marmonier, Denis; Pares, Monique; Vanhooren, Gerard; Rautmann, Guy; Behr-Gross, Marie-Emmanuelle; Dobbelaer, Roland; Fuchs, Florence

    2003-03-01

    A collaborative study was organised by the European Directorate For the Quality of Medicines (EDQM) to assess the suitability of a candidate mouse antiserum as a European Pharmacopoeia Biological reference preparation (BRP) for acellular pertussis vaccine potency testing. The candidate antiserum was obtained by immunising mice with a five-component acellular pertussis vaccine: pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and Fimbrial 2/Fimbrial 3 (Fim 2&3). The study has been divided into two separate phases. Phase I was a pre-qualification study including three laboratories. This phase was aimed at pre-qualifying the candidate BRP (cBRP) and at documenting the impact of differences in the antibody detection methodology enzyme linked immunosorbent assay (ELISA) procedures on results of pertussis antisera calibration versus the currently used standard US standard pertussis antiserum (mouse) Lot 1 (SPAM-1) (United States Food and Drug Administration (USFDA) reference serum) and the cBRP. As no significant difference between the antibody titres determined by using the different ELISA methodologies was found, a large-scale study enrolling 13 laboratories (Phase II) was carried out, each participant performing its in-house methodology. Its aim was to calibrate the cBRP (in terms of the SPAM-1 reference) and to demonstrate its equivalence or superiority to internal references. The study showed that there was no difference in positive sera titres expressed relative to their corresponding internal reference (homologous situation) or the proposed standard (heterologous situation) reference. The cBRP can, therefore, reliably act as replacement for the in-house reference preparations. Further analysis of the outcome of this study enabled to assign to the cBRP a potency of 39, 138, 34 and 56 ELISA unit per millilitre, respectively, to its anti-PT, anti-FHA, anti-PRN and anti-Fim 2&3 antibody contents. The cBRP has been adopted by the European

  11. Annual report of the Australian National Enterovirus Reference Laboratory 2010-2011.

    PubMed

    Roberts, Jason; Hobday, Linda; Ibrahim, Aishah; Aitken, Thomas; Thorley, Bruce

    2013-06-30

    Australia conducts clinical surveillance for cases of polio-like illness in children in accordance with the World Health Organization (WHO) recommended surveillance criteria for acute flaccid paralysis (AFP). AFP cases are ascertained either by clinicians notifying the Australian Paediatric Surveillance Unit or designated nurses enrolling cases as part of the Paediatric Active Enhanced Disease Surveillance system at four sentinel tertiary paediatric hospitals. The National Enterovirus Reference Laboratory (NERL), formerly the National Poliovirus Reference Laboratory, is accredited by the World Health Organization (WHO) for the testing of faecal specimens from cases of AFP and operates as a Poliovirus Regional Reference Laboratory for the Western Pacific Region. In 2010 and 2011, for the 3rd and 4th consecutive years, Australia met the WHO AFP surveillance performance indicator. This is indicative of a sensitive surveillance system capable of detecting an imported case of polio in children. However, the faecal collection rate for the virological investigation of AFP cases was below the WHO surveillance performance indicator in both years and represented a gap in Australia's polio surveillance. Enterovirus and environmental surveillance were established in Australia as virological surveillance to complement the clinical surveillance schemes. No poliovirus was detected by the clinical or virological surveillance schemes in 2010 or 2011 and Australia maintained its polio-free status. India was declared polio-free in January 2012, a significant step towards global polio eradication, leaving Afghanistan, Nigeria and Pakistan as the remaining countries endemic for wild poliovirus.

  12. The Council of Europe's "Common European Framework of Reference for Languages" (CEFR): Approach, Status, Function and Use

    ERIC Educational Resources Information Center

    Martyniuk, Waldemar

    2012-01-01

    The Council of Europe's "Common European Framework of Reference for Languages" is rapidly becoming a powerful instrument for shaping language education policies in Europe and beyond. The task of relating language policies, language curricula, teacher education and training, textbook and course design and content, examinations and…

  13. The Council of Europe's "Common European Framework of Reference for Languages" (CEFR): Approach, Status, Function and Use

    ERIC Educational Resources Information Center

    Martyniuk, Waldemar

    2012-01-01

    The Council of Europe's "Common European Framework of Reference for Languages" is rapidly becoming a powerful instrument for shaping language education policies in Europe and beyond. The task of relating language policies, language curricula, teacher education and training, textbook and course design and content, examinations and…

  14. Mozambique’s journey toward accreditation of the National Tuberculosis Reference Laboratory

    PubMed Central

    Madeira, Carla; Aguiar, Carmen; Dolores, Carolina; Mandlaze, Ana P.; Chongo, Patrina; Masamha, Jessina

    2017-01-01

    Background Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. Methods The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system. After SLMTA, the Mozambique National Institute of Health committed to accelerate the NTRL’s process toward accreditation. An action plan was designed to streamline the process. Quality indicators were defined to benchmark progress. Staff were trained to improve performance. Mentorship from an experienced assessor was provided. Fulfilment of accreditation standards was assessed by the Portuguese Accreditation Board. Results Of the eight laboratories participating in SLMTA, the NTRL was the best-performing laboratory, achieving a 53.6% improvement over the SLMTA baseline conducted in February 2011 to the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) assessment in June 2013. During the accreditation assessment in September 2014, 25 minor nonconformities were identified and addressed. In March 2015, the NTRL received Portuguese Accreditation Board recognition of technical competency for fluorescence smear microscopy, and solid and liquid culture. The NTRL is the first laboratory in Mozambique to achieve ISO 15189 accreditation. Conclusions From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan. PMID:28879162

  15. Food adulteration analysis without laboratory prepared or determined reference food adulterant values.

    PubMed

    Kalivas, John H; Georgiou, Constantinos A; Moira, Marianna; Tsafaras, Ilias; Petrakis, Eleftherios A; Mousdis, George A

    2014-04-01

    Quantitative analysis of food adulterants is an important health and economic issue that needs to be fast and simple. Spectroscopy has significantly reduced analysis time. However, still needed are preparations of analyte calibration samples matrix matched to prediction samples which can be laborious and costly. Reported in this paper is the application of a newly developed pure component Tikhonov regularization (PCTR) process that does not require laboratory prepared or reference analysis methods, and hence, is a greener calibration method. The PCTR method requires an analyte pure component spectrum and non-analyte spectra. As a food analysis example, synchronous fluorescence spectra of extra virgin olive oil samples adulterated with sunflower oil is used. Results are shown to be better than those obtained using ridge regression with reference calibration samples. The flexibility of PCTR allows including reference samples and is generic for use with other instrumental methods and food products. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. The European reference condition concept: A scientific and technical approach to identify minimally-impacted river ecosystems.

    PubMed

    Pardo, Isabel; Gómez-Rodríguez, Carola; Wasson, Jean-Gabriel; Owen, Roger; van de Bund, Wouter; Kelly, Martyn; Bennett, Cathy; Birk, Sebastian; Buffagni, Andrea; Erba, Stefania; Mengin, Nicolas; Murray-Bligh, John; Ofenböeck, Gisela

    2012-03-15

    One objective of the European Union (EU)'s Water Framework Directive (WFD: Directive 2000/60/EC) is for all European surface waters to achieve 'good status' by 2015. In support of this objective, the EU has facilitated an intercalibration exercise to ensure harmonized definitions of the status of water bodies, reflecting the deviation of their properties (mainly biotic assemblages) from a minimally disturbed state, termed the "reference condition". One of the major challenges of the WFD has been to find common approaches for defining reference conditions and to define the level of anthropogenic intervention allowed in reference sites. In this paper we describe how river reference sites were selected in the Central-Baltic region of Europe. A list of pressure criteria was provided and 14 Member States (MSs) categorized each criterion according to the method (i.e. measured, field inspection, etc.) used for reference site screening. Additionally, reference land-use and water-chemistry thresholds were agreed among countries in order to base reference site selection on objective criteria. For land-use criteria, a reference threshold and a rejection threshold were established. Sites with all criteria below the reference threshold were considered to be reference sites; sites having most criteria below the reference threshold and only some parameters between the reference and rejection threshold were "possible reference sites". These sites were retained only after carefully checking the cumulative effects of the pressures using local expertise, and a posteriori water-chemistry evaluation was necessary. In general, the most widespread method for defining a reference site was the measurement of pressures, followed by field inspections and expert judgment. However, some major pressures (e.g. hydromorphological alteration) were evaluated in a number of different ways (e.g. measured, field inspection, expert judgment). Our meta-analyses reveal a need to reinforce standardization

  17. [The role of reference laboratories in animal health programmes in South America].

    PubMed

    Bergmann, I E

    2003-08-01

    The contribution of the Panamerican Foot and Mouth Disease (FMD) Centre (PANAFTOSA), as an OIE (World organisation for animal health) regional reference laboratory for the diagnosis of FMD and vesicular stomatitis, and for the control of the FMD vaccine, has been of fundamental importance to the development, implementation and harmonisation of modern laboratory procedures in South America. The significance of the work conducted by PANAFTOSA is particularly obvious when one considers the two pillars on which eradication programmes are based, namely: a well-structured regional laboratory network, and the creation of a system which allows technology and new developments to be transferred to Member Countries as quickly and efficiently as possible. Over the past decade, PANAFTOSA has kept pace with the changing epidemiological situation on the continent, and with developments in the international political and economical situation. This has involved the strengthening of quality policies, and the elaboration and implementation of diagnostic tools that make for more thorough epidemiological analyses. The integration of PANAFTOSA into the network of national laboratories and its cooperation with technical and scientific institutes, universities and the private sector means that local needs can be met, thanks to the design and rapid implementation of methodological tools which are validated using internationally accepted criteria. This collaboration, which ensures harmonisation of laboratory tests and enhances the quality of national Veterinary Services, serves to promote greater equity, a prerequisite for regional eradication strategies and this in turn, helps to increase competitiveness in the region.

  18. Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa.

    PubMed

    Albert, Heidi; de Dieu Iragena, Jean; Kao, Kekeletso; Erni, Donatelle; Mekonen, Teferi; Onyebujoh, Philip C

    2017-01-01

    Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care. The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs) in the African Region. An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region. A total of 21 laboratories (43.0%) had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%), although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing). Barriers to accreditation included lack of training and accreditation programmes. Only 28.6% of NTRLs had developed strategic plans and budgets which included accreditation. Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient impact and cost-benefit.

  19. Collaborative study for establishment of a European Pharmacopoei Biological Reference Preparation (BRP) for B19 virus DNA testing of plasma pools by nucleic acid amplification technique.

    PubMed

    Nübling, C M; Daas, A; Buchheit, K H

    2004-01-01

    The goal of the collaborative study was to calibrate the B19 DNA content of a candidate Biological Reference Preparation (BRP) that is intended to be used for the validation of the analytical procedure, as threshold control and/or as quantitative reference material in the Nucleic Acid Amplification Technique (NAT) test of plasma pools for detection of B19 contamination. The candidate BRP was calibrated against the 1st International Standard for B19 DNA NAT assays. According to the European Pharmacopoeia monograph Human anti-D immunoglobulin, the threshold control needs to have a titre of 10( 4) IU/ml of B19 virus DNA. The lyophilised candidate BRP was prepared from 0.5 ml aliquots of a plasma pool spiked with B19 virus. The B19 virus originated from a "B19 virus window phase" blood donation (anti-B19 negative, B19-DNA high titre positive) and was diluted in a plasma pool tested negative by both serological and NAT assays for Hepatitis B Virus, Hepatitis C Virus and Human Immunodeficiency Virus 1 to obtain a B19-DNA concentration level in the range of 10( 6) copies/ml. The residual water content of the lyophilised candidate BRP was determined as 0.98 +/- 0.65% (mean +/- relative standard deviation). Sixteen laboratories (Official Medicine Control Laboratories, manufacturers of plasma derivatives, NAT test laboratories and NAT kit manufacturers) from nine countries participated. Participants were requested to test the candidate BRP and the International Standard (99/800) in four independent test runs on different days using their in-house qualitative and/or quantitative NAT methods. Sixteen laboratories reported results. Thirteen laboratories reported results from qualitative assays and 5 laboratories reported results from quantitative assays. Two laboratories reported results from both types of assay. For the qualitative assays a weighted combined potency of 5.64 log( 10) IU/ml with 95 per cent confidence limits of +/- 0.17 log( 10) which corresponds to 67 to 150

  20. [Capability of national reference laboratories in Latin America to detect emerging resistance mechanisms].

    PubMed

    Corso, Alejandra; Guerriero, Leonor; Pasterán, Fernando; Ceriana, Paola; Callejo, Raquel; Prieto, Mónica; Tuduri, Ezequiel; Lopardo, Horacio; Vay, Carlos; Smayevsky, Jorgelina; Tokumoto, Marta; Alvarez, Jorge Matheu; Pardo, Pilar Ramón; Galas, Marcelo

    2011-12-01

    To evaluate the capability of 17 national reference laboratories participating in the Latin American Quality Control Program in Bacteriology and Antibiotic Resistance (LA-EQAS) to detect emerging resistance mechanisms- namely: resistance of enterobacteria to carbapenems due to the presence of Klebsiella pneumoniae carbapenemase (KPC) and metallo-beta-lactamase (MBL) type IMP, and intermediate resistance of Staphylococcus aureus isolates to vancomycin (vancomycin-intermediate resistant S. aureus-VISA). The following three isolates were sent to the 17 participating LA-EQAS laboratories: KPC -producing Klebsiella pneumoniae PAHO-161, IMP-producing Enterobacter cloacae PAHO-166, and S. aureus PAHO-165 with intermediate resistance to vancomycin. Performance of each of the following operations was evaluated: interpretation of sensitivity tests, detection of the resistance mechanism, and assessment of either inhibition halo size (disk diffusion method) or minimum inhibitory concentration (MIC). Concordance in the detection of resistance mechanisms was 76.4%, 73.3%, and 66.7% for the K. pneumoniae PAHO-161, E. cloacae PAHO-166, and S. aureus PAHO-165 strains, respectively. Concordance between the inhibition areas observed by the participating laboratories and the ranges established by the coordinating laboratory was acceptable for all three isolates, at 90.8%, 92.8%, and 88.9%, respectively. Overall concordance in on the detection of KPC, MBL, and VISA resistance mechanisms was 72.1%. We consider the national reference laboratories in Latin America capable of recognizing these emerging resistance mechanisms and expect that maximum levels of concordance will be reached in the future.

  1. The use of reference materials in quality assurance programmes in food microbiology laboratories.

    PubMed

    In't Veld, P H

    1998-11-24

    Nine different reference materials (RMs) for use in food and water microbiology have been developed with the support of the European Commission (EC). The production process of RMs is based on spray drying bacteria suspended in milk. The highly contaminated milk powder (HCMP) obtained is mixed with sterile milk powder to achieve the desired level of contamination and is subsequently filled into gelatine capsules. The HCMP may need to be stabilised by storage for more than a year before a stable RM can be prepared. The HCMP are mixed with sterile milk powder using a pestle and mortar in order to produce homogeneous RMs. For routine use of RMs Shewhart control charts can be produced. Based on log10 transformed counts, control limits are calculated. Rules for the interpretation of results facilitate the detection of out of control situations. Besides RMs there are also CRMs (Certified Reference Materials) that are certified by the EC Community Bureau of Reference (BCR) and are intended for occasional use. Based on the BCR certificate, user tables are produced presenting the 95% confidence limits for the number of capsules likely to be examined in practice. Also power analysis is made to indicate the minimum difference between the certified value and the observed geometric mean value in relation to the number of capsules examined.

  2. EPOS Multi-Scale Laboratory platform: a long-term reference tool for experimental Earth Sciences

    NASA Astrophysics Data System (ADS)

    Trippanera, Daniele; Tesei, Telemaco; Funiciello, Francesca; Sagnotti, Leonardo; Scarlato, Piergiorgio; Rosenau, Matthias; Elger, Kirsten; Ulbricht, Damian; Lange, Otto; Calignano, Elisa; Spiers, Chris; Drury, Martin; Willingshofer, Ernst; Winkler, Aldo

    2017-04-01

    With continuous progress on scientific research, a large amount of datasets has been and will be produced. The data access and sharing along with their storage and homogenization within a unique and coherent framework is a new challenge for the whole scientific community. This is particularly emphasized for geo-scientific laboratories, encompassing the most diverse Earth Science disciplines and typology of data. To this aim the "Multiscale Laboratories" Work Package (WP16), operating in the framework of the European Plate Observing System (EPOS), is developing a virtual platform of geo-scientific data and services for the worldwide community of laboratories. This long-term project aims at merging the top class multidisciplinary laboratories in Geoscience into a coherent and collaborative network, facilitating the standardization of virtual access to data, data products and software. This will help our community to evolve beyond the stage in which most of data produced by the different laboratories are available only within the related scholarly publications (often as print-version only) or they remain unpublished and inaccessible on local devices. The EPOS multi-scale laboratory platform will provide the possibility to easily share and discover data by means of open access, DOI-referenced, online data publication including long-term storage, managing and curation services and to set up a cohesive community of laboratories. The WP16 is starting with three pilot cases laboratories: (1) rock physics, (2) palaeomagnetic, and (3) analogue modelling. As a proof of concept, first analogue modelling datasets have been published via GFZ Data Services (http://doidb.wdc-terra.org/search/public/ui?&sort=updated+desc&q=epos). The datasets include rock analogue material properties (e.g. friction data, rheology data, SEM imagery), as well as supplementary figures, images and movies from experiments on tectonic processes. A metadata catalogue tailored to the specific communities

  3. [Establishment of Networks of National Reference Centres and associated Consiliary Laboratories in Germany].

    PubMed

    Laude, G; Kist, M; Krause, G

    2009-10-01

    The German Federal Ministry of Health has funded National Reference Centres (NRC) for laboratory-based surveillance of selected infection pathogens and infections disease syndromes. This selection is based on the epidemiologic relevance of the pathogens, specific diagnostic requirements, antimicrobial resistance and need for public health measures. Currently there are 18 NRC, nominated for a duration of 3 years. Toward the end of a nomination period, each NRC is evaluated by an expert committee, based on the catalogue of core tasks. In order to expand the spectrum of competencies 47 consiliary laboratories on additional pathogens of special epidemiologic importance have been named. Their main function is to provide information and consultation on special diagnostic issues. In order to further improve the effectiveness and cooperation of the system Networks have been created. The aim of the Networks is to facilitate exchange of diagnostic methods and prevention concepts and to improve the geographic coverage of the services.

  4. Reference site selection report for the advanced liquid metal reactor at the Idaho National Engineering Laboratory

    SciTech Connect

    Sivill, R.L.

    1990-03-01

    This Reference Site Selection Report was prepared by EG G, Idaho Inc., for General Electric (GE) to provide information for use by the Department of Energy (DOE) in selecting a Safety Test Site for an Advanced Liquid Metal Reactor. Similar Evaluation studies are planned to be conducted at other potential DOE sites. The Power Reactor Innovative Small Module (PRISM) Concept was developed for ALMR by GE. A ALMR Safety Test is planned to be performed on a DOE site to demonstrate features and meet Nuclear Regulatory Commission Requirements. This study considered possible locations at the Idaho National Engineering Laboratory that met the ALMR Prototype Site Selection Methodology and Criteria. Four sites were identified, after further evaluation one site was eliminated. Each of the remaining three sites satisfied the criteria and was graded. The results were relatively close. Thus concluding that the Idaho National Engineering Laboratory is a suitable location for an Advanced Liquid Metal Reactor Safety Test. 23 refs., 13 figs., 9 tabs.

  5. Proficiency Testing of Feed Constituents: A Comparative Evaluation of European and Developing Country Laboratories and Its Implications for Animal Production.

    PubMed

    Makkar, H P S; Strnad, I; Mittendorfer, J

    2016-10-06

    Proficiency tests, with two feed samples each year, for various constituents (proximate, macro- and microminerals, feed additives, and amino acids) were conducted in 2014 and 2015. A total of 40 and 50 European and 73 and 63 developing country feed analysis laboratories participated in the study in 2014 and 2015, respectively. The data obtained from these two sets of laboratories in each year enabled a comparison of the performance of the European and developing country laboratories. Higher standard deviation and several-fold higher coefficients of variation were obtained for the developing country laboratories. The coefficients of variation for chemical composition parameters, macrominerals, microminerals, and amino acids were higher by up to 9-fold, 14-fold, 10-fold, and 14-fold, respectively, for the developing country laboratories compared with the European laboratories in 2014, while the corresponding values for 2015 were 4.6-fold, 4.4-fold, 9-fold, and 14-fold higher for developing county laboratories. Also, higher numbers of outliers were observed for developing countries (2014, 7.6-8.7% vs 2.9-3.0%; 2015, 7.7-9.5% vs 4.2-7.0%). The results suggest higher need for developing country feed analysis laboratories to improve the quality of data being generated. The likely impact of higher variability of the data generated in developing countries toward safe and quality preparation of animal diets, their impact on animal productivity, and possible ways to improve the quality of data from developing countries are discussed.

  6. Updated standards and processes for accreditation of echocardiographic laboratories from The European Association of Cardiovascular Imaging: an executive summary.

    PubMed

    Popescu, Bogdan A; Stefanidis, Alexandros; Nihoyannopoulos, Petros; Fox, Kevin F; Ray, Simon; Cardim, Nuno; Rigo, Fausto; Badano, Luigi P; Fraser, Alan G; Pinto, Fausto; Zamorano, Jose Luis; Habib, Gilbert; Maurer, Gerald; Lancellotti, Patrizio

    2014-11-01

    Standards for echocardiographic laboratories were proposed by the European Association of Echocardiography (now the European Association of Cardiovascular Imaging) 7 years ago, to raise standards of practice and improve the quality of care. Criteria and requirements were published at that time for transthoracic, transoesophageal, and stress echocardiography. This paper reassesses and updates the quality standards to take account of experience and the technical developments of modern echocardiographic practice. It also discusses quality control, the incentives for laboratories to apply for accreditation, the re-accreditation criteria, and the current status and future prospects of the laboratory accreditation process. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  7. Comparison of Leishmania typing results obtained from 16 European clinical laboratories in 2014.

    PubMed

    Van der Auwera, Gert; Bart, Aldert; Chicharro, Carmen; Cortes, Sofia; Davidsson, Leigh; Di Muccio, Trentina; Dujardin, Jean-Claude; Felger, Ingrid; Paglia, Maria Grazia; Grimm, Felix; Harms, Gundel; Jaffe, Charles L; Manser, Monika; Ravel, Christophe; Robert-Gangneux, Florence; Roelfsema, Jeroen; Töz, Seray; Verweij, Jaco J; Chiodini, Peter L

    2016-12-08

    Leishmaniasis is endemic in southern Europe, and in other European countries cases are diagnosed in travellers who have visited affected areas both within the continent and beyond. Prompt and accurate diagnosis poses a challenge in clinical practice in Europe. Different methods exist for identification of the infecting Leishmania species. Sixteen clinical laboratories in 10 European countries, plus Israel and Turkey, conducted a study to assess their genotyping performance. DNA from 21 promastigote cultures of 13 species was analysed blindly by the routinely used typing method. Five different molecular targets were used, which were analysed with PCR-based methods. Different levels of identification were achieved, and either the Leishmania subgenus, species complex, or actual species were reported. The overall error rate of strains placed in the wrong complex or species was 8.5%. Various reasons for incorrect typing were identified. The study shows there is considerable room for improvement and standardisation of Leishmania typing. The use of well validated standard operating procedures is recommended, covering testing, interpretation, and reporting guidelines. Application of the internal transcribed spacer 1 of the rDNA array should be restricted to Old World samples, while the heat-shock protein 70 gene and the mini-exon can be applied globally. This article is copyright of The Authors, 2016.

  8. Comparison of Leishmania typing results obtained from 16 European clinical laboratories in 2014

    PubMed Central

    Van der Auwera, Gert; Bart, Aldert; Chicharro, Carmen; Cortes, Sofia; Davidsson, Leigh; Di Muccio, Trentina; Dujardin, Jean-Claude; Felger, Ingrid; Paglia, Maria Grazia; Grimm, Felix; Harms, Gundel; Jaffe, Charles L.; Manser, Monika; Ravel, Christophe; Robert-Gangneux, Florence; Roelfsema, Jeroen; Töz, Seray; Verweij, Jaco J.; Chiodini, Peter L.

    2016-01-01

    Leishmaniasis is endemic in southern Europe, and in other European countries cases are diagnosed in travellers who have visited affected areas both within the continent and beyond. Prompt and accurate diagnosis poses a challenge in clinical practice in Europe. Different methods exist for identification of the infecting Leishmania species. Sixteen clinical laboratories in 10 European countries, plus Israel and Turkey, conducted a study to assess their genotyping performance. DNA from 21 promastigote cultures of 13 species was analysed blindly by the routinely used typing method. Five different molecular targets were used, which were analysed with PCR-based methods. Different levels of identification were achieved, and either the Leishmania subgenus, species complex, or actual species were reported. The overall error rate of strains placed in the wrong complex or species was 8.5%. Various reasons for incorrect typing were identified. The study shows there is considerable room for improvement and standardisation of Leishmania typing. The use of well validated standard operating procedures is recommended, covering testing, interpretation, and reporting guidelines. Application of the internal transcribed spacer 1 of the rDNA array should be restricted to Old World samples, while the heat-shock protein 70 gene and the mini-exon can be applied globally. PMID:27983510

  9. Good laboratory practice in the European Community. Role of the commission and the member states: external aspects.

    PubMed

    Berend, Klaus

    2002-01-01

    The paper recalls the history of the development of the OECD principles of good laboratory practice (GLP) and explains why the European Community has a role to play in the area of GLP. It presents briefly the current legal framework in the European Community (Directives 87/18/EEC and 88/320/EEC) and describes the role of the Commission and the member states in the practical implementation of the GLP principles within the European Community. Impacts of GLP on the relations of the European Community with third countries, both within the framework of the OECD and through bilateral trade agreements (mutual recognition agreements, MRA) based on article 133 of the treaty establishing the European Community, are then examined in greater detail.

  10. Population-based reference values for the European Organization for Research and Treatment of Cancer Head and Neck module.

    PubMed

    Hammerlid, Eva; Adnan, Ali; Silander, Ewa

    2017-10-01

    The purpose of this study was to establish population-based norms for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 (EORTC QLQ-HN35) to be used as references to facilitate the interpretation of results from health-related quality of life (HRQOL) studies of patients with head and neck cancer. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and QLQ-HN35 were sent to a random sample representing the Swedish general population. The response rate was 69% (1504 participants of 2200 invited). The scores for the QLQ-C30 were comparable to previously published reference values. The reference values for the QLQ-HN35 were low, indicating few head and neck-specific problems in the population. For illustrative purposes, we also compared these reference values to our previously published HRQOL results obtained from patients with head and neck cancer at diagnosis and from 3-year survivors. These new reference values for EORTC QLQ-HN35 may be useful in future HRQOL studies. © 2017 Wiley Periodicals, Inc.

  11. [Molecular diagnosis of HFE mutations in routine laboratories. Results of a survey from reference laboratories in France].

    PubMed

    Jouanolle, Anne-Marie; Gérolami, Victoria; Ged, Cécile; Grandchamp, Bernard; Le Gac, Gérald; Pissard, Serge; Rochette, Jacques; Aguilar-Martinez, Patricia

    2012-01-01

    HFE-related hemochromatosis (HFE hemochromatosis) or type 1 hemochromatosis is an autosomal recessive disease characterized by progressive iron overload usually expressed in adulthood. The HFE gene, located on the short arm of chromosome 6 (6p21.3), encodes a protein that plays a crucial role in iron metabolism by modulating hepcidin synthesis in the liver. Homozygosity for the p.Cys282Tyr mutation accounts for nearly 80% of cases of hemochromatosis in France. Genetic testing is the key investigation to confirm the diagnosis of HFE hemochromatosis. A survey on routine practices was carried out among the eight reference laboratories of the French national network on genetic iron disorders. The main findings from this survey are as follows: 1) the p.Cys282Tyr mutation must be searched for as an initial step to establish the diagnosis of HFE hemochromatosis. This is in agreement with the recommendations of the French Health Authority (HAS) published in 2005. In these recommendations, homozygosity for the p.Cys282Tyr mutation with at least elevated transferrin saturation, is considered the only genotype that confirms of the diagnosis of HFE hemochromatosis; 2) in combination with the p.Cys282Tyr mutation (compound heterozygous genotypes), the p.Ser65Cys and the p.His63Asp variants may contribute to the occurrence of mild iron overload; 3) family screening is mandatory following the detection of homozygous individuals for the p.Cys282Tyr mutation.

  12. Analyses of laboratory data and establishment of reference values and intervals for healthy elderly people.

    PubMed

    Kubota, K; Kadomura, T; Ohta, K; Koyama, K; Okuda, H; Kobayashi, M; Ishii, C; Fujiwara, Y; Nishiora, T; Ohmae, Y; Ohmae, T; Kitajima, M

    2012-04-01

    Protein-energy malnutrition is a common disorder in the elderly. Although serum albumin is commonly used as a nutritional marker, data is lacking on serum albumin levels in the elderly. The purpose of this study was to determine whether serum albumin levels decrease with advancing age and to establish reference value and interval of laboratory data for elderly people (75 years and over). Blood samples from 13821 healthy people, 42064 outpatients, and 15959 inpatients were collected during 2008. Blood from 127 of our nutrition support team (NST) patients was also collected during August 2006 and May 2009, and analyzed. Serum albumin, hemoglobin, total cholesterol levels and lymphocyte count were determined. We analyzed the change in each parameter in accordance with age, compared the data for elderly people with younger people, and established new reference values. Clinical outcomes were examined depending on the improved reference values. Albumin was lower in older persons than in younger persons. The estimated reference value and interval were 42 (48-36) g/l in older persons and was much lower in NST patients. Hemoglobin was decreased while cholesterol and lymphocyte count were not changed in older persons: all were markedly decreased in NST patients. Terms of hospital stay were significantly longer and mortality rates were significantly higher in older persons, comparing from above to below using a new reference value of albumin (36 g/l). The serum albumin level decreases with advancing age, but it was maintained to some extent in healthy older people. Serum albumin levels related to the clinical outcome. Hemoglobin and cholesterol levels and lymphocyte count were all lower in NST patients. These measurements may be valuable markers of nutritional status and can help in guiding the need for nutritional support.

  13. Ring trial among National Reference Laboratories for parasites to detect Trichinella spiralis larvae in pork samples according to the EU directive 2075/2005.

    PubMed

    Marucci, Gianluca; Pezzotti, Patrizio; Pozio, Edoardo

    2009-02-23

    To control Trichinella spp. infection in the European Union, all slaughtered pigs should be tested by one of the approved digestion methods described in EU directive 2075/2005. The aim of the present work was to evaluate, by a ring trial, the sensitivity of the digestion method used at the National Reference Laboratories for Parasites (NRLP). These Laboratories are responsible for the quality of the detection method in their own country. Of the 27 EU countries, only three (Hungary, Luxembourg and Malta) did not participate in the ring trial. Each participating laboratory received 10 samples of 100g of minced pork containing 3-5 larvae (3 samples), 10-20 larvae (3 samples), 30-50 larvae (3 samples), and one negative control. In each positive sample, there were living Trichinella spiralis larvae without the collagen capsule, obtained by partial artificial digestion of muscle tissue from infected mice. No false positive sample was found in any laboratories, whereas nine laboratories (37.5%) failed to detect some positive samples with the percentage of false negatives ranging from 11 to 100%. The variation between expected and reported larval counts observed among the participating laboratories was statistically significant. There was a direct correlation between the consistency of the results and the use of a validated/accredited digestion method. Conversely, there was no correlation between the consistency of the results and the number of digestions performed yearly by the NRLP. These results support the importance of validating the test.

  14. Advanced yellow fever virus genome detection in point-of-care facilities and reference laboratories.

    PubMed

    Domingo, Cristina; Patel, Pranav; Yillah, Jasmin; Weidmann, Manfred; Méndez, Jairo A; Nakouné, Emmanuel Rivalyn; Niedrig, Matthias

    2012-12-01

    Reported methods for the detection of the yellow fever viral genome are beset by limitations in sensitivity, specificity, strain detection spectra, and suitability to laboratories with simple infrastructure in areas of endemicity. We describe the development of two different approaches affording sensitive and specific detection of the yellow fever genome: a real-time reverse transcription-quantitative PCR (RT-qPCR) and an isothermal protocol employing the same primer-probe set but based on helicase-dependent amplification technology (RT-tHDA). Both assays were evaluated using yellow fever cell culture supernatants as well as spiked and clinical samples. We demonstrate reliable detection by both assays of different strains of yellow fever virus with improved sensitivity and specificity. The RT-qPCR assay is a powerful tool for reference or diagnostic laboratories with real-time PCR capability, while the isothermal RT-tHDA assay represents a useful alternative to earlier amplification techniques for the molecular diagnosis of yellow fever by field or point-of-care laboratories.

  15. Advanced Yellow Fever Virus Genome Detection in Point-of-Care Facilities and Reference Laboratories

    PubMed Central

    Patel, Pranav; Yillah, Jasmin; Weidmann, Manfred; Méndez, Jairo A.; Nakouné, Emmanuel Rivalyn; Niedrig, Matthias

    2012-01-01

    Reported methods for the detection of the yellow fever viral genome are beset by limitations in sensitivity, specificity, strain detection spectra, and suitability to laboratories with simple infrastructure in areas of endemicity. We describe the development of two different approaches affording sensitive and specific detection of the yellow fever genome: a real-time reverse transcription-quantitative PCR (RT-qPCR) and an isothermal protocol employing the same primer-probe set but based on helicase-dependent amplification technology (RT-tHDA). Both assays were evaluated using yellow fever cell culture supernatants as well as spiked and clinical samples. We demonstrate reliable detection by both assays of different strains of yellow fever virus with improved sensitivity and specificity. The RT-qPCR assay is a powerful tool for reference or diagnostic laboratories with real-time PCR capability, while the isothermal RT-tHDA assay represents a useful alternative to earlier amplification techniques for the molecular diagnosis of yellow fever by field or point-of-care laboratories. PMID:23052311

  16. Laboratory assessment by combined z score values in proficiency tests: experience gained through the European Union proficiency tests for pesticide residues in fruits and vegetables.

    PubMed

    Medina-Pastor, P; Mezcua, M; Rodríguez-Torreblanca, C; Fernández-Alba, A R

    2010-08-01

    The obligation for accredited laboratories to participate in proficiency tests under ISO 17025, performing multiresidue methods (MRMs) for pesticide residues, involves the reporting of a large number of individual z scores making the evaluation of the overall performance of the laboratories difficult. It entails, time and again, the need for ways to summarise the laboratory's overall assessment into a unique combined index. In addition, the need for ways to continually evaluate the performance of the laboratory over the years is equally acknowledged. For these reasons, following 14 years of the European Union Reference Laboratory for Pesticide Residues in Fruits and Vegetables (EUPT-FV), useful formulas have been designed to globally evaluate the assessment of the participating laboratories. The aim is to achieve a formula which is easy to understand, which can be applied and which fits the purposes of long-term evaluation detecting positive and negative trends. Moreover, consideration is needed for a fair compensation of bad results in MRM, taking into account the large number of compounds that are covered. It is therefore important to be aware of the difficulties in getting satisfactory values from a wide range of compounds. This work presents an evaluation of the main well-established combined z score formulas together with those new ones developed here which have been applied to the European proficiency test results (EUPTs) over the years. Previous formulas such as the rescaled sum of z score (RSZ), the sum squared of z score (SSZ) and the relative laboratory performance (RLP) are compared with the newer ones: the sum of weighted z scores (SWZ) and the sum of squared z scores (SZ2). By means of formula comparisons, conclusions on the advantages, drawbacks and the most fit-for-purpose approach are achieved.

  17. Laboratory facility to create reference radon + thoron atmosphere under dynamic exposure conditions.

    PubMed

    Pressyanov, D; Mitev, K; Georgiev, S; Dimitrova, I; Kolev, J

    2017-01-01

    Radon ((222)Rn) and thoron ((220)Rn) levels in the environment are typically subject to significant random and systematic variations. Creation in the laboratory of reproducible and controlled exposure conditions close to that in the real environment can be useful for testing (222)Rn and (220)Rn detectors and for research. In this report the design and performance of a novel laboratory facility with such functionality is presented. The facility allows the exposure of detectors under controlled dynamic as well as static activity concentrations of (222)Rn and (220)Rn (pure and mixed) and temperature. The temperature is measured and regulated within -15 °C ÷ +60 °C by a dedicated programmable thermostat. Different reference activity concentrations in the exposure vessel are made by regulating the flow-rate of the air that flushes (222)Rn/(220)Rn activity from the sources towards the exposure vessel. Reference atmospheres that contain (222)Rn, (220)Rn or a specified ratio of the two can be created. Pilot experiments that demonstrate the feasibility of the approach are presented. They include follow-up of a pre-defined temperature profile (in the range -5 °C ÷ +35 °C), test of the correspondence between planned and measured (222)Rn and (220)Rn activity concentrations, follow-up of a pre-defined dynamic profile of (220)Rn concentrations and test of the possibility to create mixed (220)Rn/(222)Rn atmospheres (experimentally checked for ratio of the activity concentrations from 0.27 to 4.5). The results from the experimental tests are in agreement with the values obtained by the developed theoretical model. The proposed approach can be used to plan and create stationary and dynamic reference exposure conditions that are close to the real exposure regimes in the environment.

  18. Homogeneity study of a corn flour laboratory reference material candidate for inorganic analysis.

    PubMed

    Dos Santos, Ana Maria Pinto; Dos Santos, Liz Oliveira; Brandao, Geovani Cardoso; Leao, Danilo Junqueira; Bernedo, Alfredo Victor Bellido; Lopes, Ricardo Tadeu; Lemos, Valfredo Azevedo

    2015-07-01

    In this work, a homogeneity study of a corn flour reference material candidate for inorganic analysis is presented. Seven kilograms of corn flour were used to prepare the material, which was distributed among 100 bottles. The elements Ca, K, Mg, P, Zn, Cu, Fe, Mn and Mo were quantified by inductively coupled plasma optical emission spectrometry (ICP OES) after acid digestion procedure. The method accuracy was confirmed by analyzing the rice flour certified reference material, NIST 1568a. All results were evaluated by analysis of variance (ANOVA) and principal component analysis (PCA). In the study, a sample mass of 400mg was established as the minimum mass required for analysis, according to the PCA. The between-bottle test was performed by analyzing 9 bottles of the material. Subsamples of a single bottle were analyzed for the within-bottle test. No significant differences were observed for the results obtained through the application of both statistical methods. This fact demonstrates that the material is homogeneous for use as a laboratory reference material. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Nitric Oxide Levels Regulate the Immune Response of Drosophila melanogaster Reference Laboratory Strains to Bacterial Infections

    PubMed Central

    More, Kareen; Spivack, Stephanie; Paulin, Ethan; Khojandi, Arman; Shukla, Sajala

    2014-01-01

    Studies on the innate immune response against microbial infections in Drosophila melanogaster involve mutant strains and their reference strains that act as experimental controls. We used five standard D. melanogaster laboratory reference strains (Oregon R, w1118, Canton-S, Cinnabar Brown, and Yellow White [YW]) and investigated their response against two pathogenic bacteria (Photorhabdus luminescens and Enterococcus faecalis) and two nonpathogenic bacteria (Escherichia coli and Micrococcus luteus). We detected high sensitivity among YW flies to bacterial infections and increased bacterial growth compared to the other strains. We also found variation in the transcription of certain antimicrobial peptide genes among strains, with Oregon and YW infected flies showing the highest and lowest gene transcription levels in most cases. We show that Oregon and w1118 flies possess more circulating hemocytes and higher levels of phenoloxidase activity than the other strains upon infection with the nonpathogenic bacteria. We further observed reduced fat accumulation in YW flies infected with the pathogenic bacteria, which suggests a possible decline in physiological condition. Finally, we found that nitrite levels are significantly lower in infected and uninfected YW flies compared to w1118 flies and that nitric oxide synthase mutant flies in YW background are more susceptible to bacterial infection compared to mutants in w1118 background. Therefore, increased sensitivity of YW flies to bacterial infections can be partly attributed to lower levels of nitric oxide. Such studies will significantly contribute toward a better understanding of the genetic variation between D. melanogaster reference strains. PMID:25047850

  20. Nitric oxide levels regulate the immune response of Drosophila melanogaster reference laboratory strains to bacterial infections.

    PubMed

    Eleftherianos, Ioannis; More, Kareen; Spivack, Stephanie; Paulin, Ethan; Khojandi, Arman; Shukla, Sajala

    2014-10-01

    Studies on the innate immune response against microbial infections in Drosophila melanogaster involve mutant strains and their reference strains that act as experimental controls. We used five standard D. melanogaster laboratory reference strains (Oregon R, w1118, Canton-S, Cinnabar Brown, and Yellow White [YW]) and investigated their response against two pathogenic bacteria (Photorhabdus luminescens and Enterococcus faecalis) and two nonpathogenic bacteria (Escherichia coli and Micrococcus luteus). We detected high sensitivity among YW flies to bacterial infections and increased bacterial growth compared to the other strains. We also found variation in the transcription of certain antimicrobial peptide genes among strains, with Oregon and YW infected flies showing the highest and lowest gene transcription levels in most cases. We show that Oregon and w1118 flies possess more circulating hemocytes and higher levels of phenoloxidase activity than the other strains upon infection with the nonpathogenic bacteria. We further observed reduced fat accumulation in YW flies infected with the pathogenic bacteria, which suggests a possible decline in physiological condition. Finally, we found that nitrite levels are significantly lower in infected and uninfected YW flies compared to w1118 flies and that nitric oxide synthase mutant flies in YW background are more susceptible to bacterial infection compared to mutants in w1118 background. Therefore, increased sensitivity of YW flies to bacterial infections can be partly attributed to lower levels of nitric oxide. Such studies will significantly contribute toward a better understanding of the genetic variation between D. melanogaster reference strains.

  1. A review of the work of the EU Reference Laboratory supporting the authorisation process of feed additives in the EU. [corrected].

    PubMed

    von Holst, Christoph; Robouch, Piotr; Bellorini, Stefano; González de la Huebra, María José; Ezerskis, Zigmas

    2016-01-01

    This paper describes the operation of the European Union Reference Laboratory for Feed Additives (EURL) and its role in the authorisation procedure of feed additives in the European Union. Feed additives are authorised according to Regulation (EC) No. 1831/2003, which introduced a completely revised authorisation procedure and also established the EURL. The regulations authorising feed additives contain conditions of use such as legal limits of the feed additives, which require the availability of a suitable method of analysis for official control purposes under real world conditions. It is the task of the EURL to evaluate the suitability of analytical methods as proposed by the industry for this purpose. Moreover, the paper shows that one of the major challenges is the huge variety of the methodology applied in feed additive analysis, thus requiring expertise in quite different analytical areas. In order to cope with this challenge, the EURL is supported by a network of national reference laboratories (NRLs) and only the merged knowledge of all NRLs allows for a scientifically sound assessment of the analytical methods.

  2. Facing Up to the Learning Organization Challenge: Selected European Writings. Volume II. CEDEFOP Reference Series.

    ERIC Educational Resources Information Center

    Nyhan, Barry, Ed.; Kelleher, Michael, Ed.; Cressey, Peter, Ed.; Poell, Rob, Ed.

    This volume, the second of a two-volume publication, comprises 15 papers that present the work of individual European projects dealing with learning within organizations. These five chapters in Part 1, The Meaning of the Learning Organization, examine the conceptual frameworks and dilemmas at the heart of the notion of the learning organization:…

  3. Viral diseases of wild and farmed European eel Anguilla anguilla with particular reference to the Netherlands.

    PubMed

    van Beurden, Steven J; Engelsma, Marc Y; Roozenburg, Ineke; Voorbergen-Laarman, Michal A; van Tulden, Peter W; Kerkhoff, Sonja; van Nieuwstadt, Anton P; Davidse, Aart; Haenen, Olga L M

    2012-10-10

    Diseases are an important cause of losses and decreased production rates in freshwater eel farming, and have been suggested to play a contributory role in the worldwide decline in wild freshwater eel stocks. Three commonly detected pathogenic viruses of European eel Anguilla anguilla are the aquabirnavirus eel virus European (EVE), the rhabdovirus eel virus European X (EVEX), and the alloherpesvirus anguillid herpesvirus 1 (AngHV1). In general, all 3 viruses cause a nonspecific haemorrhagic disease with increased mortality rates. This review provides an overview of the current knowledge on the aetiology, prevalence, clinical signs and gross pathology of these 3 viruses. Reported experimental infections showed the temperature dependency and potential pathogenicity of these viruses for eels and other fish species. In addition to the published literature, an overview of the isolation of pathogenic viruses from wild and farmed A. anguilla in the Netherlands during the past 2 decades is given. A total of 249 wild A. anguilla, 39 batches of glass eels intended for farming purposes, and 239 batches of farmed European eels were necropsied and examined virologically. AngHV1 was isolated from wild yellow and silver A. anguilla from the Netherlands from 1998 until the present, while EVEX was only found sporadically, and EVE was never isolated. In farmed A. anguilla AngHV1 was also the most commonly isolated virus, followed by EVE and EVEX.

  4. Internationalisation and Changing Skills Needs in European Small Firms: Synthesis Report. CEDEFOP Reference Series.

    ERIC Educational Resources Information Center

    Hassid, Joseph

    The changing skill needs being experienced by small European firms because of increasing internationalization were examined in a survey of owners/managers and employees of 85 small manufacturing businesses in Greece, Spain, Ireland, Italy, the Netherlands, Austria, and the United Kingdom and case studies of an additional 16 businesses that have…

  5. Properties of colour reference solutions of the European Pharmacopoea in CIE L*a*b* colour space.

    PubMed

    Subert, J; Farsa, O; Gajdosová, Z

    2006-12-01

    The coordinates of CIE L*a*b* uniform colour space have been acquired from the transmitance spectra of colour reference solutions of European Pharmacopoeia (Ph.Eur.). Calculation of colour differences of these solutions from purified water deltaE* gave their values in the range between 0.7 (B9 solution) to 36 (Y1 solution) CIE units. Excluding red colour reference soulutions, deltaE* values did not depend on concentrations of colour compounds linearly. Small deltaE* values founded by the brown and brownish-yellow colour reference solutions of the lowest concentrations can possibly cause some problems of visual examination of the degree of coloration of liquids according to Ph.Eur.

  6. Biosafety and Biosecurity in European Containment Level 3 Laboratories: Focus on French Recent Progress and Essential Requirements.

    PubMed

    Pastorino, Boris; de Lamballerie, Xavier; Charrel, Rémi

    2017-01-01

    Even if European Union (EU) Member States are obliged to implement EU Directives 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work, national biosafety regulations and practices varied from country to country. In fact, EU legislation on biological agents and genetically modified microorganisms is often not specific enough to ensure harmonization leading to difficulties in implementation for most laboratories. In the same way, biosecurity is a relatively new concept and a few EU Member States are known to have introduced national laboratory biosecurity legislation. In France, recent regulations have reinforced biosafety/biosecurity in containment level 3 (CL-3) laboratories but they concern a specific list of pathogens with no correlation in other European Members States. The objective of this review was to summarize European biosafety/biosecurity measures concerning CL-3 facilities focusing on French specificities. Essential requirements needed to preserve efficient biosafety measures when manipulating risk group 3 biological agents are highlighted. In addition, International, European and French standards related to containment laboratory planning, operation or biosafety equipment are described to clarify optimal biosafety and biosecurity requirements.

  7. Biosafety and Biosecurity in European Containment Level 3 Laboratories: Focus on French Recent Progress and Essential Requirements

    PubMed Central

    Pastorino, Boris; de Lamballerie, Xavier; Charrel, Rémi

    2017-01-01

    Even if European Union (EU) Member States are obliged to implement EU Directives 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work, national biosafety regulations and practices varied from country to country. In fact, EU legislation on biological agents and genetically modified microorganisms is often not specific enough to ensure harmonization leading to difficulties in implementation for most laboratories. In the same way, biosecurity is a relatively new concept and a few EU Member States are known to have introduced national laboratory biosecurity legislation. In France, recent regulations have reinforced biosafety/biosecurity in containment level 3 (CL-3) laboratories but they concern a specific list of pathogens with no correlation in other European Members States. The objective of this review was to summarize European biosafety/biosecurity measures concerning CL-3 facilities focusing on French specificities. Essential requirements needed to preserve efficient biosafety measures when manipulating risk group 3 biological agents are highlighted. In addition, International, European and French standards related to containment laboratory planning, operation or biosafety equipment are described to clarify optimal biosafety and biosecurity requirements. PMID:28620600

  8. Examining the genetic variation of reference microbial cultures used within food and environmental laboratories using fluorescent amplified fragment length polymorphism analysis.

    PubMed

    Cross, Lisa Jane; Russell, Julie Elizabeth; Desai, Meeta

    2011-08-01

    Fluorescent amplified fragment length polymorphism (FAFLP) analysis was applied to genetically fingerprint 'working culture control strains' used by accredited food microbiology laboratories. A working culture control strain is defined as a subculture from a strain initially obtained from an authenticated source [such as the National Collection of Type Cultures (NCTC)] that is maintained for use with routine testing within the laboratory. Working culture control strains from eight food examination laboratories, representing four bacterial species, were analysed by FAFLP; these were Salmonella Nottingham, Staphylococcus aureus, Listeria monocytogenes and Bacillus cereus. The resultant FAFLP profiles of the eight working culture control strains for each of these species were compared against the appropriate freeze-dried ampoules obtained directly from NCTC. FAFLP results demonstrated that within 50% of working cultures analysed, several laboratories were routinely using working cultures that were genetically different from the original reference NCTC strains. This study highlights the need for laboratories to review the protocols used to process and maintain control strains and working cultures, with a potential view to utilize single-use quality control materials. 2011 Federation of European Microbiological Societies. Published by Blackwell Publishing Ltd.

  9. Genetic counselor review of genetic test orders in a reference laboratory reduces unnecessary testing.

    PubMed

    Miller, Christine E; Krautscheid, Patti; Baldwin, Erin E; Tvrdik, Tatiana; Openshaw, Amanda S; Hart, Kim; Lagrave, Danielle

    2014-05-01

    Genetic tests are routinely ordered by health care providers (HCPs) within a wide range of medical specialties. Many providers have limited knowledge or experience with ordering and interpreting genetic tests; thus, test order errors are common. Rigorous review of genetic test orders by genetic counselors (GCs) can provide a direct financial benefit to medical institutions, patients and insurers. GCs at ARUP (Associated Regional University Pathologists) Laboratories routinely perform a preanalytic assessment of complex molecular genetic test orders that includes reviewing clinical and family history information and considering the clinical utility and cost-effectiveness of ordered tests. GCs contact the ordering institution and/or HCP as needed to collect additional clinical information and confirm the test order or suggest alternative testing based on the provided information. A retrospective review of the GC-facilitated test changes over a 21-month period at ARUP laboratories was performed. Approximately 26% of all requests for complex genetic tests assessing germ line mutations were changed following GC review. Testing fees associated with canceled tests were summed to estimate the cost-savings resulting from GC-facilitated test reviews. The test review process resulted in an average reduction in charges to the referring institutions of $48,000.00 per month. GC review of genetic test orders for appropriateness and clinical utility reduces healthcare costs to hospitals, insurers, and patients. © 2014 Wiley Periodicals, Inc.

  10. [Networks of National Reference Centers and associated Consiliary Laboratories in Germany].

    PubMed

    Laude, G; Kist, M; Krause, G

    2012-02-01

    Since 1995, the Robert Koch-Institute in agreement with the Federal Ministry of Health in Germany has increased the funding of National Reference Centers (NRC) and Consiliary Laboratories (CL) for laboratory-based surveillance of selected infection pathogens and infectious disease syndromes. Their goal is to improve efficient protection from infections and to supplement infectious disease surveillance by monitoring selected pathogens. Currently there are 19 NRC and 48 CL, nominated for a duration of 3 years. In order to enhance the effectiveness and cooperation of the system, ten National Networks were launched in 2009. The aim of these networks is to facilitate exchange on diagnostic methods and prevention concepts and to improve the geographic coverage of the services. Furthermore, the networks provide an opportunity to work on issues beyond single pathogens more productively and efficiently. In addition, the inclusion of external and international specialists should to be included more often in the future. The activities of the networks are evaluated by the commission for infectious disease epidemiology. The commission develops promotion modalities to support collaboration between NRC and CL and to adapt it to more closely meet the requirements at the national and international levels.

  11. Comprehensive Reference Ranges for Hematology and Clinical Chemistry Laboratory Parameters Derived from Normal Nigerian Adults

    PubMed Central

    Miri-Dashe, Timzing; Osawe, Sophia; Tokdung, Monday; Daniel, Nenbammun; Choji, Rahila Pam; Mamman, Ille; Deme, Kurt; Damulak, Dapus; Abimiku, Alash’le

    2014-01-01

    Background Interpretation of laboratory test results with appropriate diagnostic accuracy requires reference or cutoff values. This study is a comprehensive determination of reference values for hematology and clinical chemistry in apparently healthy voluntary non-remunerated blood donors and pregnant women. Methods and findings Consented clients were clinically screened and counseled before testing for HIV, Hepatitis B, Hepatitis C and Syphilis. Standard national blood donors’ questionnaire was administered to consented blood donors. Blood from qualified volunteers was used for measurement of complete hematology and chemistry parameters. Blood samples were analyzed from a total of 383 participants, 124 (32.4%) males, 125 (32.6%) non-pregnant females and 134 pregnant females (35.2%) with a mean age of 31 years. Our results showed that the red blood cells count (RBC), Hemoglobin (HB) and Hematocrit (HCT) had significant gender difference (p = 0.000) but not for total white blood count (p>0.05) which was only significantly higher in pregnant verses non-pregnant women (p = 0.000). Hemoglobin and Hematocrit values were lower in pregnancy (P = 0.000). Platelets were significantly higher in females than men (p = 0.001) but lower in pregnant women (p = 0.001) with marked difference in gestational period. For clinical chemistry parameters, there was no significant difference for sodium, potassium and chloride (p>0.05) but gender difference exists for Bicarbonate (HCO3), Urea nitrogen, Creatinine as well as the lipids (p<0.05). Total bilirubin was significantly higher in males than females (p = 0.000). Significant differences exist for all chemistry parameters between pregnant and non-pregnant women in this study (p<0.05), except Amylase and total cholesterol (p>0.05). Conclusions Hematological and Clinical Chemistry reference ranges established in this study showed significant gender differences. Pregnant women also differed from non

  12. The relation of the European Datum to a geocentric reference system

    NASA Technical Reports Server (NTRS)

    Marsh, J. G.; Douglas, B. C.; Klosko, S. M.

    1971-01-01

    Over 31,000 precision reduced optical observations of GEOS-1 and 2 in 70 two-day orbital arcs were used at Goddard Space Flight Center (GSFC) in a dynamical solution to determine center-of-mass coordinates for 15 tracking stations on the European Datum. Comparisons with the results obtained at Centre National d'Etudes Spatiales (CNES) give agreement of about 1.5 ppm for chord lengths. After considering a scale correction to the European Datum (ED) of 1950 to account for the absence of geoid heights at the time of its reduction, agreement to a few ppm between the CNES/GSFC and the ED chords is obtained. However, a small systematic difference between survey and satellite results remains for stations in southeastern France and Switzerland.

  13. Status of the laboratory infrastructure for detector calibration and characterization at the European XFEL

    NASA Astrophysics Data System (ADS)

    Raab, N.; Ballak, K.-E.; Dietze, T.; Ekmedzič, M.; Hauf, S.; Januschek, F.; Kaukher, A.; Kuster, M.; Lang, P. M.; Münnich, A.; Schmitt, R.; Sztuk-Dambietz, J.; Turcato, M.

    2016-12-01

    The European X-ray Free Electron Laser (XFEL.EU) will provide unprecedented peak brilliance and ultra-short and spatially coherent X-ray pulses in an energy range of 0.25 to 25 keV . The pulse timing structure is unique with a burst of 2700 pulses of 100 fs length at a temporal distance of 220 ns followed by a 99.4 ms gap. To make optimal use of this timing structure and energy range a great variety of detectors are being developed for use at XFEL.EU, including 2D X-ray imaging cameras that are able to detect images at a rate of 4.5 MHz, provide dynamic ranges up to 105 photons per pulse per pixel under different operating conditions and covering a large range of angular resolution \\cite{requirements,Markus}. In order to characterize, commission and calibrate this variety of detectors and for testing of detector prototypes the XFEL.EU detector group is building up an X-ray test laboratory that allows testing of detectors with X-ray photons under conditions that are as similar to the future beam line conditions at the XFEL.EU as is possible with laboratory sources [1]. A total of four test environments provide the infrastructure for detector tests and calibration: two portable setups that utilize low power X-ray sources and radioactive isotopes, a test environment where a commercial high power X-ray generator is in use, and a pulsed X-ray/electron source which will provide pulses as short as 25 ns in XFEL.EU burst mode combined with target anodes of different materials. The status of the test environments, three of which are already in use while one is in commissioning phase, will be presented as well as first results from performance tests and characterization of the sources.

  14. Levothyroxine soft capsules demonstrate bioequivalent pharmacokinetic exposure with the European reference tablets in healthy volunteers under fasting conditions.

    PubMed

    Al-Numani, Dina; Scarsi, Claudia; Ducharme, Murray P

    2016-02-01

    To assess the bioequivalence (BE) potential under fasting conditions between levothyroxine soft capsules and the European reference tablet formulation. Two studies were conducted to assess the BE potential as per European regulations. Study 1 was a two-way crossover BE study comparing a high strength of levothyroxine soft capsules versus levothyroxine tablets (200 μg), while study 2 was a three-way crossover dosage form proportionality study between low, medium, and high strengths of soft capsules. 70 healthy adult subjects participated in the two studies. Each treatment consisted of a 600-μg dose of levothyroxine sodium, administered under fasting conditions. Blood samples were collected for levothyroxine (T4) assay prior to dosing and up to 72 hours post dose. A washout of 35 days separated treatments in each study. Pharmacokinetics was assessed using noncompartmental methods. A total of 61 subjects completed the studies. Baseline-adjusted total T4 ratios (test/reference) and 90% confidence intervals (CIs) between soft capsules and tablets were within 80.00 - 125.00%. Comparison of the three strengths of soft capsules indicated pharmacokinetic equivalence between them (ratios and 90% CIs were contained within 80.00 - 125.00%). Overall, levothyroxine sodium was well tolerated with all products when given as single oral doses of 600 μg, except for 1 serious adverse event of secondary bacteremia reported in study 2, deemed not to be related to treatment. Levothyroxine soft capsules meet BE criteria in terms of systemic exposure when compared to a European reference tablet under fasting conditions in healthy volunteers.

  15. Report of the Federation of European Laboratory Animal Science Associations Working Group on animal identification.

    PubMed

    Dahlborn, K; Bugnon, P; Nevalainen, T; Raspa, M; Verbost, P; Spangenberg, E

    2013-01-01

    The primary aim of this report is to assist scientists in selecting more reliable/suitable identification (ID) methods for their studies. This is especially true for genetically altered (GA) animals where individual identification is strictly necessary to link samples, research design and genotype. The aim of this Federation of European Laboratory Animal Science Associations working group was to provide an update of the methods used to identify rodents in different situations and to assess their implications for animal welfare. ID procedures are an indispensable prerequisite for conducting good science but the degree of invasiveness differs between the different methods; therefore, one needs to make a good ethical evaluation of the method chosen. Based on the scientific literature the advantages and disadvantages of various methods have been presented comprehensively and this report is intended as a practical guide for researchers. New upcoming methods have been included next to the traditional techniques. Ideally, an ID method should provide reliable identification, be technically easy to apply and not inflict adverse effects on animals while taking into account the type of research. There is no gold standard method because each situation is unique; however, more studies are needed to better evaluate ID systems and the desirable introduction of new and modern approaches will need to be assessed by detailed scientific evaluation.

  16. The "Common European Framework of Reference for Languages" and the European Language Portfolio: Some History, a View of Language Learner Autonomy, and Some Implications for Language Learning in Higher Education

    ERIC Educational Resources Information Center

    Little, David

    2013-01-01

    This article is based on a plenary talk given at the CercleS seminar hosted by the University of Groningen in November 2011 to mark the tenth anniversary of the publication of the "Common European Framework of Reference for Languages" and the launch of the European Language Portfolio. The first part of the article summarizes the history…

  17. The "Common European Framework of Reference for Languages" and the European Language Portfolio: Some History, a View of Language Learner Autonomy, and Some Implications for Language Learning in Higher Education

    ERIC Educational Resources Information Center

    Little, David

    2013-01-01

    This article is based on a plenary talk given at the CercleS seminar hosted by the University of Groningen in November 2011 to mark the tenth anniversary of the publication of the "Common European Framework of Reference for Languages" and the launch of the European Language Portfolio. The first part of the article summarizes the history…

  18. EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine: version 3 - 2005.

    PubMed

    Zerah, Simone; McMurray, Janet; Bousquet, Bernard; Baum, Hannsjorg; Beastall, Graham H; Blaton, Vic; Cals, Marie-Josèphe; Duchassaing, Danielle; Gaudeau-Toussaint, Marie-Françoise; Harmoinen, Aimo; Hoffmann, Hans; Jansen, Rob T; Kenny, Desmond; Kohse, Klaus P; Köller, Ursula; Gobert, Jean-Gérard; Linget, Christine; Lund, Erik; Nubile, Giuseppe; Opp, Matthias; Pazzagli, Mario; Pinon, Georges; Queralto, José M; Reguengo, Henrique; Rizos, Demetrios; Szekeres, Thomas; Vidaud, Michel; Wallinder, Hans

    2006-01-01

    The EC4 Syllabus for Postgraduate Training is the basis for the European Register of Specialists in Clinical Chemistry and Laboratory Medicine. The syllabus: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. The syllabus is not primarily meant to be a training guide, but on the basis of the overview given (common minimal programme), national societies should formulate programmes that indicate where knowledge and experience is needed. The main points of this programme are: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory management; and Quality insurance management. The aim of this version of the syllabus is to be in accordance with the Directive of Professional Qualifications published on 30 September 2005. To prepare the common platforms planned in this directive, the disciplines are divided into four categories: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory

  19. Estrogen and progesterone receptor testing in breast carcinoma: concordance of results between local and reference laboratories in Brazil.

    PubMed

    Wludarski, Sheila Cristina Lordelo; Lopes, Lisandro Ferreira; Duarte, Ivison Xavier; Carvalho, Filomena Marino; Weiss, Lawrence; Bacchi, Carlos Eduardo

    2011-01-01

    Breast cancer accounts for approximately one quarter of all cancers in females. Estrogen and progesterone receptor testing has become an essential part of the clinical evaluation of breast carcinoma patients, and accurate results are critical in identifying patients who may benefit from hormone therapy. The present study had the aim of investigating the concordance of the results from hormone receptor tests between a reference laboratory and local (or community) laboratories in Brazil. Retrospective study at a reference pathology laboratory. The concordance in the results from hormone receptor tests between a reference laboratory and 146 local laboratories in Brazil was compared in relation to 500 invasive breast carcinoma cases, using immunohistochemistry. There was concordance in 89.4% (447/500 cases) and 85.0% (425/500 cases) of the results from estrogen (κ = 0.744, P < 0.001) and progesterone (κ = 0.688, P < 0.001) receptor tests, respectively, between local and reference laboratories. This was similar to findings in other countries. The false negative rates from estrogen and progesterone receptor tests in local laboratories were 8.7% and 14.4%, respectively. The false positive rates from estrogen and progesterone receptor tests in local laboratories were 15.5% and 16.0%, respectively. Technical and result interpretation issues may explain most of the discordances in hormone receptor testing in local laboratories. Validation of estrogen and progesterone receptor tests at local laboratories, with rigorous quality control measures, is strongly recommended in order to avoid erroneous treatment of breast cancer patients.

  20. Identification of essential outstanding questions for an adequate European laboratory response to Ebolavirus Zaire West Africa 2014.

    PubMed

    Reusken, Chantal; Niedrig, Matthias; Pas, Suzan; Anda, Pedro; Baize, Sylvain; Charrel, Remi; Di Caro, Antonino; Drosten, Christian; Fernandez-Garcia, Maria Dolores; Franco, Leticia; Gunther, Stephan; Leparc-Goffart, Isabelle; Martina, Byron; Pannetier, Delphine; Papa, Anna; Sanchez-Seco, Maria Paz; Vapalahti, Olli; Koopmans, Marion

    2015-01-01

    On August 8 2014, the World Health Organization (WHO) declared the outbreak of Ebola Virus Disease (EVD) evolving in West Africa since December 2013, a Public Health Emergency of International Concern (PHEIC). It is expected that the outbreak of Ebolavirus Disease (EVD) in West Africa will lead to increased testing of individuals in Europe for EVD. The severity of the situation in West Africa warranted a critical appraisal of the laboratory preparedness and response for EVD, with a focus on information needs for laboratories involved in diagnostics of rare viral diseases associated with the European Network for the Diagnostics of "Imported" Viral Diseases", ENIVD. Essential knowledge and knowledge gaps for an adequate laboratory response focusing on virus properties, infection kinetics, tests specifics and field performances were identified. An inventory of the laboratory capacity for EVD diagnostics among ENIVD laboratories was made.

  1. Total cholesterol performance of Abell-Levy-Brodie-Kendall reference measurement procedure: Certification of Japanese in-vitro diagnostic assay manufacturers through CDC's Cholesterol Reference Method Laboratory Network.

    PubMed

    Nakamura, Masakazu; Iso, Hiroyasu; Kitamura, Akihiko; Imano, Hironori; Kiyama, Masahiko; Yokoyama, Shinji; Kayamori, Yuzo; Koyama, Isao; Nishimura, Kunihiro; Nakai, Michikazu; Dasti, Mahnaz; Vesper, Hubert W; Teramoto, Tamio; Miyamoto, Yoshihiro

    2015-05-20

    Accurate measurement of total cholesterol (TC) is important for cardiovascular disease risk management. The US Centers for Disease Control and Prevention (CDC) and Cholesterol Reference Method Laboratory Network (CRMLN) perform Abell-Levy-Brodie-Kendall (AK) reference measurement procedure (RMP) for TC as a secondary reference method, and implement Certification Protocol for Manufacturers. Japanese CRMLN laboratory at Osaka performed the AK RMP for 22 years, and conducted TC certification for reagent/calibrator/instrument systems of six Japanese manufacturers every 2 years for 16 years. Osaka TC performance was examined and compared to CDC's reference values. AK RMP involved sample hydrolysis, cholesterol extraction, and determination of cholesterol levels by spectrophotometry. The Certification Protocol for Manufacturers includes comparison with AK RMP using at least 40 fresh specimens. Demonstration of average bias ≤3% and total coefficient of variation ≤3% qualified an analytical system for certification. In the AK RMP used in the Osaka CRMLN laboratory, the regression equation for measuring TC was y (Osaka)=1.000x (CDC)+0.032 (n=619, R(2)=1.000). Six Japanese manufacturers had allowable performance for certification. The AK RMP for TC measurement was accurate, precise, and stable for 22 years. Six Japanese manufacturers were certified for 16 years. Copyright © 2015 Elsevier B.V. All rights reserved.

  2. Serological Diagnosis of Paracoccidioidomycosis: High Rate of Inter-laboratorial Variability among Medical Mycology Reference Centers

    PubMed Central

    Vidal, Monica Scarpelli Martinelli; Del Negro, Gilda Maria Barbaro; Vicentini, Adriana Pardini; Svidzinski, Teresinha Inez Estivalet; Mendes-Giannini, Maria Jose; Almeida, Ana Marisa Fusco; Martinez, Roberto; de Camargo, Zoilo Pires; Taborda, Carlos Pelleschi; Benard, Gil

    2014-01-01

    Background Serological tests have long been established as rapid, simple and inexpensive tools for the diagnosis and follow-up of PCM. However, different protocols and antigen preparations are used and the few attempts to standardize the routine serological methods have not succeeded. Methodology/Principal findings We compared the performance of six Brazilian reference centers for serological diagnosis of PCM. Each center provided 30 sera of PCM patients, with positive high, intermediate and low titers, which were defined as the “reference” titers. Each center then applied its own antigen preparation and serological routine test, either semiquantitative double immunodifusion or counterimmmunoelectrophoresis, in the 150 sera from the other five centers blindly as regard to the “reference” titers. Titers were transformed into scores: 0 (negative), 1 (healing titers), 2 (active disease, low titers) and 3 (active disease, high titers) according to each center's criteria. Major discordances were considered between scores indicating active disease and scores indicating negative or healing titers; such discordance when associated with proper clinical and other laboratorial data, may correspond to different approaches to the patient's treatment. Surprisingly, all centers exhibited a high rate of “major” discordances with a mean of 31 (20%) discordant scores. Alternatively, when the scores given by one center to their own sera were compared with the scores given to their sera by the remaining five other centers, a high rate of major discordances was also found, with a mean number of 14.8 sera in 30 presenting a discordance with at least one other center. The data also suggest that centers that used CIE and pool of isolates for antigen preparation performed better. Conclusion There are inconsistencies among the laboratories that are strong enough to result in conflicting information regarding the patients' treatment. Renewed efforts should be promoted to improve

  3. Reference values of total serum IgE and their significance in the diagnosis of allergy in young European adults.

    PubMed

    Carosso, Aurelia; Bugiani, Massimiliano; Migliore, Enrica; Antò, Josep Maria; DeMarco, Roberto

    2007-01-01

    Allergic sensitization mediated by immunoglobulin E (IgE) is the basis of allergic diseases, and elevated total IgE, in spite of some well-known limitations, is frequently included as a diagnostic criterion for allergic diseases. The reference value of total IgE (IgE-t) in the literature (1.5-144 kU/l) was established almost 2 decades ago. The aim of this study was to establish IgE-t reference values, establishing an updated cutoff value able to identify atopic subjects, defined as a positive CAP-radioallergosorbent test to at least one of a panel of common allergens, among young European adults. The study included 6,670 subjects from 10 Western European countries within the framework of the European Community Respiratory Health Survey II. IgE-t and specific IgE (IgE-s) were measured for the main inhalant allergens; IgE-s in class 0 for all allergens (66.2%) characterized non-atopy. The reference values were estimated by means of linear regression using a 50% random subsample of non-atopic subjects. Two non-atopic subsamples were examined so that one subsample could be used to establish reference IgE-t values, and these values were compared to those in the second non-atopic subsample to validate the findings. Sensitivity and specificity for atopy were assessed on the other 50% of non-atopic and on all atopic subjects. The 95th percentile of IgE-t reference values in non-smokers was 148 kU/l in women and 169 kU/l in men, while it was 194 and 220 kU/l in female and male smokers, respectively: serum IgE-t above the 95th percentile identifies <32% and above the 99th percentile <20% of atopic adults (low sensitivity), but a serum IgE-t below the 95th percentile identifies >90% and below the 99th percentile identifies >95% of non-atopic adults (good specificity). Due to the adequate specificity, IgE-t values exceeding the normal limits confirm a suspected atopic status; however, because of the low sensitivity, values below the cutoff seem not to exclude an atopic status

  4. Method applied to the background analysis of energy data to be considered for the European Reference Life Cycle Database (ELCD).

    PubMed

    Fazio, Simone; Garraín, Daniel; Mathieux, Fabrice; De la Rúa, Cristina; Recchioni, Marco; Lechón, Yolanda

    2015-01-01

    Under the framework of the European Platform on Life Cycle Assessment, the European Reference Life-Cycle Database (ELCD - developed by the Joint Research Centre of the European Commission), provides core Life Cycle Inventory (LCI) data from front-running EU-level business associations and other sources. The ELCD contains energy-related data on power and fuels. This study describes the methods to be used for the quality analysis of energy data for European markets (available in third-party LC databases and from authoritative sources) that are, or could be, used in the context of the ELCD. The methodology was developed and tested on the energy datasets most relevant for the EU context, derived from GaBi (the reference database used to derive datasets for the ELCD), Ecoinvent, E3 and Gemis. The criteria for the database selection were based on the availability of EU-related data, the inclusion of comprehensive datasets on energy products and services, and the general approval of the LCA community. The proposed approach was based on the quality indicators developed within the International Reference Life Cycle Data System (ILCD) Handbook, further refined to facilitate their use in the analysis of energy systems. The overall Data Quality Rating (DQR) of the energy datasets can be calculated by summing up the quality rating (ranging from 1 to 5, where 1 represents very good, and 5 very poor quality) of each of the quality criteria indicators, divided by the total number of indicators considered. The quality of each dataset can be estimated for each indicator, and then compared with the different databases/sources. The results can be used to highlight the weaknesses of each dataset and can be used to guide further improvements to enhance the data quality with regard to the established criteria. This paper describes the application of the methodology to two exemplary datasets, in order to show the potential of the methodological approach. The analysis helps LCA

  5. Indirect reference intervals of plasma and serum thyrotropin (TSH) concentrations from intra-laboratory data bases from several German and Italian medical centres.

    PubMed

    Arzideh, Farhad; Wosniok, Werner; Haeckel, Rainer

    2011-04-01

    The dogma of establishing intra-laboratory reference limits (RLs) and their periodic review cannot be fulfilled by most laboratories due to the expenses involved. Thus, most laboratories adopt external sources for their RLs, often neglecting the problems of transferability. This is particularly problematic for analytes with a large diversity of existing RLs, as for example thyrotropin (TSH). Several attempts were taken to derive RLs from the large data pools stored in modern laboratory information systems. These attempts were further developed to a more sophisticated indirect procedure. The new approach can be considered a combined concept because it pre-excludes some subjects by direct criteria a-posterior. In the current study, the applicability of the new concept for modern protein bindings assays was examined for estimating RLs of serum and plasma TSH with data sets from several German and Italian laboratories. A smoothed kernel density function was estimated for the distribution of the total mixed data of the sample group (combined data of non-diseased and diseased subjects). It was assumed that the "central" part of the distribution of all data represents the non-diseased ("healthy") population. The central part was defined by truncation points using an optimisation method, and was used to estimate a Gaussian distribution of the values of presumably non-diseased subjects after Box-Cox transformation of the empirical data. This distribution was now considered as the distribution of the non-diseased subgroup. The percentiles of this parametrical distribution were calculated to obtain RLs. RLs determined by the indirect combined decomposition technique led to similar RLs as found by several recent study reports using a direct method according to international recommendations. Furthermore, the RLs obtained from 13 laboratories in two different European regions reflected the well-known differences of various analytical procedures. Stratification for gender and age

  6. Resampling approach for determination of the method for reference interval calculation in clinical laboratory practice.

    PubMed

    Pavlov, Igor Y; Wilson, Andrew R; Delgado, Julio C

    2010-08-01

    Reference intervals (RI) play a key role in clinical interpretation of laboratory test results. Numerous articles are devoted to analyzing and discussing various methods of RI determination. The two most widely used approaches are the parametric method, which assumes data normality, and a nonparametric, rank-based procedure. The decision about which method to use is usually made arbitrarily. The goal of this study was to demonstrate that using a resampling approach for the comparison of RI determination techniques could help researchers select the right procedure. Three methods of RI calculation-parametric, transformed parametric, and quantile-based bootstrapping-were applied to multiple random samples drawn from 81 values of complement factor B observations and from a computer-simulated normally distributed population. It was shown that differences in RI between legitimate methods could be up to 20% and even more. The transformed parametric method was found to be the best method for the calculation of RI of non-normally distributed factor B estimations, producing an unbiased RI and the lowest confidence limits and interquartile ranges. For a simulated Gaussian population, parametric calculations, as expected, were the best; quantile-based bootstrapping produced biased results at low sample sizes, and the transformed parametric method generated heavily biased RI. The resampling approach could help compare different RI calculation methods. An algorithm showing a resampling procedure for choosing the appropriate method for RI calculations is included.

  7. Resampling Approach for Determination of the Method for Reference Interval Calculation in Clinical Laboratory Practice▿

    PubMed Central

    Pavlov, Igor Y.; Wilson, Andrew R.; Delgado, Julio C.

    2010-01-01

    Reference intervals (RI) play a key role in clinical interpretation of laboratory test results. Numerous articles are devoted to analyzing and discussing various methods of RI determination. The two most widely used approaches are the parametric method, which assumes data normality, and a nonparametric, rank-based procedure. The decision about which method to use is usually made arbitrarily. The goal of this study was to demonstrate that using a resampling approach for the comparison of RI determination techniques could help researchers select the right procedure. Three methods of RI calculation—parametric, transformed parametric, and quantile-based bootstrapping—were applied to multiple random samples drawn from 81 values of complement factor B observations and from a computer-simulated normally distributed population. It was shown that differences in RI between legitimate methods could be up to 20% and even more. The transformed parametric method was found to be the best method for the calculation of RI of non-normally distributed factor B estimations, producing an unbiased RI and the lowest confidence limits and interquartile ranges. For a simulated Gaussian population, parametric calculations, as expected, were the best; quantile-based bootstrapping produced biased results at low sample sizes, and the transformed parametric method generated heavily biased RI. The resampling approach could help compare different RI calculation methods. An algorithm showing a resampling procedure for choosing the appropriate method for RI calculations is included. PMID:20554803

  8. Comparison of Results Analyzed by China and European Laboratories for the FOREGS Geochemical Baselines Mapping Samples

    NASA Astrophysics Data System (ADS)

    Yao, W.; Wang, X.; Nie, L.

    2010-12-01

    The geochemical data obtained from China and European laboratories for the subsoil samples of FOREGS Geochemical Baselines Mapping Project were compared. 190 sub soil samples were composed from 787 samples remained after the analysis campaign of the FOREGS Project. In addition to the FOREGS elemental analysis package, Au, Pt, Pd, B, Ge, Br, Cl, Se, N, Li and F were also analyzed by using the IGGE 76 element analytical scheme. In this study, the geochemical data statistics, scatter plotting, and the geochemical map compilation techniques were employed to investigate the differences between the analysis results. The results of the two dataset agree extremely well for about 23 elements, viz: SiO2, Sr, Al2O3, Zr, Ba, Fe2O3, Ti, Rb, Mn, Gd, CaO, Ga, MgO, P, Pb, Na2O, Y, Th, As, U Sc, Cr, and Co. The slight proportional errors exist between the datasets for the elements of Ni, K2O, Tb, Tl, Cu, S, Sm, La, Ce, Pr, Nd, Eu, Ho, Er, Tm, Yb, Lu, Ta, Nb, Hf, Dy. For the elements of Cd, Cs, Be, Sb, In, Mo, I, Sn, and Te, their geochemical maps are normal similarity, but the obvious biases exist between the two dataset for the values near the detection limits. The sensitivities of FOREGS analytical methods for W, Bi, Sn, Te, Be, and I are insufficient to produce reportable values at least 80% of the samples. Although the detection limits of Ag for both method are all sufficient to give out enough reportable values, but the big bias were found between the two datasets. This study demonstrated that the comparable analytical data of the certain elements for the global geochemical mapping samples can be achieved by the different laboratories. But for other elements, such as Ag, the further research on the selection of the proper analytical methods and on the quality control methods should to be undertaken and the final recommendation should be commonly obeyed by all participates of the global geochemical mapping program.

  9. Harmonization of European laboratory response networks by implementing CWA 15793: use of a gap analysis and an "insider" exercise as tools.

    PubMed

    Sundqvist, Bo; Bengtsson, Ulrika Allard; Wisselink, Henk J; Peeters, Ben P H; van Rotterdam, Bart; Kampert, Evelien; Bereczky, Sándor; Johan Olsson, N G; Szekely Björndal, Asa; Zini, Sylvie; Allix, Sébastien; Knutsson, Rickard

    2013-09-01

    Laboratory response networks (LRNs) have been established for security reasons in several countries including the Netherlands, France, and Sweden. LRNs function in these countries as a preparedness measure for a coordinated diagnostic response capability in case of a bioterrorism incident or other biocrimes. Generally, these LRNs are organized on a national level. The EU project AniBioThreat has identified the need for an integrated European LRN to strengthen preparedness against animal bioterrorism. One task of the AniBioThreat project is to suggest a plan to implement laboratory biorisk management CWA 15793:2011 (CWA 15793), a management system built on the principle of continual improvement through the Plan-Do-Check-Act (PDCA) cycle. The implementation of CWA 15793 can facilitate trust and credibility in a future European LRN and is an assurance that the work done at the laboratories is performed in a structured way with continuous improvements. As a first step, a gap analysis was performed to establish the current compliance status of biosafety and laboratory biosecurity management with CWA 15793 in 5 AniBioThreat partner institutes in France (ANSES), the Netherlands (CVI and RIVM), and Sweden (SMI and SVA). All 5 partners are national and/or international laboratory reference institutes in the field of public or animal health and possess high-containment laboratories and animal facilities. The gap analysis showed that the participating institutes already have robust biorisk management programs in place, but several gaps were identified that need to be addressed. Despite differences between the participating institutes in their compliance status, these variations are not significant. Biorisk management exercises also have been identified as a useful tool to control compliance status and thereby implementation of CWA 15793. An exercise concerning an insider threat and loss of a biological agent was performed at SVA in the AniBioThreat project to evaluate

  10. Evaluation of candidate reference genes for QPCR during ontogenesis and of immune-relevant tissues of European seabass (Dicentrarchus labrax).

    PubMed

    Mitter, Karin; Kotoulas, Georgios; Magoulas, Antonios; Mulero, Victor; Sepulcre, Pilar; Figueras, Antonio; Novoa, Beatrice; Sarropoulou, Elena

    2009-08-01

    The expression level of mRNA can vary significantly in different experimental conditions, such as stress, infection, developmental stage or tissue. Suitable reference genes are expected to exhibit constant expression levels. However no single gene is constitutively expressed in all cell types and under all experimental conditions. It has become clear that expression stability of the intended reference gene has to be examined before each experiment. For expression studies using quantitative real-time PCR (qPCR) at least two reference genes have to be applied. So far expression studies in the European seabass (Dicentrarchus labrax) as well as in the Gilthead seabream (Sparus aurata) have been performed with only one reference gene (S18, Ef-1 alpha or Gapdh). Though significant variations showed up in other teleost species such as the Atlantic halibut and the zebrafish affirming the need for proper normalization strategies, the present study aims at identifying suitable reference genes among nine candidates [glyceraldehyde-phosphate-dehydrogenase (Gapdh), beta-actin (two regions of beta-actin), 40S ribosomal protein S30 (Fau), ribosomal protein L13 a (L13a), beta2-tubulin (Tubb2) and tyrosine 3 monooxygenase/tryptophan 5-monooxygenase activation protein (Tyr)] for expression analysis of 8 developmental stages and a tissue panel (spleen, liver, kidney and brain) with samples infected with Nodavirus and Vibrio anguillarum in D. labrax. Besides the analysis of raw Ct-values, the gene expression stability was determined using two different software applications BestKeeper and NormFinder. According to both algorithms the best two reference genes for an appropriate normalization approach during D. labrax development are Ef-1 alpha and L13a whereas in the tissue panel Fau and L13a are recommended for qPCR normalization.

  11. Cost and turn-around time display decreases inpatient ordering of reference laboratory tests: a time series.

    PubMed

    Fang, Daniel Z; Sran, Gurmeet; Gessner, Daniel; Loftus, Pooja D; Folkins, Ann; Christopher, John Y; Shieh, Lisa

    2014-12-01

    Reference tests, also known as send-out tests, are commonly ordered laboratory tests with variable costs and turn-around times. We aim to examine the effects of displaying reference laboratory costs and turn-around times during computerised physician order entry (CPOE) on inpatient physician ordering behaviour. We conducted a prospective observational study at a tertiary care hospital involving inpatient attending physicians and residents. Physician ordering behaviour was prospectively observed between September 2010 and December 2012. An intervention was implemented to display cost and turn-around time for reference tests within our CPOE. We examined changes in the mean number of monthly physician orders per inpatient day at risk, the mean cost per order, and the average turn-around time per order. After our intervention, the mean number of monthly physician orders per inpatient day at risk decreased by 26% (51 vs 38, p<0.0001) with a decrease in mean cost per order (US$146.50 vs US$134.20, p=0.0004). There were no significant differences in mean turn-around time per order (5.6 vs 5.7 days, p=0.057). A stratified analysis of both cost and turn-around time showed significant decreases in physician ordering. The intervention projected a mean annual savings of US$330 439. Reference test cost and turn-around time variables were poorly correlated (r=0.2). These findings occurred in the setting of non-significant change to physician ordering in a control cohort of non-reference laboratory tests. Display of reference laboratory cost and turn-around time data during real-time ordering may result in significant decreases in ordering of reference laboratory tests with subsequent cost savings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. The novel 2016 WHO Neisseria gonorrhoeae reference strains for global quality assurance of laboratory investigations: phenotypic, genetic and reference genome characterization.

    PubMed

    Unemo, Magnus; Golparian, Daniel; Sánchez-Busó, Leonor; Grad, Yonatan; Jacobsson, Susanne; Ohnishi, Makoto; Lahra, Monica M; Limnios, Athena; Sikora, Aleksandra E; Wi, Teodora; Harris, Simon R

    2016-11-01

    Gonorrhoea and MDR Neisseria gonorrhoeae remain public health concerns globally. Enhanced, quality-assured, gonococcal antimicrobial resistance (AMR) surveillance is essential worldwide. The WHO global Gonococcal Antimicrobial Surveillance Programme (GASP) was relaunched in 2009. We describe the phenotypic, genetic and reference genome characteristics of the 2016 WHO gonococcal reference strains intended for quality assurance in the WHO global GASP, other GASPs, diagnostics and research worldwide. The 2016 WHO reference strains (n = 14) constitute the eight 2008 WHO reference strains and six novel strains. The novel strains represent low-level to high-level cephalosporin resistance, high-level azithromycin resistance and a porA mutant. All strains were comprehensively characterized for antibiogram (n = 23), serovar, prolyliminopeptidase, plasmid types, molecular AMR determinants, N. gonorrhoeae multiantigen sequence typing STs and MLST STs. Complete reference genomes were produced using single-molecule PacBio sequencing. The reference strains represented all available phenotypes, susceptible and resistant, to antimicrobials previously and currently used or considered for future use in gonorrhoea treatment. All corresponding resistance genotypes and molecular epidemiological types were described. Fully characterized, annotated and finished references genomes (n = 14) were presented. The 2016 WHO gonococcal reference strains are intended for internal and external quality assurance and quality control in laboratory investigations, particularly in the WHO global GASP and other GASPs, but also in phenotypic (e.g. culture, species determination) and molecular diagnostics, molecular AMR detection, molecular epidemiology and as fully characterized, annotated and finished reference genomes in WGS analysis, transcriptomics, proteomics and other molecular technologies and data analysis. © The Author 2016. Published by Oxford University Press on behalf of the

  13. The EC4 European syllabus for post-graduate training in clinical chemistry and laboratory medicine: version 4--2012.

    PubMed

    Wieringa, Gijsbert; Zerah, Simone; Jansen, Rob; Simundic, Ana-Maria; Queralto, José; Solnica, Bogdan; Gruson, Damien; Tomberg, Karel; Riittinen, Leena; Baum, Hannsjörg; Brochet, Jean-Philippe; Buhagiar, Gerald; Charilaou, Charis; Grigore, Camelia; Johnsen, Anders H; Kappelmayer, Janos; Majkic-Singh, Nada; Nubile, Giuseppe; O'Mullane, John; Opp, Matthias; Pupure, Silvija; Racek, Jaroslav; Reguengo, Henrique; Rizos, Demetrios; Rogic, Dunja; Špaňár, Július; Štrakl, Greta; Szekeres, Thomas; Tzatchev, Kamen; Vitkus, Dalius; Wallemacq, Pierre; Wallinder, Hans

    2012-08-01

    Laboratory medicine's practitioners across the European community include medical, scientific and pharmacy trained specialists whose contributions to health and healthcare is in the application of diagnostic tests for screening and early detection of disease, differential diagnosis, monitoring, management and treatment of patients, and their prognostic assessment. In submitting a revised common syllabus for post-graduate education and training across the 27 member states an expectation is set for harmonised, high quality, safe practice. In this regard an extended 'Core knowledge, skills and competencies' division embracing all laboratory medicine disciplines is described. For the first time the syllabus identifies the competencies required to meet clinical leadership demands for defining, directing and assuring the efficiency and effectiveness of laboratory services as well as expectations in translating knowledge and skills into ability to practice. In a 'Specialist knowledge' division, the expectations from the individual disciplines of Clinical Chemistry/Immunology, Haematology/Blood Transfusion, Microbiology/ Virology, Genetics and In Vitro Fertilisation are described. Beyond providing a common platform of knowledge, skills and competency, the syllabus supports the aims of the European Commission in providing safeguards to increasing professional mobility across European borders at a time when demand for highly qualified professionals is increasing and the labour force is declining. It continues to act as a guide for the formulation of national programmes supplemented by the needs of individual country priorities.

  14. Reference materials produced for a European metrological research project focussing on measurements of NORM.

    PubMed

    Larijani, C; Pearce, A K; Regan, P H; Russell, B C; Jerome, S M; Crespo, M T; de Felice, P; Lutter, G; Maringer, F; Mazánová, M

    2017-08-01

    Reliable measurement of Naturally Occurring Radioactive Materials is of significance in order to comply with environmental regulations and for radiological protection purposes. This paper discusses the standardisation of three reference materials, namely sand, tuff and TiO2 to serve as quality control materials for traceability, method validation and instrument calibration. The sample preparation, material characterization via γ, α and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and the assignment of values for both the 4n (Thorium) and 4n+2 (Uranium) decay series are described. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  15. Spectral Karyotyping for identification of constitutional chromosomal abnormalities at a national reference laboratory

    PubMed Central

    2012-01-01

    Spectral karyotyping is a diagnostic tool that allows visualization of chromosomes in different colors using the FISH technology and a spectral imaging system. To assess the value of spectral karyotyping analysis for identifying constitutional supernumerary marker chromosomes or derivative chromosomes at a national reference laboratory, we reviewed the results of 179 consecutive clinical samples (31 prenatal and 148 postnatal) submitted for spectral karyotyping. Over 90% of the cases were requested to identify either small supernumerary marker chromosomes (sSMCs) or chromosomal exchange material detected by G-banded chromosome analysis. We also reviewed clinical indications of those cases with marker chromosomes in which chromosomal origin was identified by spectral karyotyping. Our results showed that spectral karyotyping identified the chromosomal origin of marker chromosomes or the source of derivative chromosomal material in 158 (88%) of the 179 clinical cases; the identification rate was slightly higher for postnatal (89%) compared to prenatal (84%) cases. Cases in which the origin could not be identified had either a small marker chromosome present at a very low level of mosaicism (< 10%), or contained very little euchromatic material. Supplemental FISH analysis confirmed the spectral karyotyping results in all 158 cases. Clinical indications for prenatal cases were mainly for marker identification after amniocentesis. For postnatal cases, the primary indications were developmental delay and multiple congenital anomalies (MCA). The most frequently encountered markers were of chromosome 15 origin for satellited chromosomes, and chromosomes 2 and 16 for non-satellited chromosomes. We were able to obtain pertinent clinical information for 47% (41/88) of cases with an identified abnormal chromosome. We conclude that spectral karyotyping is sufficiently reliable for use and provides a valuable diagnostic tool for establishing the origin of supernumerary marker

  16. Survey of rotavirus surveillance, laboratory capacity and disease burden in the eastern part of the WHO European Region.

    PubMed

    Williams, C J; Gray, Jim; Pebody, R G; Lobanov, A

    2008-08-21

    Following the licensure of two rotavirus vaccines in Europe, we aimed to assess factors, such as surveillance, disease burden and laboratory capacity, which will be relevant for making decisions about rotavirus vaccine introduction in the different countries. We conducted an email-based survey of the national public health bodies in the World Health Organization (WHO) European Region in 2006 and report here the results from the 23 countries in the eastern part of the region. The survey included questions on rotavirus surveillance, laboratory capacity, burden (in children under the age of five years) and intention to introduce rotavirus vaccination. Countries were grouped into the four per-capita income categories defined by the World Bank. Fourteen of the 23 countries responded to the survey. All except one country reported that less than a quarter of their laboratories had rotavirus diagnostic capacity. Four countries had some form of specific rotavirus surveillance, but half were of very limited coverage. Ten countries did not report data on the incidence of rotavirus hospital admissions, although nine were able to report some data on rotavirus burden. Six of the responding countries said they were likely to introduce universal rotavirus vaccination. Rotavirus surveillance and laboratory capacity in the eastern part of the WHO European Region is limited but most countries had some estimate of rotavirus burden, often from special studies. The reported mortality rates were lower than those from a WHO mortality data source. Many countries in the eastern part of WHO European Region face a number of challenges before vaccine implementation, including strengthening surveillance, improving laboratory capacity and addressing financial barriers.

  17. [European Community Respiratory Health Survey: The main results so far with special reference to Iceland.].

    PubMed

    Gíslason, Davíð; Bjœrnsdóttir, Unnur Steina; Blœndal, Thornorsteinn; Gíslason, Thornórarinn

    2002-12-01

    The European Community Respiratory Health Survey (ECRHS) was the first project embarked on extensive study of geographical difference between countries with regards to asthma and atopy incidence in a young adult population. The same methodology and definitions were used at all study sites. The purpose of this article is to review the published results of the ECRHS with a special emphasis on the findings from the Icelandic population, and compare these results with those from the participants from the other nations and study sites. Compiled results from all study sites participating in the ECHRS hereto published were reviewed. The compiled data are derived from approximately 140.000 individuals aged 20-44 (birth-years 1946-71) from 22 nations and 48 study sites. The Icelandic population was chosen from the greater Reykjavik metropolitan area. Subjects responded to seven questions on respiratory symptoms, diagnosis of asthma and use of asthma medications. In the latter part of the investigation, 800 individuals were randomly selected from each study site. They were asked to respond to a detailed questionnaire. Subsequently spirometry, methacholine challange and skin prick testing to 11-12 common aeroallergens was performed. Additionally, allergen specific IgE and total IgE was measured. Somewhat fewer sites participated in this latter part: 17 nations and 37 study sites. The findings are presented from two angles: the compiled data from all study sites and the results from the Icelandic population; specifically comparing the Icelandic data with the participants from the other nations. The study showed a geographical difference in the incidence of asthma, bronchial hyper- responsiveness and other respiratory symptoms. In the first part of the study, an eight-fold difference in wheezing, six-fold difference in asthma, ten-fold difference in physician- diagnosed asthma and a four-fold difference in the prevalence of allergic rhinitis was found between the study sites

  18. Smoking in film and impact on adolescent smoking: with special reference to European adolescents.

    PubMed

    Sargent, J D

    2006-02-01

    This review examines the evidence supporting an association between seeing smoking depictions in movies and adolescent smoking. The portrayal of tobacco use is common in movies and often modeled by movie stars who, from a social influences standpoint, should be powerful behavior change agents. The results of studies assessing audience responses to tobacco portrayal in movies are remarkably consistent in showing a moderate to strong association between seeing movie smoking and more positive attitudes toward smoking and adolescent smoking initiation. The population-based data include cross sectional samples from different regions of the United States, all supporting a movie smoking-teen smoking link. The 2 published longitudinal studies show an independent link between exposure to movie smoking at baseline and initiation in the future, with estimates of the effect size being remarkably consistent with their cross-sectional counterparts. Experimental research adds support by showing that scene depictions of smoking enhance positive views of smokers and increase intent to smoke in the future. Taken as a whole, this rich research base provides very strong support for the notion that movie smoking plays a role in smoking initiation among adolescents that warrants action at the individual and societal level. A major gap in our understanding is the impact of Hollywood movies on adolescents outside the United States. There is a real need for studies to be conducted in European and other populations to better understand the global reach of smoking in American film, since over half of box office revenues come from outside the United States.

  19. The pooling of manpower and resources through the establishment of European reference networks and rare disease patient registries is a necessary area of collaboration for rare renal disorders.

    PubMed

    Parker, Samantha

    2014-09-01

    This review aims to provide guidance on emerging concepts and policy related to European reference networks (ERNs) for rare diseases (RDs) and the development and management of RD patient registries. A major problem facing many RDs including rare renal disorders is that patients do not have a specialist centre that they can attend where clinicians, working as a multidisciplinary team, are experts in the particular disease. Furthermore, for most RDs, no single centre, and in many cases no single country, has sufficient numbers of patients and resources to fully understand the natural history or to conduct clinical and translational research. Therefore, the pooling of manpower and resources through the establishment of ERN and RD patient registries is a common and necessary area of collaboration. The concept of European networks for RDs dates back to the early 2000s and the Commission launch of a call for European pilot reference networks for RDs. These networks of expert centres have been brought together through the desire for further knowledge and innovation in RD areas. Networks demand a holistic approach and long-term vision with close collaboration between clinicians, diagnostic laboratories, scientists, patients and their families. The development of legal measures for ERNs is in progress at the Commission and these networks will be a shared responsibility of the Commission and member states. In the context of ERNs, an essential activity is the patient registries. Patient registries are organized databases where patient information, including demographic, medical and family history, are collected, stored and available for retrieval via standardized and secure methods. Patient registries are increasingly recognized as crucial tools for RD research for which international collaboration is absolutely essential to understand the pathogenesis of rare genotypes, achieve a unified collection of phenotypic data, foster natural history studies providing the foundation

  20. Phosphorus Concentrations in Stream-Water and Reference Samples - An Assessment of Laboratory Comparability

    USGS Publications Warehouse

    McHale, Michael R.; McChesney, Dennis

    2007-01-01

    In 2003, a study was conducted to evaluate the accuracy and precision of 10 laboratories that analyze water-quality samples for phosphorus concentrations in the Catskill Mountain region of New York State. Many environmental studies in this region rely on data from these different laboratories for water-quality analyses, and the data may be used in watershed modeling and management decisions. Therefore, it is important to determine whether the data reported by these laboratories are of comparable accuracy and precision. Each laboratory was sent 12 samples for triplicate analysis for total phosphorus, total dissolved phosphorus, and soluble reactive phosphorus. Eight of these laboratories reported results that met comparability criteria for all samples; the remaining two laboratories met comparability criteria for only about half of the analyses. Neither the analytical method used nor the sample concentration ranges appeared to affect the comparability of results. The laboratories whose results were comparable gave consistently comparable results throughout the concentration range analyzed, and the differences among methods did not diminish comparability. All laboratories had high data precision as indicated by sample triplicate results. In addition, the laboratories consistently reported total phosphorus values greater than total dissolved phosphorus values, and total dissolved phosphorus values greater than soluble reactive phosphorus values, as would be expected. The results of this study emphasize the importance of regular laboratory participation in sample-exchange programs.

  1. Engineering education research in European Journal of Engineering Education and Journal of Engineering Education: citation and reference discipline analysis

    NASA Astrophysics Data System (ADS)

    Wankat, Phillip C.; Williams, Bill; Neto, Pedro

    2014-01-01

    The authors, citations and content of European Journal of Engineering Education (EJEE) and Journal of Engineering Education (JEE) in 1973 (JEE, 1975 EJEE), 1983, 1993, 2003, and available 2013 issues were analysed. Both journals transitioned from house organs to become engineering education research (EER) journals, although JEE transitioned first. In this process the number of citations rose, particularly of education and psychology sources; the percentage of research articles increased markedly as did the number of reference disciplines. The number of papers per issue, the number of single author papers, and the citations of science and engineering sources decreased. EJEE has a very broad geographic spread of authors while JEE authors are mainly US based. A 'silo' mentality where general engineering education researchers do not communicate with EER researchers in different engineering disciplines is evident. There is some danger that EER may develop into a silo that does not communicate with technically oriented engineering professors.

  2. Assessments of feline plasma biochemistry reference intervals for three in-house analysers and a commercial laboratory analyser.

    PubMed

    Baral, Randolph M; Dhand, Navneet K; Krockenberger, Mark B; Govendir, Merran

    2015-08-01

    For each species, the manufacturers of in-house analysers (and commercial laboratories) provide standard reference intervals (RIs) that do not account for any differences such as geographical population differences and do not overtly state the potential for variation between results obtained from serum or plasma. Additionally, biases have been demonstrated for in-house analysers which result in different RIs for each different type of analyser. The objective of this study was to calculate RIs (with 90% confidence intervals [CIs]) for 13 biochemistry analytes when tested on three commonly used in-house veterinary analysers, as well as a commercial laboratory analyser. The calculated RIs were then compared with those provided by the in-house analyser manufacturers and the commercial laboratory. Plasma samples were collected from 53 clinically normal cats. After centrifugation, plasma was divided into four aliquots; one aliquot was sent to the commercial laboratory and the remaining three were tested using the in-house biochemistry analysers. The distribution of results was used to choose the appropriate statistical technique for each analyte from each analyser to calculate RIs. Provided reference limits were deemed appropriate if they fell within the 90% CIs of the calculated reference limits. Transference validation was performed on provided and calculated RIs. Twenty-nine of a possible 102 provided reference limits (28%) were within the calculated 90% CIs. To ensure proper interpretation of laboratory results, practitioners should determine RIs for their practice populations and/or use reference change values when assessing their patients' clinical chemistry results. © ISFM and AAFP 2014.

  3. Health effects of endocrine-disrupting chemicals on wildlife, with special reference to the European situation.

    PubMed

    Vos, J G; Dybing, E; Greim, H A; Ladefoged, O; Lambré, C; Tarazona, J V; Brandt, I; Vethaak, A D

    2000-01-01

    Many wildlife species may be exposed to biologically active concentrations of endocrine-disrupting chemicals. There is strong evidence obtained from laboratory studies showing the potential of several environmental chemicals to cause endocrine disruption at environmentally realistic exposure levels. In wildlife populations, associations have been reported between reproductive and developmental effects and endocrine-disrupting chemicals. In the aquatic environment, effects have been observed in mammals, birds, reptiles, fish, and mollusks from Europe, North America, and other areas. The observed abnormalities vary from subtle changes to permanent alterations, including disturbed sex differentiation with feminized or masculinized sex organs, changed sexual behavior, and altered immune function. For most reported effects in wildlife, however, the evidence for a causal link with endocrine disruption is weak or nonexisting. Crucial in establishing causal evidence for chemical-induced wildlife effects appeared semifield or laboratory studies using the wildlife species of concern. Impaired reproduction and development causally linked to endocrine-disrupting chemicals are well documented in a number of species and have resulted in local or regional population changes. These include: Masculinization (imposex) in female marine snails by tributyltin, a biocide used in antifouling paints, is probably the clearest case of endocrine disruption caused by an environmental chemical. The dogwhelk is particularly sensitive, and imposex has resulted in decline or extinction of local populations worldwide, including coastal areas all over Europe and the open North Sea. DDE-induced egg-shell thinning in birds has caused severe population declines in a number of raptor species in Europe and North America. Endocrine-disrupting chemicals have adversely affected a variety of fish species. In the vicinity of certain sources (e.g., effluents of water treatment plants) and in the most

  4. The Italian reference sites of the European innovation partnership on active and healthy ageing: Progetto Mattone Internazionale as an enabling factor.

    PubMed

    Illario, Maddalena; De Luca, Vincenzo; Tramontano, Giovanni; Menditto, Enrica; Iaccarino, Guido; Bertorello, Lorenzo; Palummeri, Ernesto; Romano, Valeria; Moda, Giuliana; Maggio, Marcello; Barbolini, Mirca; Leonardini, Lisa; Addis, Antonio

    2017-01-01

    Ageing population implies an increasing demand for health care services and resources, unsustainable according to current previsions. The European Commission is tackling this challenge throughout initiatives such as the European Innovation Partnership on Active and Healthy Ageing (EIP-AHA), where all the efforts are aligned to the common goal of adding two active and healthy years to the life of European Union (EU) citizens. We presented the collaborative efforts of Italian Reference Site Collaborative Network 2012-2015. Italian regions joined forces through the "Progetto Mattone Internazionale" of the Ministry of Health developing several national and international collaborations. Activities from all five Italian reference sites are presented with different good practices and scale-up approaches for improving health in ageing population. The simultaneous development of these activities allowed the strengthening of the coordination of Italian stakeholders in the European arena fostering collaboration and supporting the streamlining of the Italian regions still outside these projects.

  5. Establishment of European Pharmacopoeia (Ph. Eur.) Biological Reference Preparations (BRP) batch 2 for rDNA hepatitis B vaccine (method A and B).

    PubMed

    Dobbelaer, R; Daas, A; Milne, C

    2004-01-01

    A collaborative study was initiated by the European Directorate for the Quality of Medicines (EDQM), to assign a potency value for candidate batch 2 of European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Hepatitis B (rDNA) antigen in vitro assays, for both method A and method B by calibrating them against the Ph. Eur. BRPs, batch 1 for methods A and B respectively. The study was prompted by the observation that the first batch of BRP for method B appeared to have lost potency over time. BRP 1 for method A showed no loss in potency, however stocks of the material were nearing depletion. Eleven laboratories participated in the study and all reported results. Participants performed 3 independent assays using both method A and method B. Method A was used to assess BRPs for method A and method B was used to assess BRPs for method B. Since BRP 1B was suspected to have lost potency, an additional sample was included in the method B test in an attempt to clarify the situation. BRP 1B was also assayed in method A against BRP 1A in the hope of also attaining further information by comparing the results from this study to those obtained in the original study to establish the first batch of BRP [1]. Although it was not the primary aim of this study to correlate in vitro potency with the immunogenicity assay in mice, a number of interested parties also performed the mouse in vivo assay to obtain data on the behaviour of the candidate BRPs in this assay. For method A, potency estimates were satisfactory in terms of repeatability and reproducibility. The candidate material was therefore assigned a value of 16.6 micrograms/ml. For method B, it appeared that the observation of reduced in vitro potency of BRP1 was confirmed. Despite the attempt to clarify the situation with additional studies, it was not possible to assign a potency value with the results obtained. A small-scale collaborative study will be organised to determine an appropriate value for the

  6. A National Laboratory and University Branch Campus Library Partnership: Shared Benefits and Challenges from Combined Reference Services

    SciTech Connect

    Buxton, Karen A.; Gover, Harvey R.

    2003-12-31

    The Hanford Technical Library of the Pacific Northwest National Laboratory and the Max E. Benitz Memorial Library of the Washington State University Tri-Cities Branch Campus have functioned both separately and in combination since moving into the same space within the Consolidated Information Center in 1997. The libraries have successfully partnered to serve different clientele at a combined reference desk since June 1997. Although having separate staffs, catalogs, and collections, the libraries share a single reference/information desk. The reference staffs work together to serve a very diverse clientele including students, faculty, engineers, scientists, contractors, regulators, and the public. The combined libraries offer significant benefits to both library staffs and their users. The libraries have expanded access to collections and information expertise, enhanced staff training opportunities, and provided additional hours of reference service to patrons while at the same time maintaining the individual identities of the two libraries.

  7. [Allowable limits of analytical error which can guarantee the reliability of reference intervals for interpretation of clinical laboratory data].

    PubMed

    Hosogaya, Shigemi; Ozaki, Yukio

    2008-07-01

    The International Organization for Standardization (ISO) developed a guide to the expression of uncertainty in measurement (GUM). The purpose of such guidance is to provide a basis for the international comparison of measurement results. In this study, we propose a basic protocol to evaluate and express uncertainty in measurement for routine test results in the clinical laboratory. We also sought to investigate the effects of measurement errors on the evaluation of biological variations in healthy subjects. To this end, we analyzed the allowable limits of analytical error which guarantee the reliability of reference intervals for the interpretation of clinical laboratory data. As a conclusion, we suggest that 1/2 or less of biological intraindividual variations is an appropriate criterion for an allowable limit of uncertainty to be applied in health check-ups, and this value is in agreement with previous reports. If this criterion as a marker for intra laboratory imprecision is met, it suggests that a given institute is able to evaluate time series changes in follow-up of individual data. If the reference interval of laboratory data for disease screening is shared by different institutes, it is suggested that a criterion of 1/4 or less of a biological inter- pulse intra-individual variation is appropriate. This criterion appears to be the goal for analytical inter-laboratory variations.

  8. A step forward in molecular diagnostics of lyssaviruses--results of a ring trial among European laboratories.

    PubMed

    Fischer, Melina; Wernike, Kerstin; Freuling, Conrad M; Müller, Thomas; Aylan, Orhan; Brochier, Bernard; Cliquet, Florence; Vázquez-Morón, Sonia; Hostnik, Peter; Huovilainen, Anita; Isaksson, Mats; Kooi, Engbert A; Mooney, Jean; Turcitu, Mihai; Rasmussen, Thomas B; Revilla-Fernández, Sandra; Smreczak, Marcin; Fooks, Anthony R; Marston, Denise A; Beer, Martin; Hoffmann, Bernd

    2013-01-01

    Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial specifically designed on the use of reverse transcription polymerase chain reaction (RT-PCR) for detection of lyssavirus genomic RNA was organized. The trial focussed on assessment and comparison of the performance of conventional and real-time assays. In total, 16 European laboratories participated. All participants were asked to investigate a panel of defined lyssavirus RNAs, consisting of Rabies virus (RABV) and European bat lyssavirus 1 and 2 (EBLV-1 and -2) RNA samples, with systems available in their laboratory. The ring trial allowed the important conclusion that conventional RT-PCR assays were really robust assays tested with a high concordance between different laboratories and assays. The real-time RT-PCR system by Wakeley et al. (2005) in combination with an intercalating dye, and the combined version by Hoffmann and co-workers (2010) showed good sensitivity for the detection of all RABV samples included in this test panel. Furthermore, all used EBLV-specific assays, real-time RT-PCRs as well as conventional RT-PCR systems, were shown to be suitable for a reliable detection of EBLVs. It has to be mentioned that differences were seen in the performance between both the individual RT-PCR systems and the laboratories. Laboratories which used more than one molecular assay for testing the sample panel always concluded a correct sample result. Due to the markedly high genetic diversity of lyssaviruses, the application of different assays in diagnostics is needed to achieve a maximum of diagnostic accuracy. To improve the knowledge about the diagnostic performance proficiency testing at an international level is recommended before using lyssavirus molecular diagnostics e

  9. Environmental Response Laboratory Network (ERLN) WebEDR Quick Reference Guide

    EPA Pesticide Factsheets

    The Web Electronic Data Review is a web-based system that performs automated data processing on laboratory-submitted Electronic Data Deliverables (EDDs). Enables users to perform technical audits on data, and against Measurement Quality Objectives (MQOs).

  10. RUBI -a Reference mUltiscale Boiling Investigation for the Fluid Science Laboratory

    NASA Astrophysics Data System (ADS)

    Schweizer, Nils; Stelzer, Marco; Schoele-Schulz, Olaf; Picker, Gerold; Ranebo, Hans; Dettmann, Jan; Minster, Olivier; Toth, Balazs; Winter, Josef; Tadrist, Lounes; Stephan, Peter; Grassi, Walter; di Marco, Paolo; Colin, Catherine; Piero Celata, Gian; Thome, John; Kabov, Oleg

    Boiling is a two-phase heat transfer process where large heat fluxes can be transferred with small driving temperature differences. The high performance of boiling makes the process very interesting for heat transfer applications and it is widely used in industry for example in power plants, refrigeration systems, and electronics cooling. Nevertheless, due to the large number of involved phenomena and their often highly dynamic nature a fundamental understanding and closed theoretical description is not yet accomplished. The design of systems incorporating the process is generally based on empirical correlations, which are commonly accompanied by large uncertainties and, thus, has to be verified by expensive test campaigns. Hence, strong efforts are currently made to develop applicable numerical tools for a reliable prediction of the boiling heat transfer performance and limits. In order to support and validate this development and, in particular as a precondition, to enhance the basic knowledge about boiling the comprehensive multi-scale experiment RUBI (Reference mUlti-scale Boiling Investigation) for the Fluid Science Laboratory on board the ISS is currently in preparation. The scientific objectives and requirements of RUBI have been defined by the members of the ESA topical team "Boiling and Multiphase Flow" and addresses fundamental aspects of boiling phenomena. The main objectives are the measurement of wall temperature and heat flux distribution underneath vapour bubbles with high spatial and tem-poral resolution by means of IR thermography accompanied by the synchronized high-speed observation of the bubble shapes. Furthermore, the fluid temperature in the vicinity and inside of the bubbles will be measured by a micro sensor array. Additional stimuli are the generation of an electric field above the heating surface and a shear flow created by a forced convection loop. The objective of these stimuli is to impose forces on the bubbles and investigate the

  11. Evaluation of ability of reference toxicity tests to identify stress in laboratory populations of the amphipod Hyalella azteca

    SciTech Connect

    McNulty, E.W.; Ellersieck, M.R.; Rabeni, C.F.; Dwyer, F.J.; Greer, E.I.; Ingersoll, C.G.

    1999-03-01

    Standard methods for conducting toxicity tests imply that the condition of test organisms can be established using reference toxicity tests. However, only a limited number of studies have evaluated whether reference toxicity tests can actually be used to determine if organisms are in good condition, at the start of a test. The authors evaluated the ability of reference toxicants to identify stress associated with starvation in laboratory populations of the amphipod Hyalella azteca using acute toxicity tests and four reference toxicants: KCl, CdCl{sub 2}, sodium pentachlorophenate (NaPCP), and carbaryl. Stress associated with severe starvation was observed with exposure of amphipods to carbaryl or NaPCP but not with exposure to KCl or CdCl{sub 2} (i.e., lower LC50 with severe starvation). Although the LC50s for NaPCP and carbaryl were statistically different between starved and fed amphipods, this difference may not be biologically significant given the variability expected in acute lethality tests. Stress associated with sieving, heat shock, or cold shock of amphipods before the start of a test was not evident with exposure to carbaryl or KCl as reference toxicants. The chemicals evaluated in this study provided minimal information about the condition of the organisms used to start a toxicity test. Laboratories should periodically perform reference toxicity tests to assess the sensitivity of life stages or strains of test organisms. However, use of other test acceptability criteria required in standard methods, such as minimum survival, growth, or reproduction of organisms in the control treatment at the end of a test, provides more useful information about the condition of organisms used to start a test compared to data generated from reference toxicity tests.

  12. Evaluation of ability of reference toxicity tests to identify stress in laboratory populations of the amphipod Hyalella azteca

    USGS Publications Warehouse

    McNulty, E.W.; Dwyer, F.J.; Ellersieck, Mark R.; Greer, E.I.; Ingersoll, C.G.; Rabeni, C.F.

    1999-01-01

    Standard methods for conducting toxicity tests imply that the condition of test organisms can be established using reference toxicity tests. However, only a limited number of studies have evaluated whether reference toxicity tests can actually be used to determine if organisms are in good condition at the start of a test. We evaluated the ability of reference toxicants to identify stress associated with starvation in laboratory populations of the amphipod Hyalella azteca using acute toxicity tests and four reference toxicants: KCl, CdCl2, sodium pentachlorophenate (NaPCP), and carbaryl. Stress associated with severe starvation was observed with exposure of amphipods to carbaryl or NaPCP but not with exposure to KCl or CdCl2 (i.e., lower LC50 with severe starvation). Although the LC50s for NaPCP and carbaryl were statistically different between starved and fed amphipods, this difference may not be biologically significant given the variability expected in acute lethality tests. Stress associated with sieving, heat shock, or cold shock of amphipods before the start of a test was not evident with exposure to carbaryl or KCl as reference toxicants. The chemicals evaluated in this study provided minimal information about the condition of the organisms used to start a toxicity test. Laboratories should periodically perform reference toxicity tests to assess the sensitivity of life stages or strains of test organisms. However, use of other test acceptability criteria required in standard methods such as minimum survival, growth, or reproduction of organisms in the control treatment at the end of a test, provides more useful information about the condition of organisms used to start a test compared to data generated from reference toxicity tests.

  13. Variable sensitivity in molecular detection of Zika virus in European expert laboratories; external quality assessment, November 2016.

    PubMed

    Charrel, Remi; Mögling, Ramona; Pas, Suzan; Papa, Anna; Baronti, Cecile; Koopmans, Marion; Zeller, Hervé; LeParc-Goffart, Isabelle; Reusken, Chantal B

    2017-08-23

    Background: Zika virus (ZIKV) infections are a significant public health concern. A high capability for ZIKV detection is an absolute requirement for adequate preparedness and response strategies and individual patient care.Objectives: To assess and improve the capability of European expert laboratories for ZIKV molecular testing through an External Quality Assessment scheme.Study design: Laboratories were provided with a panel of 12 samples which included negative samples, samples containing African or Asian lineage ZIKV at variable concentrations (10(3) to 10(9) copies/ml) and samples containing dengue virus, yellow fever virus or chikungunya virus. Results were analysed based on sample outcomes and used extraction/detection. Samples with a ZIKV RNA status scored correctly by >50% of the laboratories were designated as core sample.Results: A total of 85 panel outcomes were submitted by 50 laboratories in 31 countries. Results designated all samples as core. 33% of panel outcomes identified all samples correctly (28/85), while 15% (13/85) had a score lower than 20 out of 24 points. Analysis at laboratory level showed that only 40% of the laboratories (20/50) representing 45% of the countries scored sufficiently, i.e. had at least one test operational that scored all core samples correctly.Conclusions: There is need for improvement of molecular detection of ZIKV in 60% of the participating laboratories. While the specificity of the tests was more robust, the results of the EQA showed large variation in test sensitivity. Improvement should focus on both nucleic acid extraction and ZIKV detection methods. Copyright © 2017 American Society for Microbiology.

  14. Use of a United States-based laboratory as a hematopathology reference center for a developing country: logistics and results.

    PubMed

    Deetz, C O; Scott, M G; Ladenson, J H; Seyoum, M; Hassan, A; Kreisel, F H; Nguyen, T T; Frater, J L

    2013-02-01

    With proper logistical support and sponsorship, a laboratory in an industrialized nation might be able to act as a reference laboratory for clinicians based in a developing country. We built on previous experience in the clinical laboratory to see whether a specialized histopathology service (hematopathology) could be provided to a developing country without the expertise or experience to do it in country. Over an 13-year period, 582 cases from 579 individuals were analyzed. Principal pathologic findings included acute leukemia in 84 cases (14%), dyspoiesis in one or more of the hematopoietic lineages in 65 cases (11%, including three cases with high-grade myelodysplasia), 23 cases (4%) with findings suspicious for a chronic myeloproliferative disorder, 35 cases (6%) with findings suspicious for a lymphoproliferative disorder, and infectious organisms (presumably Leishmania in most instances) in 9 (1%) of cases. Specimens from 45 cases (8%) were unsatisfactory owing to extreme hemodilution and/or specimen degeneration. With proper support, a medical laboratory in an industrialized nation may serve as a reference facility for a developing nation. The use of existing infrastructure may be remarkably effective to achieve optimal turnaround time. Although the lack of ancillary studies and follow-up biopsies limit the ability to achieve a definitive diagnosis in many cases, this must be viewed in the context of the limited ability to diagnose or manage hematopoietic neoplasia in developing nations. © 2012 Blackwell Publishing Ltd.

  15. Proficiency testing linked to the national reference system for the clinical laboratory: a proposal for achieving accuracy.

    PubMed

    Lasky, F D

    1992-07-01

    I propose using proficiency testing (PT) to achieve one of the important goals of CLIA: accurate and reliable clinical testing. Routine methods for the clinical laboratory are traceable to Definitive (DM) or Reference Methods (RM) or to Methodological Principles (MP) through a modification of the National Reference System for the Clinical Laboratory. PT is the link used to monitor consistent field performance. Although PT has been effective as a relative measure of laboratory performance, the technical limitations of PT fluids and of routine methods currently in use make it unlikely that PT alone can be used as a reliable measure of laboratory accuracy. Instead, I recommend calibration of routine systems through correlation to DM, RM, or MP with use of patients' specimens. The manufacturer is in the best position to assume this responsibility because of also being responsible for consistent, reliable product. Analysis of different manufactured batches of reagent would be compared with predetermined goals for precision and accuracy, as illustrated with data from product testing of Kodak Ektachem clinical chemistry slides. Adoption of this proposal would give manufacturers of PT materials, manufacturers of analytical systems, PT providers, and government agencies time to understand and resolve sources of error that limit the utility of PT for the job required by law.

  16. Proficiency analysis of drug susceptibility testing by national-level tuberculosis reference laboratories from 1995 to 2003.

    PubMed

    Bai, Gill-Han; Kim, Sang-Jae; Chang, Chulhun L

    2007-11-01

    A proficiency review of antituberculous drug susceptibility testing (DST) was undertaken by the regional tuberculosis reference laboratories of the Western Pacific Region of WHO to evaluate the performance of national reference laboratories (NRLs) and to ensure that the results from the participating laboratories are reliable and similar. A panel of 30 Mycobacterium tuberculosis strains with various patterns of resistance to isoniazid, rifampin, ethambutol, and streptomycin was sent to the NRLs, and their DST results were analyzed by comparing them with the judicial results. The efficiency scores for each drug were 90 to 99% (mean, 95%) for isoniazid, 77 to 100% (mean, 94%) for rifampin, 82 to 97% (mean, 90%) for ethambutol, and 82 to 98% (mean, 89%) for streptomycin. Significant changes over time in the rates of accordance with the judicial results were observed for rifampin (P < 0.0001) and streptomycin (P = 0.0002), whereas no changes were observed for ethambutol (P = 0.0880). The efficiency score for isoniazid was consistently good throughout the nine rounds. As a whole, NRL02 showed the highest score (95%) in accordance rates for all drugs, while NRL03 (86%) and NRL04 (88%) ranked lowest. Continued proficiency testing with subsequent technical assistance improved the DST quality of participating laboratories, demonstrating the importance of the current WHO/IUATLD external quality assurance program for DST proficiency testing.

  17. Conducting a surveillance problem analysis on poor feedback from Reference Laboratory, Liberia, February 2016.

    PubMed

    Frimpong, Joseph Asamoah; Amo-Addae, Maame Pokuah; Adewuyi, Peter Adebayo; Hall, Casey Daniel; Park, Meeyoung Mattie; Nagbe, Thomas Knue

    2017-01-01

    The laboratory plays a major role in surveillance, including confirming the start and end of an outbreak. Knowing the causative agent for an outbreak informs the development of response strategies and management plans for a public health event. However, issues and challenges may arise that limit the effectiveness or efficiency of laboratories in surveillance. This case study applies a systematic approach to analyse gaps in laboratory surveillance, thereby improving the ability to mitigate these gaps. Although this case study concentrates on factors resulting in poor feedback from the laboratory, practise of this general approach to problem analysis will confer skills required in analysing most public health issues. This case study was developed based on a report submitted by the district surveillance officer in Grand Bassa County, Liberia, as a resident of the Liberian Frontline Field Epidemiology Training Program in 2016. This case study will serve as a training tool to reinforce lectures on surveillance problem analysis using the fishbone approach. It is designed for public health training in a classroom setting and can be completed within 2 hours 30 minutes.

  18. Understanding the 'Silver Book' - An important reference for standardised nomenclature in clinical laboratory sciences.

    PubMed

    Flatman, Robert; Férard, Georges; Dybkaer, René

    2016-06-29

    Clinical laboratories perform a wide menu of testing (examinations). Successful requesting, examination, and ordering in this environment requires clear standardised nomenclature. The Silver Book (SB) is an IUPAC (International Union of Pure and Applied Chemistry) publication, produced with the support of both IUPAC and the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine), that makes recommendations on logical standardised nomenclature, symbols, properties, and units in many disciplines of the clinical laboratory sciences. These recommendations are founded on and in agreement with the principles and work of the International Organization for Standardization (ISO), Bureau International des Poids et Mesures (BIPM), IUPAC, and the IFCC. Practical applications described are based on those scientific principles. The SB recommendations apply to all types of examination, not only to measurement of quantities but also examination of nominal properties where no magnitude is involved. The SB is applicable not only to clinical chemistry, but to many other clinical laboratory disciplines. For examples, reports regarding haemostasis, toxicology, clinical microbiology, reproduction and fertility, clinical pharmacology, clinical allergology, clinical molecular biology, and clinical immunohaematology have been published by the IUPAC and the IFCC. Peak scientific bodies such as the IUPAC and the IFCC have important roles in the development of sound international standards for nomenclature of examinations. Such standards support safe and effective representation of patient health information, foster portability, and empower future decision support systems.

  19. Background qualitative analysis of the European reference life cycle database (ELCD) energy datasets - part II: electricity datasets.

    PubMed

    Garraín, Daniel; Fazio, Simone; de la Rúa, Cristina; Recchioni, Marco; Lechón, Yolanda; Mathieux, Fabrice

    2015-01-01

    The aim of this paper is to identify areas of potential improvement of the European Reference Life Cycle Database (ELCD) electricity datasets. The revision is based on the data quality indicators described by the International Life Cycle Data system (ILCD) Handbook, applied on sectorial basis. These indicators evaluate the technological, geographical and time-related representativeness of the dataset and the appropriateness in terms of completeness, precision and methodology. Results show that ELCD electricity datasets have a very good quality in general terms, nevertheless some findings and recommendations in order to improve the quality of Life-Cycle Inventories have been derived. Moreover, these results ensure the quality of the electricity-related datasets to any LCA practitioner, and provide insights related to the limitations and assumptions underlying in the datasets modelling. Giving this information, the LCA practitioner will be able to decide whether the use of the ELCD electricity datasets is appropriate based on the goal and scope of the analysis to be conducted. The methodological approach would be also useful for dataset developers and reviewers, in order to improve the overall Data Quality Requirements of databases.

  20. Background qualitative analysis of the European Reference Life Cycle Database (ELCD) energy datasets - part I: fuel datasets.

    PubMed

    Garraín, Daniel; Fazio, Simone; de la Rúa, Cristina; Recchioni, Marco; Lechón, Yolanda; Mathieux, Fabrice

    2015-01-01

    The aim of this study is to identify areas of potential improvement of the European Reference Life Cycle Database (ELCD) fuel datasets. The revision is based on the data quality indicators described by the ILCD Handbook, applied on sectorial basis. These indicators evaluate the technological, geographical and time-related representativeness of the dataset and the appropriateness in terms of completeness, precision and methodology. Results show that ELCD fuel datasets have a very good quality in general terms, nevertheless some findings and recommendations in order to improve the quality of Life-Cycle Inventories have been derived. Moreover, these results ensure the quality of the fuel-related datasets to any LCA practitioner, and provide insights related to the limitations and assumptions underlying in the datasets modelling. Giving this information, the LCA practitioner will be able to decide whether the use of the ELCD fuel datasets is appropriate based on the goal and scope of the analysis to be conducted. The methodological approach would be also useful for dataset developers and reviewers, in order to improve the overall DQR of databases.

  1. Standard Setting in Relation to the Common European Framework of Reference for Languages: The Case of the State Examination of Dutch as a Second Language

    ERIC Educational Resources Information Center

    Bechger, Timo M.; Kuijper, Henk; Maris, Gunter

    2009-01-01

    This article reports on two related studies carried out to link the State examination of Dutch as a second language to the Common European Framework of Reference for languages (CEFR). In the first study, key persons from institutions for higher education were asked to determine the minimally required language level of beginning students. In the…

  2. Teaching Writing within the Common European Framework of Reference (CEFR): A Supplement Asynchronous Blended Learning Approach in an EFL Undergraduate Course in Egypt

    ERIC Educational Resources Information Center

    Shaarawy, Hanaa Youssef; Lotfy, Nohayer Esmat

    2013-01-01

    Based on the Common European Framework of Reference (CEFR) and following a blended learning approach (a supplement model), this article reports on a quasi-experiment where writing was taught evenly with other language skills in everyday language contexts and where asynchronous online activities were required from students to extend learning beyond…

  3. Standard Setting in Relation to the Common European Framework of Reference for Languages: The Case of the State Examination of Dutch as a Second Language

    ERIC Educational Resources Information Center

    Bechger, Timo M.; Kuijper, Henk; Maris, Gunter

    2009-01-01

    This article reports on two related studies carried out to link the State examination of Dutch as a second language to the Common European Framework of Reference for languages (CEFR). In the first study, key persons from institutions for higher education were asked to determine the minimally required language level of beginning students. In the…

  4. EPOS-WP16: A Platform for European Multi-scale Laboratories

    NASA Astrophysics Data System (ADS)

    Spiers, Chris; Drury, Martyn; Kan-Parker, Mirjam; Lange, Otto; Willingshofer, Ernst; Funiciello, Francesca; Rosenau, Matthias; Scarlato, Piergiorgio; Sagnotti, Leonardo; W16 Participants

    2016-04-01

    The participant countries in EPOS embody a wide range of world-class laboratory infrastructures ranging from high temperature and pressure experimental facilities, to electron microscopy, micro-beam analysis, analogue modeling and paleomagnetic laboratories. Most data produced by the various laboratory centres and networks are presently available only in limited "final form" in publications. As such many data remain inaccessible and/or poorly preserved. However, the data produced at the participating laboratories are crucial to serving society's need for geo-resources exploration and for protection against geo-hazards. Indeed, to model resource formation and system behaviour during exploitation, we need an understanding from the molecular to the continental scale, based on experimental data. This contribution will describe the work plans that the laboratories community in Europe is making, in the context of EPOS. The main objectives are: - To collect and harmonize available and emerging laboratory data on the properties and processes controlling rock system behaviour at multiple scales, in order to generate products accessible and interoperable through services for supporting research activities. - To co-ordinate the development, integration and trans-national usage of the major solid Earth Science laboratory centres and specialist networks. The length scales encompassed by the infrastructures included range from the nano- and micrometer levels (electron microscopy and micro-beam analysis) to the scale of experiments on centimetre sized samples, and to analogue model experiments simulating the reservoir scale, the basin scale and the plate scale. - To provide products and services supporting research into Geo-resources and Geo-storage, Geo-hazards and Earth System Evolution.

  5. Heparin-induced thrombocytopenia: reducing misdiagnosis via collaboration between an inpatient anticoagulation pharmacy service and hospital reference laboratory.

    PubMed

    Burnett, Allison E; Bowles, Harmony; Borrego, Matthew E; Montoya, Tiffany N; Garcia, David A; Mahan, Charles

    2016-11-01

    Misdiagnosis of heparin-induced thrombocytopenia (HIT) is common and exposes patients to high-risk therapies and potentially serious adverse events. The primary objective of this study was to evaluate the impact of collaboration between an inpatient pharmacy-driven anticoagulation management service (AMS) and hospital reference laboratory to reduce inappropriate HIT antibody testing via pharmacist intervention and use of the 4T pre-test probability score. Secondary objectives included clinical outcomes and cost-savings realized through reduced laboratory testing and decreased unnecessary treatment of HIT. This was a single center, pre-post, observational study. The hospital reference laboratory contacted the AMS when they received a blood sample for an enzyme-linked immunosorbent HIT antibody (HIT Ab). Trained pharmacists prospectively scored each HIT Ab ordered by using the 4T score with subsequent communication to physicians recommending for or against processing and reporting of lab results. Utilizing retrospective chart review and a database for all patients with a HIT Ab ordered during the study period, we compared the incidence of HIT Ab testing before and after implementation of the pharmacy-driven 4T score intervention. Our intervention significantly reduced the number of inappropriate HIT Ab tests processed (176 vs. 63, p < 0.0001), with no increase in thrombotic or hemorrhagic events. Overall incidence of suspected and confirmed HIT was <3 and <0.005 %, respectively. Overall cost savings were $75,754 (US) or 62 % per patient exposed to heparin between the pre and post intervention groups. Collaboration between inpatient pharmacy AMS and hospital reference laboratories can result in reduction of misdiagnosis of HIT and significant cost savings with similar safety.

  6. [Mechanics and effects of European reference pricing for vaccines in Germany according to §130a Abs. 2 SGB V: an analysis using the example of influenza vaccines].

    PubMed

    Barth, J; Hammerschmidt, T; Vollmar, J; Bierbaum, M; Schöffski, O

    2014-04-01

    On 01 January 2011 the bill for the reorganisation of the pharmaceutical market became effective. Since that time there is a European reference pricing (ERP) system for vaccines in order to bring down the German vaccine prices to an assumed lower European level. This study describes the implementation, functioning and effect of this new system. For influenza vaccines the impact of ERP on the price level and spread of prices is analysed. The description of the mechanism is based on the law and corresponding regulations of the head association of sickness funds (GKV-SV). The analysis of vaccine prices is based on the data of the i:data report (status of 01 September 2011) of ifap Service Institute. The European reference price is calculated as the average price of the manufacturer-selling-prices of the corresponding vaccine in the 4 countries of the European Union whose gross national income comes closest to the German one and in which the vaccine is distributed. The relied prices are weighted by sales and purchasing power parities of the respective countries. This analysis suggests that in particular the practical implementation of the reference price system should be further improved and specified. The calculation of the reference prices should ensure price comparability. In addition, significant problems remain in the deduction of discounts, because no distinction is made in the documentation of vaccinating doctors, whether vaccination was performed as a compulsory or statutory benefit. The comparison of the manufacturer-selling-prices of individual influenza vaccines with the corresponding reference prices shows an enlargement of the existing price differences, which have evolved in a competitive environment, after the implementation of the reference pricing -system. There is still a need for improvement in implementing the reference pricing system. In the most competitive vaccine market of influenza vaccines, the ERP-system lowers the prices, but seems to

  7. Inter-laboratory variation in the chemical analysis of acidic forest soil reference samples from eastern North America

    USGS Publications Warehouse

    Ross, Donald S.; Bailiey, Scott W; Briggs, Russell D; Curry, Johanna; Fernandez, Ivan J.; Fredriksen, Guinevere; Goodale, Christine L.; Hazlett, Paul W.; Heine, Paul R; Johnson, Chris E.; Larson, John T; Lawrence, Gregory B.; Kolka, Randy K; Ouimet, Rock; Pare, D; Richter, Daniel D.; Shirmer, Charles D; Warby, Richard A.F.

    2015-01-01

    Long-term forest soil monitoring and research often requires a comparison of laboratory data generated at different times and in different laboratories. Quantifying the uncertainty associated with these analyses is necessary to assess temporal changes in soil properties. Forest soil chemical properties, and methods to measure these properties, often differ from agronomic and horticultural soils. Soil proficiency programs do not generally include forest soil samples that are highly acidic, high in extractable Al, low in extractable Ca and often high in carbon. To determine the uncertainty associated with specific analytical methods for forest soils, we collected and distributed samples from two soil horizons (Oa and Bs) to 15 laboratories in the eastern United States and Canada. Soil properties measured included total organic carbon and nitrogen, pH and exchangeable cations. Overall, results were consistent despite some differences in methodology. We calculated the median absolute deviation (MAD) for each measurement and considered the acceptable range to be the median 6 2.5 3 MAD. Variability among laboratories was usually as low as the typical variability within a laboratory. A few areas of concern include a lack of consistency in the measurement and expression of results on a dry weight basis, relatively high variability in the C/N ratio in the Bs horizon, challenges associated with determining exchangeable cations at concentrations near the lower reporting range of some laboratories and the operationally defined nature of aluminum extractability. Recommendations include a continuation of reference forest soil exchange programs to quantify the uncertainty associated with these analyses in conjunction with ongoing efforts to review and standardize laboratory methods.

  8. Cytopathology laboratory accreditation, with special reference to the American Society of Cytology programs.

    PubMed

    Gupta, P K; Erozan, Y S

    1989-01-01

    The features of the Laboratory Accreditation Program of the American Society of Cytology that pertain to quality assurance in cytopathology are reviewed. The areas considered include: (1) specimen procurement and cytopreparation, (2) the role of the cytotechnologist in cytoscreening, evaluation and reporting, (3) the role of the cytopathologist and (4) quality control measures. Attention to the issues raised in these areas is essential to achieving the best possible cytopathology practice in the most efficient and economical manner.

  9. An assessment of the developmental toxicity of BDE-99 in the European starling using an integrated laboratory and field approach.

    PubMed

    Eng, Margaret L; Elliott, John E; Williams, Tony D

    2014-10-01

    Developmental exposure of wildlife to anthropogenic contaminants can have long-term effects that are difficult to assess in field monitoring studies, and may not be evident in laboratory studies that lack ecological components. The objective of this study was to assess the long-term effects of early exposure to contaminants under ecological conditions in a model passerine species, the European starling (Sturnus vulgaris). We selected 2,2',4,4',5-pentabromodiphenyl ether (BDE-99) as a representative contaminant, as it is one of the major constituents of the commercial penta-BDE flame retardant mixture, and has been reported in avian egg and tissue samples worldwide. We developed a novel approach to assess the developmental toxicity of BDE-99 in starlings by combining aspects of laboratory and field studies. We dosed free-living nestlings living in natural broods in the field with environmentally relevant concentrations of BDE-99 (0-173.8 ng/g bw/day) for the duration of the nesting cycle. To simulate monitoring of long-term effects we brought birds into captivity just prior to fledging and used photoperiod manipulations to induce reproductive development. We assessed a range of physiological and development measures such as hematocrit, oxidative stress, thyroid hormones, neuroanatomy, growth, molt rate, bill color, and testes development. We found some evidence of thyroid hormone disruption, but there were no effects on any other measures of physiology or development. The European starling could serve as a valuable model species for assessing early exposure and long-term effects of anthropogenic contaminants in terrestrial wildlife using this combined field/laboratory approach.

  10. The OIE World Animal Health Information System: the role of OIE Reference Laboratories and Collaborating Centres in disease reporting.

    PubMed

    Ben Jebara, K

    2010-12-01

    One of the main objectives of the World Organisation for Animal Health (OIE) is to ensure transparency in and knowledge of the world animal health situation. To achieve this objective, the OIE relies on its network of Member Countries, which is complemented by the activities of 221 Reference Laboratories (RLs) and Collaborating Centres. The RL mandate states that, in the case of positive results for diseases notifiable to the OIE, the laboratory should inform the OIE Delegate of the Member Country from which the samples originated and send a copy of the information to OIE Headquarters. However, since 2006 the OIE has received a lower than expected number of notifications from RLs, which implies eitherthat the majority of samples are sent to national laboratories or that some RLs are not fully complying with their mandate. The OIE sent a questionnaire to RLs in preparation for the Second Global Conference of OIE Reference Laboratories and Collaborating Centres (Paris, France, 21-23 June 2010). Two main factors emerged: the need for RLs to clarify their role and responsibilities in disease reporting and the need for an awareness campaign to sensitise national Veterinary Services to the importance of conducting more surveillance (and consequently of submitting samples to RLs) for all OIE-listed diseases. Reference laboratories indicated two main reasons for not sharing more data on positive samples with the OIE: i) a perceived contradiction between their mandate as OIE RLs and the standards of the International Organization for Standardization (ISO) dealing with confidentiality; and ii) certain Member Countries or stakeholders asking RLs not to share positive results with the OIE, for political or economic reasons. The OIE has put forward proposals to help RLs resolve these problems in future. The use of ISO standards must be clarified and there must be improved communication between the OIE and its RLs. A lack of transparency about a significant disease event can

  11. [Molecular characterization of hepatitis C virus in patients referred to a reference laboratory of public health, University Hospital "Antonio Patricio de Alcalá", Cumani, Venezuela].

    PubMed

    Sulbarán, María Zulay; Montaño, Lérida; Sulbarán, Yoneira; Loureiro, Carmen Luisa; Flores, Carmen Rosa; Farías, Yurviris; Maldonado, Antonio; Guillen, Genny; Rangel, Héctor; Pujol, Flor

    2016-03-01

    The World Health Organization estimates that approximately 170 million people are chronically infected with hepatitis C virus (HCV). This study evaluated the presence of antibodies against HCV by two immunoassays. HCV genotypes were analyzed by phylogenetic analysis of viral genome fragments amplified from the 5 'non-coding (5'NC) region and non-structural region 5b (NS5b), using reverse transcription and nested polymerase chain reaction (RT-PCR), in patients referred from January 2010 to February 2013 to the Reference Laboratory of Public Health, University Hospital "Antonio Patricio de Alcalá". The prevalence of anti-HCV antibodies was 0.57% (17/3005), being the group of patients older than 41 years the most affected (0.9%). A total of 16 samples were found positive for HCV RNA by RT-PCR in the 5'NC region (16/17, 94%). Phylogenetic analysis of the 5'NC region allowed to identify the circulation of genotypes 2 and 1, and one genotype 3 and one 4. By phylogenetic analysis of the NS5b region, diverse subtypes of HCV genotype 2 were identified (2a, 2j and 2s). This finding is in accordance with previous studies that indicate that this genotype is relatively diverse in our country.

  12. Estimation of soil adsorption coefficients of organic compounds by HPLC screening using the second generation of the European reference soil set.

    PubMed

    Gawlik, B M; Kettrup, A; Muntau, H

    2000-11-01

    The European reference soil set was introduced as common basis for a better comparability of soil sorption data measured within the framework of chemical testing of environmental chemicals. The success of the EUROSOILS, as the set is commonly called, convinced the European Commission's Joint Research Centre to evaluate the possibility of producing a remake of these unique and new type of reference materials maintaining the principal sorption-controlling properties of the soils. In this paper the recently proposed second generation of the EUROSOILS is used to evaluate a HPLC-screening technique for the estimation of soil adsorption coefficients of organic chemicals. It could be shown that the derived correlations between HPLC capacity factors of the test substances and the respective soil adsorption coefficients resulting from batch experiments with the second version of the EUROSOILS agreed with those derived for the first generation of reference soils at a different occasion.

  13. Impact of the Yosemite hantavirus outbreak on hantavirus antibody testing at a national reference laboratory.

    PubMed

    Prince, Harry E; Lieberman, Jay M

    2013-08-01

    In conjunction with the 2012 Yosemite hantavirus outbreak, the number of sera our facility tested for hantavirus antibodies increased. We tracked test results and used the data set to determine if a more efficient testing algorithm was possible. Sera were screened using laboratory-developed pan-hantavirus IgG and IgM enzyme immunoassays (EIAs), with an index of >1.10 defined as positive. Sera that were IgM positive by screening (screen IgM(+)) were tested for Sin Nombre virus (SNV)-specific IgM using a laboratory-developed EIA; screen IgM(+) IgG(+) sera were also tested for SNV IgG using a laboratory-developed immunoblot assay. SNV antibody-positive samples were sent to state public health laboratories (PHL) or the CDC for confirmation. Of 3,946 sera tested from July through December 2012, 205 were screen IgM(+) IgG negative (IgG(-)); 7/205 were SNV IgM(+), but only 1/5 sent to PHL/CDC was confirmed as SNV IgM(+). Of 61 screen IgM(+) IgG(+) sera, 16 were SNV antibody positive; 13/16 sera (from 11 patients) went to PHL/CDC, where SNV infection was confirmed for all patients. Of 12 confirmed patients, 7 had been exposed at Yosemite. A modified algorithm defining screen indices of ≥2.00 as positive identified 11/12 confirmed cases while reducing the number of sera requiring SNV-specific antibody testing by 65%; the patient missed was not tested until 3 months after the onset of symptoms. Hantavirus antibody testing at our facility identified 12 SNV-infected patients, including 7 exposed at Yosemite. Some screen IgM(+) IgG(-) SNV IgM(+) results were false positives, emphasizing the value of PHL/CDC confirmatory testing. We identified a modified algorithm requiring analysis of fewer specimens for SNV-specific antibodies without loss of sensitivity.

  14. Impact of the Yosemite Hantavirus Outbreak on Hantavirus Antibody Testing at a National Reference Laboratory

    PubMed Central

    Lieberman, Jay M.

    2013-01-01

    In conjunction with the 2012 Yosemite hantavirus outbreak, the number of sera our facility tested for hantavirus antibodies increased. We tracked test results and used the data set to determine if a more efficient testing algorithm was possible. Sera were screened using laboratory-developed pan-hantavirus IgG and IgM enzyme immunoassays (EIAs), with an index of >1.10 defined as positive. Sera that were IgM positive by screening (screen IgM+) were tested for Sin Nombre virus (SNV)-specific IgM using a laboratory-developed EIA; screen IgM+ IgG+ sera were also tested for SNV IgG using a laboratory-developed immunoblot assay. SNV antibody-positive samples were sent to state public health laboratories (PHL) or the CDC for confirmation. Of 3,946 sera tested from July through December 2012, 205 were screen IgM+ IgG negative (IgG−); 7/205 were SNV IgM+, but only 1/5 sent to PHL/CDC was confirmed as SNV IgM+. Of 61 screen IgM+ IgG+ sera, 16 were SNV antibody positive; 13/16 sera (from 11 patients) went to PHL/CDC, where SNV infection was confirmed for all patients. Of 12 confirmed patients, 7 had been exposed at Yosemite. A modified algorithm defining screen indices of ≥2.00 as positive identified 11/12 confirmed cases while reducing the number of sera requiring SNV-specific antibody testing by 65%; the patient missed was not tested until 3 months after the onset of symptoms. Hantavirus antibody testing at our facility identified 12 SNV-infected patients, including 7 exposed at Yosemite. Some screen IgM+ IgG− SNV IgM+ results were false positives, emphasizing the value of PHL/CDC confirmatory testing. We identified a modified algorithm requiring analysis of fewer specimens for SNV-specific antibodies without loss of sensitivity. PMID:23740929

  15. Research on vaccines during pregnancy: reference values for vital signs and laboratory assessments.

    PubMed

    Sheffield, Jeanne S; Munoz, Flor M; Beigi, Richard H; Rasmussen, Sonja A; Edwards, Kathryn M; Read, Jennifer S; Heine, R Phillips; Ault, Kevin A; Swamy, Geeta K; Jevaji, Indira; Spong, Catherine Y; Fortner, Kimberly B; Patel, Shital M; Nesin, Mirjana

    2013-09-13

    The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss enrollment and safety assessments of pregnant women in clinical trials of vaccines. Experts in obstetrics, maternal-fetal medicine, infectious diseases, pediatrics, neonatology, genetics, vaccinology and clinical trial design were charged with identifying normal ranges for vital signs and laboratory assessments in pregnancy. A grading system for adverse events was then developed. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Validation of the Beckman Coulter AcT 5 diff analyzer in a reference laboratory.

    PubMed

    Aulesa, C; Prieto, M

    2006-01-01

    At the Valle de Hebron Hospital's Central Laboratory, we have performed a study evaluating the performance, reliability, and practicability of the Beckman Coulter AcT 5 analyzer. The results observed with known controls showed within- and between-run imprecision of 1.05% to 6.97% for the basic hemogram parameters. With patient samples, the results were analogous, with within- and between-run imprecision of 1.33% to 5.98%. To complete the evaluation of the AcT 5 counter, we analyzed the influence of possible interfering factors such as the presence of jaundice, lipemia, hemolysis, platelet aggregates, and schistocytes on the results of the automated leukocyte differential as performed by the cell counter with the new chlorazol black stain. We studied the performance of the AcT 5 with regards to ease of use, speed, and cost. Finally, we evaluated the impact of introducing the AcT 5 counter into routine laboratory use as support to resolve problems raised with the Beckman Coulter GenS and LH-750 and the Bayer Advia 120 counters due to samples with interfering factors.

  17. Structure and presentation of a World Wide Web database of CSF virus isolates held at the EU reference laboratory.

    PubMed

    Greiser-Wilke, I; Zimmermann, B; Fritzemeier, J; Floegel, G; Moennig, V

    2000-04-13

    A computerized database was generated with the epidemiological data of more than 600 CSF virus strains and isolates kept in the EU Reference Laboratory for Classical Swine Fever in Hanover. In addition, as sequence data from defined regions of the genome are increasingly being used for genetic typing of new isolates and are thus being published, it was decided to integrate them into the database. In order to make the epidemiological and the sequence data available to other laboratories through the World Wide Web, a searchable web interface was programmed, which can be accessed using an Internet browser like Netscape or Internet Explorer. The possibility to exchange data via the web has the potential to increase our knowledge concerning genetic and epidemiological links between outbreaks worldwide.

  18. Racial/Ethnic-Specific Reference Intervals for Common Laboratory Tests: A Comparison among Asians, Blacks, Hispanics, and White.

    PubMed

    Lim, Eunjung; Miyamura, Jill; Chen, John J

    2015-09-01

    Reference intervals (RIs) for common clinical laboratory tests are usually not developed separately for different subpopulations. The aim of this study was to investigate racial/ethnic differences in RIs of common biochemical and hematological laboratory tests using the National Health and Nutrition Examination Survey (NHANES) 2011-2012 data. This current study included 3,077 participants aged 18-65 years who reported their health status as "Excellent," "Very good," or "Good," with known race/ethnicity as white, black, Hispanic, or Asian. Quantile regression analyses adjusted for sex were conducted to evaluate racial/ethnic differences in the normal ranges of 38 laboratory tests. Significant racial/ethnic differences were found in almost all laboratory tests. Compared to whites, the normal range for Asians significantly shifted to higher values in globulin and total protein and to lower values in creatinine, hematocrit, hemoglobin, mean cell hemoglobin, mean cell hemoglobin concentration, and mean platelet volume. These results indicate that racial/ethnic subpopulations have unique distributions in the labortoary tests and race/ethnicity may need to be incorporated in the development of their RIs. Establishment of racial/ethnic-specific RIs may have significant clinical and public health implication for more accurate disease diagnosis and appropriate treatment to improve quality of patient care, especially for a state with diverse racial/ethnic subpopuations such as Hawai'i.

  19. European multicentre evaluation of the Du Pont Dimension 380 under the auspices of the European Group for the Evaluation of Analytical Systems in Laboratory Medicine (EGE-Lab).

    PubMed

    Hänseler, E; Vonderschmitt, D; Haeckel, R; Römer, M; Collombel, C; Goudable, J; Pourcher, E

    1991-01-01

    The Clinical Chemistry Analyzer Dimension 380 manufactured by Du Pont de Nemours was tested in a multicentre evaluation according to the guide-lines of the European Committee for Clinical Laboratory Standards (ECCLS) and in part to the protocol of the Société Française de Biologie Clinique (SFBC). The instrument and the reagents were evaluated as a system, since both reagents and reagent cartridges are specifically designed for the instrument. Fourteen analytes including electrolytes, substrates and enzymes were tested. The evaluators summarized their experience as follows: 1. All parameters tested yield results comparable to established procedures. 2. Very good performance of the ion-selective-electrode unit. 3. The imprecision data of the system are, for most parameters, between 1 and 4% CV and thus equal to or better than those of the instruments compared. 4. No reagent or sample carry-over was detected after a minor modification of the instrument. 5. The linearity of Dimension test methods in general covers the range stated by the manufacturer. 6. Very good stability of the calibration curves (up to 2 months). 7. Good practicability of the whole system, including handling of reagents and a very user-friendly software.

  20. Serum clinical biochemical and hematologic reference ranges of laboratory-reared and wild-caught Xenopus laevis.

    PubMed

    Wilson, Sabrina; Felt, Stephen; Torreilles, Stéphanie; Howard, Antwain; Behan, Colleen; Moorhead, Roberta; Green, Sherril

    2011-09-01

    The South African clawed frogs Xenopus laevis and X. tropicalis are fully aquatic amphibians and well-established animal models. Because genetically engineered laboratory Xenopus are now being produced, the establishment of normal reference ranges for serum biochemical and hematologic parameters is essential for phenotyping and as a diagnostic aide. We determined normal reference ranges for hematologic values from 3 populations of X. laevis: wild-caught frogs (n = 43) and frogs from 2 commercial sources (A, n = 166; B, n = 109). For serum biochemistry, we determined normal reference ranges for frogs from source A and wild-caught frogs divided by sex and season. Significant differences across populations were found in WBC and RBC counts, hemoglobin concentration, hematocrit, mean corpuscular hemoglobin concentration, and mean corpuscular volume. Among serum biochemical analytes, significant differences were found for albumin:globulin ratio, anion gap, and concentrations of albumin, globulin, total protein, lipase, alanine transaminase, γ-glutamyl transpeptidase; creatine phosphokinase; indirect, direct, and total bilirubin; cholesterol, low-density lipoprotein lipase, carbon dioxide, glucose, lactacte dehydrogenase, calcium, chloride, and sodium. We hypothesize that these differences can be attributed to differences in water quality, habitat, ambient temperature, diet, sex, recent transport or shipment, and genetic background. However, testing that hypothesis is beyond the scope of the current study. In addition, clinical chemistry and hematologic reference range values Xenopus laevis are quite distinct from those for other species and are most consistent with the only values published for another fully aquatic amphibian, the Eastern hellbender (Cryptobranchus alleganiensis).

  1. [The common position of the Czech professional associations on the consensus of the European Atherosclerosis Society and the European Federation of Clinical Chemistry and Laboratory Medicine regarding investigation on blood lipids and interpretation of their levels].

    PubMed

    Soška, Vladimír; Franeková, Janka; Friedecký, Bedřich; Jabor, Antonín; Kraml, Pavel; Rosolová, Hana; Vrablík, Michal

    The aim of this opinion is to summarize and to comment the consensus of the European Atherosclerosis Society and European Federation of Clinical Chemistry and Laboratory Medicine, which covers two main areas: 1) whether it is necessary / required to be fasting or non-fasting before blood sampling for lipids measurement, and what are the changes in the concentration of blood lipids during the day; 2) What decision limits (cut off value) of lipids and lipoproteins should be reported from laboratories and what is the recommended procedure for people with extreme / critical blood lipid values. Following parameters are discused: total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, lipoprotein(a). This opinion should be the object of interest both for professionals in clinical laboratories and for physicians in hospitals and out-patients departments.Key words: apolipoproteins - blood collection - cholesterol - laboratory testing - lipoprotein(a) - cut off limits - triglycerides.

  2. Neither snow nor rain: contingency planning by a clinical reference laboratory courier service for weather related emergencies.

    PubMed

    Bankson, Daniel D; Heim, Joseph A

    2014-01-01

    To optimize transportation processes, we present herein a contingency plan that coordinates interim measures used to ensure continued and timely services when climate based events might cause an interruption of the usual specimen transportation processes. As an example, we outline the implementation and effectiveness of a contingency plan for network laboratory courier automobile transportation during times of mountain pass highway closure. Data available from an approximately 3-year period from October 10, 2010 through August 29, 2013 revealed a total of 690 complete closures in the eastbound or westbound lanes of the Interstate-90 highway in the Snoqualmie Pass area in the state of Washington. Despite the frequency of closures, the Washington State Department of Transportation was effective in limiting the duration of closures. Road closures of less than 1 hour accounted for 58.7% of the total closures. No recorded closures prevented dispatched couriers from completing a prescheduled Snoqualmie Pass route. We identified no delays as being clinically significant, despite that there were 5 instances of delays greater than 4 hours. We implemented a contingency plan of aiding courier logistics during all times of pass closure. The plan includes an easy to interpret Condition Dashboard as a status indicator and a Decision Tree that references and summarizes information. Overall, the contingency plan allows for an objective, robust, proactive decision support system that has enabled operational flexibility and has contributed to continued safe, on-time specimen transportation; clients and courier and reference laboratory staff have appreciated these features and associated outcomes.

  3. A combined reference panel from the 1000 Genomes and UK10K projects improved rare variant imputation in European and Chinese samples

    PubMed Central

    Chou, Wen-Chi; Zheng, Hou-Feng; Cheng, Chia-Ho; Yan, Han; Wang, Li; Han, Fang; Richards, J. Brent; Karasik, David; Kiel, Douglas P.; Hsu, Yi-Hsiang

    2016-01-01

    Imputation using the 1000 Genomes haplotype reference panel has been widely adapted to estimate genotypes in genome wide association studies. To evaluate imputation quality with a relatively larger reference panel and a reference panel composed of different ethnic populations, we conducted imputations in the Framingham Heart Study and the North Chinese Study using a combined reference panel from the 1000 Genomes (N = 1,092) and UK10K (N = 3,781) projects. For rare variants with 0.01% < MAF ≤ 0.5%, imputation in the Framingham Heart Study with the combined reference panel increased well-imputed genotypes (with imputation quality score ≥0.4) from 62.9% to 76.1% when compared to imputation with the 1000 Genomes. For the North Chinese samples, imputation of rare variants with 0.01% < MAF ≤ 0.5% with the combined reference panel increased well-imputed genotypes by from 49.8% to 61.8%. The predominant European ancestry of the UK10K and the combined reference panels may explain why there was less of an increase in imputation success in the North Chinese samples. Our results underscore the importance and potential of larger reference panels to impute rare variants, while recognizing that increasing ethnic specific variants in reference panels may result in better imputation for genotypes in some ethnic groups. PMID:28004816

  4. A combined reference panel from the 1000 Genomes and UK10K projects improved rare variant imputation in European and Chinese samples.

    PubMed

    Chou, Wen-Chi; Zheng, Hou-Feng; Cheng, Chia-Ho; Yan, Han; Wang, Li; Han, Fang; Richards, J Brent; Karasik, David; Kiel, Douglas P; Hsu, Yi-Hsiang

    2016-12-22

    Imputation using the 1000 Genomes haplotype reference panel has been widely adapted to estimate genotypes in genome wide association studies. To evaluate imputation quality with a relatively larger reference panel and a reference panel composed of different ethnic populations, we conducted imputations in the Framingham Heart Study and the North Chinese Study using a combined reference panel from the 1000 Genomes (N = 1,092) and UK10K (N = 3,781) projects. For rare variants with 0.01% < MAF ≤ 0.5%, imputation in the Framingham Heart Study with the combined reference panel increased well-imputed genotypes (with imputation quality score ≥0.4) from 62.9% to 76.1% when compared to imputation with the 1000 Genomes. For the North Chinese samples, imputation of rare variants with 0.01% < MAF ≤ 0.5% with the combined reference panel increased well-imputed genotypes by from 49.8% to 61.8%. The predominant European ancestry of the UK10K and the combined reference panels may explain why there was less of an increase in imputation success in the North Chinese samples. Our results underscore the importance and potential of larger reference panels to impute rare variants, while recognizing that increasing ethnic specific variants in reference panels may result in better imputation for genotypes in some ethnic groups.

  5. Laboratory genetic-based reference values for cholinesterase activity in a Colombian population: A step forward in personalized diagnostics.

    PubMed

    Sánchez, Luz Helena; Medina, Olga Marcela; Gómez, Guillermo; González, Clara Isabel; Flórez-Vargas, Óscar

    2015-08-01

    The determination of cholinesterase (ChE) activity has been commonly applied in the biomonitoring of exposure to organophosphate and carbamate pesticides. However, ChE activity is influenced by genetic factors. Integrating genotype and phenotype information in clinical laboratory tests would increase the accuracy of the reference values in well-defined populations. To establish genetic-based reference values for acetylcholinesterase (AChE) and butyrylcholinesterase (BChE) activity in a Colombian population. A total of 397 healthy adults from Bucaramanga were included in the study. AChE and BChE activities were measured in blood samples by potentiometry and spectrophotometry, respectively. Genotyping for ACHE rs17880573 and BCHE rs1803274 was performed using the TaqMan allelic discrimination assay. The statistical analyses to obtain the reference values were performed with the MedCalc® software. Allele frequencies were 10.58% for rs17880573 A and 8.82% for rs1803274 A. People with genotypes rs1803274 AA and AG showed a reduction of 20.69% and 10.92% respectively in mean BChE activity compared to people with genotype GG. No significant differences were identified in AChE activity between rs17880573 alleles or genotypes. In the overall sample, the corresponding reference values were as follows: for AChE activity, 0.62-0.98 D pH/h and for BChE activity, 4796.3-10321.1 U/L for people carrying the allele rs1803274A and 5768.2-11180.4 U/L for people carrying the genotype rs1803274 GG. We strongly recommend using these genetic-based reference values for ChE enzymes in our well-defined population in daily clinical practice.

  6. Engineering Education Research in "European Journal of Engineering Education" and "Journal of Engineering Education": Citation and Reference Discipline Analysis

    ERIC Educational Resources Information Center

    Wankat, Phillip C.; Williams, Bill; Neto, Pedro

    2014-01-01

    The authors, citations and content of "European Journal of Engineering Education" ("EJEE") and "Journal of Engineering Education" ("JEE") in 1973 ("JEE," 1975 "EJEE"), 1983, 1993, 2003, and available 2013 issues were analysed. Both journals transitioned from house organs to become…

  7. Engineering Education Research in "European Journal of Engineering Education" and "Journal of Engineering Education": Citation and Reference Discipline Analysis

    ERIC Educational Resources Information Center

    Wankat, Phillip C.; Williams, Bill; Neto, Pedro

    2014-01-01

    The authors, citations and content of "European Journal of Engineering Education" ("EJEE") and "Journal of Engineering Education" ("JEE") in 1973 ("JEE," 1975 "EJEE"), 1983, 1993, 2003, and available 2013 issues were analysed. Both journals transitioned from house organs to become…

  8. Comparison of GLONASS and GPS time transfers between two west European time laboratories and VNIIFTRI

    NASA Technical Reports Server (NTRS)

    Daly, P.; Koshelyaevsky, N. B.; Lewandowski, Wlodzimierz; Petit, Gerard; Thomas, Claudine

    1992-01-01

    The University of Leeds built a Global Positioning System/Global Orbiting Navigation Satellite System (GPS/GLONASS) receiver about five years ago and since then has provided continuous information about GLONASS time and its comparison with GPS time. For the last two years, VNIIFTRI (All Union Institute for Physical, Technical and Radiotechnical Measurements) and some other Soviet time laboratories have used Soviet built GLONASS navigation receivers for time comparisons. Since June 1991, VNIIFTIR has been operating a GPS time receiver on loan from the BIPM (Bureau International des Poids et Mesures). This offered, for the first time, an opportunity for direct comparison of time transfers using GPS and GLONASS. This experiment shows that even with relatively imprecise data recording and processing, in terms of time metrology, GLONASS can provide continental time transfer at a level of several tens of nanoseconds.

  9. Comparison of GLONASS and GPS time transfers between two west European time laboratories and VNIIFTRI

    NASA Technical Reports Server (NTRS)

    Daly, P.; Koshelyaevsky, N. B.; Lewandowski, Wlodzimierz; Petit, Gerard; Thomas, Claudine

    1992-01-01

    The University of Leeds built a Global Positioning System/Global Orbiting Navigation Satellite System (GPS/GLONASS) receiver about five years ago and since then has provided continuous information about GLONASS time and its comparison with GPS time. For the last two years, VNIIFTRI (All Union Institute for Physical, Technical and Radiotechnical Measurements) and some other Soviet time laboratories have used Soviet built GLONASS navigation receivers for time comparisons. Since June 1991, VNIIFTIR has been operating a GPS time receiver on loan from the BIPM (Bureau International des Poids et Mesures). This offered, for the first time, an opportunity for direct comparison of time transfers using GPS and GLONASS. This experiment shows that even with relatively imprecise data recording and processing, in terms of time metrology, GLONASS can provide continental time transfer at a level of several tens of nanoseconds.

  10. Analytical validation of a reference laboratory ELISA for the detection of feline leukemia virus p27 antigen.

    PubMed

    Buch, Jesse S; Clark, Genevieve H; Cahill, Roberta; Thatcher, Brendon; Smith, Peter; Chandrashekar, Ramaswamy; Leutenegger, Christian M; O'Connor, Thomas P; Beall, Melissa J

    2017-09-01

    Feline leukemia virus (FeLV) is an oncogenic retrovirus of cats. Immunoassays for the p27 core protein of FeLV aid in the detection of FeLV infections. Commercial microtiter-plate ELISAs have rapid protocols and visual result interpretation, limiting their usefulness in high-throughput situations. The purpose of our study was to validate the PetChek FeLV 15 ELISA, which is designed for the reference laboratory, and incorporates sequential, orthogonal screening and confirmatory protocols. A cutoff for the screening assay was established with 100% accuracy using 309 feline samples (244 negative, 65 positive) defined by the combined results of FeLV PCR and an independent reference p27 antigen ELISA. Precision of the screening assay was measured using a panel of 3 samples (negative, low-positive, and high-positive). The intra-assay coefficient of variation (CV) was 3.9-7.9%; the inter-assay CV was 6.0-8.6%. For the confirmatory assay, the intra-assay CV was 3.0-4.7%, and the inter-assay CV was 7.4-9.7%. The analytical sensitivity for p27 antigen was 3.7 ng/mL for inactivated whole FeLV and 1.2 ng/mL for purified recombinant FeLV p27. Analytical specificity was demonstrated based on the absence of cross-reactivity to related retroviruses. No interference was observed for samples containing added bilirubin, hemoglobin, or lipids. Based on these results, the new high-throughput design of the PetChek FeLV 15 ELISA makes it suitable for use in reference laboratory settings and maintains overall analytical performance.

  11. Quality of blood culture testing - a survey in intensive care units and microbiological laboratories across four European countries

    PubMed Central

    2013-01-01

    Introduction Blood culture (BC) testing before initiation of antimicrobial therapy is recommended as a standard of care in international sepsis guidelines and has been shown to reduce intensive care unit (ICU) stay, antibiotic use, and costs in hospitalized patients. Whereas microbiological laboratory practice has been highly standardized, shortfalls in the preanalytic procedures in the ICU (that is indication, time-to-incubation, blood volume and numbers of BC sets) have a significant effect on the diagnostic yield. The objective of this study was to gain insights into current practices regarding BC testing in intensive care units. Methods Qualitative survey, data collection by 138 semi-structured telephone interviews in four European countries (Italy, UK, France and Germany) between September and November 2009 in 79 clinical microbiology laboratories (LABs) and 59 ICUs. Results Whereas BC testing is expected to remain the gold standard for sepsis diagnostics in all countries, there are substantial differences regarding preanalytic procedures. The decision to launch BC testing is carried out by physicians vs. ICU nurses in the UK in 92 vs. 8%, in France in 75 vs. 25%, in Italy in 88 vs. 12% and in Germany in 92 vs. 8%. Physicians vs. nurses collect BCs in the UK in 77 vs. 23%, in France in 0 vs. 100%, in Italy in 6 vs. 94% and in Germany in 54 vs. 46%. The mean time from blood collection to incubation in the UK is 2 h, in France 3 h, in Italy 4 h, but 20 h in German remote LABs (2 h in in-house LABs), due to the large number of remote nonresident microbiological laboratories in Germany. There were major differences between the perception of the quality of BC testing between ICUs and LABs. Among German ICU respondents, 62% reported that they have no problems with BC testing, 15% reported time constraints, 15% cost pressure, and only 8% too long time to incubation. However, the corresponding LABs of these German ICUs reported too many false positive results due

  12. GUIDELINES FOR DEVELOPMENT OF PROGRAMS IN SCIENCE INSTRUCTION, REPORT OF A STUDY MAKING SPECIFIC REFERENCE TO THE TEACHING FUNCTION OF THE LABORATORY IN SECONDARY SCHOOL SCIENCE PROGRAM.

    ERIC Educational Resources Information Center

    National Academy of Sciences - National Research Council, Washington, DC.

    A DISCUSSION OF THE GENERAL PHILOSOPHY AND PRINCIPLES OF SCIENCE EDUCATION WITH PARTICULAR REFERENCE TO LABORATORY WORK AND SUGGESTIONS FOR THE IMPROVEMENT OF SCIENCE TEACHING ARE PRESENTED. THE DISCUSSION OF GENERAL PRINCIPLES INCLUDES SUCH TOPICS AS (1) THE PURPOSE OF THE LABORATORY IN SCIENCE TEACHING, (2) THE NATURE OF THE CURRENT SCIENTIFIC…

  13. A reference interval study for common biochemical analytes in Eastern Turkey: a comparison of a reference population with laboratory data mining

    PubMed Central

    Bakan, Ebubekir; Polat, Harun; Ozarda, Yesim; Ozturk, Nurinnisa; Baygutalp, Nurcan Kilic; Umudum, Fatma Zuhal; Bakan, Nuri

    2016-01-01

    Introduction The aim of this study was to define the reference intervals (RIs) in a Turkish population living in Northeast Turkey (Erzurum) for 34 analytes using direct and indirect methods. In the present study, the regional RIs obtained were compared with other RI studies, primarily the nationwide study performed in Turkey. Materials and methods For the direct method, 435 blood samples were collected from a healthy group of females (N = 218) and males (N = 217) aged between 18 and 65 years. The sera were analysed in Ataturk University hospital laboratory using Roche reagents and analysers for 34 analytes. The data from 1,366,948 records were used to calculate the indirect RIs using a modified Bhattacharya method. Results Significant gender-related differences were observed for 17 analytes. There were also some apparent differences between RIs derived from indirect and direct methods particularly in some analytes (e.g. gamma-glutamyltransferase, creatine kinase, LDL-cholesterol and iron). The RIs derived with the direct method for some, but not all, of the analytes were generally comparable with the RIs reported in the nationwide study and other previous studies in Turkey.There were large differences between RIs derived by the direct method and the expected values shown in the kit insert (e.g. aspartate aminotransferase, total-cholesterol, HDL-cholesterol, and vitamin B12). Conclusions These data provide region-specific RIs for 34 analytes determined by the direct and indirect methods. The observed differences in RIs between previous studies could be related to nutritional status and environmental factors. PMID:27346966

  14. A reference interval study for common biochemical analytes in Eastern Turkey: a comparison of a reference population with laboratory data mining.

    PubMed

    Bakan, Ebubekir; Polat, Harun; Ozarda, Yesim; Ozturk, Nurinnisa; Baygutalp, Nurcan Kilic; Umudum, Fatma Zuhal; Bakan, Nuri

    2016-01-01

    The aim of this study was to define the reference intervals (RIs) in a Turkish population living in Northeast Turkey (Erzurum) for 34 analytes using direct and indirect methods. In the present study, the regional RIs obtained were compared with other RI studies, primarily the nationwide study performed in Turkey. For the direct method, 435 blood samples were collected from a healthy group of females (N = 218) and males (N = 217) aged between 18 and 65 years. The sera were analysed in Ataturk University hospital laboratory using Roche reagents and analysers for 34 analytes. The data from 1,366,948 records were used to calculate the indirect RIs using a modified Bhattacharya method. Significant gender-related differences were observed for 17 analytes. There were also some apparent differences between RIs derived from indirect and direct methods particularly in some analytes (e.g. gamma-glutamyltransferase, creatine kinase, LDL-cholesterol and iron). The RIs derived with the direct method for some, but not all, of the analytes were generally comparable with the RIs reported in the nationwide study and other previous studies in Turkey.There were large differences between RIs derived by the direct method and the expected values shown in the kit insert (e.g. aspartate aminotransferase, total-cholesterol, HDL-cholesterol, and vitamin B12). These data provide region-specific RIs for 34 analytes determined by the direct and indirect methods. The observed differences in RIs between previous studies could be related to nutritional status and environmental factors.

  15. Homogeneity and stability studies during the preparation of a laboratory reference material of soy leaves for the determination of metals.

    PubMed

    dos Santos, Ana M P; Lima, Daniel C; de Jesus, Robson M; Ferreira, Sergio L C

    2011-01-01

    The homogeneity and stability of metals were tested in a candidate laboratory reference material of soy leaves. Inductively coupled plasma-optical emission spectrometry was used to quantify calcium, magnesium, manganese, iron, zinc, copper, and vanadium. A 6 kg amount of the material, which was dried, ground, and classified as mesh 60, was distributed among 100 bottles. The between-bottle homogeneity test was established by analyzing two subsamples from nine bottles. For the within-bottle test, five determinations of each element of a single bottle were performed. The stability test was performed at temperatures of -10, +27, and +40 degrees C, and after storage times of 4, 12, 24, and 52 weeks. The obtained results indicated that the material was homogeneous and stable under the conditions studied.

  16. Quality guidelines and standards for genetic laboratories/clinics in prenatal diagnosis on fetal samples obtained by invasive procedures. An attempt to establish a common European framework for quality assessment. EUCROMIC Quality Assessment Group.

    PubMed

    1997-01-01

    At a workshop in Leuven, November 8-10, 1996, 24 clinical and laboratory geneticists from 15 countries in Europe met and discussed minimum standards for prenatal diagnosis. These guidelines are intended for use as a reference manual by genetic centres all over Europe, especially in countries without national guidelines, in their efforts to achieve and maintain high standards. The workshop was restricted to discuss quality assessment on established invasive procedures for cytogenetic and molecular studies. The committee brought together from their own countries substantial experience of genetic counselling, cytogenetics, molecular biology and quality assessment. It is hoped that future discussions, embracing all aspects of clinical and laboratory genetic services will lead to the establishment of common guidelines for all European countries.

  17. Harmonization of Pulsed-Field Gel Electrophoresis Protocols for Epidemiological Typing of Strains of Methicillin-Resistant Staphylococcus aureus: a Single Approach Developed by Consensus in 10 European Laboratories and Its Application for Tracing the Spread of Related Strains

    PubMed Central

    Murchan, Stephen; Kaufmann, Mary Elizabeth; Deplano, Ariane; de Ryck, Raf; Struelens, Marc; Zinn, Christina Elsberg; Fussing, Vivian; Salmenlinna, Saara; Vuopio-Varkila, Jaana; El Solh, Névine; Cuny, Christina; Witte, Wolfgang; Tassios, Panayotis T.; Legakis, Nikolas; van Leeuwen, Willem; van Belkum, Alex; Vindel, Anna; Laconcha, Idoia; Garaizar, Javier; Haeggman, Saara; Olsson-Liljequist, Barbro; Ransjo, Ulrika; Coombes, Geoffrey; Cookson, Barry

    2003-01-01

    Pulsed-fieldgel electrophoresis (PFGE) is the most common genotypic method used in reference and clinical laboratories for typing methicillin-resistant Staphylococcus aureus (MRSA). Many different protocols have been developed in laboratories that have extensive experience with the technique and have established national databases. However, the comparabilities of the different European PFGE protocols for MRSA and of the various national MRSA clones themselves had not been addressed until now. This multinational European Union (EU) project has established for the first time a European database of representative epidemic MRSA (EMRSA) strains and has compared them by using a new “harmonized” PFGE protocol developed by a consensus approach that has demonstrated sufficient reproducibility to allow the successful comparison of pulsed-field gels between laboratories and the tracking of strains around the EU. In-house protocols from 10 laboratories in eight European countries were compared by each center with a “gold standard” or initial harmonized protocol in which many of the parameters had been standardized. The group found that it was not important to standardize some elements of the protocol, such as the type of agarose, DNA block preparation, and plug digestion. Other elements were shown to be critical, namely, a standard gel volume and concentration of agarose, the DNA concentration in the plug, the ionic strength and volume of running buffer used, the running temperature, the voltage, and the switching times of electrophoresis. A new harmonized protocol was agreed on, further modified in a pilot study in two laboratories, and finally tested by all others. Seven laboratories' gels were found to be of sufficiently good quality to allow comparison of the strains by using a computer software program, while two gels could not be analyzed because of inadequate destaining and DNA overloading. Good-quality gels and inclusion of an internal quality control strain

  18. E-health, phase two: the imperative to integrate process automation with communication automation for large clinical reference laboratories.

    PubMed

    White, L; Terner, C

    2001-01-01

    The initial efforts of e-health have fallen far short of expectations. They were buoyed by the hype and excitement of the Internet craze but limited by their lack of understanding of important market and environmental factors. E-health now recognizes that legacy systems and processes are important, that there is a technology adoption process that needs to be followed, and that demonstrable value drives adoption. Initial e-health transaction solutions have targeted mostly low-cost problems. These solutions invariably are difficult to integrate into existing systems, typically requiring manual interfacing to supported processes. This limitation in particular makes them unworkable for large volume providers. To meet the needs of these providers, e-health companies must rethink their approaches, appropriately applying technology to seamlessly integrate all steps into existing business functions. E-automation is a transaction technology that automates steps, integration of steps, and information communication demands, resulting in comprehensive automation of entire business functions. We applied e-automation to create a billing management solution for clinical reference laboratories. Large volume, onerous regulations, small margins, and only indirect access to patients challenge large laboratories' billing departments. Couple these problems with outmoded, largely manual systems and it becomes apparent why most laboratory billing departments are in crisis. Our approach has been to focus on the most significant and costly problems in billing: errors, compliance, and system maintenance and management. The core of the design relies on conditional processing, a "universal" communications interface, and ASP technologies. The result is comprehensive automation of all routine processes, driving out errors and costs. Additionally, compliance management and billing system support and management costs are dramatically reduced. The implications of e-automated processes can extend

  19. Towards the Learning Region: Education and Regional Innovation in the European Union and the United States. CEDEFOP Reference Document.

    ERIC Educational Resources Information Center

    Nyhan, Barry, Ed.; Attwell, Graham, Ed.; Deitmer, Ludger, Ed.

    This book provides an overview of innovative education practices throughout regions in the United States (US) and Europe. It contains 16 papers written by experts from the educational, economic, and regional development fields in the US and the European Union (EU). Introductory materials are: a foreword (David O'Sullivan); preface (Stavros…

  20. Sequencing an Ashkenazi reference panel supports population-targeted personal genomics and illuminates Jewish and European origins

    PubMed Central

    Carmi, Shai; Hui, Ken Y.; Kochav, Ethan; Liu, Xinmin; Xue, James; Grady, Fillan; Guha, Saurav; Upadhyay, Kinnari; Ben-Avraham, Dan; Mukherjee, Semanti; Bowen, B. Monica; Thomas, Tinu; Vijai, Joseph; Cruts, Marc; Froyen, Guy; Lambrechts, Diether; Plaisance, Stéphane; Van Broeckhoven, Christine; Van Damme, Philip; Van Marck, Herwig; Barzilai, Nir; Darvasi, Ariel; Offit, Kenneth; Bressman, Susan; Ozelius, Laurie J.; Peter, Inga; Cho, Judy H.; Ostrer, Harry; Atzmon, Gil; Clark, Lorraine N.; Lencz, Todd; Pe’er, Itsik

    2014-01-01

    The Ashkenazi Jewish (AJ) population is a genetic isolate close to European and Middle Eastern groups, with genetic diversity patterns conducive to disease mapping. Here we report high-depth sequencing of 128 complete genomes of AJ controls. Compared with European samples, our AJ panel has 47% more novel variants per genome and is eightfold more effective at filtering benign variants out of AJ clinical genomes. Our panel improves imputation accuracy for AJ SNP arrays by 28%, and covers at least one haplotype in ≈67% of any AJ genome with long, identical-by-descent segments. Reconstruction of recent AJ history from such segments confirms a recent bottleneck of merely ≈350 individuals. Modelling of ancient histories for AJ and European populations using their joint allele frequency spectrum determines AJ to be an even admixture of European and likely Middle Eastern origins. We date the split between the two ancestral populations to ≈12–25 Kyr, suggesting a predominantly Near Eastern source for the repopulation of Europe after the Last Glacial Maximum. PMID:25203624

  1. [Influenza surveillance in nine consecutive seasons, 2003-2012: results from National Influenza Reference Laboratory, Istanbul Faculty Of Medicine, Turkey].

    PubMed

    Akçay Ciblak, Meral; Kanturvardar Tütenyurd, Melis; Asar, Serkan; Tulunoğlu, Merve; Fındıkçı, Nurcihan; Badur, Selim

    2012-10-01

    Influenza is a public health problem that affects 5-20% of the world population annually causing high morbidity and mortality especially in risk groups. In addition to determining prevention and treatment strategies with vaccines and antivirals, surveillance data plays an important role in combat against influenza. Surveillance provides valuable data on characteristics of influenza activity, on types, sub-types, antigenic properties and antiviral resistance profile of circulating viruses in a given region. The first influenza surveillance was initiated as a pilot study in 2003 by now named National Influenza Reference Laboratory, Istanbul Faculty of Medicine. Surveillance was launched at national level by Ministry of Health in 2004 and two National Influenza Laboratories, one in Istanbul and the other in Ankara, have been conducting surveillance in Turkey. Surveillance data obtained for nine consecutive years, 2003-2012, by National Influenza Reference Laboratory in Istanbul Faculty of Medicine have been summarized in this report. During 2003-2012 influenza surveillance seasons, a total of 11.077 nasal swabs collected in viral transport medium were sent to the National Influenza Reference Laboratory, Istanbul for analysis. Immun-capture ELISA followed by MDCK cell culture was used for detection of influenza viruses before 2009 and real-time RT-PCR was used thereafter. Antigenic characterizations were done by hemagglutination inhibition assay with the reactives supplied by World Health Organization. Analysis of the results showed that influenza B viruses have entered the circulation in 2005-2006 seasons, and have contributed to the epidemics at increasing rates every year except in the 2009 pandemic season. Influenza B Victoria and Yamagata lineages were cocirculating for two seasons. For other seasons either lineage was in circulation. Antigenic characterization revealed that circulating B viruses matched the vaccine composition either partially or totally for only

  2. Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride.

    PubMed

    Marković, Bojan; Ignjatović, Janko; Vujadinović, Mirjana; Savić, Vedrana; Vladimirov, Sote; Karljiković-Rajić, Katarina

    2015-01-01

    Inter-laboratory verification of European pharmacopoeia (EP) monograph on derivative spectrophotometry (DS) method and its application for chitosan hydrochloride was carried out on two generation of instruments (earlier GBC Cintra 20 and current technology TS Evolution 300). Instruments operate with different versions of Savitzky-Golay algorithm and modes of generating digital derivative spectra. For resolution power parameter, defined as the amplitude ratio A/B in DS method EP monograph, comparable results were obtained only with algorithm's parameters smoothing points (SP) 7 and the 2nd degree polynomial and those provided corresponding data with other two modes on TS Evolution 300 Medium digital indirect and Medium digital direct. Using quoted algorithm's parameters, the differences in percentages between the amplitude ratio A/B averages, were within accepted criteria (±3%) for assay of drug product for method transfer. The deviation of 1.76% for the degree of deacetylation assessment of chitosan hydrochloride, determined on two instruments, (amplitude (1)D202; the 2nd degree polynomial and SP 9 in Savitzky-Golay algorithm), was acceptable, since it was within allowed criteria (±2%) for assay deviation of drug substance, for method transfer in pharmaceutical analyses.

  3. [Comparison of dietary reference intakes (DRI) between different countries of the European Union, The United States and the World Health Organization].

    PubMed

    Cuervo, M; Corbalán, M; Baladía, E; Cabrerizo, L; Formiguera, X; Iglesias, C; Lorenzo, H; Polanco, I; Quiles, J; Romero de Avila, M D; Russolillo, G; Villarino, A; Alfredo Martínez, J

    2009-01-01

    In Spain, there are some organizations and scientific societies that have edited reference values of recommended nutrient intake, but whose data does not always agree in terms of format and content. To review the definitions, data and methodology that other countries or groups of countries have followed to obtain and document their own reference values in order to offer basic information to facilitate the establishment of the best reference values for the Spanish population. FIELD: Review of the available information in different countries (or groups of countries) from the European Union, the United States and World Health Organization. The analysed data concerned to healthy populations. Reference intakes differ among the examined countries according to population groups, included nutrients, methodology and frequency of published reviews. However, most of the countries define major concepts in the same way, although with different names in each country. On the other hand, most of the studied cases represent only a scientific organization in charge of the publication and update of the values of dietary reference intakes, but not in Spain. In that context, it looks convenient to reach a consensus among all Spanish organizations and scientific societies that are involved in this task, in order to establish an acceptable reference values.

  4. Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: II. Performance of a laboratory network running the HPLC candidate reference measurement procedure and evaluation of a candidate reference material.

    PubMed

    Helander, Anders; Wielders, Jos P M; Jeppsson, Jan-Olof; Weykamp, Cas; Siebelder, Carla; Anton, Raymond F; Schellenberg, François; Whitfield, John B

    2010-11-01

    Carbohydrate-deficient transferrin (CDT) is a descriptive term used for a temporary change in the transferrin glycosylation profile caused by alcohol, and used as a biomarker of chronic high alcohol consumption. The use of an array of methods for measurement of CDT in various absolute or relative amounts, and sometimes covering different transferrin glycoforms, has complicated the comparability of results and caused confusion among medical staff. This situation prompted initiation of an IFCC Working Group on CDT standardization. This second publication of the WG-CDT covers the establishment of a network of reference laboratories running a high-performance liquid chromatography (HPLC) candidate reference measurement procedure, and evaluation of candidate secondary reference materials. The network laboratories demonstrated good and reproducible performance and thus can be used to assign target values for calibrators and controls. A candidate secondary reference material based on native human serum lyophilized with a cryo-/lyoprotectant to prevent protein denaturation was found to be commutable and stable during storage. A proposed strategy for calibration of different CDT methods is also presented. In an external quality assurance study involving 66 laboratories and covering the current routine CDT assays (HPLC, capillary electrophoresis and immunoassay), recalculation of observed results based on the nominal values for the candidate calibrator reduced the overall coefficient of variation from 18.9% to 5.5%. The logistics for distribution of reference materials and review of results were found to be functional, indicating that a full reference system for CDT may soon be available.

  5. Development and Implementation of a Coagulation Factor Testing Method Utilizing Autoverification in a High-volume Clinical Reference Laboratory Environment

    PubMed Central

    Riley, Paul W.; Gallea, Benoit; Valcour, Andre

    2017-01-01

    Background: Testing coagulation factor activities requires that multiple dilutions be assayed and analyzed to produce a single result. The slope of the line created by plotting measured factor concentration against sample dilution is evaluated to discern the presence of inhibitors giving rise to nonparallelism. Moreover, samples producing results on initial dilution falling outside the analytic measurement range of the assay must be tested at additional dilutions to produce reportable results. Methods: The complexity of this process has motivated a large clinical reference laboratory to develop advanced computer algorithms with automated reflex testing rules to complete coagulation factor analysis. A method was developed for autoverification of coagulation factor activity using expert rules developed with on an off the shelf commercially available data manager system integrated into an automated coagulation platform. Results: Here, we present an approach allowing for the autoverification and reporting of factor activity results with greatly diminished technologist effort. Conclusions: To the best of our knowledge, this is the first report of its kind providing a detailed procedure for implementation of autoverification expert rules as applied to coagulation factor activity testing. Advantages of this system include ease of training for new operators, minimization of technologist time spent, reduction of staff fatigue, minimization of unnecessary reflex tests, optimization of turnaround time, and assurance of the consistency of the testing and reporting process. PMID:28706751

  6. Review of 16S and ITS Direct Sequencing Results for Clinical Specimens Submitted to a Reference Laboratory

    PubMed Central

    Payne, Michael; Azana, Robert; Hoang, Linda M. N.

    2016-01-01

    We evaluated the performance of 16S and internal transcribed spacer (ITS) region amplification and sequencing of rDNA from clinical specimens, for the respective detection and identification of bacterial and fungal pathogens. Direct rDNA amplification of 16S and ITS targets from clinical samples was performed over a 4-year period and reviewed. All specimens were from sterile sites and submitted to a reference laboratory for evaluation. Results of 16S and ITS were compared to histopathology, Gram and/or calcofluor stain microscopy results. A total of 277 16S tests were performed, with 64 (23%) positive for the presence of bacterial DNA. Identification of an organism was more likely in microscopy positive 16S samples 14/21 (67%), compared to 35/175 (20%) of microscopy negative samples. A total of 110 ITS tests were performed, with 14 (13%) positive. The yield of microscopy positive ITS samples, 9/44 (21%), was higher than microscopy negative samples 3/50 (6%). Given these findings, 16S and ITS are valuable options for culture negative specimens from sterile sites, particularly in the setting of positive microscopy findings. Where microscopy results are negative, the limited sensitivity of 16S and ITS in detecting and identifying an infectious agent needs to be considered. PMID:27366168

  7. Applications of Mars Global Reference Atmospheric Model (Mars-GRAM 2005) Supporting Mission Site Selection for Mars Science Laboratory

    NASA Technical Reports Server (NTRS)

    Justh, Hilary L.; Justus, Carl G.

    2008-01-01

    The Mars Global Reference Atmospheric Model (Mars-GRAM 2005) is an engineering level atmospheric model widely used for diverse mission applications. An overview is presented of Mars-GRAM 2005 and its new features. One new feature of Mars-GRAM 2005 is the 'auxiliary profile' option. In this option, an input file of temperature and density versus altitude is used to replace mean atmospheric values from Mars-GRAM's conventional (General Circulation Model) climatology. An auxiliary profile can be generated from any source of data or alternate model output. Auxiliary profiles for this study were produced from mesoscale model output (Southwest Research Institute's Mars Regional Atmospheric Modeling System (MRAMS) model and Oregon State University's Mars mesoscale model (MMM5)model) and a global Thermal Emission Spectrometer(TES) database. The global TES database has been specifically generated for purposes of making Mars-GRAM auxiliary profiles. This data base contains averages and standard deviations of temperature, density, and thermal wind components,averaged over 5-by-5 degree latitude-longitude bins and 15 degree L(s) bins, for each of three Mars years of TES nadir data. Results are presented using auxiliary profiles produced from the mesoscale model output and TES observed data for candidate Mars Science Laboratory (MSL) landing sites. Input parameters rpscale (for density perturbations) and rwscale (for wind perturbations) can be used to "recalibrate" Mars-GRAM perturbation magnitudes to better replicate observed or mesoscale model variability.

  8. Latino and European American early adolescents' exposure to music with substance-use references: examining parent-child communication as a moderator.

    PubMed

    Kam, Jennifer A; Wang, Ningxin; Harvey, Jessica

    2014-02-01

    This study hypothesized that frequent exposure to and attention to music with substance-use references would be indirectly related to alcohol, cigarette, or marijuana use through pro-substance-use beliefs (e.g., norms, outcome expectancies, and refusal efficacy). Parent-child communication, however, would attenuate such associations, which would differ by ethnicity. Multigroup mediation and moderation analyses were conducted, using cross-sectional survey data from 253 Latino and 308 European American 6th-8th grades students. For Latino and European American early adolescents, best-friend-injunctive norms and weak refusal efficacy were significant mediators, but not positive outcome expectancies. Descriptive norms were a significant mediator, but only for European American early adolescents. Although targeted parent-child communication and parental mediation did not moderate the associations between the music-exposure variables and the pro-substance-use beliefs variables, targeted parent-child communication attenuated the association between listening to favorite songs and alcohol consumption. Parental mediation attenuated the association between attention to music and alcohol consumption.

  9. A comparative study of germline BRCA1 and BRCA2 mutation screening methods in use in 20 European clinical diagnostic laboratories

    PubMed Central

    Ellison, Gillian; Wallace, Andrew; Kohlmann, Alexander; Patton, Simon

    2017-01-01

    Background: Thousands of clinically relevant variations in BRCA1 and BRCA2 have been discovered and this poses a significant challenge with respect to the accurate detection, analysis turn-around time, characterisation and interpretation of these sequence variants. Methods: We evaluated the performance of different BRCA1/2 gene testing practices in routine diagnostic use in 20 European laboratories, with a focus on next-generation sequencing-based strategies as this is the technical approach implemented by or under adoption by most European clinical laboratories. Participant laboratories, selected on expertise and diagnostic service quality, tested 10 identical DNA samples containing a range of challenging pathogenic variants. Results: A small number of errors in the detection of pathogenic and significant variants were identified (2.6% diagnostic error rate). There was a high degree of concordance (>97%) across all laboratories for all variants detected. No systematic technical flaw was identified in the strategies employed across the participating laboratories. Conclusions: The discrepancies identified are most likely due to human error or the way the methodology has been implemented locally, for example, next-generation sequencing bioinformatics pipelines, rather than technical limitations of the methods. The choice of BRCA1/2 testing method will therefore depend on multiple factors including required throughput and turn-around times, access to equipment, expertise and budget. PMID:28751759

  10. Final Report: Letter to Mr. Kim Abbott, DOE-OAK Cal/EPA-UC Berkeley Bioremediation Reference Laboratory, Report, September 15, 1996 - November 1, 1998

    SciTech Connect

    Fuhs, G. Wolfgang

    1999-03-15

    Letter-format report to Project Officer summarizing information on the establishment at the University of California Berkeley campus of a Bioremediation Reference Laboratory to provide independent reference services and testing as needed to assist the California Environmental Protection Agency in the evaluation of bioremediation technologies submitted for the certification/ verification of performance claims under California statute. The project resulted in the establishment of a technical capability not otherwise available to the Agency.

  11. Economic impact of childhood/adolescent ADHD in a European setting: the Netherlands as a reference case.

    PubMed

    Le, Hoa H; Hodgkins, Paul; Postma, Maarten J; Kahle, Jennifer; Sikirica, Vanja; Setyawan, Juliana; Erder, M Haim; Doshi, Jalpa A

    2014-07-01

    Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent psychiatric disorder in children/adolescents. This study reviews available European-based studies of ADHD-related costs and applies the findings to the Netherlands to estimate annual national costs for children/adolescents from a societal perspective. A systematic literature search was conducted for primary studies in Europe, published January 1, 1990 through April 23, 2013. Per-person cost estimates were converted to 2012 Euros and used to estimate annual national ADHD-related costs based on the Dutch 2011 census, ADHD prevalence rates, family composition, and employment rates. Seven studies met the inclusion criteria. The average total ADHD-related costs ranged from €9,860 to 14,483 per patient and annual national costs were between €1,041 and €1,529 million (M). The largest cost category was education (€648 M), representing 62 and 42 % of the low- and high-value overall national estimates, respectively. By comparison, ADHD patient healthcare costs ranged between €84 M (8 %) and €377 M (25 %), and social services costs were €4.3 M (0.3-0.4 %). While the majority of the costs were incurred by ADHD patients themselves, €161 M (11-15 %) was healthcare costs to family members that were attributable to having an ADHD child/adolescent. In addition, productivity losses of family members were €143-€339 M (14-22 %). Despite uncertainties because of the small number of studies identified and the wide range in the national cost estimates, our results suggest that ADHD imposes a significant economic burden on multiple public sectors in Europe. The limited number of European-based studies examining the economic burden of ADHD highlights the need for more research in this area.

  12. Investigation of synthesized Be-bearing silicate glass as laboratory reference sample at X-ray electron probe microanalysis of silicates

    NASA Astrophysics Data System (ADS)

    Belozerova, Olga Yu.; Mikhailov, Mikhail A.; Demina, Tamara V.

    2017-01-01

    The article discusses estimates of the stability and homogeneity in Be-Mg-Al-silicate glass produced by the authors and its applicability as a laboratory reference sample for X-ray electron probe microanalysis (EPMA) of Be-bearing silicate matters: crystals and quenching melt (glasses), silicates and oxides. The results were obtained using Superprobe-733 and Superprobe JXA-8200 (JEOL Ltd, Japan) devices. The sample homogeneity was studied on macro (10-100 μm) and micro (1-10 μm) levels and was evaluated by the scheme of dispersion analysis. The applicability of Be-bearing silicate glass as a reference sample for Mg, Al, Si determinations was tested on the international certified reference glasses and laboratory reference samples of minerals with a known composition. The obtained experimental metrological characteristics correspond to the "applied geochemistry" type of analysis (second category) and suggest that Be-bearing silicate glass is appropriate as a laboratory reference sample for EPMA of Be-bearing silicate matters, silicates and oxides. Using Be-Mg-Al-silicate glass as a reference sample we obtained satisfactory data on the composition of both some minerals including cordierite and beryllium cordierite, beryllium indialite, beryl and metastable phases (chrysoberyl, compounds with structure of β-quartz and petalite).

  13. Establishment of reference intervals for von Willebrand factor antigen and eight coagulation factors in a Korean population following the Clinical and Laboratory Standards Institute guidelines.

    PubMed

    Jang, Ja-Hyun; Seo, Ja-Young; Bang, Sung-Hwan; Park, In-Ae; Kim, Hee-Jin; Kim, Sun-Hee

    2010-04-01

    Establishment of reference intervals for coagulation molecules is important but is costly and sometimes not feasible. Since reference intervals from manufacturers or the literature are mostly out of date or involved Western populations, the authors determined reference intervals for VWF: Ag and eight factors in a Korean population. VWF: Ag, factor VIII (FVIII), FII, FV, FVII, FIX, FX, FXI, and FXII were determined in Korean individuals visiting for routine checkup following the CLSI (Clinical and Laboratory Standards Institute) guidelines. Reagents by Diagnostica Stago were used on the STA Compact Analyzer (Diagnostica Stago). Exclusion criteria were medical history or laboratory findings that could affect the factor levels. Influence of demographic factors was analyzed. Mean +/- 2 x SD or central 95 percentile was used, as appropriate. We obtained data from 266 adults for VWF: Ag, 371 adults for FVIII, and minimum 136 adults for the rest. Reference interval for VWF was 51-176% (52-155% in blood group O and 71-186% for non-O). Reference interval for FVIII was 64-197% (55-150% in O and 77-205% in non-O). Reference interval for FII was 77-121%, FV 81-160%, FVII 68-149%, FIX 67-154%, FX 69-126%, FXI 59-138%, and FXII 48-177%. The medians of VWF: Ag, FVIII, and FIX were significantly higher in the elderly group (> or =60 years). We established local reference intervals for VWF: Ag and eight coagulation factors in a Korean population according to the CLSI guidelines. Significantly, different reference intervals were obtained in blood group O vs. non-O for VWF: Ag and FVIII. The reference intervals obtained in this study could be adopted in other clinical laboratories after appropriate validation.

  14. Japanese Society for Laboratory Hematology flow cytometric reference method of determining the differential leukocyte count: external quality assurance using fresh blood samples.

    PubMed

    Kawai, Y; Nagai, Y; Ogawa, E; Kondo, H

    2017-04-01

    To provide target values for the manufacturers' survey of the Japanese Society for Laboratory Hematology (JSLH), accurate standard data from healthy volunteers were needed for the five-part differential leukocyte count. To obtain such data, JSLH required an antibody panel that achieved high specificity (particularly for mononuclear cells) using simple gating procedures. We developed a flow cytometric method for determining the differential leukocyte count (JSLH-Diff) and validated it by comparison with the flow cytometric differential leukocyte count of the International Council for Standardization in Haematology (ICSH-Diff) and the manual differential count obtained by microscopy (Manual-Diff). First, the reference laboratory performed an imprecision study of JSLH-Diff and ICSH-Diff, as well as performing comparison among JSLH-Diff, Manual-Diff, and ICSH-Diff. Then two reference laboratories and seven participating laboratories performed imprecision and accuracy studies of JSLH-Diff, Manual-Diff, and ICSH-Diff. Simultaneously, six manufacturers' laboratories provided their own representative values by using automated hematology analyzers. The precision of both JSLH-Diff and ICSH-Diff methods was adequate. Comparison by the reference laboratory showed that all correlation coefficients, slopes and intercepts obtained by the JSLH-Diff, ICSH-Diff, and Manual-Diff methods conformed to the criteria. When the imprecision and accuracy of JSLH-Diff were assessed at seven laboratories, the CV% for lymphocytes, neutrophils, monocytes, eosinophils, and basophils was 0.5~0.9%, 0.3~0.7%, 1.7~2.6%, 3.0~7.9%, and 3.8~10.4%, respectively. More than 99% of CD45 positive leukocytes were identified as normal leukocytes by JSLH-Diff. When JSLH-Diff method were validated by comparison with Manual-Diff and ICSH-Diff, JSLH-Diff showed good performance as a reference method. © 2016 John Wiley & Sons Ltd.

  15. Characterisation of meteoritic samples with the Rosetta Cosima TOF-SIMS laboratory reference model --- a covariance approach

    NASA Astrophysics Data System (ADS)

    Stenzel, O.; Varmuza, K.; Engrand, C.; Ferrière, L.; Brandstätter, F.; Koeberl, C.; Filzmoser, P.; Hilchenbach, M.

    2014-07-01

    The time-of-flight secondary ion mass spectrometer Cosima onboard Rosetta will analyze cometary grains ejected off the nucleus of comet 67P/Churyumov-Gerasimenko from September 2014 onwards. In our effort to understand the composition and the history of these cometary grains, we study the characteristics of different meteorite samples with the Cosima reference instruments at the Max Planck Institute for Solar System Research in Göttingen, with the goal to separate individual compounds and their fragmentation patterns. Different types of meteorite samples are prepared in the laboratory. Among these are one ordinary chondrite H4 (Ochansk), one unequilibrated ordinary chondrite H3 (Tieschitz), one carbonaceous chondrite CR (Renazzo), and a martian shergottite (Tissint). Grains of sizes up to 100 μ m are pressed into a blank gold metal target. The grains are identified with the instrument microscope and positive and negative secondary ion mass spectra are accumulated on different positions on selected grains. The mass spectra are accumulating all secondary ions up to mass 300 with reasonable detection efficiency and a mass resolution of 1400@ 100 amu. This mass resolution is sufficient to separate organic (hydrogen-rich) molecule peaks from minerals or elemental mass peaks. We are trying to assess how the covariances of count rates between different parts of the mass spectra, i.e., specific atomic and molecule peaks of a single meteorite, can be used to infer some properties of its constituents and how this differs between the different meteorites that show varying degrees of alteration. In a first step, we look at the covariance and the correlation matrices S of the mass spectra for individual meteorite samples. The elements s_{ij} of S are the covariances/correlations of the mass spectra at the masses i and j for a given meteorite sample. This will help us, after future analysis, to place the cometary grains into the proper compositional and evolutionary context

  16. Standardization of allergen products: 2. Detailed characterization of GMP-produced recombinant Phl p 5.0109 as European Pharmacopoeia reference standard.

    PubMed

    Himly, M; Nandy, A; Kahlert, H; Thilker, M; Steiner, M; Briza, P; Neubauer, A; Klysner, S; van Ree, R; Buchheit, K-H; Vieths, S; Ferreira, F

    2016-04-01

    The Biological Standardization Programme of the European Directorate for Quality of Medicines and Healthcare (EDQM) aims at the establishment of well-characterized reference standards based on recombinant allergens and validated assays for the quantification of major allergen content. The objective of this study was to examine the detailed physicochemical and immunological characterization of recombinant Phl p 5.0109, the second available allergen reference standard. Recombinant Phl p 5.0109 PP5ar06007 was produced under GMP conditions and analyzed by an array of physicochemical and immunological methods for identity, quantity, homogeneity, and folding stability in bulk solution, as well as thermal denaturation, aggregation state, and biological activity when formulated for long-time storage. PP5ar06007 revealed as a highly homogeneous, monomeric, well-folded preparation of rPhl p 5.0109, as documented by mass spectrometry, SDS-PAGE, isoelectric focusing, size-exclusion chromatography with light scattering, circular dichroism, and infrared spectroscopy. Upon storage at +4°C, PP5ar06007 retained the monomeric state for at least 2 months. A protein quantity of 1.56 ± 0.03 mg/ml was determined by amino acid analysis in PP5ar06007, and its biological activity was shown to be comparable to natural Phl p 5 in terms of basophil activation and T-cell reactivity. Recombinant Phl p 5.0109 PP5ar06007 was characterized extensively at the physicochemical and immunological level. It revealed to be a highly stable, monomeric, and immunologically equivalent of its natural counterpart. PP5ar06007 is now available as European Pharmacopoeia allergen reference standard for grass pollen products. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. Effects of laboratory housing on exploratory behaviour, novelty discrimination and spatial reference memory in a subterranean, solitary rodent, the Cape mole-rat (Georychus capensis).

    PubMed

    Oosthuizen, Maria Kathleen; Scheibler, Anne-Gita; Bennett, Nigel Charles; Amrein, Irmgard

    2013-01-01

    A large number of laboratory and field based studies are being carried out on mole-rats, both in our research group and others. Several studies have highlighted the development of adverse behaviours in laboratory animals and have emphasised the importance of enrichment for captive animals. Hence we were interested in evaluating how laboratory housing would affect behavioural performance in mole-rats. We investigated exploratory behaviour, the ability to discriminate between novel and familiar environments and reference memory in the solitary Cape mole-rat (Georychus capensis). Our data showed that both wild and captive animals readily explore open spaces and tunnels. Wild animals were however more active than their captive counterparts. In the Y maze two trial discrimination task, wild animals failed to discriminate between novel and familiar environments, while laboratory housed mole-rats showed preferential spatial discrimination in terms of the length of time spent in the novel arm. The performance of the laboratory and wild animals were similar when tested for reference memory in the Y maze, both groups showed a significant improvement compared to the first day, from the 3rd day onwards. Wild animals made more mistakes whereas laboratory animals were slower in completing the task. The difference in performance between wild and laboratory animals in the Y-maze may be as a result of the lower activity of the laboratory animals. Laboratory maintained Cape mole-rats show classic behaviours resulting from a lack of stimulation such as reduced activity and increased aggression. However, they do display an improved novelty discrimination compared to the wild animals. Slower locomotion rate of the laboratory animals may increase the integration time of stimuli, hence result in a more thorough inspection of the surroundings. Unlike the captive animals, wild animals show flexibility in their responses to unpredictable events, which is an important requirement under

  18. The use of HeartQoL in patients with coronary heart disease: Association with risk factors and European reference values. The EUROASPIRE IV study of the European Society of Cardiology.

    PubMed

    De Smedt, Delphine; Clays, Els; Höfer, Stefan; Oldridge, Neil; Kotseva, Kornelia; Maggioni, Aldo Pietro; Pogosova, Nana; Dolzhenko, Maryna; De Bacquer, Dirk

    2016-07-01

    HeartQoL is a recently developed core health-related quality of life instrument for patients with coronary heart disease. The current study aims to investigate its association with patients' coronary risk profile and to provide reference values for patients with coronary heart disease across Europe. Analyses are based on the EUROASPIRE IV (EUROpean Action on Secondary and Primary prevention through Intervention to Reduce Events) cross-sectional survey. Patients with a diagnosis of coronary heart disease were examined and interviewed six months to three years after their coronary event. The HeartQoL questionnaire was completed by 7261 coronary heart disease patients. Reference values were calculated and the association with the coronary risk profile was assessed. Significantly worse outcomes were observed in higher-risk patient groups. Both metabolic and behavioural risk factors were associated with worse HeartQoL outcomes. Further, the HeartQoL scores decreased as the number of risk factors increased. The mean global reference values in males were 2.27 ± 0.65 (<60 years), 2.30 ± 0.61 (between 60 and 69 years) and 2.19 ± 0.64 (≥70 years). Likewise, in females, the respective global HeartQoL reference values were 2.02 ± 0.67, 2.01 ± 0.66 and 1.83 ± 0.70. The ceiling effect in males was 11.4%, 10.4% and 7.4% for the three age classes respectively, whereas in females the ceiling effect was 5.2%, 3.5% and 1.9%, respectively. HeartQoL scores were associated with patients' coronary risk profile. The reference values may help other researchers to interpret HeartQoL scores. Further research should focus on the minimal important difference needed to evaluate the effect of therapies and lifestyle changes. © The European Society of Cardiology 2016.

  19. Applying the Writing Scales of the "Common European Framework of Reference for Languages" to the New HSK Test of Proficiency in Chinese: Realities, Problems and Some Suggestions for Chinese Language Teachers and Learners

    ERIC Educational Resources Information Center

    Hsiao, Ya Ping; Broeder, Peter

    2013-01-01

    This article explores levels of proficiency in Chinese with reference to the new HSK (Hanyu Shuiping Kaoshi) Chinese Proficiency Test and the "Common European Framework of Reference for Languages" (CEFR). Special attention is given to learning and teaching the writing of Chinese characters and the use of Pinyin, a phonetic Romanization…

  20. Applying the Writing Scales of the "Common European Framework of Reference for Languages" to the New HSK Test of Proficiency in Chinese: Realities, Problems and Some Suggestions for Chinese Language Teachers and Learners

    ERIC Educational Resources Information Center

    Hsiao, Ya Ping; Broeder, Peter

    2013-01-01

    This article explores levels of proficiency in Chinese with reference to the new HSK (Hanyu Shuiping Kaoshi) Chinese Proficiency Test and the "Common European Framework of Reference for Languages" (CEFR). Special attention is given to learning and teaching the writing of Chinese characters and the use of Pinyin, a phonetic Romanization…

  1. Total cholesterol performance of Abell–Levy–Brodie–Kendall reference measurement procedure: Certification of Japanese in-vitro diagnostic assay manufacturers through CDC’s Cholesterol Reference Method Laboratory Network☆

    PubMed Central

    Nakamura, Masakazu; Iso, Hiroyasu; Kitamura, Akihiko; Imano, Hironori; Kiyama, Masahiko; Yokoyama, Shinji; Kayamori, Yuzo; Koyama, Isao; Nishimura, Kunihiro; Nakai, Michikazu; Dasti, Mahnaz; Vesper, Hubert W.; Teramoto, Tamio; Miyamoto, Yoshihiro

    2015-01-01

    Background Accurate measurement of total cholesterol (TC) is important for cardiovascular disease risk management. The US Centers for Disease Control and Prevention (CDC) and Cholesterol Reference Method Laboratory Network (CRMLN) perform Abell–Levy–Brodie–Kendall (AK) reference measurement procedure (RMP) for TC as a secondary reference method, and implement Certification Protocol for Manufacturers. Japanese CRMLN laboratory at Osaka performed the AK RMP for 22 years, and conducted TC certification for reagent/calibrator/instrument systems of six Japanese manufacturers every 2 years for 16 years. Osaka TC performance was examined and compared to CDC’s reference values. Methods AK RMP involved sample hydrolysis, cholesterol extraction, and determination of cholesterol levels by spectrophotometry. The Certification Protocol for Manufacturers includes comparison with AK RMP using at least 40 fresh specimens. Demonstration of average bias ≤3% and total coefficient of variation ≤3% qualified an analytical system for certification. Results In the AK RMP used in the Osaka CRMLN laboratory, the regression equation for measuring TC was y (Osaka) = 1.000x (CDC) + 0.032 (n = 619, R2 = 1.000). Six Japanese manufacturers had allowable performance for certification. Conclusions The AK RMP for TC measurement was accurate, precise, and stable for 22 years. Six Japanese manufacturers were certified for 16 years. PMID:25818239

  2. Reference standard space hippocampus labels according to the European Alzheimer's Disease Consortium-Alzheimer's Disease Neuroimaging Initiative harmonized protocol: Utility in automated volumetry.

    PubMed

    Wolf, Dominik; Bocchetta, Martina; Preboske, Gregory M; Boccardi, Marina; Grothe, Michel J

    2017-08-01

    A harmonized protocol (HarP) for manual hippocampal segmentation on magnetic resonance imaging (MRI) has recently been developed by an international European Alzheimer's Disease Consortium-Alzheimer's Disease Neuroimaging Initiative project. We aimed at providing consensual certified HarP hippocampal labels in Montreal Neurological Institute (MNI) standard space to serve as reference in automated image analyses. Manual HarP tracings on the high-resolution MNI152 standard space template of four expert certified HarP tracers were combined to obtain consensual bilateral hippocampus labels. Utility and validity of these reference labels is demonstrated in a simple atlas-based morphometry approach for automated calculation of HarP-compliant hippocampal volumes within SPM software. Individual tracings showed very high agreement among the four expert tracers (pairwise Jaccard indices 0.82-0.87). Automatically calculated hippocampal volumes were highly correlated (rL/R = 0.89/0.91) with gold standard volumes in the HarP benchmark data set (N = 135 MRIs), with a mean volume difference of 9% (standard deviation 7%). The consensual HarP hippocampus labels in the MNI152 template can serve as a reference standard for automated image analyses involving MNI standard space normalization. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  3. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE).

    PubMed

    Lippi, Giuseppe; Banfi, Giuseppe; Church, Stephen; Cornes, Michael; De Carli, Gabriella; Grankvist, Kjell; Kristensen, Gunn B; Ibarz, Mercedes; Panteghini, Mauro; Plebani, Mario; Nybo, Mads; Smellie, Stuart; Zaninotto, Martina; Simundic, Ana-Maria

    2015-02-01

    Laboratory diagnostics develop through different phases that span from test ordering (pre-preanalytical phase), collection of diagnostic specimens (preanalytical phase), sample analysis (analytical phase), results reporting (postanalytical phase) and interpretation (post-postanalytical phase). Although laboratory medicine seems less vulnerable than other clinical and diagnostic areas, the chance of errors is not negligible and may adversely impact on quality of testing and patient safety. This article, which continues a biennial tradition of collective papers on preanalytical quality improvement, is aimed to provide further contributions for pursuing quality and harmony in the preanalytical phase, and is a synopsis of lectures of the third European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)-Becton Dickinson (BD) European Conference on Preanalytical Phase meeting entitled 'Preanalytical quality improvement. In pursuit of harmony' (Porto, 20-21 March 2015). The leading topics that will be discussed include unnecessary laboratory testing, management of test request, implementation of the European Union (EU) Directive on needlestick injury prevention, harmonization of fasting requirements for blood sampling, influence of physical activity and medical contrast media on in vitro diagnostic testing, recent evidence about the possible lack of necessity of the order of draw, the best practice for monitoring conditions of time and temperature during sample transportation, along with description of problems emerging from inappropriate sample centrifugation. In the final part, the article includes recent updates about preanalytical quality indicators, the feasibility of an External Quality Assessment Scheme (EQAS) for the preanalytical phase, the results of the 2nd EFLM WG-PRE survey, as well as specific notions about the evidence-based quality management of the preanalytical phase.

  4. Contribution of 32 GWAS-Identified Common Variants to Severe Obesity in European Adults Referred for Bariatric Surgery

    PubMed Central

    Yousseif, Ahmed; Pucci, Andrea; Santini, Ferruccio; Karra, Efthimia; Querci, Giorgia; Pelosini, Caterina; McCarthy, Mark I.; Lindgren, Cecilia M.; Batterham, Rachel L.

    2013-01-01

    The prevalence of severe obesity, defined as body mass index (BMI) ≥35.0 kg/m2, is rising rapidly. Given the disproportionately high health burden and healthcare costs associated with this condition, understanding the underlying aetiology, including predisposing genetic factors, is a biomedical research priority. Previous studies have suggested that severe obesity represents an extreme tail of the population BMI variation, reflecting shared genetic factors operating across the spectrum. Here, we sought to determine whether a panel of 32 known common obesity-susceptibility variants contribute to severe obesity in patients (n = 1,003, mean BMI 48.4±8.1 kg/m2) attending bariatric surgery clinics in two European centres. We examined the effects of these 32 common variants on obesity risk and BMI, both as individual markers and in combination as a genetic risk score, in a comparison with normal-weight controls (n = 1,809, BMI 18.0–24.9 kg/m2); an approach which, to our knowledge, has not been previously undertaken in the setting of a bariatric clinic. We found strong associations with severe obesity for SNP rs9939609 within the FTO gene (P = 9.3×10−8) and SNP rs2815752 near the NEGR1 gene (P = 3.6×10−4), and directionally consistent nominal associations (P<0.05) for 12 other SNPs. The genetic risk score associated with severe obesity (P = 8.3×10−11) but, within the bariatric cohort, this score did not associate with BMI itself (P = 0.264). Our results show significant effects of individual BMI-associated common variants within a relatively small sample size of bariatric patients. Furthermore, the burden of such low-penetrant risk alleles contributes to severe obesity in this population. Our findings support that severe obesity observed in bariatric patients represents an extreme tail of the population BMI variation. Moreover, future genetic studies focused on bariatric patients may provide valuable insights into the pathogenesis of

  5. Inter-laboratory variation in the chemical analysis of acidic forest soil reference samples from eastern North America

    Treesearch

    D.S. Ross; S.W. Bailey; R.D. Briggs; J. Curry; I.J. Fernandez; G. Fredriksen; C.L. Goodale; P.W. Hazlett; P.R. Heine; C.E. Johnson; J.T. Larson; G.B. Lawrence; R.K. Kolka; R. Ouimet; D. Pare; D. deB. Richter; C.D. Schirmer; R.A. Warby

    2015-01-01

    Long-term forest soil monitoring and research often requires a comparison of laboratory data generated at different times and in different laboratories. Quantifying the uncertainty associated with these analyses is necessary to assess temporal changes in soil properties. Forest soil chemical properties, and methods to measure these properties, often differ from...

  6. Optimisation of an analytical method and results from the inter-laboratory comparison of the migration of regulated substances from food packaging into the new mandatory European Union simulant for dry foodstuffs.

    PubMed

    Jakubowska, Natalia; Beldì, Giorgia; Peychès Bach, Aurélie; Simoneau, Catherine

    2014-01-01

    This paper presents the outcome of the development, optimisation and validation at European Union level of an analytical method for using poly(2,6-diphenyl phenylene oxide--PPPO), which is stipulated in Regulation (EU) No. 10/2011, as food simulant E for testing specific migration from plastics into dry foodstuffs. Two methods for fortifying respectively PPPO and a low-density polyethylene (LDPE) film with surrogate substances that are relevant to food contact were developed. A protocol for cleaning the PPPO and an efficient analytical method were developed for the quantification of butylhydroxytoluene (BHT), benzophenone (BP), diisobutylphthalate (DiBP), bis(2-ethylhexyl) adipate (DEHA) and 1,2-cyclohexanedicarboxylic acid, diisononyl ester (DINCH) from PPPO. A protocol for a migration test from plastics using small migration cells was also developed. The method was validated by an inter-laboratory comparison (ILC) with 16 national reference laboratories for food contact materials in the European Union. This allowed for the first time data to be obtained on the precision and laboratory performance of both migration and quantification. The results showed that the validation ILC was successful even when taking into account the complexity of the exercise. The results showed that the method performance was 7-9% repeatability standard deviation (rSD) for most substances (regardless of concentration), with 12% rSD for the high level of BHT and for DiBP at very low levels. The reproducibility standard deviation results for the 16 European Union laboratories were in the range of 20-30% for the quantification from PPPO (for the three levels of concentrations of the five substances) and 15-40% from migration experiments from the fortified plastic at 60°C for 10 days and subsequent quantification. Considering the lack of data previously available in the literature, this work has demonstrated that the validation of a method is possible both for migration from a film and for

  7. Nutritional status, nutrient intake and use of enzyme supplements in paediatric patients with Cystic Fibrosis; a European multicentre study with reference to current guidelines.

    PubMed

    Calvo-Lerma, Joaquim; Hulst, Jessie M; Asseiceira, Inês; Claes, Ine; Garriga, Maria; Colombo, Carla; Fornés, Victoria; Woodcock, Sandra; Martins, Tiago; Boon, Mieke; Ruperto, Mar; Walet, Sylvia; Speziali, Chiara; Witters, Peter; Masip, Etna; Barreto, Celeste; de Boeck, Kris; Ribes-Koninckx, Carmen

    2017-07-01

    The New European guidelines have established the most updated recommendations on nutrition and pancreatic enzyme replacement therapy (PERT) in CF. In the context of MyCyFAPP project - a European study in children with CF aimed at developing specific tools for improvement of self-management - the objective of the current study was to assess nutritional status, daily energy and macronutrient intake, and PERT dosing with reference to these new guidelines. Cross sectional study in paediatric patients with CF from 6 European centres. SD-scores for weight-for-age (WFA), height-for-age (HFA) and body mass index-for-age (BMI) were obtained. Through a specific 4-day food and enzyme-dose record, energy and macronutrients intake and PERT-use (LU/g lipids) were automatically calculated by the MyCyFAPP system. Comparisons were made using linear regression models. The lowest quartiles for BMI and HFA were between 0 and -1SD in all the centres with no significant differences, and 33.5% of the patients had a SD-score <0 for all three parameters. The minimum energy intake recommendation was not reached by 40% of the children and mean nutrients intake values were 14%, 51% and 34% of the total energy for protein, carbohydrates and lipids respectively. When assessed per centre, reported PERT doses were in the recommended range in only 13.8% to 46.6% of the patients; from 5.6% up to 82.7% of children were above the recommended doses and 3.3% to 75% were below. Among the 6 centres, a large variability and inconsistency with new guidelines on nutrition and PERT-use was found. Our findings document the lack of a general criterion to adjust PERT and suggest the potential benefit of educational and self-managerial tools to ensure adherence to therapies, both for clinical staff and families. They will be taken into account when developing these new tools during the next stages of MyCyFAPP Project. Copyright © 2017 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights

  8. Use of diagnostic accuracy as a metric for evaluating laboratory proficiency with microarray assays using mixed-tissue RNA reference samples.

    PubMed

    Pine, P S; Boedigheimer, M; Rosenzweig, B A; Turpaz, Y; He, Y D; Delenstarr, G; Ganter, B; Jarnagin, K; Jones, W D; Reid, L H; Thompson, K L

    2008-11-01

    Effective use of microarray technology in clinical and regulatory settings is contingent on the adoption of standard methods for assessing performance. The MicroArray Quality Control project evaluated the repeatability and comparability of microarray data on the major commercial platforms and laid the groundwork for the application of microarray technology to regulatory assessments. However, methods for assessing performance that are commonly applied to diagnostic assays used in laboratory medicine remain to be developed for microarray assays. A reference system for microarray performance evaluation and process improvement was developed that includes reference samples, metrics and reference datasets. The reference material is composed of two mixes of four different rat tissue RNAs that allow defined target ratios to be assayed using a set of tissue-selective analytes that are distributed along the dynamic range of measurement. The diagnostic accuracy of detected changes in expression ratios, measured as the area under the curve from receiver operating characteristic plots, provides a single commutable value for comparing assay specificity and sensitivity. The utility of this system for assessing overall performance was evaluated for relevant applications like multi-laboratory proficiency testing programs and single-laboratory process drift monitoring. The diagnostic accuracy of detection of a 1.5-fold change in signal level was found to be a sensitive metric for comparing overall performance. This test approaches the technical limit for reliable discrimination of differences between two samples using this technology. We describe a reference system that provides a mechanism for internal and external assessment of laboratory proficiency with microarray technology and is translatable to performance assessments on other whole-genome expression arrays used for basic and clinical research.

  9. Construction of Ag/AgCl Reference Electrode from Used Felt-Tipped Pen Barrel for Undergraduate Laboratory

    ERIC Educational Resources Information Center

    Inamdar, Shaukatali N.; Bhat, Mohsin A.; Haram, Santosh K.

    2009-01-01

    A reference electrode is one of the prerequisites of electrochemical investigations. Many electrodes are commercially available but are expensive and prone to accidental breakage by students. Here we report a simple, easy-to-fabricate, inexpensive, reliable, unbreakable, and reproducible Ag/AgCl reference electrode. The empty barrel of a…

  10. Construction of Ag/AgCl Reference Electrode from Used Felt-Tipped Pen Barrel for Undergraduate Laboratory

    ERIC Educational Resources Information Center

    Inamdar, Shaukatali N.; Bhat, Mohsin A.; Haram, Santosh K.

    2009-01-01

    A reference electrode is one of the prerequisites of electrochemical investigations. Many electrodes are commercially available but are expensive and prone to accidental breakage by students. Here we report a simple, easy-to-fabricate, inexpensive, reliable, unbreakable, and reproducible Ag/AgCl reference electrode. The empty barrel of a…

  11. Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA).

    PubMed

    Simundic, Ana-Maria; Cornes, Michael; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Kovalevskaya, Svjetlana; Sprongl, Ludek; Sumarac, Zorica; Church, Stephen

    2013-08-01

    European questionnaire survey was conducted by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PA) to assess how phlebotomy is performed in EFLM countries, including differences in personnel, level of education and skills, and to investigate the presence and compliance of national phlebotomy guidelines on this matter. A questionnaire was constructed containing questions elucidating different aspects of the organization behind the phlebotomy praxis on a national basis, including questions on the staff performing phlebotomy, the education of these staff members, and the existence of and adherence to national guidelines. All 39 EFLM member countries were invited to participate. In total 28/39 (72%) EFLM member countries responded. Seven out of the 28 (25%) have national phlebotomy guidelines and five have implemented other guidelines. The estimated compliance with phlebotomy guidance for the laboratories in the countries that have national guidelines available is poor, regardless to whether the phlebotomy was under the laboratory control or not. Most countries were interested in EFLM guidelines and to participate in a pilot EFLM preanalytical phase external quality assessment (EQA) scheme. In the responding EFLM member countries, the majority of phlebotomy is performed by nurses and laboratory technicians. Their basic education is generally 4-5 years of high school, followed by 2-5 years of colleague or university studies. Only a third (10/28; 36%) of the participating member countries has any specific training available as a continuous educational resource. A specific training for phlebotomy is not part of the education required to become qualified in 6/28 (21%) and 9/28 (32%) of countries for nurses and laboratory technicians, respectively. In countries and professions where training is required, most require more than 5 h of training. Based on the results of this survey we conclude the

  12. Multianalyte Conventional Reference Material (MacRM): A Useful Tool for Nationwide Standardization of Laboratory Measurements for Medical Care-A Model Study in Japan.

    PubMed

    Shinohara, Katsuyuki; Hamasaki, Naotaka; Takagi, Yasushi; Yatomi, Yutaka; Kikuchi, Hiroshi; Hosogaya, Shigemi; Kawai, Yohko; Miyachi, Hayato; Kaneko, Kenji; Miyajima, Yoshifumi; Matsumoto, Hiroyuki; Yamamoto, Yoshikazu; Iwagami, Miyuki; Osawa, Susumu; Umeda, Mamoru; Koide, Hirofumi; Yoshimura, Daisuke; Kato, Hideo

    2016-02-01

    The Japanese Committee for Clinical Laboratory Standards (JCCLS) has developed a multianalyte conventional reference material (MacRM) for nationwide standardization of laboratory measurements. To prepare the MacRM, pooled sera were obtained from healthy Japanese individuals. Target values of the pooled sera for 30 analytes were assigned on the basis of the measurement results of 45 certified clinical laboratories whose calibration was verified by measuring certified reference materials (CRMs) provided by the National Institute of Standards and Technology, the Institute for Reference Materials and Measurements, and JCCLS. Commutability of MacRM was assessed by comparison with results for 150 individual inpatients at Fukuoka University Chikushi Hospital. Survey samples were prepared by essentially the same method for MacRM but without target values. The survey samples were used to assess agreement among 165 laboratories that used various assay kits and platforms calibrated with the MacRM. The commutability of MacRM was confirmed for 30 analytes with sera from 150 individual patients. The imprecision (CV) of measurements of survey samples (high and low concentrations) among the 165 laboratories was 0.4%-10.0%. Twenty-six of 30 analytes were within the goals for interinstitutional allowable bias. An aliquot of MacRM stored frozen at -80 °C remained stable for ≥4 years. The MacRM was successfully applied as a calibrator to achieve nationwide standardization for 30 analytes measured by 165 laboratories that used various methods from different manufacturers. © 2015 American Association for Clinical Chemistry.

  13. ASVCP quality assurance guidelines: external quality assessment and comparative testing for reference and in-clinic laboratories.

    PubMed

    Camus, Melinda S; Flatland, Bente; Freeman, Kathleen P; Cruz Cardona, Janice A

    2015-12-01

    The purpose of this document is to educate providers of veterinary laboratory diagnostic testing in any setting about comparative testing. These guidelines will define, explain, and illustrate the importance of a multi-faceted laboratory quality management program which includes comparative testing. The guidelines will provide suggestions for implementation of such testing, including which samples should be tested, frequency of testing, and recommendations for result interpretation. Examples and a list of vendors and manufacturers supplying control materials and services to veterinary laboratories are also included. © 2015 American Society for Veterinary Clinical Pathology.

  14. Equilibrium of vegetation and climate at the European rear edge. A reference for climate change planning in mountainous Mediterranean regions.

    PubMed

    Ruiz-Labourdette, Diego; Martínez, Felipe; Martín-López, Berta; Montes, Carlos; Pineda, Francisco D

    2011-05-01

    Mediterranean mountains harbour some of Europe's highest floristic richness. This is accounted for largely by the mesoclimatic variety in these areas, along with the co-occurrence of a small area of Eurosiberian, Boreal and Mediterranean species, and those of Tertiary Subtropical origin. Throughout the twenty-first century, we are likely to witness a climate change-related modification of the biogeographic scenario in these mountains, and there is therefore a need for accurate climate regionalisations to serve as a reference of the abundance and distribution of species and communities, particularly those of a relictic nature. This paper presents an objective mapping method focussing on climate regions in a mountain range. The procedure was tested in the Cordillera Central Mountains of the Iberian Peninsula, in the western Mediterranean, one of the ranges occupying the largest area of the Mediterranean Basin. This regionalisation is based upon multivariate analyses and upon detailed cartography employing 27 climatic variables. We used spatial interpolation of data based on geographic information. We detected high climatic diversity in the mountain range studied. We identified 13 climatic regions, all of which form a varying mosaic throughout the annual temperature and rainfall cycle. This heterogeneity results from two geographically opposed gradients. The first one is the Mediterranean-Euro-Siberian variation of the mountain range. The second gradient involves the degree of oceanicity, which is negatively related to distance from the Atlantic Ocean. The existing correlation between the climatic regions detected and the flora existing therein enables the results to be situated within the projected trends of global warming, and their biogeographic and ecological consequences to be analysed.

  15. The quality of the extra-analytical phase of laboratory practice in some developing European countries and Mexico - a multicentric study.

    PubMed

    Simundic, Ana-Maria; Bilic-Zulle, Lidija; Nikolac, Nora; Supak-Smolcic, Vesna; Honovic, Lorena; Avram, Sanja; Beregovaja, Elena; Dobreanu, Minodora; Guimaraes, Joao-Tiago; Kovacs, Gabor L; Singh, Nada Majkic; Sierra-Amor, Rosa Isabel; Sypniewska, Grazyna; Zima, Tomas

    2011-02-01

    This cross-sectional multicentric survey study aimed to assess the quality of the extra-analytical phase of laboratory activities in some developing European countries and Mexico. We assessed the quality of the extra-analytical practices in participating laboratories regarding the: a) sample acceptance criteria; b) phlebotomy procedures; c) test results reporting and d) recording non-conformities. A survey was performed during the April-May 2009. A total of 15 clinical laboratories from the following countries were included: Bosnia, Croatia, Czech Republic, Hungary, Mexico, Poland, Portugal, Romania, Serbia and Ukraine. Questions were scored (scores from 1-4) and average scores was calculated for each category. The overall score for all respondents (n = 443) was 3.10 ± 0.33. The average score was 3.11 ± 0.56 for sample acceptance criteria, 2.76 ± 0.58 for phlebotomy and 3.34 ± 0.53, for test results reporting (F = 116.49; p < 0.001). Laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures (F = 16.62; p < 0.001). Moreover, the highest scores for sample acceptance criteria (F = 8.32; p < 0.001), phlebotomy procedures (F = 13.28; p < 0.001) and for reporting non-conformities (F = 33.62; p < 0.001) were observed for accredited laboratories or laboratories under preparation for accreditation. The overall quality of the extra-analytical practices in countries in this survey is not satisfactory. Phlebotomy practices are the most critical extra-analytical activity. Since laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures, we believe that the most significant improvement could be made by implementing the total quality management system and standardizing laboratory procedures.

  16. The Kjeldahl method as a primary reference procedure for total protein in certified reference materials used in clinical chemistry. I. A review of Kjeldahl methods adopted by laboratory medicine.

    PubMed

    Chromý, Vratislav; Vinklárková, Bára; Šprongl, Luděk; Bittová, Miroslava

    2015-01-01

    We found previously that albumin-calibrated total protein in certified reference materials causes unacceptable positive bias in analysis of human sera. The simplest way to cure this defect is the use of human-based serum/plasma standards calibrated by the Kjeldahl method. Such standards, commutative with serum samples, will compensate for bias caused by lipids and bilirubin in most human sera. To find a suitable primary reference procedure for total protein in reference materials, we reviewed Kjeldahl methods adopted by laboratory medicine. We found two methods recommended for total protein in human samples: an indirect analysis based on total Kjeldahl nitrogen corrected for its nonprotein nitrogen and a direct analysis made on isolated protein precipitates. The methods found will be assessed in a subsequent article.

  17. Operational Definition of Active and Healthy Aging (AHA): The European Innovation Partnership (EIP) on AHA Reference Site Questionnaire: Montpellier October 20-21, 2014, Lisbon July 2, 2015.

    PubMed

    Bousquet, Jean; Malva, Joao; Nogues, Michel; Mañas, Leocadio Rodriguez; Vellas, Bruno; Farrell, John

    2015-12-01

    A core operational definition of active and healthy aging (AHA) is needed to conduct comparisons. A conceptual AHA framework proposed by the European Innovation Partnership on Active and Healthy Ageing Reference Site Network includes several items such as functioning (individual capability and underlying body systems), well-being, activities and participation, and diseases (including noncommunicable diseases, frailty, mental and oral health disorders). The instruments proposed to assess the conceptual framework of AHA have common applicability and availability attributes. The approach includes core and optional domains/instruments depending on the needs and the questions. A major common domain is function, as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). WHODAS 2.0 can be used across all diseases and healthy individuals. It covers many of the AHA dimensions proposed by the Reference Site network. However, WHODAS 2.0 does not include all dimensions proposed for AHA assessment. The second common domain is health-related quality of life (HRQoL). A report of the AHA questionnaire in the form of a spider net has been proposed to facilitate usual comparisons across individuals and groups of interest. Copyright © 2015. Published by Elsevier Inc.

  18. The role of European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase in standardization and harmonization of the preanalytical phase in Europe.

    PubMed

    Cornes, Michael P; Church, Stephen; van Dongen-Lases, Edmée; Grankvist, Kjell; Guimarães, João T; Ibarz, Mercedes; Kovalevskaya, Svetlana; Kristensen, Gunn Bb; Lippi, Giuseppe; Nybo, Mads; Sprongl, Ludek; Sumarac, Zorica; Simundic, Ana-Maria

    2016-09-01

    Patient safety is a leading challenge in healthcare and from the laboratory perspective it is now well established that preanalytical errors are the major contributor to the overall rate of diagnostic and therapeutic errors. To address this, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase (EFLM WG-PRE) was established to lead in standardization and harmonization of preanalytical policies and practices at a European level. One of the key activities of the WG-PRE is the organization of the biennial EFLM-BD conference on the preanalytical phase to provide a forum for National Societies (NS) to discuss their issues. Since 2012, a year after the first Preanalytical phase conference, there has been a rapid growth in the number of NS with a working group engaged in preanalytical phase activities and there are now at least 19 countries that have one. As a result of discussions with NS at the third conference held in March 2015 five key areas were identified as requiring harmonisation. These were test ordering, sample transport and storage, patient preparation, sampling procedures and management of unsuitable specimens. The article below summarises the work that has and will be done in these areas. The goal of this initiative is to ensure the EFLM WG-PRE produces work that meets the needs of the European laboratory medicine community. Progress made in the identified areas will be updated at the next preanalytical phase conference and show that we have produced guidance that has enhanced standardisation in the preanalytical phase and improved patient safety throughout Europe. © The Author(s) 2016.

  19. “Are my Laboratory Results Normal?” Considerations to be Made Concerning Reference Intervals and Decision Limits

    PubMed Central

    Ceriotti, Ferruccio; Henny, Joseph

    2008-01-01

    This paper looks at the topic of reference intervals from the point of view of the patient or the clinician. The differences between the concepts of reference intervals (biological characteristic of a well defined population) and the various types of decision limits are illustrated and discussed. Decision limits can be defined in different ways: based on a Bayesian approach, on epidemiological studies or on clinical experience, but differ from reference intervals because, while the latter deals with physiology, decision limits are related to some kind of disease or risk of developing it. PMID:27683305

  20. Using European travellers as an early alert to detect emerging pathogens in countries with limited laboratory resources

    PubMed Central

    Guerin, Philippe J; Grais, Rebecca Freeman; Rottingen, John Arne; Valleron, Alain Jacques

    2007-01-01

    Background The volume, extent and speed of travel have dramatically increased in the past decades, providing the potential for an infectious disease to spread through the transportation network. By collecting information on the suspected place of infection, existing surveillance systems in industrialized countries may provide timely information for areas of the world without adequate surveillance currently in place. We present the results of a case study using reported cases of Shigella dysenteriae serotype 1 (Sd1) in European travellers to detect "events" of Sd1, related to either epidemic cases or endemic cases in developing countries. Methods We identified papers from a Medline search for reported events of Sd1 from 1940 to 2002. We requested data on shigella infections reported to the responsible surveillance entities in 17 European countries. Reports of Sd1 from the published literature were then compared with Sd1 notified cases among European travellers from 1990 to 2002. Results Prior to a large epidemic in 1999–2000, no cases of Sd1 had been identified in West Africa. However, if travellers had been used as an early warning, Sd1 could have been identified in this region as earlier as 1992. Conclusion This project demonstrates that tracking diseases in European travellers could be used to detect emerging disease in developing countries. This approach should be further tested with a view to the continuous improvement of national health surveillance systems and existing European networks, and may play a significant role in aiding the international public health community to improve infectious disease control. PMID:17239228

  1. Hematology and Plasma Chemistry Reference Intervals for Mature Laboratory Pine Voles (Microtus pinetorum) as Determined by Using the Nonparametric Rank Percentile Method

    PubMed Central

    Harvey, Stephen B; Krimer, Paula M; Correa, Maria T; Hanes, Martha A

    2008-01-01

    Plasma biochemical and hematologic values are important parameters for assessing animal health and experimental results. Although normal reference values for many rodent species have been published, there is a dearth of similar information for the genus Microtus. In addition, most studies use a mean and standard deviation to establish reference intervals, but doing so is not the recommendation of the Clinical and Laboratory Standards Institute (formerly the National Committee on Clinical Laboratory Standards) or the International Federation of Clinical Chemistry and Laboratory Medicine. The purpose of this study was to establish normal reference parameters for plasma biochemistry and hematology in mature pine voles (Microtus pinetorum) by using the nonparametric rank percentile method as recommended by the 2 laboratory medicine organizations mentioned. Samples of cardiac blood from a closed colony of pine voles were collected at euthanasia and evaluated under rodent settings on 2 automated hematology analyzers from 2 different manufacturers and on the same type of automated biochemistry analyzer. There were no sex-associated clinically significant differences between the sexes; younger animals had a lower hematocrit, higher mean corpuscular volume, and lower mean corpuscular hemoglobin concentration than did older animals. Only platelet counts differed when comparing hematologic values from different analyzers. Relative to rats and mice, pine voles have a lower mean corpuscular volume and higher red blood cell count, higher blood urea nitrogen, much higher alanine aminotransferase, and lower glucose and phosphorous concentrations. Hematology and plasma biochemical results obtained in this study are considered representative for healthy adult laboratory pine voles under similar environmental conditions. PMID:18702449

  2. Hematology and plasma chemistry reference intervals for mature laboratory pine voles (Microtus pinetorum) as determined by using the nonparametric rank percentile method.

    PubMed

    Harvey, Stephen B; Krimer, Paula M; Correa, Maria T; Hanes, Martha A

    2008-07-01

    Plasma biochemical and hematologic values are important parameters for assessing animal health and experimental results. Although normal reference values for many rodent species have been published, there is a dearth of similar information for the genus Microtus. In addition, most studies use a mean and standard deviation to establish reference intervals, but doing so is not the recommendation of the Clinical and Laboratory Standards Institute (formerly the National Committee on Clinical Laboratory Standards) or the International Federation of Clinical Chemistry and Laboratory Medicine. The purpose of this study was to establish normal reference parameters for plasma biochemistry and hematology in mature pine voles (Microtus pinetorum) by using the nonparametric rank percentile method as recommended by the 2 laboratory medicine organizations mentioned. Samples of cardiac blood from a closed colony of pine voles were collected at euthanasia and evaluated under rodent settings on 2 automated hematology analyzers from 2 different manufacturers and on the same type of automated biochemistry analyzer. There were no sex-associated clinically significant differences between the sexes; younger animals had a lower hematocrit, higher mean corpuscular volume, and lower mean corpuscular hemoglobin concentration than did older animals. Only platelet counts differed when comparing hematologic values from different analyzers. Relative to rats and mice, pine voles have a lower mean corpuscular volume and higher red blood cell count, higher blood urea nitrogen, much higher alanine aminotransferase, and lower glucose and phosphorous concentrations. Hematology and plasma biochemical results obtained in this study are considered representative for healthy adult laboratory pine voles under similar environmental conditions.

  3. The Asian project for collaborative derivation of reference intervals: (2) results of non-standardized analytes and transference of reference intervals to the participating laboratories on the basis of cross-comparison of test results.

    PubMed

    Ichihara, Kiyoshi; Ceriotti, Ferruccio; Kazuo, Mori; Huang, Yang-Yang; Shimizu, Yoshihisa; Suzuki, Haruki; Kitagawa, Masami; Yamauchi, Kazuyoshi; Hayashi, Sadao; Tsou, Chia-Chun; Yamamoto, Yoshikazu; Ishida, Shigeo; Leong, Linda; Sano, Michitaka; Lim, Hwan Sub; Suwabe, Akira; Woo, Hee-Yeon; Kojima, Keiya; Okubo, Yoshio

    2013-07-01

    The 2009 Asian multicenter study for derivation of reference intervals (RIs) featured: 1) centralized measurements to exclude reagent-dependent variations; 2) inclusion of non-standardized analytes (hormones, tumor makers, etc.) in the target; and 3) cross-check of test results between the central and local laboratories. Transferability of centrally derived RIs for non-standardized analytes based on the cross-check was examined. Forty non-standardized analytes were centrally measured in sera from 3541 reference individuals recruited by 63 laboratories. Forty-four laboratories collaborated in the cross-check study by locally measuring aliquots of sera from 9 to 73 volunteers (average 22.2). Linear relationships were obtained by the major-axis regression. Error in converting RIs using the regression line was expressed by the coefficient of variation of slope b [CV(b)]. CV(b) <10% was set as the cut-off value allowing the conversion. The significance of factors for partitioning RIs was determined similarly as in the first report. Significant sex-, age-, and region-related changes in test results were observed in 17, 15, and 11 of the 40 analytes, respectively. In the cross-comparison study, test results were not harmonized in the majority of immunologically measured analytes, but their average CV(b)s were <10% except for total protein, cystatin C, CA19-9, free thyroxine, and triiodothyronine. After conversion, 74% of centrally derived RIs were transferred to each local laboratory. Our results point to the feasibility of: 1) harmonizing test results across different laboratories; and 2) sharing centrally derived RIs of non-standardized analytes by means of comparative measurement of a set of commutable specimens.

  4. Preparation and certification of two new bulk welding fume reference materials for use in laboratories undertaking analysis of occupational hygiene samples.

    PubMed

    Butler, Owen; Musgrove, Darren; Stacey, Peter

    2014-01-01

    Workers can be exposed to fume, arising from welding activities, which contain toxic metals and metalloids. Occupational hygienists need to assess and ultimately minimize such exposure risks. The monitoring of the concentration of particles in workplace air is one assessment approach whereby fume, from representative welding activities, is sampled onto a filter and returned to a laboratory for analysis. Inductively coupled plasma-atomic emission spectrometry and inductively coupled plasma-mass spectrometry are generally employed as instrumental techniques of choice for the analysis of such filter samples. An inherent difficulty, however, with inductively coupled plasma-based analytical techniques is that they typically require a sample to be presented for analysis in the form of a solution. The efficiency of the required dissolution step relies heavily upon the skill and experience of the analyst involved. A useful tool in assessing the efficacy of this dissolution step would be the availability and subsequent analysis of welding fume reference materials with stated elemental concentrations and matrices that match as closely as possible the matrix composition of welding fume samples submitted to laboratories for analysis. This article describes work undertaken at the Health and Safety Laboratory to prepare and certify two new bulk welding fume reference materials that can be routinely used by analysts to assess the performance of the digestion procedures they employ in their laboratories.

  5. Preparation and Certification of Two New Bulk Welding Fume Reference Materials for Use in Laboratories Undertaking Analysis of Occupational Hygiene Samples

    PubMed Central

    Butler, Owen; Musgrove, Darren; Stacey, Peter

    2014-01-01

    Workers can be exposed to fume, arising from welding activities, which contain toxic metals and metalloids. Occupational hygienists need to assess and ultimately minimize such exposure risks. The monitoring of the concentration of particles in workplace air is one assessment approach whereby fume, from representative welding activities, is sampled onto a filter and returned to a laboratory for analysis. Inductively coupled plasma-atomic emission spectrometry and inductively coupled plasma-mass spectrometry are generally employed as instrumental techniques of choice for the analysis of such filter samples. An inherent difficulty, however, with inductively coupled plasma-based analytical techniques is that they typically require a sample to be presented for analysis in the form of a solution. The efficiency of the required dissolution step relies heavily upon the skill and experience of the analyst involved. A useful tool in assessing the efficacy of this dissolution step would be the availability and subsequent analysis of welding fume reference materials with stated elemental concentrations and matrices that match as closely as possible the matrix composition of welding fume samples submitted to laboratories for analysis. This article describes work undertaken at the Health and Safety Laboratory to prepare and certify two new bulk welding fume reference materials that can be routinely used by analysts to assess the performance of the digestion procedures they employ in their laboratories. PMID:24499055

  6. Examining the Role of Source Credibility and Reference Group Proximity on Personalized Normative Feedback Interventions for College Student Alcohol Use: A Randomized Laboratory Experiment.

    PubMed

    Hummer, Justin F; Davison, Gerald C

    2016-11-09

    Personalized normative feedback (PNF) interventions are designed to reduce misperceived drinking norms by delivering feedback regarding the actual drinking behavior of college students, thereby leading to subsequent reductions in one's own drinking. We examined the roles of data source credibility and reference group proximity in the effectiveness of a laboratory-based PNF intervention to reduce perceived drinking norms and thereby decrease intentions to drink. Following completion of an online preintervention survey and using a 2 (highly credible data source/low credible data source) × 2 (proximal reference group/distal reference group) between-subjects factorial design, 104 college student drinkers were randomly assigned to condition. Participants then completed a postintervention questionnaire to assess for changes in various aspects of drinking. Highly credible feedback was associated with greater reductions in perceived weekly drinking by American college students compared to feedback with low credibility. Similarly, more proximal than distal reference group feedback led to greater reductions in perceived weekly drinking by a same-gender/same-class year students at one's university. No condition effects emerged for intended drinks per week. PNF interventions may benefit from considering data source credibility and reference group proximity to reduce misperceptions of college student drinking, depending on the goals and resources of practitioners implementing such programs. Even the use of such a distal reference group as American college students can indeed lead to a reduction of normative perceptions provided there is an emphasis on the credibility of the data source.

  7. Reference intervals for plasma free metanephrines with an age adjustment for normetanephrine for optimized laboratory testing of phaeochromocytoma.

    PubMed

    Eisenhofer, Graeme; Lattke, Peter; Herberg, Maria; Siegert, Gabriele; Qin, Nan; Därr, Roland; Hoyer, Jana; Villringer, Arno; Prejbisz, Aleksander; Januszewicz, Andrzej; Remaley, Alan; Martucci, Victoria; Pacak, Karel; Ross, H Alec; Sweep, Fred C G J; Lenders, Jacques W M

    2013-01-01

    Measurements of plasma normetanephrine and metanephrine provide a useful diagnostic test for phaeochromocytoma, but this depends on appropriate reference intervals. Upper cut-offs set too high compromise diagnostic sensitivity, whereas set too low, false-positives are a problem. This study aimed to establish optimal reference intervals for plasma normetanephrine and metanephrine. Blood samples were collected in the supine position from 1226 subjects, aged 5-84 y, including 116 children, 575 normotensive and hypertensive adults and 535 patients in whom phaeochromocytoma was ruled out. Reference intervals were examined according to age and gender. Various models were examined to optimize upper cut-offs according to estimates of diagnostic sensitivity and specificity in a separate validation group of 3888 patients tested for phaeochromocytoma, including 558 with confirmed disease. Plasma metanephrine, but not normetanephrine, was higher (P < 0.001) in men than in women, but reference intervals did not differ. Age showed a positive relationship (P < 0.0001) with plasma normetanephrine and a weaker relationship (P = 0.021) with metanephrine. Upper cut-offs of reference intervals for normetanephrine increased from 0.47 nmol/L in children to 1.05 nmol/L in subjects over 60 y. A curvilinear model for age-adjusted compared with fixed upper cut-offs for normetanephrine, together with a higher cut-off for metanephrine (0.45 versus 0.32 nmol/L), resulted in a substantial gain in diagnostic specificity from 88.3% to 96.0% with minimal loss in diagnostic sensitivity from 93.9% to 93.6%. These data establish age-adjusted cut-offs of reference intervals for plasma normetanephrine and optimized cut-offs for metanephrine useful for minimizing false-positive results.

  8. Reference intervals for plasma free metanephrines with an age adjustment for normetanephrine for optimized laboratory testing of phaeochromocytoma

    PubMed Central

    Eisenhofer, Graeme; Lattke, Peter; Herberg, Maria; Siegert, Gabriele; Qin, Nan; Därr, Roland; Hoyer, Jana; Villringer, Arno; Prejbisz, Aleksander; Januszewicz, Andrzej; Remaley, Alan; Martucci, Victoria; Pacak, Karel; Ross, H Alec; Sweep, Fred C G J; Lenders, Jacques W M

    2016-01-01

    Background Measurements of plasma normetanephrine and metanephrine provide a useful diagnostic test for phaeochromocytoma, but this depends on appropriate reference intervals. Upper cut-offs set too high compromise diagnostic sensitivity, whereas set too low, false-positives are a problem. This study aimed to establish optimal reference intervals for plasma normetanephrine and metanephrine. Methods Blood samples were collected in the supine position from 1226 subjects, aged 5–84 y, including 116 children, 575 normotensive and hypertensive adults and 535 patients in whom phaeochromocytoma was ruled out. Reference intervals were examined according to age and gender. Various models were examined to optimize upper cut-offs according to estimates of diagnostic sensitivity and specificity in a separate validation group of 3888 patients tested for phaeochromocytoma, including 558 with confirmed disease. Results Plasma metanephrine, but not normetanephrine, was higher (P < 0.001) in men than in women, but reference intervals did not differ. Age showed a positive relationship (P < 0.0001) with plasma normetanephrine and a weaker relationship (P = 0.021) with metanephrine. Upper cut-offs of reference intervals for normetanephrine increased from 0.47 nmol/L in children to 1.05 nmol/L in subjects over 60 y. A curvilinear model for age-adjusted compared with fixed upper cut-offs for normetanephrine, together with a higher cut-off for metanephrine (0.45 versus 0.32 nmol/L), resulted in a substantial gain in diagnostic specificity from 88.3% to 96.0% with minimal loss in diagnostic sensitivity from 93.9% to 93.6%. Conclusions These data establish age-adjusted cut-offs of reference intervals for plasma normetanephrine and optimized cut-offs for metanephrine useful for minimizing false-positive results. PMID:23065528

  9. From the Cosmos to the Geosphere: the quest of four European Deep Underground Laboratories originally built for Astroparticle Physics to understand Global Environmental Change

    NASA Astrophysics Data System (ADS)

    Agrafioti, I.

    2014-12-01

    A number of deep underground laboratories exist around the world, all originally developed to advance our understanding of the Universe. They were built to host 'low-background' Astroparticle Physics experiments, needing to be shielded from interference produced by cosmic radiation. These unique infrastructures show great diversity in terms of depth, size, and geological and environmental characteristics. Over the last decade, the four European deep underground laboratories - LSM in France, LSC in Spain, LNGS in Italy and Boulby in the UK - supported by their funding agencies, have been making great efforts to get integrated into a single distributed research infrastructure. At the same time, they have been asking "how can our facilities, primarily built for Astroparticle Physics, be used to tackle global challenges?". Astroparticle Physicists have wide experience in forming long-term large international collaborations, developing innovative technologies, building unique facilities and organising data handling, reduction, storage and analysis: all of these were put to the disposal of scientists from other disciplines. As a result, a number of very interesting multidisciplinary projects have been hosted in the labs with excellent scientific results: geologists, climatologists, environmental scientists and biologists from academia and public authorities have all used these deep underground environments. Even more recently, the four European labs have decided to go one step further: in order to treat global challenges, global cooperation is necessary, so they are trying to unite the global deep underground science community around these multidisciplinary synergies. The objective of this talk is to present the bottom-up policy adopted by these world-leading European research infrastructures related to global environmental change, including some of the most interesting scientific results received so far (e.g. muon tide detector for continuous, passive monitoring of

  10. Virtual Visualisation Laboratory for Science and Mathematics Content (Vlab-SMC) with Special Reference to Teaching and Learning of Chemistry

    NASA Astrophysics Data System (ADS)

    Badioze Zaman, Halimah; Bakar, Norashiken; Ahmad, Azlina; Sulaiman, Riza; Arshad, Haslina; Mohd. Yatim, Nor Faezah

    Research on the teaching of science and mathematics in schools and universities have shown that available teaching models are not effective in instilling the understanding of scientific and mathematics concepts, and the right scientific and mathematics skills required for learners to become good future scientists (mathematicians included). The extensive development of new technologies has a marked influence on education, by facilitating the design of new learning and teaching materials, that can improve the attitude of learners towards Science and Mathematics and the plausibility of advanced interactive, personalised learning process. The usefulness of the computer in Science and Mathematics education; as an interactive communication medium that permits access to all types of information (texts, images, different types of data such as sound, graphics and perhaps haptics like smell and touch); as an instrument for problem solving through simulations of scientific and mathematics phenomenon and experiments; as well as measuring and monitoring scientific laboratory experiments. This paper will highlight on the design and development of the virtual Visualisation Laboratory for Science & Mathematics Content (VLab-SMC) based on the Cognitivist- Constructivist-Contextual development life cycle model as well as the Instructional Design (ID) model, in order to achieve its objectives in teaching and learning. However, this paper with only highlight one of the virtual labs within VLab-SMC that is, the Virtual Lab for teaching Chemistry (VLab- Chem). The development life cycle involves the educational media to be used, measurement of content, and the authoring and programming involved; whilst the ID model involves the application of the cognitivist, constructivist and contextual theories in the modeling of the modules of VLab-SMC generally and Vlab-Chem specifically, using concepts such as 'learning by doing', contextual learning, experimental simulations 3D and real

  11. The species accuracy of the Most Probable Number (MPN) European Union reference method for enumeration of Escherichia coli in marine bivalves.

    PubMed

    Grevskott, Didrik Hjertaker; Svanevik, Cecilie Smith; Wester, Astrid Louise; Lunestad, Bjørn Tore

    2016-12-01

    Continuous European Union programmes with specified methods for enumeration of Escherichia coli in bivalves for human consumption are currently running. The objective of this research was to examine the species accuracy of the five times three tube Most Probable Number (MPN) EU reference method used for detection of E. coli in marine bivalves. Among 549 samples of bivalves harvested from Norwegian localities during 2014 and 2015, a total number of 200 bacterial isolates were prepared from randomly selected culture-positive bivalves. These presumptive E. coli isolates were characterized biochemically by the Analytical Profile Index (API) 20E, as well as by Matrix Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS). The majority of isolates (90%) were identified as E. coli, by both API 20E and MALDI-TOF MS. Ten isolates (5%) were identified as Klebsiella pneumoniae, while one isolate was identified as K. oxytoca by both methods, whereas three isolates were identified as Acinetobacter baumannii, Citrobacter braakii, and Enterobacter cloacae, respectively. The identification of the remaining six isolates were not in compliance between the two methods. Copyright © 2016 Elsevier B.V. All rights reserved.

  12. [Report of the NEDO project "Research and development to promote the creation and utilization of an intellectual infrastructure: development of reference materials for laboratory medicine" "Development of pure substance-type certified reference materials"].

    PubMed

    Takatsu, Akiko

    2009-06-01

    There is an increasing demand to establish a metrological traceability system for in vitro diagnostics and medical devices. Pure substance-type reference materials are playing key roles in metrological traceability, because they form the basis for many traceability chains in chemistry. The National Metrology Institute of Japan (NMIJ), in the National Institute of Advanced Industrial Science and Technology (AIST), has been developing purity-certified reference materials (CRMs) in this field, such as cholesterol, creatinine, and urea. In the New Energy and Industrial Technology Development Organization (NEDO) project, entitled: "Research and Development to Promote the Creation and Utilization of an Intellectual Infrastructure: Development of Reference Materials for Laboratory Medicine", several pure substance-type CRMs were developed. For a pure protein solution CRM, amino acid analysis and nitrogen determination were chosen as the certification methods. The development and certification processes for the C-reactive protein (CRP) solution CRM were completed, with the recombinant human CRP solution as a candidate material. This CRP solution CRM is now available as NMIJ CRM. For cortisol CRM, a purified candidate material and highly pure primary reference material were prepared. Each impure compound in the materials was identified and quantified. The pure cortisol CRM will be available in 2009. These two CRMs provide a traceability link between routine clinical methods and the SI unit.

  13. Linking English-Language Test Scores onto the Common European Framework of Reference: An Application of Standard-Setting Methodology. TOEFL iBT Research Report TOEFL iBt-06. ETS RR-08-34

    ERIC Educational Resources Information Center

    Tannenbaum, Richard J.; Wylie, E. Caroline

    2008-01-01

    The Common European Framework of Reference (CEFR) describes language proficiency in reading, writing, speaking, and listening on a 6-level scale. In this study, English-language experts from across Europe linked CEFR levels to scores on three tests: the TOEFL® iBT test, the TOEIC® assessment, and the TOEIC "Bridge"™ test.…

  14. The measurement of haemostatic factors in 16 European laboratories: quality assessment for the Multicentre ECAT Angina Pectoris Study. Report from the European Concerted Action on Thrombosis and Disabilities (ECAT).

    PubMed

    Thompson, S G; Duckert, F; Haverkate, F; Thomson, J M

    1989-04-25

    As part of a European multicentre prospective study involving the measurement of a number of haemostatic factors, a quality assessment (QA) scheme was organized. This paper describes the preparation, design and results of the first QA exercise, involving 16 European laboratories and 10 haemostatic assays. The design allowed the investigation, for each assay, of the variability between duplicates and the variability between days within each centre, and of the agreement between centres. A graphical presentation of each centre's performance in comparison to that of others was adopted, which preserved the confidentiality of each centre's results. The factor VIII clotting activity assay (VIII:C) and the rocket immuno-electrophoresis assays of von Willebrand factor related antigen (vWF R:Ag), antithrombin III, protein C and histidine-rich glycoprotein showed the highest between-duplicate and between-day coefficients of variation (CVs), whereas the clotting assays of activated partial thromboplastin time and fibrinogen had the lowest CVs. CVs for the enzymatic assays using synthetic substrates of antithrombin III, plasminogen and alpha-2-antiplasmin were between these extremes. The between-centre CVs were high for both the VIII:C and vWF R:Ag assays. The QA exercise showed that, in multicentre studies involving the measurement of haemostatic factors, it is feasible to undertake analysis locally at each centre.

  15. Visceral fat reference values derived from healthy European men and women aged 20-30 years using GE Healthcare dual-energy x-ray absorptiometry

    PubMed Central

    Kucharski, Robert; Sołtysiak, Marta; Taszarek, Aleksandra; Miazgowski, Bartosz; Widecka, Krystyna

    2017-01-01

    Dual energy X-ray absorptiometry (DXA) is an established technique used in clinical and research settings to evaluate total and regional fat. Additionally, recently developed software allow to quantify visceral adipose tissue (VAT). Currently, there are no reference values available for GE Healthcare DXA systems for VAT. The aim of this study was to develop reference values for VAT in healthy European adults aged 20–30 years using a GE Healthcare Prodigy densitometer along with the dedicated CoreScan application. We also assessed the associations of VAT with traditional cardiometabolic risk factors. In 421 participants (207 men; 214 women), we performed DXA whole-body scans and calculated total body fat (BF) and VAT (in gender-specific percentiles). We also measured blood pressure and fasting glucose, insulin, and blood lipids. Males, in comparison with females, had 2-fold greater VAT both in units of mass (542 ± 451 g; 95% CI: 479.6‒605.1 g vs. 258 ± 226 g; 95% CI: 226.9‒288.6 g) and volume (570 ± 468 cm3; 95% CI: 505.1‒635.2 cm3 vs. 273 ± 237 cm3; 95% CI: 240.6‒305.3 cm3). They also had significantly higher the VAT/BF ratio. VAT showed a stronger positive correlation than BF with blood pressure, triglycerides, LDL-cholesterol, glucose, insulin, and homeostasis model assessment-insulin resistance index and a stronger negative correlation with HDL-cholesterol. Among these variables, VAT had the highest area under the curve for triglycerides ≥150 mg/dL (0.727 in males and 0.712 in females). In conclusion, we provide reference values for VAT obtained from healthy adults using the GE Healthcare DXA. These values may be useful in the diagnosis of visceral obesity, for identifying subjects with high obesity-related risks, in epidemiological studies, as a target for therapies, and in physically trained individuals. In both genders, VAT was associated with traditional cardiometabolic risk factors, particularly hypertriglyceridemia. PMID:28683146

  16. Visceral fat reference values derived from healthy European men and women aged 20-30 years using GE Healthcare dual-energy x-ray absorptiometry.

    PubMed

    Miazgowski, Tomasz; Kucharski, Robert; Sołtysiak, Marta; Taszarek, Aleksandra; Miazgowski, Bartosz; Widecka, Krystyna

    2017-01-01

    Dual energy X-ray absorptiometry (DXA) is an established technique used in clinical and research settings to evaluate total and regional fat. Additionally, recently developed software allow to quantify visceral adipose tissue (VAT). Currently, there are no reference values available for GE Healthcare DXA systems for VAT. The aim of this study was to develop reference values for VAT in healthy European adults aged 20-30 years using a GE Healthcare Prodigy densitometer along with the dedicated CoreScan application. We also assessed the associations of VAT with traditional cardiometabolic risk factors. In 421 participants (207 men; 214 women), we performed DXA whole-body scans and calculated total body fat (BF) and VAT (in gender-specific percentiles). We also measured blood pressure and fasting glucose, insulin, and blood lipids. Males, in comparison with females, had 2-fold greater VAT both in units of mass (542 ± 451 g; 95% CI: 479.6‒605.1 g vs. 258 ± 226 g; 95% CI: 226.9‒288.6 g) and volume (570 ± 468 cm3; 95% CI: 505.1‒635.2 cm3 vs. 273 ± 237 cm3; 95% CI: 240.6‒305.3 cm3). They also had significantly higher the VAT/BF ratio. VAT showed a stronger positive correlation than BF with blood pressure, triglycerides, LDL-cholesterol, glucose, insulin, and homeostasis model assessment-insulin resistance index and a stronger negative correlation with HDL-cholesterol. Among these variables, VAT had the highest area under the curve for triglycerides ≥150 mg/dL (0.727 in males and 0.712 in females). In conclusion, we provide reference values for VAT obtained from healthy adults using the GE Healthcare DXA. These values may be useful in the diagnosis of visceral obesity, for identifying subjects with high obesity-related risks, in epidemiological studies, as a target for therapies, and in physically trained individuals. In both genders, VAT was associated with traditional cardiometabolic risk factors, particularly hypertriglyceridemia.

  17. Comparison of results of fluconazole and voriconazole disk diffusion testing for Candida spp. with results from a central reference laboratory in the ARTEMIS DISK Global Antifungal Surveillance Program.

    PubMed

    Pfaller, Michael A; Boyken, Linda; Hollis, Richard J; Kroeger, Jennifer; Messer, Shawn A; Tendolkar, Shailesh; Diekema, Daniel J

    2009-09-01

    The accuracy of antifungal susceptibility testing is important for reliable resistance surveillance and for the clinical management of patients with serious infections due to Candida spp. Our primary objective was to compare the results of fluconazole and voriconazole disk diffusion testing of 3227 Candida spp. performed by 47 centers participating in the ARTEMIS program with disk diffusion and MIC results obtained by the central reference laboratory. The overall categoric agreement between participant disk diffusion test results and reference MIC results was 87% for fluconazole and 95.2% for voriconazole. Likewise good agreement was observed between participant disk diffusion test results and reference laboratory disk diffusion test results, with an agreement of 90.5%, 1% very major error (VME), and 3.4% major error (ME) for fluconazole and 94.2%, 1.1% VME, and 2.5% ME for voriconazole. The disk diffusion test was reliable for detecting those isolates of Candida spp. that were characterized as resistant to fluconazole and voriconazole by MIC testing. External quality assurance data obtained by surveillance programs such as the ARTEMIS Global Antifungal Surveillance Program ensure the generation of useful surveillance data and result in the continued improvement of antifungal susceptibility testing protocols.

  18. [Clinical, radiological and laboratory features of liver hydatidosis of patients from a hospital of national reference, Lima 1997-2010].

    PubMed

    Montúfar-Valer, Augudberto; Huapaya-Jurado, Francisco L

    2014-07-01

    To describe the clinical, laboratory and radiological features of patients with hepatic hydatid cyst treated at the department of general surgery of a national referral hospital in Lima (Peru). A cross-sectional study was performed, all patients diagnosed with hepatic hydatid cyst hospitalized between 1997 and 2010 were included. Sociodemographic data (age, sex, origin and usual activity), clinical, laboratory, radiographic and data referrals to treatment were collected. The most common symptom was abdominal pain (93.9%), while the most frequent sign was the increase in liver span (68.7%). 86.4% of patients had a leukocyte formulated within normal ranges, eosinophilia was only present in 25.9% of cases. The right hepatic lobe was the most affected (80%) and in 40.8% of patient's condition one segment was found. In 75.4% of patients the cysts were unique. The most frequent complications were: communication to the bile duct (48.9%), hydatid abscesses (32.6%), cholangitis (4%), hydatid cyst and broken more peritonitis (4%). The population more affected was young adults aged 30 to 39 years. The population studied lives mostly in the department of Lima, but come from departments where hepatic hydatid disease has been described as endemic. Although this population is mostly urban, epidemiological characteristics do not vary in relation to that described in previous research.

  19. Population-based characterization of the genetic landscape of chronic lymphocytic leukemia patients referred for cytogenetic testing in British Columbia, Canada: the role of provincial laboratory standardization.

    PubMed

    Gerrie, Alina S; Huang, Steven J T; Bruyere, Helene; Dalal, Chinmay; Hrynchak, Monica; Karsan, Aly; Ramadan, Khaled M; Smith, Adam C; Tyson, Christine; Toze, Cynthia L; Gillan, Tanya L

    2014-01-01

    Detection of recurrent chromosome abnormalities by fluorescence in situ hybridization (FISH) is an essential component of care in chronic lymphocytic leukemia (CLL) patients. In the province of British Columbia (BC), Canada, population 4.6 million, CLL patients receive uniform evaluation and therapy with FISH testing performed in three jurisdictions. The aims of this study were to (i) validate CLL-FISH testing among the BC cytogenetic laboratories to ensure standardization of results and (ii) characterize population-level CLL-FISH abnormalities by pooling provincial data. From 2004 to 2011, 585 consecutive patients underwent pretreatment CLL-FISH testing at laboratory A (50.1%), laboratory B (32.3%), or laboratory C (17.6%). For validation purposes, 26 CLL-FISH abnormalities were tested by each laboratory's protocol, with 91% result concordance. Discordant results involved percent abnormalities at or near cutoff values; therefore, a 10% universal cutoff was established when pooling results. Applying the universal cutoff to the provincial cohort, CLL-FISH abnormalities were detected in 74.9%: 54.9% 13q-, 18.8% +12, 8.5% 11q-, and 7.7% 17p-. In this large population-based cohort of patients referred for CLL-FISH testing, frequencies of abnormalities detected by FISH analysis were highly consistent with those reported in single-institution and clinical trial populations. Provinces or districts that work together to care for CLL patients can effectively pool data with appropriate laboratory validation to ensure standardization of results. Copyright © 2014 Elsevier Inc. All rights reserved.

  20. Comparison of point-of-care testing (POCT): i-STAT(®) international normalized ratio (INR) vs reference laboratory INR in pediatric patients undergoing major surgery.

    PubMed

    Spielmann, Nelly; Mauch, Jacqueline Y; Madjdpour, Caveh; Schmugge, Markus; Albisetti, Manuela; Weiss, Markus; Haas, Thorsten

    2011-10-01

    The aim of the study was to compare international normalized ratio (INR) results obtained by point-of-care testing (i-STAT® device) with the reference laboratory INR in children undergoing major surgery with expected significant blood loss.   Pediatric patients undergoing craniofacial, spine, hip, or cancer surgery were included. Blood samples for coagulation testing were tested at several intraoperative time points and generally withdrawn from the arterial catheter, if accessible. A volume of 1.4 ml citrated blood was used for the reference laboratory INR test, and 0.1 ml of blood was taken for the whole blood INR test using the i-STAT® device. Blood samples for both tests were withdrawn at the same time and immediately analyzed with both devices. A total of 169 paired blood samples were taken intraoperatively from 44 pediatric patients [IQR 0.9-10.7 years (median 3.3)]. Reference laboratory INR ranged from 0.96 to 3.43 (mean 1.40; sd 0.32) and INR of i-STAT® from 0.95 to 2.29 (mean 1.26; sd 0.22). The correlation coefficient was 0.83 (P < 0.001), and the bias values were 0.12 and 0.55 at the medical decision level of ≤2.0 and >2.0, respectively. In the perioperative setting, point-of-care INR testing in children using the i-STAT® device is a reliable and easy-to-handle method for INR values ≤2.0, while INR values >2.0 might be underestimated. © 2011 Blackwell Publishing Ltd.

  1. Reference intervals, longitudinal analyses, and index of individuality of commonly measured laboratory variables in captive bald eagles (Haliaeetus leucocephalus).

    PubMed

    Jones, Michael P; Arheart, Kristopher L; Cray, Carolyn

    2014-06-01

    The objectives of this study were to determine reference intervals, perform longitudinal analyses, and determine the index of individuality (IoI) of 8 hematologic, and 13 biochemical and electrophoretic variables for a group of captive bald eagles (Haliaeetus leucocephalus). Reference intervals were determined from blood samples collected during annual wellness examinations for 41 eagles (23 male and 18 female) with ages ranging between 6 and 43 years (18.7 +/- 7.4, mean +/- SD) at the time of sample collection. Longitudinal analyses and IoI were determined for measured hematologic, biochemical, and protein electrophoretic variables, both individually and as a group, for a subset of 16 eagles (10 male and 6 female) during a 12-year period. This smaller group of eagles ranged in age between 2 and 20 years at the start of the study period, and between 14 and 32 years (21.9 +/- 5.0, mean +/- SD) at the end of the study period. Significant increases with age within the group of 16 eagles were observed only for red blood cells, percent heterophils, total protein, and beta-globulin protein fraction, while albumin:globulin decreased significantly with age. A low IoI (> or = 1.4) was determined for all hematologic and biochemical variables except gamma globulins, which had high IoI (< or = 0.6) for 3 individuals within the subset of 16.

  2. Diagnostic reverse-transcription polymerase chain reaction kit for filoviruses based on the strain collections of all European biosafety level 4 laboratories.

    PubMed

    Panning, Marcus; Laue, Thomas; Olschlager, Stephan; Eickmann, Markus; Becker, Stephan; Raith, Sabine; Courbot, Marie-Claude Georges; Nilsson, Mikael; Gopal, Robin; Lundkvist, Ake; di Caro, Antonino; Brown, David; Meyer, Hermann; Lloyd, Graham; Kummerer, Beate M; Gunther, Stephan; Drosten, Christian

    2007-11-15

    A network of European biosafety level 4 laboratories has designed the first industry-standard molecular assay for all filoviruses species, based on the strain collections of all participants. It uses 5 optimized L gene primers and 3 probes, as well as an internal control with a separate detection probe. Detection limits (probit analysis, 95% detection chance) were as follows: Zaire ebolavirus, 487 copies/mL of plasma; Sudan ebolavirus Maleo, 586 copies/mL; Sudan ebolavirus Gulu, 1128 copies/mL; Cote d'Ivoire ebolavirus, 537 copies/mL; Reston ebolavirus, 4546 copies/mL; Lake Victoria marburgvirus Musoke, 860 copies/mL; and Lake Victoria marburgvirus Ravn, 1551 copies/mL. The assay facilitates reliable detection or exclusion screening of filovirus infections.

  3. Laboratory blood analysis in Strigiformes-Part I: hematologic reference intervals and agreement between manual blood cell counting techniques.

    PubMed

    Ammersbach, Mélanie; Beaufrère, Hugues; Gionet Rollick, Annick; Tully, Thomas

    2015-03-01

    While hematologic reference intervals (RI) are available for multiple raptorial species of the order Accipitriformes and Falconiformes, there is a lack of valuable hematologic information in Strigiformes that can be used for diagnostic and health monitoring purposes. The objective was to report RI in Strigiformes for hematologic variables and to assess agreement between manual cell counting techniques. A multi-center prospective study was designed to assess hematologic RI and blood cell morphology in owl species. Samples were collected from individuals representing 13 Strigiformes species, including Great Horned Owl, Snowy Owl, Eurasian Eagle Owl, Barred Owl, Great Gray Owl, Ural Owl, Northern Saw-Whet Owls, Northern Hawk Owl, Spectacled Owl, Barn Owl, Eastern Screech Owl, Long-Eared Owl, and Short-Eared Owl. Red blood cell count was determined manually using a hemocytometer. White blood cell count was determined using 3 manual counting techniques: (1) phloxine B technique, (2) Natt and Herrick technique, and (3) estimation from the smear. Differential counts and blood cell morphology were determined on smears. Reference intervals were determined and agreement between methods was calculated. Important species-specific differences were observed in blood cell counts and granulocyte morphology. Differences in WBC count between species did not appear to be predictable based on phylogenetic relationships. Overall, most boreal owl species exhibited a lower WBC count than other species. Important disagreements were found between different manual WBC counting techniques. Disagreements observed between manual counting techniques suggest that technique-specific RI should be used in Strigiformes. © 2015 American Society for Veterinary Clinical Pathology.

  4. Comparison of species-level identification and antifungal susceptibility results from diagnostic and reference laboratories for bloodstream Candida surveillance isolates, South Africa, 2009-2010.

    PubMed

    Naicker, Serisha D; Govender, Nevashan; Patel, Jaymati; Zietsman, Inge L; Wadula, Jeannette; Coovadia, Yacoob; Kularatne, Ranmini; Seetharam, Sharona; Govender, Nelesh P

    2016-11-01

    From February 2009 through August 2010, we compared species-level identification of bloodstream Candida isolates and susceptibility to fluconazole, voriconazole, and caspofungin between diagnostic and reference South African laboratories during national surveillance for candidemia. Diagnostic laboratories identified isolates to genus/species level and performed antifungal susceptibility testing, as indicated. At a reference laboratory, viable Candida isolates were identified to species-level using automated systems, biochemical tests, or DNA sequencing; broth dilution susceptibility testing was performed. Categorical agreement (CA) was calculated for susceptibility results of isolates with concordant species identification. Overall, 2172 incident cases were detected, 773 (36%) by surveillance audit. The Vitek 2 YST system (bioMérieux Inc, Marcy l'Etoile, France) was used for identification (360/863, 42%) and susceptibility testing (198/473, 42%) of a large proportion of isolates. For the five most common species (n = 1181), species-level identification was identical in the majority of cases (Candida albicans: 98% (507/517); Candida parapsilosis: 92% (450/488); Candida glabrata: 89% (89/100); Candida tropicalis: 91% (49/54), and Candida krusei: 86% (19/22)). However, diagnostic laboratories were significantly less likely to correctly identify Candida species other than C. albicans versus C. albicans (607/664, 91% vs. 507/517, 98%; P < .001). Susceptibility data were compared for isolates belonging to the five most common species and fluconazole, voriconazole, and caspofungin in 860, 580, and 99 cases, respectively. Diagnostic laboratories significantly under-reported fluconazole resistance in C. parapsilosis (225/393, 57% vs. 239/393, 61%; P < .001) but over-reported fluconazole non-susceptibility in C. albicans (36/362, 10% vs. 3/362, 0.8%; P < .001). Diagnostic laboratories were less likely to correctly identify Candida species other than C. albicans, under

  5. An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: 2nd round.

    PubMed

    Ehling, G; Hecht, M; Heusener, A; Huesler, J; Gamer, A O; van Loveren, H; Maurer, Th; Riecke, K; Ullmann, L; Ulrich, P; Vandebriel, R; Vohr, H-W

    2005-08-15

    The original local lymph node assay (LLNA) is based on the use of radioactive labelling to measure cell proliferation. Other endpoints for the assessment of proliferation are also authorized by the OECD Guideline 429 provided there is appropriate scientific support, including full citations and description of the methodology (OECD, 2002. OECD Guideline for the Testing of Chemicals; Skin Sensitization: Local Lymph Node Assay, Guideline 429. Paris, adopted 24th April 2002.). Here, we describe the outcome of the second round of an inter-laboratory validation of alternative endpoints in the LLNA conducted in nine laboratories in Europe. The validation study was managed and supervised by the Swiss Agency for Therapeutic Products (Swissmedic) in Bern. Ear-draining lymph node (LN) weight and cell counts were used to assess LN cell proliferation instead of [3H]TdR incorporation. In addition, the acute inflammatory skin reaction was measured by ear weight determination of circular biopsies of the ears to identify skin irritation properties of the test items. The statistical analysis was performed in the department of statistics at the university of Bern. Similar to the EC(3) values defined for the radioactive method, threshold values were calculated for the endpoints measured in this modification of the LLNA. It was concluded that all parameters measured have to be taken into consideration for the categorisation of compounds due to their sensitising potencies. Therefore, an assessment scheme has been developed which turned out to be of great importance to consistently assess sensitisation versus irritancy based on the data of the different parameters. In contrast to the radioactive method, irritants have been picked up by all the laboratories applying this assessment scheme.

  6. European Trends in the Development of Occupations and Qualifications. Findings of Research, Studies and Analyses for Policy and Practice. Volume II. CEDEFOP Reference Document.

    ERIC Educational Resources Information Center

    Sellin, Burkart, Ed.

    This document contains 23 papers on European trends in vocational education and training (VET) and the development of occupations and qualifications. The following papers are included: "Vocational Socialisation and Competence Development: The Historical Dimension" (Walter R. Heinz); "European Trends in the Development of Vocational…

  7. Fasting Is Not Routinely Required for Determination of a Lipid Profile: Clinical and Laboratory Implications Including Flagging at Desirable Concentration Cutpoints-A Joint Consensus Statement from the European Atherosclerosis Society and European Federation of Clinical Chemistry and Laboratory Medicine.

    PubMed

    Nordestgaard, Børge G; Langsted, Anne; Mora, Samia; Kolovou, Genovefa; Baum, Hannsjörg; Bruckert, Eric; Watts, Gerald F; Sypniewska, Grazyna; Wiklund, Olov; Borén, Jan; Chapman, M John; Cobbaert, Christa; Descamps, Olivier S; von Eckardstein, Arnold; Kamstrup, Pia R; Pulkki, Kari; Kronenberg, Florian; Remaley, Alan T; Rifai, Nader; Ros, Emilio; Langlois, Michel

    2016-07-01

    To critically evaluate the clinical implications of the use of non-fasting rather than fasting lipid profiles and to provide guidance for the laboratory reporting of abnormal non-fasting or fasting lipid profiles. Extensive observational data, in which random non-fasting lipid profiles have been compared with those determined under fasting conditions, indicate that the maximal mean changes at 1-6 h after habitual meals are not clinically significant [+0.3 mmol/L (26 mg/dL) for triglycerides; -0.2 mmol/L (8 mg/dL) for total cholesterol; -0.2 mmol/L (8 mg/dL) for LDL cholesterol; +0.2 mmol/L (8 mg/dL) for calculated remnant cholesterol; -0.2 mmol/L (8 mg/dL) for calculated non-HDL cholesterol]; concentrations of HDL cholesterol, apolipoprotein A1, apolipoprotein B, and lipoprotein(a) are not affected by fasting/non-fasting status. In addition, non-fasting and fasting concentrations vary similarly over time and are comparable in the prediction of cardiovascular disease. To improve patient compliance with lipid testing, we therefore recommend the routine use of non-fasting lipid profiles, whereas fasting sampling may be considered when non-fasting triglycerides are >5 mmol/L (440 mg/dL). For non-fasting samples, laboratory reports should flag abnormal concentrations as triglycerides ≥2 mmol/L (175 mg/dL), total cholesterol ≥5 mmol/L (190 mg/dL), LDL cholesterol ≥3 mmol/L (115 mg/dL), calculated remnant cholesterol ≥0.9 mmol/L (35 mg/dL), calculated non-HDL cholesterol ≥3.9 mmol/L (150 mg/dL), HDL cholesterol ≤1 mmol/L (40 mg/dL), apolipoprotein A1 ≤1.25 g/L (125 mg/dL), apolipoprotein B ≥1.0 g/L (100 mg/dL), and lipoprotein(a) ≥50 mg/dL (80th percentile); for fasting samples, abnormal concentrations correspond to triglycerides ≥1.7 mmol/L (150 mg/dL). Life-threatening concentrations require separate referral for the risk of pancreatitis when triglycerides are >10 mmol/L (880 mg/dL), for homozygous familial hypercholesterolemia when LDL cholesterol

  8. Trace Elements, With Special Reference to Mercury, in Fish Collected Upstream and Downstream of Los Alamos National Laboratory

    SciTech Connect

    P. R. Fresquez; J. D. Huchton; M. A. Mullen

    1999-11-01

    Trace elements (Ag, As, Ba, Be, Cr, Cd, Cu, Hg, Ni, Pb, Sb, Se, and Tl) were determined in muscle (fillet) of average sized fish (mostly carp, catfish, and sucker) collected from the confluences of major canyons that cross Los Alamos National Laboratory (LANL) lands with the Rio Grande (RG). Also, trace elements were determined in fish from reservoirs upstream (Abiquiu [AR]) and downstream (Cochiti [CR]) of LANL from 1991 through 1999. In general, all of the (mean) trace elements, including Hg, were either at the limits of detection (LOD) or in low concentrations at all study sites. Of the trace elements (e.g., Ba, Cu, and Hg) that were found to be above the LOD in fish muscle collected from LANL canyons/RG, none were in significantly higher (p < 0.05) concentrations than in muscle of fish collected from background locations. Mercury concentrations (mean of means) in fish from AR (all other trace elements were at LOD) were significantly higher (p < 0.10) than Hg concentrations in fish from CR, and Hg concentrations in fish collected from both reservoirs exhibited significantly (AR = p <0.05 and CR = p < 0.10) decreasing trends over time.

  9. Inter-laboratory comparison on the size and stability of monodisperse and bimodal synthetic reference particles for standardization of extracellular vesicle measurements

    NASA Astrophysics Data System (ADS)

    Nicolet, Anaïs; Meli, Felix; van der Pol, Edwin; Yuana, Yuana; Gollwitzer, Christian; Krumrey, Michael; Cizmar, Petr; Buhr, Egbert; Pétry, Jasmine; Sebaihi, Noham; de Boeck, Bert; Fokkema, Vincent; Bergmans, Rob; Nieuwland, Rienk

    2016-03-01

    In future, measurements of extracellular vesicles in body fluids could become a standard diagnostic tool in medicine. For this purpose, reliable and traceable methods, which can be easily applied in hospitals, have to be established. Within the European Metrological Research Project (EMRP) ‘Metrological characterization of micro-vesicles from body fluids as non-invasive diagnostic biomarkers’ (www.metves.eu), various nanoparticle reference materials were developed and characterized. We present results of an international comparison among four national metrology institutes and a university hospital. The size distributions of five monodisperse and two bimodal spherical particle samples with diameters ranging from 50 nm to 315 nm made out of silica and polystyrene were compared. Furthermore, the stability of the samples was verified over a period of 18 months. While monodisperse reference particle samples above a certain size level lead to good agreements of the size measurements among the different methods, small and bimodal samples show the limitations of current ‘clinical’ methods. All samples proved to be stable within the uncertainty of the applied methods.

  10. Development and single laboratory validation of an optical biosensor assay for tetrodotoxin detection as a tool to combat emerging risks in European seafood.

    PubMed

    Campbell, Katrina; Barnes, Paul; Haughey, Simon A; Higgins, Cowan; Kawatsu, Kentaro; Vasconcelos, Vitor; Elliott, Christopher T

    2013-09-01

    Tetrodotoxin (TTX) is a potent neurotoxin emerging in European waters due to increasing ocean temperatures. Its detection in seafood is currently performed as a consequence of using the Association of Analytical Communities (AOAC) mouse bioassay (MBA) for paralytic shellfish poisoning (PSP) toxins, but TTX is not monitored routinely in Europe. Due to ethical and performance-related issues associated with this bioassay, the European Commission has recently published directives extending procedures that may be used for official PSP control. An AOAC-accredited high-performance liquid chromatography (HPLC) method has now been accepted by the European Union as a first action screening method for PSP toxins to replace the MBA. However, this AOAC HPLC method is not capable of detecting TTX, so this potent toxin would be undetected; thereby, a separate method of analysis is required. Surface plasmon resonance (SPR) optical biosensor technology has been proven as a potential alternative screening method to detect PSP toxins in seafood. The addition of a similar SPR inhibition assay for TTX would complement the PSP assay in removing the MBA. The present report describes the development and single laboratory validation in accordance with AOAC and IUPAC guidelines of an SPR method to be used as a rapid screening tool to detect TTX in the sea snail Charonia lampas lampas, a species which has been implicated in 2008 in the first case of human TTX poisoning in Europe. As no current regulatory limits are set for TTX in Europe, single laboratory validation was undertaken using those for PSP toxins at 800 μg/kg. The decision limit (CCα) was 100 μg/kg, with the detection capability (CCβ) found to be ≤200 μg/kg. Repeatability and reproducibility were assessed at 200, 400, and 800 μg/kg and showed relative standard deviations of 8.3, 3.8, and 5.4% and 7.8, 8.3, and 3.7% for both parameters at each level, respectively. At these three respective levels, the recovery of the assay

  11. Manual versus automated γ-H2AX foci analysis across five European laboratories: can this assay be used for rapid biodosimetry in a large scale radiation accident?

    PubMed

    Rothkamm, Kai; Barnard, Stephen; Ainsbury, Elizabeth A; Al-Hafidh, Jenna; Barquinero, Joan-Francesc; Lindholm, Carita; Moquet, Jayne; Perälä, Marjo; Roch-Lefèvre, Sandrine; Scherthan, Harry; Thierens, Hubert; Vral, Anne; Vandersickel, Veerle

    2013-08-30

    The identification of severely exposed individuals and reassurance of the 'worried well' are of prime importance for initial triage following a large scale radiation accident. We aim to develop the γ-H2AX foci assay into a rapid biomarker tool for use in accidents. Here, five laboratories established a standard operating procedure and analysed 100 ex vivo γ-irradiated, 4 or 24h incubated and overnight-shipped lymphocyte samples from four donors to generate γ-H2AX reference data, using manual and/or automated foci scoring strategies. In addition to acute, homogeneous exposures to 0, 1, 2 and 4Gy, acute simulated partial body (4Gy to 50% of cells) and protracted exposures (4Gy over 24h) were analysed. Data from all laboratories could be satisfactorily fitted with linear dose response functions. Average yields observed at 4h post exposure were 2-4 times higher than at 24h and varied considerably between laboratories. Automated scoring caused larger uncertainties than manual scoring and was unable to identify partial exposures, which were detectable in manually scored samples due to their overdispersed foci distributions. Protracted exposures were detectable but doses could not be accurately estimated with the γ-H2AX assay. We conclude that the γ-H2AX assay may be useful for rapid triage following a recent acute radiation exposure. The potentially higher speed and convenience of automated relative to manual foci scoring needs to be balanced against its compromised accuracy and inability to detect partial body exposures. Regular re-calibration or inclusion of reference samples may be necessary to ensure consistent results between laboratories or over long time periods.

  12. Reference method for detection of Pgp mediated multidrug resistance in human hematological malignancies: a method validated by the laboratories of the French Drug Resistance Network.

    PubMed

    Huet, S; Marie, J P; Gualde, N; Robert, J

    1998-12-15

    Multidrug resistance (MDR) associated with overexpression of the MDR1 gene and of its product, P-glycoprotein (Pgp), plays an important role in limiting cancer treatment efficacy. Many studies have investigated Pgp expression in clinical samples of hematological malignancies but failed to give definitive conclusion on its usefulness. One convenient method for fluorescent detection of Pgp in malignant cells is flow cytometry which however gives variable results from a laboratory to another one, partly due to the lack of a reference method rigorously tested. The purpose of this technical note is to describe each step of a reference flow cytometric method. The guidelines for sample handling, staining and analysis have been established both for Pgp detection with monoclonal antibodies directed against extracellular epitopes (MRK16, UIC2 and 4E3), and for Pgp functional activity measurement with Rhodamine 123 as a fluorescent probe. Both methods have been validated on cultured cell lines and clinical samples by 12 laboratories of the French Drug Resistance Network. This cross-validated multicentric study points out crucial steps for the accuracy and reproducibility of the results, like cell viability, data analysis and expression.

  13. Seroprevalence of anti-Toxoplasma IgG and IgM among individuals who were referred to medical laboratories in Mazandaran province, northern Iran.

    PubMed

    Sharif, Mehdi; Daryani, Ahmad; Ebrahimnejad, Zahra; Gholami, Shirzad; Ahmadpour, Ehsan; Borhani, Samaneh; Lamsechi, Narges

    2016-01-01

    Toxoplasma gondii (T. gondii) is a protozoan parasite that can cause toxoplasmosis in humans. However, there is no current data regarding Toxoplasma infection among individuals who were referred to medical laboratories in Mazandaran province (northern Iran). Therefore, we performed a population-based study of Toxoplasma seroprevalence in this region. A total of 1832 sera samples (from 654 men and 1178 women) were collected from people who were referred to medical laboratories in different cities throughout Mazandaran province between March and July 2012. The serum titers of anti-T. gondii IgG and IgM were measured using enzyme-linked immunosorbent assays. The seroprevalence of anti-Toxoplasma IgG was 55.5%; and 14.4% of the positive samples were seropositive for anti-Toxoplasma IgM. The highest seroprevalence was observed among people who were >50 years old (90.6%), and the lowest seroprevalence was observed among children who were 0-9 years old (9.4%; P<0.001). There was no significant difference in the seroprevalences for each sex in the study population. However, a regional sex-specific difference in seroprevalence was observed between men (54.1%) and women (70.6%; P=0.003) in the western cities of Mazandaran. As the seroprevalence of T. gondii in western and eastern Mazandaran was higher than that in the central cities, there is a need to evaluate the nature of the infection chain in these areas.

  14. European Elder (Elderberry)

    MedlinePlus

    ... Common Names: European elder, black elder, elderberry, elder flower, sambucus Latin Name: Sambucus nigra Background European elder ... Saxon word “aeld,” meaning fire. The terms “elder flower” and “elderberry” may refer to either European elder ...

  15. Evaluating Mars Science Laboratory Landing Sites with the Mars Global Reference Atmospheric Model (Mars-GRAM 2005)

    NASA Technical Reports Server (NTRS)

    Justh, H. L.; Justus, C. G.

    2008-01-01

    The Mars Global Reference Atmospheric Model (Mars-GRAM) is an engineering-level atmospheric model widely used for diverse mission applications. Mars-GRAM s perturbation modeling capability is commonly used, in a Monte-Carlo mode, to perform high fidelity engineering end-to-end simulations for entry, descent, and landing (EDL) [1]. From the surface to 80 km altitude, Mars-GRAM is based on the NASA Ames Mars General Circulation Model (MGCM). Mars-GRAM and MGCM use surface topography from Mars Global Surveyor Mars Orbiter Laser Altimeter (MOLA), with altitudes referenced to the MOLA areoid, or constant potential surface. Traditional Mars-GRAM options for representing the mean atmosphere along entry corridors include: (1) Thermal Emission Spectrometer (TES) mapping years 1 and 2, with Mars-GRAM data coming from NASA Ames Mars General Circulation Model (MGCM) results driven by observed TES dust optical depth or (2) TES mapping year 0, with user-controlled dust optical depth and Mars-GRAM data interpolated from MGCM model results driven by selected values of globally-uniform dust optical depth. Mars-GRAM 2005 has been validated [2] against Radio Science data, and both nadir and limb data from TES [3]. There are several new features included in Mars-GRAM 2005. The first is the option to use input data sets from MGCM model runs that were designed to closely simulate conditions observed during the first two years of TES observations at Mars. The TES Year 1 option includes values from April 1999 through January 2001. The TES Year 2 option includes values from February 2001 through December 2002. The second new feature is the option to read and use any auxiliary profile of temperature and density versus altitude. In exercising the auxiliary profile Mars-GRAM option, values from the auxiliary profile replace data from the original MGCM databases. Some examples of auxiliary profiles include data from TES nadir or limb observations and Mars mesoscale model output at a particular

  16. [Evaluation of the distribution of non-tuberculous mycobacteria strains isolated in National Tuberculosis Reference Laboratory in 2009-2010, Turkey].

    PubMed

    Albayrak, Nurhan; Simşek, Hülya; Sezen, Figen; Arslantürk, Ahmet; Tarhan, Gülnur; Ceyhan, Ismail

    2012-10-01

    Non-tuberculous mycobacteria (NTM) are commonly encountered environmental bacteria, and most of them are associated with lung diseases. Diagnosis of infections caused by NTM is based on clinical, radiological and microbiological findings. The aim of this study was to investigate the distribution of non-tuberculous mycobacterial species isolated from clinical specimens as etiologic agents. The NTM strains isolated from clinical specimens in National Tuberculosis Reference Laboratory (NTRL), together with the strains that were sent to NTRL for the advanced identification of non-tuberculous mycobacterial species that have clinical or microbiological significance, were analysed retrospectively. The strains belonged to January 2009 - December 2010 period. If the same NTM type was isolated more than once in the clinical specimens of a patient, then it was defined microbiologically as a causative agent. Identification of mycobacteria species was performed by using a commercial line-probe assay (GenoType Mycobacterium CM/AS; Hain Lifescience, Germany). In our study, pulmonary and non-pulmonary samples obtained from 206 patients yielded mycobacterial growth in their cultures, and of them 24 (11.7%) were identified as NTM. On the other hand, 51 of the 101 samples sent to NTRL for identification were confirmed as NTM. Of the patients who were found to be infected with NTM (n= 75), 59 (78.7%) were male and the mean age was 50.9 ± 18.8 years. The most frequently identified NTM species was M.fortuitum (33.3%, n= 25), followed by M.abscessus (18.7%, n= 14), M.gordonae (10.7%, n= 8) and M.avium (%8; n= 6). The other types of NTM species identified in our laboratory were M.chelonae (n= 3), M.intracellulare (n= 3), M.kansasii (n= 3), M.peregrinum (n= 2), M.scrofulaceum (n= 2), M.szulgai (n= 2), M.celatum (n= 1), M.haemophilum (n= 1), M.smegmatis (n= 1) and M.xenopi (n= 1). Rapidly growing NTM species (M.fortuitum and M.abscessus) were the most frequent (52%) species isolated in our

  17. Prevalence of toxoplasmosis and related risk factors among humans referred to main laboratories of Urmia city, North West of Iran, 2013.

    PubMed

    Sadaghian, Mohammad; Amani, Sasan; Jafari, Rasool

    2016-06-01

    Toxoplasmosis is mostly asymptomatic infection in immunocompetent individuals while it can cause a severe infection in human fetus during pregnancy and immunocompromised patients. This study aimed to determine the prevalence of anti-Toxoplasma IgM and IgG seropositivity and potential risk factors of the infection in humans referred to Urmia City main diagnostic laboratories, Urmia, Iran. Totally 195 blood samples were collected from the individuals referred to main diagnostic laboratories of Urmia City, 2013. Serum concentration of anti-Toxoplasma IgG and IgM were determined using ELISA method. Demographic variables of the participants were collected by interviewing, which are including sex, age, occupation, educational and residential status, eating undercooked meat, consumption of raw vegetable and the method of washing raw vegetables. None of all 200 serum sample were anti-Toxoplasma IgM positive, but different concentrations of anti-Toxoplasma IgG were observed in 88 (45.12 %) of samples. The significant higher rate of anti-Toxoplasma IgG seropositivity were observed in people with soil related jobs (P = 0.005, OR = 2.266; 95 % CI 1.260, 4.078) and history of eating raw vegetables at restaurant (P = 0.036, OR = 1.985; 95 % CI 0.991, 3.978). Also anti-Toxoplasma IgG concentration mean was significantly higher in people who were commonly eaten raw vegetable at restaurants (P < 0.001, t = 7.918). The prevalence of chronic toxoplasmosis is considerably high while the acute infection is very low in the studied area. Having soil related jobs and eating raw vegetables at restaurants increases the risk of acquiring the infection.

  18. Study of demographic, clinical, laboratory and electromyographic symptoms in Myasthenia Gravis patients referred to the neurology clinic of Rasoul Akram hospital in 2015.

    PubMed

    Sadri, Y; Haghi-Ashtiani, B; Zamani, B; Akhundi, F H

    2015-01-01

    Introduction. Myasthenia Gravis is an autoimmune disorder, which is clinically a neuromuscular illness that shows itself as muscular weakness and fatigue. The diagnosis of Myasthenia Gravis depends on clinical evaluation, electrophysiological assessment, and autoantibody detection in serum. Known antibodies could be found in about 90% of the patients, which had a causative relation with disease symptoms. Therefore, the purpose of this paper was a survey on demographic features, clinical, laboratorial, and electromyographic signs of patients with Myasthenia Gravis referred to the neurology clinic of Rasoul Akram hospital. Materials and methods. This study was a descriptive cross-sectional one that used an easy sampling method: 54 patients with Myasthenia Gravis who were referred to the neurology clinic of Rasoul Akram were elected in 2015. The patients' information was recorded in the checklists based on the variables and the data were analyzed by using SPSS software version 21. The results. The demographic and the clinical symptoms data of 54 known Myasthenia Gravis patients, whose diagnosis was made according to the clinical symptoms, electrophysiological findings and autoantibody detection, were analyzed in this paper. There were 31 females (57.4%) and 23 males (42.6%) with an average age of 47.3 years. The average age of diagnosis of Myasthenia Gravis in these patients was 42.8 years. Among the patients, 19 (35.2%) had a hospitalization history because of their disease. Due to laboratory findings, 10 patients (18.5%) had Musk antibody, 34 patients (62.9%) had acetylcholine receptor antibodies and 10 patients (18.5%) had none of these two antibodies. Moreover, in electromyographic findings, 38 patients (70.37%) had positive findings and 16 patients (29.6%) had normal findings. Discussion and Conclusion. Due to the chronic nature of this disease, and its rising trend, educating the people for the early detection of the disease, was necessary as soon as possible so

  19. Demographics of the European apicultural industry.

    PubMed

    Chauzat, Marie-Pierre; Cauquil, Laura; Roy, Lise; Franco, Stéphanie; Hendrikx, Pascal; Ribière-Chabert, Magali

    2013-01-01

    Over the last few years, many European and North American countries have reported a high rate of disorders (mortality, dwindling and disappearance) affecting honeybee colonies (Apis mellifera). Although beekeeping has become an increasingly professional activity in recent years, the beekeeping industry remains poorly documented in Europe. The European Union Reference Laboratory for Honeybee Health sent a detailed questionnaire to each Member State, in addition to Kosovo and Norway, to determine the demographics and state of their beekeeping industries. Based on data supplied by the National Reference Laboratory for honeybee diseases in each European country, a European database was created to describe the beekeeping industry including the number and types of beekeepers, operation size, industry production, and health (notifiable diseases, mortalities). The total number of beekeepers in Europe was estimated at 620,000. European honey production was evaluated at around 220,000 tons in 2010. The price of honey varied from 1.5 to 40 €/kg depending on the country and on the distribution network. The estimated colony winter mortality varied from 7 to 28% depending on the country and the origin of the data (institutional survey or beekeeping associations). This survey documents the high heterogeneity of the apicultural industry within the European Union. The high proportion of non-professional beekeepers and the small mean number of colonies per beekeeper were the only common characteristics at European level. The tremendous variation in European apicultural industries has implication for any comprehensive epidemiological or economic analysis of the industry. This variability needs to be taken into account for such analysis as well as for future policy development. The industry would be served if beekeeping registration was uniformly implemented across member states. Better information on the package bee and queen production would help in understanding the ability of

  20. Demographics of the European Apicultural Industry

    PubMed Central

    Chauzat, Marie-Pierre; Cauquil, Laura; Roy, Lise; Franco, Stéphanie; Hendrikx, Pascal; Ribière-Chabert, Magali

    2013-01-01

    Over the last few years, many European and North American countries have reported a high rate of disorders (mortality, dwindling and disappearance) affecting honeybee colonies (Apis mellifera). Although beekeeping has become an increasingly professional activity in recent years, the beekeeping industry remains poorly documented in Europe. The European Union Reference Laboratory for Honeybee Health sent a detailed questionnaire to each Member State, in addition to Kosovo and Norway, to determine the demographics and state of their beekeeping industries. Based on data supplied by the National Reference Laboratory for honeybee diseases in each European country, a European database was created to describe the beekeeping industry including the number and types of beekeepers, operation size, industry production, and health (notifiable diseases, mortalities). The total number of beekeepers in Europe was estimated at 620 000. European honey production was evaluated at around 220 000 tons in 2010. The price of honey varied from 1.5 to 40 €/kg depending on the country and on the distribution network. The estimated colony winter mortality varied from 7 to 28% depending on the country and the origin of the data (institutional survey or beekeeping associations). This survey documents the high heterogeneity of the apicultural industry within the European Union. The high proportion of non-professional beekeepers and the small mean number of colonies per beekeeper were the only common characteristics at European level. The tremendous variation in European apicultural industries has implication for any comprehensive epidemiological or economic analysis of the industry. This variability needs to be taken into account for such analysis as well as for future policy development. The industry would be served if beekeeping registration was uniformly implemented across member states. Better information on the package bee and queen production would help in understanding the ability of

  1. The Optics and Alignment of the Divergent Beam Laboratory X-ray Powder Diffractometer and its Calibration Using NIST Standard Reference Materials

    PubMed Central

    Cline, James P.; Mendenhall, Marcus H.; Black, David; Windover, Donald; Henins, Albert

    2015-01-01

    The laboratory X-ray powder diffractometer is one of the primary analytical tools in materials science. It is applicable to nearly any crystalline material, and with advanced data analysis methods, it can provide a wealth of information concerning sample character. Data from these machines, however, are beset by a complex aberration function that can be addressed through calibration with the use of NIST Standard Reference Materials (SRMs). Laboratory diffractometers can be set up in a range of optical geometries; considered herein are those of Bragg-Brentano divergent beam configuration using both incident and diffracted beam monochromators. We review the origin of the various aberrations affecting instruments of this geometry and the methods developed at NIST to align these machines in a first principles context. Data analysis methods are considered as being in two distinct categories: those that use empirical methods to parameterize the nature of the data for subsequent analysis, and those that use model functions to link the observation directly to a specific aspect of the experiment. We consider a multifaceted approach to instrument calibration using both the empirical and model based data analysis methods. The particular benefits of the fundamental parameters approach are reviewed. PMID:26958446

  2. The Optics and Alignment of the Divergent Beam Laboratory X-ray Powder Diffractometer and its Calibration Using NIST Standard Reference Materials.

    PubMed

    Cline, James P; Mendenhall, Marcus H; Black, David; Windover, Donald; Henins, Albert

    2015-01-01

    The laboratory X-ray powder diffractometer is one of the primary analytical tools in materials science. It is applicable to nearly any crystalline material, and with advanced data analysis methods, it can provide a wealth of information concerning sample character. Data from these machines, however, are beset by a complex aberration function that can be addressed through calibration with the use of NIST Standard Reference Materials (SRMs). Laboratory diffractometers can be set up in a range of optical geometries; considered herein are those of Bragg-Brentano divergent beam configuration using both incident and diffracted beam monochromators. We review the origin of the various aberrations affecting instruments of this geometry and the methods developed at NIST to align these machines in a first principles context. Data analysis methods are considered as being in two distinct categories: those that use empirical methods to parameterize the nature of the data for subsequent analysis, and those that use model functions to link the observation directly to a specific aspect of the experiment. We consider a multifaceted approach to instrument calibration using both the empirical and model based data analysis methods. The particular benefits of the fundamental parameters approach are reviewed.

  3. Survey of the Diagnostic Retooling Process in National TB Reference Laboratories, with Special Focus on Rapid Speciation Tests Endorsed by WHO in 2007

    PubMed Central

    van Kampen, Sanne C.; Oskam, Linda; Tuijn, Coosje J.; Klatser, Paul R.

    2012-01-01

    Background Successful integration of new diagnostics in national tuberculosis (TB) control programs, also called ‘retooling’, is highly dependent on operational aspects related to test availability, accessibility and affordability. This survey aimed to find out whether recommendations to use new diagnostics lead to successful retooling in high TB endemic countries, using immunochromatographic tests (ICTs) for TB culture speciation as a case study. ICTs are recommended to accurately confirm the presence of bacteria of the Mycobacterium tuberculosis complex in liquid culture isolates. Methods and Findings Questionnaires were sent to national TB reference laboratories (NRLs) in 42 high TB endemic countries to address their access to information on ICT implementation, logistics related to availability, accessibility and affordability of ICTs, and testing algorithms. Results from 16 responding countries indicated that half of the NRLs were aware of the contents of WHO guidance documents on liquid culture and ICT implementation, as well as their eligibility for a negotiated pricing agreement for ICT procurement. No major issues with availability and accessibility of ICTs were raised. When asked about testing algorithms, ICTs were not used as stand-alone or first test for TB culture identification as recommended by WHO. Conclusions The low response rate was a limitation of this survey and together with NRLs managers' unawareness of global guidance, suggests a lack of effective communication between partners of the global laboratory network and NRLs. TB tests could become more affordable to high TB endemic countries, if the possibility to negotiate lower prices for commercial products is communicated to them more successfully. NRLs need additional guidance to identify where available technologies can be most usefully implemented and in what order, taking into account long-term laboratory strategies. PMID:22937050

  4. Survey of the diagnostic retooling process in national TB reference laboratories, with special focus on rapid speciation tests endorsed by WHO in 2007.

    PubMed

    van Kampen, Sanne C; Oskam, Linda; Tuijn, Coosje J; Klatser, Paul R

    2012-01-01

    Successful integration of new diagnostics in national tuberculosis (TB) control programs, also called 'retooling', is highly dependent on operational aspects related to test availability, accessibility and affordability. This survey aimed to find out whether recommendations to use new diagnostics lead to successful retooling in high TB endemic countries, using immunochromatographic tests (ICTs) for TB culture speciation as a case study. ICTs are recommended to accurately confirm the presence of bacteria of the Mycobacterium tuberculosis complex in liquid culture isolates. Questionnaires were sent to national TB reference laboratories (NRLs) in 42 high TB endemic countries to address their access to information on ICT implementation, logistics related to availability, accessibility and affordability of ICTs, and testing algorithms. Results from 16 responding countries indicated that half of the NRLs were aware of the contents of WHO guidance documents on liquid culture and ICT implementation, as well as their eligibility for a negotiated pricing agreement for ICT procurement. No major issues with availability and accessibility of ICTs were raised. When asked about testing algorithms, ICTs were not used as stand-alone or first test for TB culture identification as recommended by WHO. The low response rate was a limitation of this survey and together with NRLs managers' unawareness of global guidance, suggests a lack of effective communication between partners of the global laboratory network and NRLs. TB tests could become more affordable to high TB endemic countries, if the possibility to negotiate lower prices for commercial products is communicated to them more successfully. NRLs need additional guidance to identify where available technologies can be most usefully implemented and in what order, taking into account long-term laboratory strategies.

  5. Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE).

    PubMed

    Cornes, Michael; van Dongen-Lases, Edmée; Grankvist, Kjell; Ibarz, Mercedes; Kristensen, Gunn; Lippi, Giuseppe; Nybo, Mads; Simundic, Ana-Maria

    2017-01-01

    It has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%-68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have been a number of studies recently looking at whether order of draw remains a problem with modern phlebotomy techniques and materials, or it is an outdated practice followed simply because of historical reasons. In the following article, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols are not always followed or possible, EFLM WG-PRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection.

  6. Comprehensive inter-laboratory calibration of reference materials for delta18O versus VSMOW using various on-line high-temperature conversion techniques.

    PubMed

    Brand, Willi A; Coplen, Tyler B; Aerts-Bijma, Anita T; Böhlke, J K; Gehre, Matthias; Geilmann, Heike; Gröning, Manfred; Jansen, Henk G; Meijer, Harro A J; Mroczkowski, Stanley J; Qi, Haiping; Soergel, Karin; Stuart-Williams, Hilary; Weise, Stephan M; Werner, Roland A

    2009-04-01

    Internationally distributed organic and inorganic oxygen isotopic reference materials have been calibrated by six laboratories carrying out more than 5300 measurements using a variety of high-temperature conversion techniques (HTC)a in an evaluation sponsored by the International Union of Pure and Applied Chemistry (IUPAC). To aid in the calibration of these reference materials, which span more than 125 per thousand, an artificially enriched reference water (delta(18)O of +78.91 per thousand) and two barium sulfates (one depleted and one enriched in (18)O) were prepared and calibrated relative to VSMOW2b and SLAP reference waters. These materials were used to calibrate the other isotopic reference materials in this study, which yielded: Reference material delta(18)O and estimated combined uncertainty IAEA-602 benzoic acid+71.28 +/- 0.36 per thousand USGS 35 sodium nitrate+56.81 +/- 0.31 per thousand IAEA-NO-3 potassium nitrate+25.32 +/- 0.29 per thousand IAEA-601 benzoic acid+23.14 +/- 0.19 per thousand IAEA-SO-5 barium sulfate+12.13 +/- 0.33 per thousand NBS 127 barium sulfate+8.59 +/- 0.26 per thousand VSMOW2 water 0 per thousand IAEA-600 caffeine-3.48 +/- 0.53 per thousand IAEA-SO-6 barium sulfate-11.35 +/- 0.31 per thousand USGS 34 potassium nitrate-27.78 +/- 0.37 per thousand SLAP water-55.5 per thousand The seemingly large estimated combined uncertainties arise from differences in instrumentation and methodology and difficulty in accounting for all measurement bias. They are composed of the 3-fold standard errors directly calculated from the measurements and provision for systematic errors discussed in this paper. A primary conclusion of this study is that nitrate samples analyzed for delta(18)O should be analyzed with internationally distributed isotopic nitrates, and likewise for sulfates and organics. Authors reporting relative differences of oxygen-isotope ratios (delta(18)O) of nitrates, sulfates, or organic material should explicitly state in their

  7. Comprehensive inter-laboratory calibration of reference materials for δ18O versus VSMOW using various on-line high-temperature conversion techniques

    USGS Publications Warehouse

    Brand, Willi A.; Coplen, Tyler B.; Aerts-Bijma, Anita T.; Bohlke, John Karl; Gehre, Matthias; Geilmann, Heike; Groning, Manfred; Jansen, Henk G.; Meijer, Harro A. J.; Mroczkowski, Stanley J.; Qi, Haiping; Soergel, Karin; Stuart-Williams, Hilary; Weise, Stephan M.; Werner, Roland A.

    2009-01-01

    Internationally distributed organic and inorganic oxygen isotopic reference materials have been calibrated by six laboratories carrying out more than 5300 measurements using a variety of high-temperature conversion techniques (HTC) in an evaluation sponsored by the International Union of Pure and Applied Chemistry (IUPAC). To aid in the calibration of these reference materials, which span more than 125‰, an artificially enriched reference water (δ18O of +78.91‰) and two barium sulfates (one depleted and one enriched in 18O) were prepared and calibrated relative to VSMOW2 and SLAP reference waters. These materials were used to calibrate the other isotopic reference materials in this study, which yielded:Reference materialδ18O and estimated combined uncertainty IAEA-602 benzoic acid+71.28 ± 0.36‰USGS35 sodium nitrate+56.81 ± 0.31‰IAEA-NO-3 potassium nitrate+25.32 ± 0.29‰IAEA-601 benzoic acid+23.14 ± 0.19‰IAEA-SO-5 barium sulfate+12.13 ± 0.33‰NBS 127 barium sulfate+8.59 ± 0.26‰VSMOW2 water0‰IAEA-600 caffeine−3.48 ± 0.53‰IAEA-SO-6 barium sulfate−11.35 ± 0.31‰USGS34 potassium nitrate−27.78 ± 0.37‰SLAP water−55.5‰The seemingly large estimated combined uncertainties arise from differences in instrumentation and methodology and difficulty in accounting for all measurement bias. They are composed of the 3-fold standard errors directly calculated from the measurements and provision for systematic errors discussed in this paper. A primary conclusion of this study is that nitrate samples analyzed for δ18O should be analyzed with internationally distributed isotopic nitrates, and likewise for sulfates and organics. Authors reporting relative differences of oxygen-isotope ratios (δ18O) of nitrates, sulfates, or organic material should explicitly state in their reports the δ18O values of two or more internationally distributed nitrates (USGS34, IAEA-NO-3, and USGS35), sulfates (IAEA-SO-5, IAEA

  8. Comparison of Clinical Laboratory Standards Institute and European Committee on Antimicrobial Susceptibility Testing guidelines for the interpretation of antibiotic susceptibility at a University teaching hospital in Nairobi, Kenya: a cross-sectional study.

    PubMed

    Kassim, Ali; Omuse, Geoffrey; Premji, Zul; Revathi, Gunturu

    2016-04-11

    The Clinical Laboratory Standards Institute (CLSI) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidelines are the most popular breakpoint guidelines used in antimicrobial susceptibility testing worldwide. The EUCAST guidelines are freely available to users while CLSI is available for non-members as a package of three documents for US $500 annually. This is prohibitive for clinical microbiology laboratories in resource poor settings. We set out to compare antibiotic susceptibility determined by the two guidelines to determine whether adoption of EUCAST guidelines would significantly affect our susceptibility patterns. We reviewed minimum inhibitory concentrations (MIC) of various antibiotics routinely reported for Escherichia coli (E. coli), Staphylococcus aureus (S. aureus) and Pseudomonas aeruginosa (P. aeruginosa) isolates from an automated microbiology identification system (VITEK-2) at the Aga Khan University Hospital Nairobi's Pathology department. These MICs were then analyzed using both CLSI 2015 and EUCAST 2015 guidelines and classified as resistant, intermediate or susceptible. We compared the susceptibility and agreement between the CLSI and EUCAST categorizations. Susceptibility data from a total of 5165 E. coli, 1103 S. aureus and 532 P. aeruginosa isolates were included. The concordance rates of the two guidelines for E. coli, S. aureus and P. aeruginosa ranged from 78.2 to 100 %, 94.6 to 100 % and 89.1 to 95.5 % respectively. The kappa statistics for E. coli MICs revealed perfect agreement between CLSI and EUCAST for cefotaxime, ceftriaxone and trimethoprim-sulfamethoxazole, almost perfect agreement for ampicillin, ciprofloxacin, cefuroxime, gentamicin and ceftazidime, substantial agreement for meropenem, moderate agreement for cefepime and amoxicillin-clavulanate, fair agreement for nitrofurantoin and poor agreement for amikacin. For S. aureus the kappa statistics revealed perfect agreement for penicillin

  9. E-Learning and Training in Europe: A Survey into the Use of e-Learning in Training and Professional Development in the European Union. CEDEFOP Reference Series.

    ERIC Educational Resources Information Center

    European Centre for the Development of Vocational Training, Thessaloniki (Greece).

    A study investigated the extent of e-learning learning supported by information and communication technologies (ICT) methods in vocational education and training (VET) in the European Union (EU). The survey conducted via the Internet received 653 replies from organizations in the EU. Just over 80 percent of respondents were suppliers or users of…

  10. Quality of Agricultural Products and Protection of the Environment: Training, Knowledge Dissemination and Certification. Synthesis Report of a Study in Five European Countries. CEDEFOP Reference Series.

    ERIC Educational Resources Information Center

    Papadaki-Klavdianou, A.; Menkisoglou-Spiroudi, O.; Tsakiridou, E.

    This book examines existing European environmental education and agricultural practices friendly to the environment. Focus is on studies conducted in five countries Germany, Greece, the Netherlands, Portugal, and Spain--that aimed to define new knowledge qualifications related to environmental issues in producing alternative agricultural products…

  11. Herbal reference standards.

    PubMed

    Schwarz, Michael; Klier, Bernhard; Sievers, Hartwig

    2009-06-01

    This review describes the current definitions and regulatory requirements that apply to reference standards that are used to analyse herbal products. It also describes and discusses the current use of reference substances and reference extracts in the European and United States pharmacopoeias.

  12. IFCC reference procedures for measurement of the catalytic concentrations of enzymes: corrigendum, notes and useful advice. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)--IFCC Scientific Division.

    PubMed

    Schumann, Gerhard; Canalias, Francesca; Joergensen, Poul J; Kang, Dongchon; Lessinger, Jean-Marc; Klauke, Rainer; Committee On Reference Systems For Enzymes C-Rse; International Federation of Clinical Chemistry and Laboratory Medicine Scientific Division

    2010-05-01

    The primary reference measurement procedures (PRMPs) for the international standardization of catalytic concentration measurements of alpha-amylase, alanine aminotransferase, aspartate aminotransferase (AST), creatine kinase (CK), gamma-glutamyltransferase and lactate dehydrogenase have been performed in reference laboratories for several years. The IFCC Committee on Reference Systems for Enzymes and two reference laboratories, with official accreditation for the PRMPs, have collected useful information on some of the steps of the reference procedures that require special attention. This document comprises errata corrige for minor mistakes in published PRMPs for AST and CK. Several notes on the PRMPs are emphasized. This includes details that are very important for improved standardization, and general suggestions for reducing measurement uncertainty.

  13. Sample collections from healthy volunteers for biological variation estimates' update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine.

    PubMed

    Carobene, Anna; Strollo, Marta; Jonker, Niels; Barla, Gerhard; Bartlett, William A; Sandberg, Sverre; Sylte, Marit Sverresdotter; Røraas, Thomas; Sølvik, Una Ørvim; Fernandez-Calle, Pilar; Díaz-Garzón, Jorge; Tosato, Francesca; Plebani, Mario; Coşkun, Abdurrahman; Serteser, Mustafa; Unsal, Ibrahim; Ceriotti, Ferruccio

    2016-10-01

    Biological variation (BV) data have many fundamental applications in laboratory medicine. At the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) the reliability and limitations of current BV data were discussed. The EFLM Working Group on Biological Variation is working to increase the quality of BV data by developing a European project to establish a biobank of samples from healthy subjects to be used to produce high quality BV data. The project involved six European laboratories (Milan, Italy; Bergen, Norway; Madrid, Spain; Padua, Italy; Istanbul, Turkey; Assen, The Netherlands). Blood samples were collected from 97 volunteers (44 men, aged 20-60 years; 43 women, aged 20-50 years; 10 women, aged 55-69 years). Initial subject inclusion required that participants completed an enrolment questionnaire to verify their health status. The volunteers provided blood specimens once per week for 10 weeks. A short questionnaire was completed and some laboratory tests were performed at each sampling consisting of blood collected under controlled conditions to provide serum, K2EDTA-plasma and citrated-plasma samples. Samples from six out of the 97 enroled subjects were discarded as a consequence of abnormal laboratory measurements. A biobank of 18,000 aliquots was established consisting of 120 aliquots of serum, 40 of EDTA-plasma, and 40 of citrated-plasma from each subject. The samples were stored at -80 °C. A biobank of well-characterised samples collected under controlled conditions has been established delivering a European resource to enable production of contemporary BV data.

  14. Laboratory blood analysis in Strigiformes-Part II: plasma biochemistry reference intervals and agreement between the Abaxis Vetscan V2 and the Roche Cobas c501.

    PubMed

    Ammersbach, Mélanie; Beaufrère, Hugues; Gionet Rollick, Annick; Tully, Thomas

    2015-03-01

    Limited plasma biochemical information is available in Strigiformes. Only one study investigated the agreement between a point-of-care with a reference laboratory analyzer for biochemistry variables in birds. The objective was to report reference intervals (RI) for plasma biochemistry variables in Strigiformes, and to assess agreement between the Abaxis Vetscan V2 and Roche Cobas c501. A prospective study was designed to assess plasma biochemistry RI for concentration of calcium, phosphorus, total protein, albumin, globulin, glucose, bilirubin, uric acid, bile acids, sodium, potassium, and chloride, and activities of AST, GGT, CK, amylase, lipase, LDH, and GLDH. In addition, the agreement between the Vetscan and the Cobas in owl species was assessed. A total of 190 individuals were sampled belonging to 12 Strigiformes species including Barn Owls, Barred Owls, Great Horned Owls, Eurasian Eagle Owls, Spectacled Owls, Eastern Screech Owls, Long-Eared Owls, Short-Eared Owls, Great Gray Owls, Snowy Owls, Northern Saw-Whet Owls, and Northern Hawk-Owls. Order-, species-, and method-specific RI were determined on both analyzers. Although Vetscan data were not equivalent to the Cobas, 4 analytes (glucose, AST, CK, and total protein, with correction for bias) were within acceptable agreement, 3 analytes (uric acid, calcium, and phosphorus) were within close agreement, and the remaining analytes were in strong disagreement. Species-specific differences were observed notably for the concentration of glucose in Barn Owls and electrolytes in Northern Saw-Whet Owls. Overall, this study suggests that the Vetscan has acceptable clinical performance in Strigiformes for some analytes and highlights discrepancies for several analytes. © 2015 American Society for Veterinary Clinical Pathology.

  15. Evaluation of the social, clinical and laboratorial profile of patients diagnosed with leprosy in a reference center in São Paulo*

    PubMed Central

    Porto, Ana Carolina Souza; Figueira, Renata Borges Fortes Costa; Barreto, Jaison Antônio; Lauris, José Roberto Pereira

    2015-01-01

    BACKGROUND Leprosy is the main infectious cause of disability. It is said to be eradicated in São Paulo since 2005, but diagnosis is still late. OBJECTIVES To investigate the social, clinical and laboratorial profile of leprosy patients diagnosed between 01/2007 and 12/2011, in a reference center in São Paulo. METHODS Retrospective descriptive study. Data of all new leprosy cases diagnosed between 01/2007 and 12/2011 were raised in São Paulo. RESULTS 103 men and 71 women were diagnosed, most of them were multibacillary. Mean age at diagnosis was 49 yrs; 2,2% were children; 70% had incomplete primary education; 50% were referred without diagnostic suspicion of leprosy. Mean time since first symptoms/signs and diagnosis was 2 years; 64% of patients had some degree of disability, and 26% had grade 2. 23 cases were diagnosed only after being summoned, and 80% of these had no disability. Agreement between the Ridley and Jopling and the WHO classification was 75% (kappa index = 0.44). Serology for IgM anti-PGL1 (87 patients) showed a mean value of 0.25, and an association between MB classification and test positivity (p <0.001). CONCLUSIONS Leprosy diagnosis in São Paulo is late. The disease mainly affected the socially disadvantaged and economically active population. Failure to detect the disease (41% in the last 10 years) could be due to the lack of suspicion and to decentralization. For the classification of patients with advanced leprosy, both the WHO and R&J classifications proved to be helpful tools. PMID:25830985

  16. Retrospective analysis of 55,769 HbA1c EQA results obtained from professional laboratories and medical offices participating in surveys organized by two European EQA centers over a nine-year period.

    PubMed

    Morandi, Pierre-Alain; Deom, André; Kesseler, Dagmar; Cohen, Richard

    2011-01-01

    External Quality Assessment (EQA) is an essential tool for laboratories to monitor the performances of their analyses. It also allows a comparison of methods and types of laboratories (professional laboratories vs. medical offices). We, therefore, compared 55,769 HbA1c EQA results obtained between 1999 and 2008 by laboratories participating in EQA schemes organized by two European centers, Switzerland (center 1) and France (center 2). We used simple, nonparametrical statistics suited to EQA results to calculate the yearly and global precision performances. All the results, including the outliers, were included in the calculations. The best global precision performances were obtained by professional laboratories and medical offices using DCA POCT devices, followed by professional laboratories with the Integra, Hitachi, Cobas Mira, and HPLC groups of devices, and finally by both types of laboratories with the NycoCard POCT devices. When considering yearly precision performances, an overall improvement over time was observed for almost all diagnostic devices of center 1, whereas the trend was less clear for center 2. The HbA1c EQA results collected and analyzed over a 9-year period showed that the DCA POCT devices used either by professional laboratories or medical offices had better reproducibility than laboratory devices (other than POCT) and that a general improvement of yearly precision performances was observed, especially when frequent EQA schemes were organized. © 2011 Wiley-Liss, Inc.

  17. Analysis of vitamin D status at two academic medical centers and a national reference laboratory: result patterns vary by age, gender, season, and patient location

    PubMed Central

    2013-01-01

    Background Testing for 25-hydroxyvitamin D [25(OH)D] has increased dramatically in recent years. The present report compares overall utilization and results for 25(OH)D orders at two academic medical centers - one in New York and one in Iowa – in order to characterize the vitamin D status of our inpatient and outpatient populations. Results are also compared to those from a national reference laboratory to determine whether patterns at these two institutions reflect those observed nationally. Methods Retrospective data queries of 25(OH)D orders and results were conducted using the laboratory information systems at Weill Cornell Medical College / New York Presbyterian Hospital (WCMC), University of Iowa Hospitals and Clinics (UIHC), and ARUP Laboratories (ARUP). Chart review was conducted for cases with very high or low serum 25(OH)D levels in the WCMC and UIHC datasets. Results The majority of tests were ordered on females and outpatients. Average serum 25(OH)D levels were higher in female versus male patients across most ages in the WCMC, UIHC, and ARUP datasets. As expected, average serum 25(OH)D levels were higher in outpatients than inpatients. Serum 25(OH)D levels showed seasonal periodicity, with average levels higher in summer than winter and correlating to regional UV index. Area plots demonstrated a peak of increased 25(OH)D insufficiency / deficiency in adolescent females, although overall worse 25(OH)D status was found in male versus female patients in the WCMC, UIHC, and ARUP datasets. Surprisingly, improved 25(OH)D status was observed in patients starting near age 50. Finally, chart review of WCMC and UIHC datasets revealed over-supplementation (especially of ≥ 50,000 IU weekly doses) in the rare cases of very high 25(OH)D levels. General nutritional deficiency and/or severe illness was found in most cases of severe 25(OH)D deficiency. Conclusions 25(OH)D status of patients seen by healthcare providers varies according to age, gender, season

  18. Predicting skin sensitization potential and inter-laboratory reproducibility of a human Cell Line Activation Test (h-CLAT) in the European Cosmetics Association (COLIPA) ring trials.

    PubMed

    Sakaguchi, Hitoshi; Ryan, Cindy; Ovigne, Jean-Marc; Schroeder, Klaus R; Ashikaga, Takao

    2010-09-01

    Regulatory policies in Europe prohibited the testing of cosmetic ingredients in animals for a number of toxicological endpoints. Currently no validated non-animal test methods exist for skin sensitization. Evaluation of changes in cell surface marker expression in dendritic cell (DC)-surrogate cell lines represents one non-animal approach. The human Cell Line Activation Test (h-CLAT) examines the level of CD86 and CD54 expression on the surface of THP-1 cells, a human monocytic leukemia cell line, following 24h of chemical exposure. To examine protocol transferability, between-lab reproducibility, and predictive capacity, the h-CLAT has been evaluated by five independent laboratories in several ring trials (RTs) coordinated by the European Cosmetics Association (COLIPA). The results of the first and second RTs demonstrated that the protocol was transferable and basically had good between-lab reproducibility and predictivity, but there were some false negative data. To improve performance, protocol and prediction model were modified. Using the modified prediction model in the first and second RT, accuracy was improved. However, about 15% of the outcomes were not correctly identified, which exposes some of the limitations of the assay. For the chemicals evaluated, the limitation may due to chemical being a weak allergen or having low solubility (ex. alpha-hexylcinnamaldehyde). The third RT evaluated the modified prediction model and satisfactory results were obtained. From the RT data, the feasibility of utilizing cell lines as surrogate DC in development of in vitro skin sensitization methods shows promise. The data also support initiating formal pre-validation of the h-CLAT in order to fully understand the capabilities and limitations of the assay.

  19. Analysis of Diagnostic Findings From the European Mobile Laboratory in Guéckédou, Guinea, March 2014 Through March 2015

    PubMed Central

    Kerber, Romy; Krumkamp, Ralf; Diallo, Boubacar; Jaeger, Anna; Rudolf, Martin; Lanini, Simone; Bore, Joseph Akoi; Koundouno, Fara Raymond; Becker-Ziaja, Beate; Fleischmann, Erna; Stoecker, Kilian; Meschi, Silvia; Mély, Stéphane; Newman, Edmund N. C.; Carletti, Fabrizio; Portmann, Jasmine; Korva, Misa; Wolff, Svenja; Molkenthin, Peter; Kis, Zoltan; Kelterbaum, Anne; Bocquin, Anne; Strecker, Thomas; Fizet, Alexandra; Castilletti, Concetta; Schudt, Gordian; Ottowell, Lisa; Kurth, Andreas; Atkinson, Barry; Badusche, Marlis; Cannas, Angela; Pallasch, Elisa; Bosworth, Andrew; Yue, Constanze; Pályi, Bernadett; Ellerbrok, Heinz; Kohl, Claudia; Oestereich, Lisa; Logue, Christopher H.; Lüdtke, Anja; Richter, Martin; Ngabo, Didier; Borremans, Benny; Becker, Dirk; Gryseels, Sophie; Abdellati, Saïd; Vermoesen, Tine; Kuisma, Eeva; Kraus, Annette; Liedigk, Britta; Maes, Piet; Thom, Ruth; Duraffour, Sophie; Diederich, Sandra; Hinzmann, Julia; Afrough, Babak; Repits, Johanna; Mertens, Marc; Vitoriano, Inês; Bah, Amadou; Sachse, Andreas; Boettcher, Jan Peter; Wurr, Stephanie; Bockholt, Sabrina; Nitsche, Andreas; Županc, Tatjana Avšič; Strasser, Marc; Ippolito, Giuseppe; Becker, Stephan; Raoul, Herve; Carroll, Miles W.; De Clerck, Hilde; Van Herp, Michel; Sprecher, Armand; Koivogui, Lamine; Magassouba, N'Faly; Keïta, Sakoba; Drury, Patrick; Gurry, Cèline; Formenty, Pierre; May, Jürgen; Gabriel, Martin; Wölfel, Roman; Günther, Stephan; Di Caro, Antonino

    2016-01-01

    Background. A unit of the European Mobile Laboratory (EMLab) consortium was deployed to the Ebola virus disease (EVD) treatment unit in Guéckédou, Guinea, from March 2014 through March 2015. Methods. The unit diagnosed EVD and malaria, using the RealStar Filovirus Screen reverse transcription–polymerase chain reaction (RT-PCR) kit and a malaria rapid diagnostic test, respectively. Results. The cleaned EMLab database comprised 4719 samples from 2741 cases of suspected EVD from Guinea. EVD was diagnosed in 1231 of 2178 hospitalized patients (57%) and in 281 of 563 who died in the community (50%). Children aged <15 years had the highest proportion of Ebola virus–malaria parasite coinfections. The case-fatality ratio was high in patients aged <5 years (80%) and those aged >74 years (90%) and low in patients aged 10–19 years (40%). On admission, RT-PCR analysis of blood specimens from patients who died in the hospital yielded a lower median cycle threshold (Ct) than analysis of blood specimens from survivors (18.1 vs 23.2). Individuals who died in the community had a median Ct of 21.5 for throat swabs. Multivariate logistic regression on 1047 data sets revealed that low Ct values, ages of <5 and ≥45 years, and, among children aged 5–14 years, malaria parasite coinfection were independent determinants of a poor EVD outcome. Conclusions. Virus load, age, and malaria parasite coinfection play a role in the outcome of EVD. PMID:27638946

  20. Analysis of Diagnostic Findings From the European Mobile Laboratory in Guéckédou, Guinea, March 2014 Through March 2015.

    PubMed

    Kerber, Romy; Krumkamp, Ralf; Diallo, Boubacar; Jaeger, Anna; Rudolf, Martin; Lanini, Simone; Bore, Joseph Akoi; Koundouno, Fara Raymond; Becker-Ziaja, Beate; Fleischmann, Erna; Stoecker, Kilian; Meschi, Silvia; Mély, Stéphane; Newman, Edmund N C; Carletti, Fabrizio; Portmann, Jasmine; Korva, Misa; Wolff, Svenja; Molkenthin, Peter; Kis, Zoltan; Kelterbaum, Anne; Bocquin, Anne; Strecker, Thomas; Fizet, Alexandra; Castilletti, Concetta; Schudt, Gordian; Ottowell, Lisa; Kurth, Andreas; Atkinson, Barry; Badusche, Marlis; Cannas, Angela; Pallasch, Elisa; Bosworth, Andrew; Yue, Constanze; Pályi, Bernadett; Ellerbrok, Heinz; Kohl, Claudia; Oestereich, Lisa; Logue, Christopher H; Lüdtke, Anja; Richter, Martin; Ngabo, Didier; Borremans, Benny; Becker, Dirk; Gryseels, Sophie; Abdellati, Saïd; Vermoesen, Tine; Kuisma, Eeva; Kraus, Annette; Liedigk, Britta; Maes, Piet; Thom, Ruth; Duraffour, Sophie; Diederich, Sandra; Hinzmann, Julia; Afrough, Babak; Repits, Johanna; Mertens, Marc; Vitoriano, Inês; Bah, Amadou; Sachse, Andreas; Boettcher, Jan Peter; Wurr, Stephanie; Bockholt, Sabrina; Nitsche, Andreas; Županc, Tatjana Avšič; Strasser, Marc; Ippolito, Giuseppe; Becker, Stephan; Raoul, Herve; Carroll, Miles W; De Clerck, Hilde; Van Herp, Michel; Sprecher, Armand; Koivogui, Lamine; Magassouba, N'Faly; Keïta, Sakoba; Drury, Patrick; Gurry, Cèline; Formenty, Pierre; May, Jürgen; Gabriel, Martin; Wölfel, Roman; Günther, Stephan; Di Caro, Antonino

    2016-10-15

     A unit of the European Mobile Laboratory (EMLab) consortium was deployed to the Ebola virus disease (EVD) treatment unit in Guéckédou, Guinea, from March 2014 through March 2015.  The unit diagnosed EVD and malaria, using the RealStar Filovirus Screen reverse transcription-polymerase chain reaction (RT-PCR) kit and a malaria rapid diagnostic test, respectively.  The cleaned EMLab database comprised 4719 samples from 2741 cases of suspected EVD from Guinea. EVD was diagnosed in 1231 of 2178 hospitalized patients (57%) and in 281 of 563 who died in the community (50%). Children aged <15 years had the highest proportion of Ebola virus-malaria parasite coinfections. The case-fatality ratio was high in patients aged <5 years (80%) and those aged >74 years (90%) and low in patients aged 10-19 years (40%). On admission, RT-PCR analysis of blood specimens from patients who died in the hospital yielded a lower median cycle threshold (Ct) than analysis of blood specimens from survivors (18.1 vs 23.2). Individuals who died in the community had a median Ct of 21.5 for throat swabs. Multivariate logistic regression on 1047 data sets revealed that low Ct values, ages of <5 and ≥45 years, and, among children aged 5-14 years, malaria parasite coinfection were independent determinants of a poor EVD outcome.  Virus load, age, and malaria parasite coinfection play a role in the outcome of EVD. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

  1. Differences in serum thyroglobulin measurements by 3 commercial immunoradiometric assay kits and laboratory standardization using Certified Reference Material 457 (CRM-457).

    PubMed

    Lee, Ji In; Kim, Ji Young; Choi, Joon Young; Kim, Hee Kyung; Jang, Hye Won; Hur, Kyu Yeon; Kim, Jae Hyeon; Kim, Kwang-Won; Chung, Jae Hoon; Kim, Sun Wook

    2010-09-01

    Serum thyroglobulin (Tg) is essential in the follow-up of patients with differentiated thyroid carcinoma (DTC). However, interchangeability and standardization between Tg assays have not yet been achieved, even with the development of an international Tg standard (Certified Reference Material 457 [CRM-457]). Serum Tg from 30 DTC patients and serially diluted CRM-457 were measured using 3 different immunoradiometric assays (IRMA-1, IRMA-2, IRMA-3). The intraclass correlation coefficient (ICC) method was used to describe the concordance of each IRMA to CRM-457. The serum Tg measured by 3 different IRMAs correlated well (r > .85, p < .0001), but clinically relevant discrepancies were found in 13.3% of patients. IRMA-3, which claims to be standardized to CRM-457, showed the best ICC (p(1) = .98) for the CRM-457. Hospitals caring for patients with DTC should either set their own cutoffs for IRMAs for Tg based on their patient pools, or adopt IRMAs standardized to CRM-457 and calibrate their laboratory using CRM-457.

  2. Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO).

    PubMed

    Thelen, Marc H M; Vanstapel, Florent J L A; Kroupis, Christos; Vukasovic, Ines; Boursier, Guilaime; Barrett, Edward; Bernabeu Andreu, Francisco; Brguljan, Pika Meško; Brugnoni, Duilio; Lohmander, Maria; Sprongl, Ludek; Vodnik, Tatjana; Ghita, Irina; Vaubourdolle, Michel; Huisman, Willem

    2015-07-01

    The recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national bodies responsible for accreditation describe the scope of every laboratory accreditation in a way that leaves no room for doubt about the range of competence of the particular laboratories. According to EA recommendations scopes may be fixed, mentioning every single test that is part of the accreditation, or flexible, mentioning all combinations of medical field, examination type and materials for which the laboratory is competent. Up to now national accreditation bodies perpetuate use of fixed scopes, partly by inertia, partly out of fear that a too flexible scope may lead to over-valuation of the competence of laboratories, most countries only use fixed scopes. The EA however promotes use of flexible scopes, since this allows for more readily innovation, which contributes to quality in laboratory medicine. In this position paper, the Working Group Accreditation and ISO/CEN Standards belonging to the Quality and Regulation Committee of the EFLM recommends using an approach that has led to successful introduction of the flexible scope for ISO15189 accreditation as intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.

  3. A comparison of the structure of American (Homarus americanus) and European (Homarus gammarus) lobster cuticle with particular reference to shell disease susceptibility.

    PubMed

    Davies, Charlotte E; Whitten, Miranda M A; Kim, Anita; Wootton, Emma C; Maffeis, Thierry G G; Tlusty, Michael; Vogan, Claire L; Rowley, Andrew F

    2014-03-01

    The integument of arthropods is an important first-line defence against the invasion of parasites and pathogens. Once damaged, this can be subject to colonisation by microbial agents from the surrounding environment, which in crustaceans can lead to a condition termed shell disease syndrome. This condition has been reported in several crustacean species, including crabs and lobsters. The syndrome is a progressive condition where the outer cuticle becomes pitted and eroded, and in extreme cases is compromised, leaving animals susceptible to septicaemia. This study examined the susceptibility of juvenile American (Homarus americanus) and European (Homarus gammarus) lobsters to shell disease, as a result of mechanical damage. Scanning electron microscopy was used as a method to identify differences in the cuticle structure and consequences of mechanical damage. Claw regions were aseptically punctured, whilst carapaces were abraded using sterile sandpaper, to mimic natural damage. After a period of between 10 and 12 weeks, lobsters were sacrificed, fixed and stored for later examination. The carapace and claws of juvenile American lobsters were shown to be thinner and more vulnerable to abrasion damage than their European counterparts. In addition, the number and distribution of setal pits and pore canal openings also differed between the two species of lobster. Mechanical damage resulted in the formation of shell disease lesions on the claw and carapace of both lobster species. However, American lobsters, unlike their European counterparts, had extensive bacterial colonisation on the margins of these lesions. Overall, it is concluded that the cuticle of the American lobster is more susceptible to damage and resulting microbial colonisation. This may have implications for susceptibility of both species of lobster to shell disease syndrome.

  4. EDEX Educational Expansion and Labour Market: A Comparative Study of Five European Countries--France, Germany, Italy, Spain and the United Kingdom with Special Reference to the United States. CEDEFOP Reference Series.

    ERIC Educational Resources Information Center

    Beduwe, Catherine; Planas, Jordi

    The long-term economic and social impacts of the rise in levels of education on mechanisms of access to employment and on human resources management were examined in a comparative study of educational expansion and the labor markets of France, Germany, Italy, Spain, and the United Kingdom, with special reference to the United States. Five teams of…

  5. Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE).

    PubMed

    Simundic, Ana-Maria; Church, Stephen; Cornes, Michael P; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Nikolac, Nora; van Dongen-Lases, Edmee; Eker, Pinar; Kovalevskaya, Svjetlana; Kristensen, Gunn B B; Sprongl, Ludek; Sumarac, Zorica

    2015-08-01

    An observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines. A structured checklist including 29 items was created to assess the compliance of European phlebotomy procedures with the CLSI H3-A6 guideline. A risk occurrence chart of individual phlebotomy steps was created from the observed error frequency and severity of harm of each guideline key issue. The severity of errors occurring during phlebotomy was graded using the risk occurrence chart. Twelve European countries participated with a median of 33 (18-36) audits per country, and a total of 336 audits. The median error rate for the total phlebotomy procedure was 26.9 % (10.6-43.8), indicating a low overall compliance with the recommended CLSI guideline. Patient identification and test tube labelling were identified as the key guideline issues with the highest combination of probability and potential risk of harm. Administrative staff did not adhere to patient identification procedures during phlebotomy, whereas physicians did not adhere to test tube labelling policy. The level of compliance of phlebotomy procedures with the CLSI H3-A6 guidelines in 12 European countries was found to be unacceptably low. The most critical steps in need of immediate attention in the investigated countries are patient identification and tube labelling.

  6. Study of the Vitamin D Levels in Patients Referred to Clinical Laboratories in Mashhad in 2015 and their Relationship with the Patients’ Lipid Profiles

    PubMed Central

    Shamsian, Ali Akbar; Rezaee, Seyyed Abdolrahim; Rajabiian, Majid; Moghaddam, Habibolah Taghizadeh; Saeidi, Masumeh; Bahreini, Abbas

    2016-01-01

    Introduction Vitamin D is a steroid hormone that has a significant role in the metabolism of minerals, especially calcium and phosphorus; it also is a major determinant of the strength of bones. This hormone has a significant effect on three major health issues that people worldwide encounter, i.e., high blood pressure, cancer, and diabetes. Considering the limited and dispersed studies on the prevalence of vitamin D deficiency in Iran and the relationship of vitamin D with lipid profiles in different people, this study was conducted to determine the vitamin D levels in patients and its relationship with their lipid profiles. Methods A retrospective cross-sectional study was conducted in 2015 on 1,110 patients who were referred to the two laboratories at Jihad Daneshgahi and to eight specialist laboratories in Mashhad through random sampling of patients for whom serum vitamin D and serum lipid tests were prescribed. The data that were obtained were entered into SPSS 13 software. Results Sixty-eight percent of the patients in the study were deficient in vitamin D. The vitamin D levels in males were significantly lower than those in females (p < 0.05). The relationship between age and vitamin D deficiency was significant as well (p < 0.05). A positive and significant relationship was observed between age and vitamin D deficiency (p = 0.000, r = 0.187), i.e., vitamin D deficiency was more apparent in patients whose ages were in the range of 40–59. The relationship between the levels of vitamin D and serum lipids was significant and positive (p = 0.05), with the exception of LDL. Conclusion About two-thirds of the population that was studied had a vitamin D deficiency. There was a positive and significant relationship between serum vitamin D and serum lipids and serum calcium. The results of this study showed the necessity for more research and the implementation of preventive measures related to vitamin D deficiency. It is recommended that vitamin D enrichment

  7. Study of the Vitamin D Levels in Patients Referred to Clinical Laboratories in Mashhad in 2015 and their Relationship with the Patients' Lipid Profiles.

    PubMed

    Shamsian, Ali Akbar; Rezaee, Seyyed Abdolrahim; Rajabiian, Majid; Moghaddam, Habibolah Taghizadeh; Saeidi, Masumeh; Bahreini, Abbas

    2016-04-01

    Vitamin D is a steroid hormone that has a significant role in the metabolism of minerals, especially calcium and phosphorus; it also is a major determinant of the strength of bones. This hormone has a significant effect on three major health issues that people worldwide encounter, i.e., high blood pressure, cancer, and diabetes. Considering the limited and dispersed studies on the prevalence of vitamin D deficiency in Iran and the relationship of vitamin D with lipid profiles in different people, this study was conducted to determine the vitamin D levels in patients and its relationship with their lipid profiles. A retrospective cross-sectional study was conducted in 2015 on 1,110 patients who were referred to the two laboratories at Jihad Daneshgahi and to eight specialist laboratories in Mashhad through random sampling of patients for whom serum vitamin D and serum lipid tests were prescribed. The data that were obtained were entered into SPSS 13 software. Sixty-eight percent of the patients in the study were deficient in vitamin D. The vitamin D levels in males were significantly lower than those in females (p < 0.05). The relationship between age and vitamin D deficiency was significant as well (p < 0.05). A positive and significant relationship was observed between age and vitamin D deficiency (p = 0.000, r = 0.187), i.e., vitamin D deficiency was more apparent in patients whose ages were in the range of 40-59. The relationship between the levels of vitamin D and serum lipids was significant and positive (p = 0.05), with the exception of LDL. About two-thirds of the population that was studied had a vitamin D deficiency. There was a positive and significant relationship between serum vitamin D and serum lipids and serum calcium. The results of this study showed the necessity for more research and the implementation of preventive measures related to vitamin D deficiency. It is recommended that vitamin D enrichment programs be planned and implemented.

  8. Epidermolysis bullosa House Austria and Epidermolysis bullosa clinical network : Example of a centre of expertise implemented in a European reference network to face the burden of a rare disease.

    PubMed

    Laimer, Martin; Pohla-Gubo, Gabriela; Diem, Anja; Prodinger, Christine; Bauer, Johann W; Hintner, Helmut

    2017-01-01

    Accurately addressing the diverse and complex issues of rare diseases (RD) in terms of prevention, recognition, diagnosis, treatment, care and research along key RD specificities, such as great heterogeneity, a limited number of patients, scarcity of relevant knowledge and expertise as well as enormous costs for patient care is a challenging task for healthcare providers and authorities that makes a supranational approach particularly feasible. The European Union has acknowledged RD matters by several initiatives, including efforts to implement national centres of expertise and European reference networks as well as a cross-border referral mechanism to foster access to expert services and to boost dissemination of clinical expertise and research activities. Exemplified by the EB House Austria, a centre of expertise for epidermolysis bullosa cross-linked with international reference partner institutions, this strategy proves its potential to be translated into optimized patient care and to meet the major medical, scientific, social and health-economic impact of RD.

  9. Effect of Diuron on aquatic bacteria in laboratory-scale wastewater treatment ponds with special reference to Aeromonas species studied by colony hybridization.

    PubMed

    Sumpono; Perotti, P; Belan, A; Forestier, C; Lavedrine, B; Bohatier, J

    2003-01-01

    Six laboratory-scale wastewater treatment ponds were filled with sediment and water obtained from a reference pond (a wastewater treatment plant located in a rural environment at Montel-de-Gelat, Puy-de-Dôme, France). They were kept at 20 degrees C, with alternative light and dark periods (12 h-12 h), and fed with raw effluent supplied weekly. Three of them were treated with Diuron (dissolved in DMSO) at a final concentration 10 mg/l, while the other three received only DMSO. Physico-chemical parameters, total bacteria, cultivable bacteria, and Aeromonas spp. were measured periodically until 41 days after the Diuron contamination. Total bacteria were treated with 4,6-diamidino 2-phenylindole (DAPI) and counted by epifluoroscence microscopy. The cultivable bacteria were quantified on plate count agar medium and Aeromonas spp. using colony hybridization. In the contaminated pilots, biochemical oxygen demand (BOD5), chemical oxygen demand (COD), suspended solids (SS), volatile suspended solids (VSS), ammonium, phosphorus, and bacteria increased, but dissolved oxygen decreased. The abundance of total bacteria, cultivable bacteria (multiplied by 30), and Aeromonas spp. increased for two weeks after Diuron introduction, reverting to initial values three weeks later. The percentage of cultivable bacteria relative to total bacteria was 0.2% in controls and 1.2% in treated pilots, while the percentage of Aeromonas spp. relative to cultivable bacteria decreased from 6-10% to 2%. Our results suggest that Diuron, which acts on the photosystem II of phototrophs, supports the development of cultivable bacteria through new carbon sources derived from the decomposition of photosynthetic micro-organisms, but does not specifically support Aeromonas spp.

  10. Factors predictive of obstructive sleep apnea in patients undergoing pre-operative evaluation for bariatric surgery and referred to a sleep laboratory for polysomnography

    PubMed Central

    Duarte, Ricardo Luiz de Menezes; Magalhães-da-Silveira, Flavio José

    2015-01-01

    Objective: To identify the main predictive factors for obtaining a diagnosis of obstructive sleep apnea (OSA) in patients awaiting bariatric surgery. Methods: Retrospective study of consecutive patients undergoing pre-operative evaluation for bariatric surgery and referred for in-laboratory polysomnography. Eight variables were evaluated: sex, age, neck circumference (NC), BMI, Epworth Sleepiness Scale (ESS) score, snoring, observed apnea, and hypertension. We employed ROC curve analysis to determine the best cut-off value for each variable and multiple linear regression to identify independent predictors of OSA severity. Results: We evaluated 1,089 patients, of whom 781 (71.7%) were female. The overall prevalence of OSA-defined as an apnea/hypopnea index (AHI) ≥ 5.0 events/h-was 74.8%. The best cut-off values for NC, BMI, age, and ESS score were 42 cm, 42 kg/m2, 37 years, and 10 points, respectively. All eight variables were found to be independent predictors of a diagnosis of OSA in general, and all but one were found to be independent predictors of a diagnosis of moderate/severe OSA (AHI ≥ 15.0 events/h), the exception being hypertension. We devised a 6-item model, designated the NO-OSAS model (NC, Obesity, Observed apnea, Snoring, Age, and Sex), with a cut-off value of ≥ 3 for identifying high-risk patients. For a diagnosis of moderate/severe OSA, the model showed 70.8% accuracy, 82.8% sensitivity, and 57.9% specificity. Conclusions: In our sample of patients awaiting bariatric surgery, there was a high prevalence of OSA. At a cut-off value of ≥ 3, the proposed 6-item model showed good accuracy for a diagnosis of moderate/severe OSA. PMID:26578136

  11. [Criticism of the gonioscopic classifications of the glaucoma: with particular reference to the classification issued by the European Glaucoma Society in 2008].

    PubMed

    Bordeianu, Constantin Dan

    2014-01-01

    To critically analyze the gonioscopic classifications of glaucoma, especially of the classification issued by the European Glaucoma Society in 2008, in order to reveal its advantages and shortcomings. The paper tries to determine the extent to which this classification is clear (being based on a coherent and consistently followed set of criteria), is comprehensive (framing all forms of glaucoma), helps to understand the sickness (using a logical framing system), and facilitates therapeutic decision making (offering direct therapeutic suggestions). The paper shows that, compared with all the previous classifications, the 2008 European Glaucoma Society classification is one step ahead (in the way of classifying the group of secondary angle-closure glaucomas), two steps behind (in rejecting two useful categories of congenital glaucoma), and similar in several respects: that it is based on criticizable fundamental and secondary criteria that cannot cover all forms of sickness gathered at a particular crossing; that it uses several equally weighted criteria for one single crossing (division); that it frames one clinical entity in several clinical categories; that it does not reflect reality in some aspects; and that it does not offer direct therapeutic suggestions: after framing a case in a scheme built on the basis of gonioscopic observation, it requires a second stage of pathogenic analysis, so that the ophthalmologist is able to decide the correct treatment only in the third stage. This tortuous thinking pathway, with successive stages - that are not followed by all doctors, explains many of the erroneous therapeutic decisions. All these considerations justify the efforts to find a new classification, able to correct the abovementioned shortcomings.

  12. Wind Technology, Cost, and Performance Trends in Denmark, Germany, Ireland, Norway, the European Union, and the United States: 2007 - 2012; NREL (National Renewable Energy Laboratory)

    SciTech Connect

    Hand, Maureen

    2015-06-15

    This presentation provides a summary of IEA Wind Task 26 report on Wind Technology, Cost, and Performance Trends in Denmark, Germany, Ireland, Norway, the European Union, and the United States: 2007-2012

  13. European Gene Mapping Project (EUROGEM): breakpoint panels for human chromosomes based on the CEPH reference families. Centre d'Etude du Polymorphisme Humain.

    PubMed

    Cox, S A; Attwood, J; Bryant, S P; Bains, R; Povey, S; Rebello, M; Kapsetaki, M; Moschonas, N K; Grzeschik, K H; Otto, M; Dixon, M; Sudworth, H E; Kooy, R F; Wright, A; Teague, P; Terrenato, L; Vergnaud, G; Monfouilloux, S; Weissenbach, J; Alibert, O; Dib, C; Fauré, S; Bakker, E; Pearson, N M; Spurr, N K

    1996-11-01

    Meiotic breakpoint panels for human chromosomes 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, 14, 15, 17, 18, 20 and X were constructed from genotypes from the CEPH reference families. Each recombinant chromosome included has a breakpoint well-supported with reference to defined quantitative criteria. The panels were constructed at both a low-resolution, useful for a first-pass localization, and high-resolution, for a more precise placement. The availability of such panels will reduce the number of genotyping experiments necessary to order new polymorphisms with respect to existing genetic markers. This paper shows only a representative sample of the breakpoints detected. The complete data are available on the World Wide Web (URL http:/(/)www.icnet.uk/axp/hgr/eurogem++ +/HTML/data.html) or by anonymous ftp (ftp.gene.ucl.ac.uk in/pub/eurogem/maps/breakpoints).

  14. A reference case for economic evaluations in osteoarthritis: an expert consensus article from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).

    PubMed

    Hiligsmann, Mickaël; Cooper, Cyrus; Guillemin, Francis; Hochberg, Marc C; Tugwell, Peter; Arden, Nigel; Berenbaum, Francis; Boers, Maarten; Boonen, Annelies; Branco, Jaime C; Maria-Luisa, Brandi; Bruyère, Olivier; Gasparik, Andrea; Kanis, John A; Kvien, Tore K; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Pinedo-Villanueva, Rafael; Pinto, Daniel; Reiter-Niesert, Susanne; Rizzoli, René; Rovati, Lucio C; Severens, Johan L; Silverman, Stuart; Reginster, Jean-Yves

    2014-12-01

    General recommendations for a reference case for economic studies in rheumatic diseases were published in 2002 in an initiative to improve the comparability of cost-effectiveness studies in the field. Since then, economic evaluations in osteoarthritis (OA) continue to show considerable heterogeneity in methodological approach. To develop a reference case specific for economic studies in OA, including the standard optimal care, with which to judge new pharmacologic and non-pharmacologic interventions. Four subgroups of an ESCEO expert working group on economic assessments (13 experts representing diverse aspects of clinical research and/or economic evaluations) were charged with producing lists of recommendations that would potentially improve the comparability of economic analyses in OA: outcome measures, comparators, costs and methodology. These proposals were discussed and refined during a face-to-face meeting in 2013. They are presented here in the format of the recommendations of the recently published Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, so that an initiative on economic analysis methodology might be consolidated with an initiative on reporting standards. Overall, three distinct reference cases are proposed, one for each hand, knee and hip OA; with diagnostic variations in the first two, giving rise to different treatment options: interphalangeal or thumb-based disease for hand OA and the presence or absence of joint malalignment for knee OA. A set of management strategies is proposed, which should be further evaluated to help establish a consensus on the "standard optimal care" in each proposed reference case. The recommendations on outcome measures, cost itemisation and methodological approaches are also provided. The ESCEO group proposes a set of disease-specific recommendations on the conduct and reporting of economic evaluations in OA that could help the standardisation and comparability of studies that evaluate

  15. World Health Organization 2006 child growth standards and 2007 growth reference charts: A discussion paper by the committee on Nutrition of the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

    PubMed

    Turck, Dominique; Michaelsen, Kim F; Shamir, Raanan; Braegger, Christian; Campoy, Cristina; Colomb, Virginie; Decsi, Tamás; Domellöf, Magnus; Fewtrell, Mary; Kolacek, Sanja; Mihatsch, Walter; Moreno, Luis A; van Goudoever, Johannes

    2013-08-01

    Growth charts are essential for evaluating children's health including their nutrition; however, the evaluation of child growth trajectories and consequently the decision to intervene are highly dependent on the growth charts used. The aim of this discussion paper of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition Committee on Nutrition is to provide information on the background and rationale of the World Health Organization (WHO) 2006 child growth standards and WHO 2007 growth reference charts, describe their development, outline their main innovative aspects, discuss potential limitations, and make recommendations. WHO 2006 child growth standards (0-5 years) are based on prospectively collected data describing the growth of healthy infants who were breast-fed according to WHO recommendations, showing a pattern of linear growth, which is remarkably consistent between different countries and ethnic groups. WHO 2007 growth reference charts (5-19 years) are based mainly on a re-analysis of National Centre for Health Statistics data from 1977, without information on feeding. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition Committee on Nutrition recommends that WHO child growth standards should be used to monitor growth in all children in the age range 0 to 2 years in Europe, whether breast- or formula-fed, and that they should be considered to be used in the age range 2 to 5 years. Implementation of the WHO child growth standards should be preceded by evaluation of the implication of their use on national healthcare policies. Health professionals should be guided on their use and interpretation and an adequate communication strategy should be available locally to ensure that parents receive clear and consistent advice. The decision on whether to implement the WHO growth references (5-19 years) should be made by national bodies because the growth pattern during the 5- to 19-year period differs between

  16. Histopathological lesions and DNA adducts in the liver of European flounder (Platichthys flesus) collected in the Seine estuary versus two reference estuarine systems on the French Atlantic coast.

    PubMed

    Cachot, Jérôme; Cherel, Yan; Larcher, Thibaut; Pfohl-Leszkowicz, Annie; Laroche, Jean; Quiniou, Louis; Morin, Jocelyne; Schmitz, Julien; Burgeot, Thierry; Pottier, Didier

    2013-02-01

    An epidemiological survey was conducted in the Seine estuary and in two smaller and relatively preserved estuaries on the French Atlantic coast in order to estimate the occurrence of liver lesions in European flounder, Platichthys flesus, and also to seek putative risk factors for the recorded pathologies. Four hundred and seventy-eight fish of both sexes and of different size ranges were sampled in the three studied areas, 338 of which in the Seine estuary. All fish were examined for histopathological liver lesions, while DNA adducts and otoliths were analyzed on a subsample. Five categories of hepatic lesions were recorded with the following prevalence for the Seine estuary: 36.7 % inflammations, 8 % parasites (mainly encysted nematodes), 6.5 % foci of cellular alteration (FCA), 5.3 % foci of necrosis or regeneration (FNR), and 1.5 % tumors. Inflammation occurrence increased according to age, contrary to parasitic infestations and FCA which were more prevalent in young fish, notably those of <1 year old (group 0). Tumors were only observed in females of more than two winters. Females exhibited a higher prevalence of tumors (3.0 %) and FCA (6.5 %) than males (0 and 2.6 %, respectively). Parasitic and infectious lesions and FNR were equally distributed in males and females. The prevalence of FNR was also shown to vary according to sampling season, with significantly more occurrences of liver necrosis in the fish collected in summer than in spring. Spatial differences were observed with a higher occurrence of encysted parasites in flounders from the upper Seine estuary, while inflammations predominated in flounders living downstream. Temporal trends were also noted, with an increased prevalence of parasitic infestations, inflammations, and FCA in the 2002-2003 period in comparison to the 1996-1997 one. The three flounder populations from the Seine estuary (Normandy), Ster estuary (Brittany), and Bay of Veys (Normandy) showed different spectra of hepatic lesions

  17. An evaluation of two commercially available ELISAs and one in-house reference laboratory ELISA for the determination of human anti-rabies virus antibodies.

    PubMed

    Welch, Ryan J; Anderson, Brian L; Litwin, Christine M

    2009-06-01

    The envelope glycoprotein G of rabies virus in vaccines induces the production of neutralizing antibodies important in the protection against the disease. The measurement of anti-envelope glycoprotein antibodies is a good predictor of the degree of humoral immunity in people during anti-rabies treatment or after vaccination. Several assays exist for the serological determination of antibody protection against rabies virus infection. Antibody neutralization by the rapid fluorescent focus inhibition test (RFFIT) or the fluorescent antibody virus neutralization (FAVN) test is currently the gold standard. Performance of the highly complex RFFIT and FAVN tests, however, requires specialized reference laboratories with expertise with this assay. Although not widely used, ELISA test kits are available and may be an additional option for testing that is more accessible. The aim of the present study was to evaluate available ELISA assays for the determination of anti-rabies antibodies. We compared the Bio-Rad Platelia Rabies II ELISA, DRG Rabies Virus IgG Ab ELISA and Focus Diagnostics Rabies Antibody Detection by ELISA to RFFIT. Bland-Altman plots comparing the Bio-Rad Platelia assay and the Focus Diagnostics assay to RFFIT showed a low degree of variability between the ELISA assays and RFFIT results except in samples with high RFFIT values. The agreement, sensitivity and specificity of Bio-Rad Platelia Rabies II ELISA when compared to RFFIT were 95.1 %, 94.1 % and 95.8 %, respectively. The DRG Rabies assay compared to RFFIT had an agreement of 77.7 %, a sensitivity of 86.7 % and a specificity of 69.4 %. The agreement, sensitivity and specificity of Focus Diagnostics Rabies Detection by ELISA when compared to RFFIT were 82.2 %, 91.7 % and 73.0 %, respectively. Overall, the Bio-Rad Platelia assay showed higher accuracy and specificity than either the DRG or Focus assays. All of these ELISAs, however, measure all antibody types and do not discriminate the neutralizing

  18. A Side by Side Comparison of Bruker Biotyper and VITEK MS: Utility of MALDI-TOF MS Technology for Microorganism Identification in a Public Health Reference Laboratory.

    PubMed

    Lévesque, Simon; Dufresne, Philippe J; Soualhine, Hafid; Domingo, Marc-Christian; Bekal, Sadjia; Lefebvre, Brigitte; Tremblay, Cécile

    2015-01-01

    Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) has emerged as a rapid, highly accurate, and cost-effective method for routine identification of a wide range of microorganisms. We carried out a side by side comparative evaluation of the performance of Bruker Biotyper versus VITEK MS for identification of a large and diverse collection of microorganisms. Most difficult and/or unusual microorganisms, as well as commonly encountered microorganisms were selected, including Gram-positive and negative bacteria, mycobacteria, actinomycetes, yeasts and filamentous fungi. Six hundred forty two strains representing 159 genera and 441 species from clinical specimens previously identified at the Laboratoire de santé publique du Québec (LSPQ) by reference methods were retrospectively chosen for the study. They included 254 Gram-positive bacteria, 167 Gram-negative bacteria, 109 mycobacteria and aerobic actinomycetes and 112 yeasts and moulds. MALDI-TOF MS analyses were performed on both systems according to the manufacturer's instructions. Of the 642 strains tested, the name of the genus and / or species of 572 strains were referenced in the Bruker database while 406 were present in the VITEK MS IVD database. The Biotyper correctly identified 494 (86.4%) of the strains, while the VITEK MS correctly identified 362 (92.3%) of the strains (excluding 14 mycobacteria that were not tested). Of the 70 strains not present in the Bruker database at the species level, the Biotyper correctly identified 10 (14.3%) to the genus level and 2 (2.9%) to the complex/group level. For 52 (74.2%) strains, we obtained no identification, and an incorrect identification was given for 6 (8.6%) strains. Of the 178 strains not present in the VITEK MS IVD database at the species level (excluding 71 untested mycobacteria and actinomycetes), the VITEK MS correctly identified 12 (6.8%) of the strains each to the genus and to the complex/group level. For 97 (54

  19. Postnatal Identification of Trisomy 21: An Overview of 7,133 Postnatal Trisomy 21 Cases Identified in a Diagnostic Reference Laboratory in China

    PubMed Central

    Wu, Menghua; Jiang, Shuai; Wu, Binbin; Luo, Huali; Wen, Jingyi; Hu, Chaohui; Yu, Shihui

    2015-01-01

    This study describes the cytogenetic characteristics of 7,133 trisomy 21 (Tri21) identified from 247,818 consecutive postnatal cases karyotyped in a single reference laboratory in China for a period of 4 years. The average detection rate of Tri21 is 2.88% ranging from 3.39% in 2011 to 2.52% in 2014. The decreased detection rates over the years might reflect a possible impact of noninvasive prenatal testing applied rapidly in China and elective termination of affected pregnancies. 95.32% of the Tri21 karyotypes are standard Tri21, 4.53% are Robertsonian Tri21, and less than 1% are other Tri21 forms. There are more mosaic Tri21 in older children and adults, consistent with previous observations that clinical features in individuals with mosaic Tri21 are generally milder and easily missed during perinatal period. The male/female (M/F ratio) for the total 7,133 Tri21 cases and for the 6,671 cases with non-mosaic standard Tri21 are 1.50 and 1.53 respectively, significantly higher than the 0.93 for all the 247,818 cases we karyotyped, the 1.30 for the Down syndrome (DS) identified during perinatal period in China, and the 1.20 for the livebirth in Chinese population. In contrast, the mosaic standard Tri21 case has a significantly lower proportion of males when compared with the non-mosaic standard Tri21, indicating different underlying mechanisms leading to their formations. Opposite M/F ratios in different subtypes of ROB Tri21 were observed. A long list of rare or private karyotypes where Tri21 are concurrently present was identified. The large collection of Tri21 cases with a diversity of clinical findings and a wide age range allowed us to determine the frequency of the different karyotypes of Down syndrome in China, given the fact that this kind of national epidemiological data is lacking currently. PMID:26176847

  20. A Side by Side Comparison of Bruker Biotyper and VITEK MS: Utility of MALDI-TOF MS Technology for Microorganism Identification in a Public Health Reference Laboratory

    PubMed Central

    Lévesque, Simon; Dufresne, Philippe J.; Soualhine, Hafid; Domingo, Marc-Christian; Bekal, Sadjia; Lefebvre, Brigitte; Tremblay, Cécile

    2015-01-01

    Matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS) has emerged as a rapid, highly accurate, and cost-effective method for routine identification of a wide range of microorganisms. We carried out a side by side comparative evaluation of the performance of Bruker Biotyper versus VITEK MS for identification of a large and diverse collection of microorganisms. Most difficult and/or unusual microorganisms, as well as commonly encountered microorganisms were selected, including Gram-positive and negative bacteria, mycobacteria, actinomycetes, yeasts and filamentous fungi. Six hundred forty two strains representing 159 genera and 441 species from clinical specimens previously identified at the Laboratoire de santé publique du Québec (LSPQ) by reference methods were retrospectively chosen for the study. They included 254 Gram-positive bacteria, 167 Gram-negative bacteria, 109 mycobacteria and aerobic actinomycetes and 112 yeasts and moulds. MALDI-TOF MS analyses were performed on both systems according to the manufacturer’s instructions. Of the 642 strains tested, the name of the genus and / or species of 572 strains were referenced in the Bruker database while 406 were present in the VITEK MS IVD database. The Biotyper correctly identified 494 (86.4%) of the strains, while the VITEK MS correctly identified 362 (92.3%) of the strains (excluding 14 mycobacteria that were not tested). Of the 70 strains not present in the Bruker database at the species level, the Biotyper correctly identified 10 (14.3%) to the genus level and 2 (2.9%) to the complex/group level. For 52 (74.2%) strains, we obtained no identification, and an incorrect identification was given for 6 (8.6%) strains. Of the 178 strains not present in the VITEK MS IVD database at the species level (excluding 71 untested mycobacteria and actinomycetes), the VITEK MS correctly identified 12 (6.8%) of the strains each to the genus and to the complex/group level. For 97

  1. Postnatal Identification of Trisomy 21: An Overview of 7,133 Postnatal Trisomy 21 Cases Identified in a Diagnostic Reference Laboratory in China.

    PubMed

    Zhao, Weiwei; Chen, Fan; Wu, Menghua; Jiang, Shuai; Wu, Binbin; Luo, Huali; Wen, Jingyi; Hu, Chaohui; Yu, Shihui

    2015-01-01

    This study describes the cytogenetic characteristics of 7,133 trisomy 21 (Tri21) identified from 247,818 consecutive postnatal cases karyotyped in a single reference laboratory in China for a period of 4 years. The average detection rate of Tri21 is 2.88% ranging from 3.39% in 2011 to 2.52% in 2014. The decreased detection rates over the years might reflect a possible impact of noninvasive prenatal testing applied rapidly in China and elective termination of affected pregnancies. 95.32% of the Tri21 karyotypes are standard Tri21, 4.53% are Robertsonian Tri21, and less than 1% are other Tri21 forms. There are more mosaic Tri21 in older children and adults, consistent with previous observations that clinical features in individuals with mosaic Tri21 are generally milder and easily missed during perinatal period. The male/female (M/F ratio) for the total 7,133 Tri21 cases and for the 6,671 cases with non-mosaic standard Tri21 are 1.50 and 1.53 respectively, significantly higher than the 0.93 for all the 247,818 cases we karyotyped, the 1.30 for the Down syndrome (DS) identified during perinatal period in China, and the 1.20 for the livebirth in Chinese population. In contrast, the mosaic standard Tri21 case has a significantly lower proportion of males when compared with the non-mosaic standard Tri21, indicating different underlying mechanisms leading to their formations. Opposite M/F ratios in different subtypes of ROB Tri21 were observed. A long list of rare or private karyotypes where Tri21 are concurrently present was identified. The large collection of Tri21 cases with a diversity of clinical findings and a wide age range allowed us to determine the frequency of the different karyotypes of Down syndrome in China, given the fact that this kind of national epidemiological data is lacking currently.

  2. Future directions in the European union for veterinary education as related to food-producing animals, with special reference to Greece.

    PubMed

    Kyriakis, Spyridon C; Alexopoulos, Constantinos; Tassis, Panayiotis D; Tzika, Eleni D; Kritas, Spyridon K; Burriel, Angeliki R

    2004-01-01

    During the past 50 years, procedures for raising food-producing animals have changed. Intensification of food production was necessary to keep prices low and to fulfill market demands for the continuously increasing worldwide population. Intensification of farming procedures produced many new problems, some of which had a considerable impact on public opinion about how animals are raised and how food of animal origin is produced and preserved. "Man made diseases" of animals such as bovine spongiform encephalopathy (BSE); contamination of foods with dioxins either through contamination of animal feeds or from the environment; and increased microbial resistance to drugs used for treatment, for prophylaxis of animals from infectious agents, and for growth promotion are some well-known hazards of intensified farming. Veterinarians working on food-producing animals are faced with an increased demand for foods of high quality and safety in developed countries, and higher quantities in the rest of the world. These qualitative and quantitative changes indicate that they must adjust to these new conditions. They will be most successful if their education is adjusted to meet the challenges that the public has created for them through new concepts of the production of food of animal origin. One such concept is the production of foods under fully certified procedures from the farm to the consumer's table. Food safety measures protecting public health will better be achieved if the education of the future veterinarian includes the principles of Hazard Analysis Critical Control Points (HACCP) starting at farm level. This article provides some market-driven ideas in this direction for European Union (EU) countries, including Greece.

  3. European Concerted Action on Anticoagulation. A multicentre calibration study of WHO international reference preparations for thromboplastin, rabbit (RBT/90) and human (rTF/95)

    PubMed Central

    Poller, L; Keown, M; Chauhan, N; van den Besselaar, A M H P; Tripodi, A; Shiach, C; Jespersen, J

    2005-01-01

    A 10 centre calibration was performed after six years to determine the international sensitivity index (ISI) of rTF/95 relative to RBT/90, and to assess any international normalised ratio (INR) bias compared with the original multicentre calibration. After exclusion of one outlying centre, the follow up calibration gave a mean ISI for rTF/95 of 0.99, which although a small difference, is significantly greater than the mean ISI of 0.94 obtained previously. The change in ISI for international reference preparation (IRP) rTF/95 relative to RBT/90 would lead to a slight bias in INR for human compared with rabbit thromboplastins. At a theoretical INR of 3.0, the INR bias is 6.0%, and this is below the accepted 10% level of clinical relevance. Ongoing stability monitoring of World Health Organisation thromboplastin IRP is advised. PMID:15917425

  4. Retrospective analysis of 88,429 serum and urine glucose EQA results obtained from professional laboratories and medical offices participating in surveys organized by three European EQA centers between 1996 and 2007.

    PubMed

    Morandi, Pierre-Alain; Deom, André; Kesseler, Dagmar; Cohen, Richard

    2010-09-01

    The aim of this study was to provide inter-laboratory imprecision comparisons of different groups of diagnostic systems as well as a comparison of professional laboratories with medical offices performance on the basis of 88,429 glucose results obtained in external quality assessment (EQA) schemes organized by three European EQA centers between 1996 and 2007. A simple, non-parametrical statistical model suited to all EQA results, including outliers, was used to calculate yearly and global performance. The best performance was obtained from professional laboratories with a group of three diagnostic systems--Hitachi, Integra, and Vitros, followed by Cobas Mira, and finally by Reflotron. For medical offices, the best performance was achieved with the Cobas Mira diagnostic systems, followed by the Reflotron, SpotChem, and Vitros DT60 diagnostic systems. A slight but overall improvement in performance over time was observed for most diagnostic devices. The analysis of glucose EQA results collected over a 12-year period showed that professional laboratories obtained better performances than medical offices, and that a general improvement in yearly performance was observed for both types of laboratories.

  5. A Technological Acceptance of E-Learning Tools Used in Practical and Laboratory Teaching, According to the European Higher Education Area

    ERIC Educational Resources Information Center

    Martinez-Torres, M. R.; Toral, S. L. Marin; Garcia, F. Barrero; Vazquez, S. Gallardo; Oliva, M. Arias; Torres, T.

    2008-01-01

    The application of scientific tools to analyse the use of Internet-based e-learning tools in academic settings is in general an ignored area. E-learning tools are actually an emergent topic as a result of the new ideas introduced by the European Higher Education Area. Lifelong learning, or the promotion of student initiative, is the new paradigm…

  6. European PTTI report

    NASA Technical Reports Server (NTRS)

    Cordara, Franco; Grimaldi, Sabrina; Leschiutta, Sigfrido

    1994-01-01

    Time and frequency metrology in Europe presents some peculiar features in its three main components: research on clocks, comparisons and dissemination methods, and dissemination services. Apart from the usual activities of the national metrological laboratories, an increasing number of cooperation between the European countries are promoted inside some European organizations, such as the ECC, EFTA, EUROMET, and WECC. Cooperation between these organizations is covered. The present, evolving situation will be further influenced by the recent political changes in Eastern Europe.

  7. Japanese standard reference material for JDS Lot 2 haemoglobin A1c. I: Comparison of Japan Diabetes Society-assigned values to those obtained by the Japanese and USA domestic standardization programmes and by the International Federation of Clinical Chemistry reference laboratories.

    PubMed

    Tominaga, Makoto; Makino, Hideichi; Yoshino, Gen; Kuwa, Katsuhiko; Takei, Izumi; Aono, Yukuko; Hoshino, Tadao; Umemoto, Masao; Shimatsu, Akira; Sanke, Tokio; Kuwashima, Masamichi; Taminato, Tomohiko; Ono, Junko

    2005-01-01

    The Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus of the Japan Diabetes Society (JDS) previously recommended use of the primary calibrator (JDS Lot 1) prepared by the former Committee for Standardization of Glycohemoglobin for standardizing the measurement of haemoglobin A1c (HbA1c). Owing to the depletion of vials of Lot 1 in March 2001, the present committee certified a new reference material, Lot 2, now distributed by the Health Care Technology Foundation (HECTEF). The standardization programme for HbA1c measurement in Japan is currently based on Lot 2, which has values assigned from within Lot 1; the Lot 1 values were consensus values based on assays by laboratories in the Japanese national quality control programme. In this study, for the purpose of international comparison and standardization, Lot 2 was assayed by the JDS reference laboratories, the National Glycoprotein Standardization Program (NGSP) in the USA, and by reference laboratories approved by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The HbA1c values of JDS Lot 2 were transferred from those assigned to Lot 1 using KO500, a high-resolution HPLC method, at three laboratories approved by the JDS committee. Subsequently, vials of JDS Lot 2 were shipped to and assayed by the NGSP in the USA and 10 IFCC reference laboratories. The JDS-assigned HbA1c values (from Lot 1) are 4.04 for Level 1, 5.38 for Level 2, 7.32 for Level 3, 9.88 for Level 4, and 12.63 for Level 5, all expressed as a percentage of total haemoglobin. The values obtained by NGSP and the IFCC laboratories gave the following formulas: NGSP value(%)=JDS value(%)+0.3%; IFCC value(%)=1.068xJDS value(%)-1.741%. Although the values obtained by the IFCC laboratories are significantly lower than the values assigned to Lot 2 by the JDS, the relationship is linear. In addition, standardization of HbA1c based on JDS Lot 2 is currently at a satisfactory level in Japan. As a

  8. European Measurement Comparisons of Environmental Radioactivity

    SciTech Connect

    Waetjen, Uwe

    2008-08-14

    The scheme of European measurement comparisons to verify radioactivity monitoring in the European Union is briefly explained. After a review of comparisons conducted during the years 1990, the approach of IRMM organising these comparisons since 2003 is presented. IRMM is providing comparison samples with a reference value traceable to the SI units and which is fully documented to all participants and national authorities after completion of the comparison. The sample preparation and determination of traceable reference values at IRMM, the sample treatment and measurement in the participating laboratories, as well as the evaluation of comparison results are described in some detail using the example of an air filter comparison. The results of a comparison to determine metabolised {sup 40}K, {sup 90}Sr and {sup 137}Cs in milk powder are presented as well. The necessary improvements in the estimation of measurement uncertainty by the participating laboratories are discussed. The performance of individual laboratories which have participated in at least four comparison exercises over the years is studied in terms of observable trends.

  9. Embedding of laboratory wastes in clay or concrete blocks, with special reference to baking osmic acid and cacodylic acid wastes with clay.

    PubMed

    Murakami, T; Murakami, T; Yamana, S

    1998-12-01

    Liquid laboratory waste containing osmic acid and cacodylic acid was mixed with potter's clay or hydraulic cement. The clay-waste product was kneaded into blocks and baked in a klin (1,200-1,400 degrees C). The cement-waste product was allowed to harden into concrete blocks. Some of the baked clay blocks and concrete blocks were ground, and immersed in 1 N NaOH or 10% HCI solutions for 3-6 months. X-ray microanalysis of the dried samples of these solutions showed that no leakage of osmium and arsenic occurred in the baked clay embedding, and that some leakage of these agents occurred in the concrete embedding. The present study indicates that the baked clay embedding method is useful for safe storage of dangerous laboratory wastes. Additional experiments suggested that glass embedding is also useful for safe storage of laboratory wastes or harmful metals.

  10. Comparison of broiler performance when fed diets containing corn grain with insect-protected (corn rootworm and European corn borer) and herbicide-tolerant (glyphosate) traits, control corn, or commercial reference corn--revisited.

    PubMed

    Taylor, M L; Hartnell, G; Nemeth, M; Karunanandaa, K; George, B

    2005-12-01

    A 42-d feeding experiment with growing Ross x Ross 508 broilers showed that the nutritional value of insect-protected and herbicide-tolerant corn was comparable to that of the genetically similar control and 5 commercial reference corn hybrids. MON 88017 provides protection from feeding damage by coleopteran pest corn rootworm and is tolerant to the action of glyphosate, the active ingredient in the Roundup family of agricultural herbicides. MON 88017 x MON 810 was developed by the traditional breeding of MON 88017 with MON 810, which provides protection from the European corn borer and other lepidopteran pests. A randomized complete block design was used with 8 dietary treatments in each of 5 replicated blocks of pens. No differences among diets were observed (P > 0.05) in performance (final live weights, feed intake, feed conversion, and adjusted feed conversion), carcass yield (chill, fat pad, breast, thigh, wing, and drum weight), or percentage of moisture, protein, and fat in breast meat and moisture and fat in thigh meat. Thigh protein was similar (P > 0.05) in broilers fed diets containing MON 88017 x MON 810 and conventional control or all commercial reference corns; however, differences (P < 0.05) were noted for the percentage of thigh protein among broilers fed the control and 2 of the 5 reference diets, attributable to biological variability among the conventional corn hybrids. Broilers overall performed consistently and had similar carcass yield and meat composition when fed diets containing MON 88017 or MON 88017 x MON 810 as compared with those fed the conventional control and commercial diets, supporting a conclusion of nutritional equivalence.

  11. Comparison of broiler performance when fed diets containing corn grain with insect-protected (corn rootworm and European corn borer) and herbicide-tolerant (glyphosate) traits, control corn, or commercial reference corn.

    PubMed

    Taylor, M L; Hartnell, G; Nemeth, M; Karunanandaa, K; George, B

    2005-04-01

    A 42-d feeding experiment with growing Ross x Ross 508 broilers showed that the nutritional value of insect-protected and herbicide-tolerant corn was comparable to that of the genetically similar control and 5 commercial reference corn hybrids. MON 88017 provides protection from feeding damage by coleopteran pest corn rootworm and is tolerant to the action of glyphosate, the active ingredient in the Roundup family of agricultural herbicides. MON 88017 x MON 810 was developed by the traditional breeding of MON 88017 with MON 810, which provides protection from the European corn borer and other lepidopteran pests. A randomized complete block design was used with 8 dietary treatments in each of 5 replicated blocks of pens. No differences among diets were observed (P > 0.05) in performance (final live weights, feed intake, feed conversion, and adjusted feed conversion), carcass yield (chill, fat pad, breast, thigh, wing, and drum weight), or percentage of moisture, protein, and fat in breast meat and moisture and fat in thigh meat. Thigh protein was similar (P > 0.05) in broilers fed diets containing MON 88017 x MON 810 and conventional control or all commercial reference corns; however, differences (P < 0.05) were noted for the percentage of thigh protein among broilers fed the control and 2 of the 5 reference diets, attributable to biological variability among the conventional corn hybrids. Broilers overall performed consistently and had similar carcass yield and meat composition when fed diets containing MON 88017 or MON 88017 x MON 810 as compared with those fed the conventional control and commercial diets, supporting a conclusion of nutritional equivalence.

  12. FELASA recommendations for the education and training of laboratory animal technicians: category A: report of the Federation of European Laboratory Animal Science Associations Working Group on Education of Animal Technicians (Category A) accepted by the FELASA Board of Management.

    PubMed

    Weiss Convenor, J; Bukelskiene, V; Chambrier, Ph; Ferrari, L; van der Meulen, M; Moreno, M; Mulkens, F; Sigg, H; Yates, N

    2010-07-01

    The future laboratory animal technician in Europe will be provided with three different levels of education. All candidates have to start with an introductory course to reach level A0. At this level (A0) they will be able to assist in the laboratory animal facility by undertaking limited specific duties under supervision. Most A0 assistants will continue their education and training for at least one year while in full-time employment. This process will include continual assessment with the option of a final examination to become qualified at level A1. A1 represents a comprehensively educated laboratory animal technician with theoretical background knowledge and practical skills. Some of the A1 laboratory animal technicians may continue specific education for at least another year of full-time employment. They will develop knowledge and expertise as well as supervisory and basic managerial skills in order to obtain level A2.

  13. Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE).

    PubMed

    Lippi, Giuseppe; Baird, Geoffrey S; Banfi, Giuseppe; Bölenius, Karin; Cadamuro, Janne; Church, Stephen; Cornes, Michael P; Dacey, Anna; Guillon, Antoine; Hoffmann, Georg; Nybo, Mads; Premawardhana, Lakdasa Devananda; Salinas, María; Sandberg, Sverre; Slingerland, Robbert; Stankovic, Ana; Sverresdotter, Sylte Marit; Vermeersch, Pieter; Simundic, Ana-Maria

    2017-03-01

    It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WGPRE on the same topic, and brings together the summaries of the presentations that will be given at the 4th EFLM-BD meeting "Improving quality in the preanalytical phase through innovation" in Amsterdam, 24-25 March, 2017.

  14. Validation of 24-hour flucytosine MIC determination by comparison with 48-hour determination by the Clinical and Laboratory Standards Institute M27-A3 broth microdilution reference method.

    PubMed

    Lockhart, Shawn R; Bolden, Carol B; Iqbal, Naureen; Kuykendall, Randall J

    2011-12-01

    Flucytosine and itraconazole are the only antifungal agents for which the Clinical Laboratory and Standards Institute recommendations include MIC breakpoint readings at 48 h only. Here we show good essential and categorical agreement between the flucytosine MIC readings at 48 and 24 h for Candida species.

  15. The operational performance of hydrogen masers in the Deep Space Network (the performance of laboratory reference frequency standards in an operational environment)

    NASA Technical Reports Server (NTRS)

    Ward, S. C.

    1981-01-01

    Spacecraft navigation to the outer planets (Jupiter and beyond) places very stringent demands upon the performance of frequency and time (F&T) reference standards. The Deep Space Network (DSN) makes use of hydrogen masers as an aid in meeting the routine F&T operational requirements within the 64 m antenna network. Results as of October 1980 indicate the hydrogen masers are performing within the required specifications. Two problem areas are discussed: insufficient control over the environment in which the reference standards reside; and frequency drift.

  16. Standardization of collection requirements for fasting samples: for the Working Group on Preanalytical Phase (WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

    PubMed

    Simundic, A M; Cornes, M; Grankvist, K; Lippi, G; Nybo, M

    2014-05-15

    Standardized protocols for patient preparation for laboratory testing are currently lacking. Moreover, a great heterogeneity exists in the definitions of "fasting" currently being used among healthcare workers and in the literature. Marked metabolic and hormonal changes occur after food ingestion, mainly due to the absorption of fluids, lipids, proteins, carbohydrates and other food constituents. This postprandial response varies markedly in response to numerous factors, such as eating behavior, food composition, fasting duration, time of the day, chronic and acute smoking, coffee and alcohol consumption. It is therefore crucial to minimize the total variability by controlling as many of these modifying factors as possible. Control of the abovementioned effects on postprandial response can only be achieved by standardizing the way patients are prepared for laboratory testing, i.e. by defining the fasting duration, as well as what is and what is not allowed (e.g., coffee, tea, smoking, water) during the period of fasting prior to sample collection. The aim of this article is to describe the range of effects of different approaches to fasting on laboratory tests, and to provide a framework for the harmonization of definitions for fasting requirements for laboratory tests. Copyright © 2013 Elsevier B.V. All rights reserved.

  17. Isotope reference materials

    USGS Publications Warehouse

    Coplen, Tyler B.

    2010-01-01

    Measurement of the same isotopically homogeneous sample by any laboratory worldwide should yield the same isotopic composition within analytical uncertainty. International distribution of light element isotopic reference materials by the International Atomic Energy Agency and the U.S. National Institute of Standards and Technology enable laboratories to achieve this goal.

  18. A Request for Planning Funds for a Research and Study Abroad Facility in Geneva, Switzerland in Affiliation with the European Laboratory for Particle Physics

    SciTech Connect

    campbell, myron

    2013-03-31

    To create a research and study abroad program that would allow U.S. undergraduate students access to the world-leading research facilities at the European Organization for Nuclear Research (CERN), the World Health Organization, various operations of the United Nations and other international organizations based in Geneva.The proposal is based on the unique opportunities currently existing in Geneva. The Large Hadron Collider (LHC) is now operational at CERN, data are being collected, and research results are already beginning to emerge. At the same time, a related reduction of activity at U.S. facilities devoted to particle physics is expected. In addition, the U.S. higher-education community has an ever-increasing focus on international organizations dealing with world health pandemics, arms control and human rights, a nexus also centered in Geneva.

  19. In vitro susceptibility of filamentous fungi to itraconazole, voriconazole and posaconazole by Clinical and Laboratory Standards Institute reference method and E-test.

    PubMed

    Kondori, N; Svensson, E; Mattsby-Baltzer, I

    2011-09-01

    The use of anti-fungal agents has increased dramatically in recent years and new drugs have been developed. Several methods are available for determinations of their specific biological activities, i.e. the standard method for minimum inhibitory concentration-determination is described in M-38 [Clinical and Laboratory Standards Institute document M-38 (CLSI M-38)]. However, alternative methods, such as the E-test, are currently available in Mycology laboratories. The susceptibilities of clinical isolates of Aspergillus spp. (n = 29), Fusarium spp. (n = 5), zygomycetes (n = 21) and Schizophyllum (n = 1) were determined for itraconazole, voriconazole and posaconazole, using the CLSI M-38-A broth dilution method and also by the E-test. A good overall agreement (83.7%) between the two methods for all drugs and organisms was observed. Analyses of voriconazole showed a better agreement (93%) between the methods than posaconazole and itraconazole (85% and 74% respectively). Aspergillus spp. were the most susceptible fungi to the anti-fungal agents tested in this study. Posaconazole was the most active drug against filamentous fungi in vitro, followed by itraconazole and voriconazole. The latter (voriconazole) demonstrated no significant in vitro activity against zygomycetes.

  20. [ONLINE: program for online connection of laboratory apparatus with personal computers with special reference to the requirements of toxicological animal studies].

    PubMed

    Rattel, B; Schliack, M

    1989-01-01

    This paper deals with ONLINE, a program for interfacing laboratory devices with personal computers (PC) via RS-232C. ONLINE was used in our department of toxicology for the evaluation of animal weights and for data transfer from a hematology analyzer to the PC. The program allows simplex as well as duplex connection and supports the programming of communication parameters for the data transfer when using the RS-232C. Files can be generated for the uptake of data up to 100,000 data points. Selected parts of these files can be used for the calculation of descriptive statistical parameters. ONLINE requires a computer compatible to MS-DOS with at least 256 kBytes RAM and with both a serial and a parallel port.

  1. Comparative evaluation of Etest and sensititre yeastone panels against the Clinical and Laboratory Standards Institute M27-A2 reference broth microdilution method for testing Candida susceptibility to seven antifungal agents.

    PubMed

    Alexander, Barbara D; Byrne, Terry C; Smith, Kelly L; Hanson, Kimberly E; Anstrom, Kevin J; Perfect, John R; Reller, L Barth

    2007-03-01

    To assess their utility for antifungal susceptibility testing in our clinical laboratory, the Etest and Sensititre methods were compared with the Clinical and Laboratory Standards Institute (CLSI) M27-A2 reference broth microdilution method. Fluconazole (FL), itraconazole (I), voriconazole (V), posaconazole (P), flucytosine (FC), caspofungin (C), and amphotericin B (A) were tested with 212 Candida isolates. Reference MICs were determined after 48 h of incubation, and Etest and Sensititre MICs were determined after 24 h and 48 h of incubation. Overall, excellent essential agreement (EA) between the reference and test methods was observed for Etest (95%) and Sensititre (91%). Etest showed an >or=92% EA for MICs for all drugs tested; Sensititre showed a >or=92% EA for MICs for I, FC, A, and C but 82% for FL and 85% for V. The overall categorical agreement (CA) was 90% for Etest and 88% for Sensititre; minor errors accounted for the majority of all categorical errors for both systems. Categorical agreement was lowest for Candida glabrata and Candida tropicalis with both test systems. Etest and Sensititre provided better CA at 24 h compared to 48 h for C. glabrata; however, CA for C. glabrata was <80% for FL with both test systems despite MIC determination at 24 h. Agreement between technologists for both methods was >or=98% for each agent against all organisms tested. Overall, Etest and Sensititre methods compared favorably with the CLSI reference method for determining the susceptibility of Candida. However, further evaluation of their performance for determining the MICs of azoles, particularly for C. glabrata, is warranted.

  2. Brazilian Portuguese Ethnonymy and Europeanisms.

    ERIC Educational Resources Information Center

    Stephens, Thomas M.

    1994-01-01

    Delineates the incorporation and analyzes the impact of European borrowings in Brazilian racio-ethnic terminology. This overview covers French, Italian, Spanish, and English influences. Borrowings from European languages have had a small impact on the calculus of Brazilian racio-ethnic terms. (43 references) (Author/CK)

  3. Comprehensive inter-laboratory calibration of reference materials for δ18O versus VSMOW using various on-line high-temperature conversion techniques

    USGS Publications Warehouse

    Brand, Willi A.; Coplen, Tyler B.; Aerts-Bijma, Anita T.; Böhlke, J.K.; Gehre, Matthias; Geilmann, Heike; Groning, Manfred; Jansen, Henk G.; Meijer, Harro A. J.; Mroczkowski, Stanley J.; Qi, Haiping; Soergel, Karin; Stuart-Williams, Hilary; Weise, Stephan M.; Werner, Roland A.

    2009-01-01

    −55.5‰ The seemingly large estimated combined uncertainties arise from differences in instrumentation and methodology and difficulty in accounting for all measurement bias. They are composed of the 3-fold standard errors directly calculated from the measurements and provision for systematic errors discussed in this paper. A primary conclusion of this study is that nitrate samples analyzed for δ18O should be analyzed with internationally distributed isotopic nitrates, and likewise for sulfates and organics. Authors reporting relative differences of oxygen-isotope ratios (δ18O) of nitrates, sulfates, or organic material should explicitly state in their reports the δ18O values of two or more internationally distributed nitrates (USGS34, IAEA-NO-3, and USGS35), sulfates (IAEA-SO-5, IAEA-SO-6, and NBS 127), or organic material (IAEA-601 benzoic acid, IAEA-602 benzoic acid, and IAEA-600 caffeine), as appropriate to the material being analyzed, had these reference materials been analyzed with unknowns. This procedure ensures that readers will be able to normalize the δ18O values at a later time should it become necessary. The high-temperature reduction technique for analyzing δ18O and δ2H is not as widely applicable as the well-established combustion technique for carbon and nitrogen stable isotope determination. To obtain the most reliable stable isotope data, materials should be treated in an identical fashion; within the same sequence of analyses, samples should be compared with working reference materials that are as similar in nature and in isotopic composition as feasible. 

  4. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 °C. Part 9: reference procedure for the measurement of catalytic concentration of alkaline phosphatase International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Scientific Division, Committee on Reference Systems of Enzymes (C-RSE) (1)).

    PubMed

    Schumann, Gerhard; Klauke, Rainer; Canalias, Francesca; Bossert-Reuther, Steffen; Franck, Paul F H; Gella, F-Javier; Jørgensen, Poul J; Kang, Dongchon; Lessinger, Jean-Marc; Panteghini, Mauro; Ceriotti, Ferruccio

    2011-09-01

    Abstract This paper is the ninth in a series dealing with reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 °C and the certification of reference preparations. Other parts deal with: Part 1. The concept of reference procedures for the measurement of catalytic activity concentrations of enzymes; Part 2. Reference procedure for the measurement of catalytic concentration of creatine kinase; Part 3. Reference procedure for the measurement of catalytic concentration of lactate dehydrogenase; Part 4. Reference procedure for the measurement of catalytic concentration of alanine aminotransferase; Part 5. Reference procedure for the measurement of catalytic concentration of aspartate aminotransferase; Part 6. Reference procedure for the measurement of catalytic concentration of γ-glutamyltransferase; Part 7. Certification of four reference materials for the determination of enzymatic activity of γ-glutamyltransferase, lactate dehydrogenase, alanine aminotransferase and creatine kinase at 37 °C; Part 8. Reference procedure for the measurement of catalytic concentration of α-amylase. The procedure described here is derived from the previously described 30 °C IFCC reference method. Differences are tabulated and commented on in Appendix 1.

  5. Extrapolating laboratory avian toxicity data to free-living birds: Comparison of the toxicity of parathion to captive and free-living European starlings

    USGS Publications Warehouse

    Grue, C.E.; Rattner, B.A.; Bunck, C.M.

    1993-01-01

    In 1985 and 1986, we captured nesting wild female European starlings with young 8-10 days of age. Birds were weighted, banded, and given one of four dosages of the OP insecticide parathion (50, 72, 104 or 150 mg/kg dissolved in corn oil) or pure corn-oil (control). and their young weighed. Nest boxes (7- 12/treatment) were observed and young re-weighed 2-3 days postdose to determine presence/absence of the females. If necessary, males were captured and fate of young used to confirm female response. Brain ChE inhibition in dosed birds (based on a pilot study) was 55-74%. EC50's (failure to return to nest box) for the females was 74 mg/kg in 1985 and 92 mg/kg in 1986. Confidence limit (95%) for these estimates overlapped LD50's for captive female starlings dosed with the OP in spring and early summer 1987 (136, 128 mg/kg, respectively). Results suggest that responses of captive and free-living birds to potentially lethal concentrations of OP's are similar, despite the additional stresses in the wild.

  6. X-Ray Diffraction Reference Intensity Ratios of Amorphous and Poorly Crystalline Phases: Implications for CheMin on the Mars Science Laboratory

    NASA Technical Reports Server (NTRS)

    Morris, R. V.; Achilles, C. N.; Chipera, S. J.; Ming, D. W.; Rampe, E. B.

    2013-01-01

    The CheMin instrument on the Mars Science Laboratory (MSL) rover Curiosity is an X-ray diffraction (XRD) and X-ray fluorescence (XRF) instrument capable of providing the mineralogical and chemical compositions of rocks and soils on the surface of Mars. CheMin uses a microfocus X-ray tube with a Co target, transmission geometry, and an energy-discriminating X-ray sensitive CCD to produce simultaneous 2-D XRD patterns and energy-dispersive X-ray histograms from powdered samples. Piezoelectric vibration of the cell is used to randomize the sample to reduce preferred orientation effects. Instrument details are provided in [1, 2, 3]. Analyses of rock and soil samples by the Mars Exploration Rovers (MER) show nanophase ferric oxide (npOx) is a significant component of the Martian global soil [4] and is thought to be one of the major contributing phases that the Curiosity rover will encounter if a soil sample is analyzed in Gale Crater. Because of the nature of this material, npOx will likely contribute to an X-ray amorphous or short-order component of a XRD pattern measured by the CheMin instrument.

  7. Comprehensive inter-laboratory calibration of reference materials for d18O versus VSMOW using various on-line high-temperature conversion techniques

    USGS Publications Warehouse

    Coplen, Tyler B.; Bohlke, Johnkarl F.; Mroczkowski, Stanley J.; Qi, Haiping; Brand, Willi A.; Aerts-Bijma, Anita T.; Gehre, Matthias; Geilmann, Heike; Groning, Manfred

    2009-01-01

    IAEA-602 benzoic acid +71.28?±?0.36‰ USGS35 sodium nitrate +56.81?±?0.31‰ IAEA-NO-3 potassium nitrate +25.32?±?0.29‰ IAEA-601 benzoic acid +23.14?±?0.19‰ IAEA-SO-5 barium sulfate +12.13?±?0.33‰ NBS 127 barium sulfate +8.59?±?0.26‰ VSMOW2 water 0‰ IAEA-600 caffeine -3.48?±?0.53‰ IAEA-SO-6 barium sulfate -11.35?±?0.31‰ USGS34 potassium nitrate -27.78?±?0.37‰ SLAP water -55.5‰ The seemingly large estimated combined uncertainties arise from differences in instrumentation and methodology and difficulty in accounting for all measurement bias. They are composed of the 3-fold standard errors directly calculated from the measurements and provision for systematic errors discussed in this paper. A primary conclusion of this study is that nitrate samples analyzed for d18O should be analyzed with internationally distributed isotopic nitrates, and likewise for sulfates and organics. Authors reporting relative differences of oxygen-isotope ratios (d18O) of nitrates, sulfates, or organic material should explicitly state in their reports the d18O values of two or more internationally distributed nitrates (USGS34, IAEA-NO-3, and USGS35), sulfates (IAEA-SO-5, IAEA-SO-6, and NBS 127), or organic material (IAEA-601 benzoic acid, IAEA-602 benzoic acid, and IAEA-600 caffeine), as appropriate to the material being analyzed, had these reference materials been analyzed with unknowns. This procedure ensures that readers will be able to normalize the d18O values at a later time should it become necessary. The high-temperature reduction technique for analyzing d18O and d2H is not as widely applicable as the well-established combustion technique for carbon and nitrogen stable isotope determination. To obtain the most reliable stable isotope data, materials should be treated in an identical fashion; within the same sequence of analyses, samples should be compared with working reference materials that are as similar in nature and in isotopic composition as feasible."

  8. Comparison of exhaust emissions from Swedish environmental classified diesel fuel (MK1) and European Program on Emissions, Fuels and Engine Technologies (EPEFE) reference fuel: a chemical and biological characterization, with viewpoints on cancer risk.

    PubMed

    Westerholm, R; Christensen, A; Törnqvist, M; Ehrenberg, L; Rannug, U; Sjögren, M; Rafter, J; Soontjens, C; Almén, J; Grägg, K

    2001-05-01

    Diesel fuels, classified as environmentally friendly, have been available on the Swedish market since 1991. The Swedish diesel fuel classification is based upon the specification of selected fuel composition and physical properties to reduce potential environmental and health effects from direct human exposure to exhaust. The objective of the present investigation was to compare the most stringent, environmentally classified Swedish diesel fuel (MK1) to the reference diesel fuel used in the "European Program on Emissions, Fuels and Engine Technologies" (EPEFE) program. The study compares measurements of regulated emissions, unregulated emissions, and biological tests from a Volvo truck using these fuels. The regulated emissions from these two fuels (MK1 vs EPEFE) were CO (-2.2%), HC (12%), NOx (-11%), and particulates (-11%). The emissions of aldehydes, alkenes, and carbon dioxide were basically equivalent. The emissions of particle-associated polycyclic aromatic hydrocarbons (PAHs) and 1-nitropyrene were 88% and 98% lower than those of the EPEFE fuel, respectively. The emissions of semi-volatile PAHs and 1-nitropyrene were 77% and 80% lower than those from the EPEFE fuel, respectively. The reduction in mutagenicity of the particle extract varied from -75 to -90%, depending on the tester strain. The reduction of mutagenicity of the semi-volatile extract varied between -40 and -60%. Furthermore, the dioxin receptor binding activity was a factor of 8 times lower in the particle extracts and a factor of 4 times lower in the semi-volatile extract than that of the EPEFE fuel. In conclusion, the MK1 fuel was found to be more environmentally friendly than the EPEFE fuel.

  9. The Validation and Implications of Using Whole Genome Sequencing as a Replacement for Traditional Serotyping for a National Salmonella Reference Laboratory

    PubMed Central

    Yachison, Chris A.; Yoshida, Catherine; Robertson, James; Nash, John H. E.; Kruczkiewicz, Peter; Taboada, Eduardo N.; Walker, Matthew; Reimer, Aleisha; Christianson, Sara; Nichani, Anil; Paccagnella, Ana; Nadon, Celine

    2017-01-01

    Salmonella serotyping remains the gold-standard tool for the classification of Salmonella isolates and forms the basis of Canada’s national surveillance program for this priority foodborne pathogen. Public health officials have been increasingly looking toward whole genome sequencing (WGS) to provide a large set of data from which all the relevant information about an isolate can be mined. However, rigorous validation and careful consideration of potential implications in the replacement of traditional surveillance methodologies with WGS data analysis tools is needed. Two in silico tools for Salmonella serotyping have been developed, the Salmonella in silico Typing Resource (SISTR) and SeqSero, while seven gene MLST for serovar prediction can be adapted for in silico analysis. All three analysis methods were assessed and compared to traditional serotyping techniques using a set of 813 verified clinical and laboratory isolates, including 492 Canadian clinical isolates and 321 isolates of human and non-human sources. Successful results were obtained for 94.8, 88.2, and 88.3% of the isolates tested using SISTR, SeqSero, and MLST, respectively, indicating all would be suitable for maintaining historical records, surveillance systems, and communication structures currently in place and the choice of the platform used will ultimately depend on the users need. Results also pointed to the need to reframe serotyping in the genomic era as a test to understand the genes that are carried by an isolate, one which is not necessarily congruent with what is antigenically expressed. The adoption of WGS for serotyping will provide the simultaneous collection of information that can be used by multiple programs within the current surveillance paradigm; however, this does not negate the importance of the various programs or the role of serotyping going forward. PMID:28649236

  10. The standardized fish bioassay procedure for detecting and culturing actively toxic Pfiesteria, used by two reference laboratories for atlantic and gulf coast states.

    PubMed

    Burkholder, J M; Marshall, H G; Glasgow, H B; Seaborn, D W; Deamer-Melia, N J

    2001-10-01

    In the absence of purified standards of toxins from Pfiesteria species, appropriately conducted fish bioassays are the "gold standard" that must be used to detect toxic strains of Pfiesteria spp. from natural estuarine water or sediment samples and to culture actively toxic Pfiesteria. In this article, we describe the standardized steps of our fish bioassay as an abbreviated term for a procedure that includes two sets of trials with fish, following the Henle-Koch postulates modified for toxic rather than infectious agents. This procedure was developed in 1991, and has been refined over more than 12 years of experience in research with toxic Pfiesteria. The steps involve isolating toxic strains of Pfiesteria (or other potentially, as-yet-undetected, toxic Pfiesteria or Pfiesteria-like species) from fish-killing bioassays with natural samples; growing the clones with axenic algal prey; and retesting the isolates in a second set of fish bioassays. The specific environmental conditions used (e.g., temperature, salinity, light, other factors) must remain flexible, given the wide range of conditions from which natural estuarine samples are derived. We present a comparison of information provided for fish culture conditions, reported in international science journals in which such research is routinely published, and we provide information from more than 2,000 fish bioassays with toxic Pfiesteria, along with recommendations for suitable ranges and frequency of monitoring of environmental variables. We present data demonstrating that algal assays, unlike these standardized fish bioassays, should not be used to detect toxic strains of Pfiesteria spp. Finally, we recommend how quality control/assurance can be most rapidly advanced among laboratories engaged in studies that require research-quality isolates of toxic Pfiesteria spp.

  11. The standardized fish bioassay procedure for detecting and culturing actively toxic Pfiesteria, used by two reference laboratories for atlantic and gulf coast states.

    PubMed Central

    Burkholder, J M; Marshall, H G; Glasgow, H B; Seaborn, D W; Deamer-Melia, N J

    2001-01-01

    In the absence of purified standards of toxins from Pfiesteria species, appropriately conducted fish bioassays are the "gold standard" that must be used to detect toxic strains of Pfiesteria spp. from natural estuarine water or sediment samples and to culture actively toxic Pfiesteria. In this article, we describe the standardized steps of our fish bioassay as an abbreviated term for a procedure that includes two sets of trials with fish, following the Henle-Koch postulates modified for toxic rather than infectious agents. This procedure was developed in 1991, and has been refined over more than 12 years of experience in research with toxic Pfiesteria. The steps involve isolating toxic strains of Pfiesteria (or other potentially, as-yet-undetected, toxic Pfiesteria or Pfiesteria-like species) from fish-killing bioassays with natural samples; growing the clones with axenic algal prey; and retesting the isolates in a second set of fish bioassays. The specific environmental conditions used (e.g., temperature, salinity, light, other factors) must remain flexible, given the wide range of conditions from which natural estuarine samples are derived. We present a comparison of information provided for fish culture conditions, reported in international science journals in which such research is routinely published, and we provide information from more than 2,000 fish bioassays with toxic Pfiesteria, along with recommendations for suitable ranges and frequency of monitoring of environmental variables. We present data demonstrating that algal assays, unlike these standardized fish bioassays, should not be used to detect toxic strains of Pfiesteria spp. Finally, we recommend how quality control/assurance can be most rapidly advanced among laboratories engaged in studies that require research-quality isolates of toxic Pfiesteria spp. PMID:11677184

  12. Laboratory-based investigation of suspected mumps cases submitted to the German National Reference Centre for Measles, Mumps, and Rubella, 2008 to 2013.

    PubMed

    Mankertz, Annette; Beutel, Ulrike; Schmidt, Franz-Josef; Borgmann, Stefan; Wenzel, Jürgen J; Ziegler, Peter; Weißbrich, Benedikt; Santibanez, Sabine

    2015-10-01

    From 2008 to 2013, sample sets from 534 patients displaying clinical symptoms of mumps were submitted to the German Reference Centre for Measles, Mumps and Rubella. Mumps virus infection was confirmed in 216 cases (40%) by PCR and/or serology. Confirmed cases were more frequently seen in male than in female patients (128 vs. 81); the age group predominantly affected was 15 to 29 years old (65%, median age: 26.4 years). The majority of the confirmed cases had a remote history of vaccination with one or two doses of a mumps-containing vaccine (69%). Our results indicate that mumps virus caused two outbreaks in Bavaria in 2008 and 2010/2011 and a third one in Lower Saxony in 2011. Mumps virus genotype G was preponderantly detected from 2008 to 2013. For 107 of the 216 patients with a confirmed mumps infection, we correlated the results from PCR and serology. PCR detected cases during the first week after onset of symptoms (74% positive results). PCR worked best with throat swabs and oral fluids (61% and 60% positive results, respectively). IgM was more reliable with a longer time after onset of symptoms (67%), but indirect IgM serology was of insufficient sensitivity for vaccinated mumps cases (30%); the IgM μ-capture assay detected more cases in this group. Mumps virus is able to initiate an infection in vaccinated patients (secondary vaccine failure, SVF) although it is unclear to what extent. Since SVF does occur in highly vaccinated populations and IgM will not increase to detectable levels in all SVF patients, we strongly recommend using PCR plus serology tests to avoid false-negative diagnoses in vaccinated individuals with clinical signs of mumps. Copyright © 2015 Elsevier GmbH. All rights reserved.

  13. Comparison of a spectrophotometric microdilution method with RPMI-2% glucose with the National Committee for Clinical Laboratory Standards reference macrodilution method M27-P for in vitro susceptibility testing of amphotericin B, flucytosine, and fluconazole against Candida albicans.

    PubMed Central

    Rodríguez-Tudela, J L; Berenguer, J; Martínez-Suárez, J V; Sanchez, R

    1996-01-01

    The National Committee for Clinical Laboratory Standards has proposed a reference broth macrodilution method for in vitro antifungal susceptibility testing of yeasts (the M27-P method). This method is cumbersome and time-consuming and includes MIC endpoint determination by visual and subjective inspection of growth inhibition after 48 h of incubation. An alternative microdilution procedure was compared with the M27-P method for determination of the amphotericin B, flucytosine, and fluconazole susceptibilities of 8 American Type Culture Collection strains (6 of them were quality control or reference strains) and 50 clinical isolates of candida albicans. This microdilution method uses as culture medium RPMI 1640 supplemented with 18 g of glucose per liter (RPMI-2% glucose). Preparation of drugs, basal medium, and inocula was done by following the recommendations of the National Committee for Clinical Laboratory Standards. The MIC endpoint was calculated objectively from the turbidimetric data read at 24 h. Increased growth of C. albicans in RPMI-2% glucose and its spectrophotometric reading allowed for the rapid (24 h) and objective calculation of MIC endpoints compared with previous microdilution methods with standard RPMI 1640. Nevertheless, good agreement was shown between the M27-P method and this microdilution test. The MICs obtained for the quality control or reference strains by the microdilution method were in the ranges published for those strains. For clinical isolates, the percentages of agreement were 100% for amphotericin B and fluconazole and 98.1% for flucytosine. These data suggest that this microdilution method may serve as a less subjective and more rapid alternative to the M27-P method for antifungal susceptibility testing of yeasts. PMID:8878570

  14. Proficiency Program for Real-Time PCR Diagnosis of Bordetella pertussis Infections in French Hospital Laboratories and at the French National Reference Center for Whooping Cough and other Bordetelloses▿ †

    PubMed Central

    Caro, Valérie; Guiso, Nicole; Alberti, Corinne; Liguori, Sandrine; Burucoa, Christophe; Couetdic, Gérard; Doucet-Populaire, Florence; Ferroni, Agnès; Papin-Gibaud, Sophie; Grattard, Florence; Réglier-Poupet, Hélène; Raymond, Josette; Soler, Catherine; Bouchet, Sylvie; Charreau, Sandrine; Couzon, Brigitte; Leymarie, Isabelle; Tavares, Nicole; Choux, Mathilde; Bingen, Edouard; Bonacorsi, Stéphane

    2009-01-01

    With the support of a ministerial program for innovative and expensive technologies, dedicated to the economic evaluation of laboratory diagnosis of pertussis by real-time PCR, external quality assessment for real-time IS481 PCR was carried out. Coordinated by the National Centre of Reference of Pertussis and other Bordetelloses (NCR), this study aimed to harmonize and to assess the performances of eight participating microbiology hospital laboratories throughout the French territory. Between January 2006 and February 2007, 10 proficiency panels were sent by the NCR (ascending proficiency program), representing a total of 49 samples and including eight panels to analyze and evaluate the global sensitivity and specificity of real-time PCR, one to assess the limit of detection, and one to evaluate nucleic acid extraction methods. As part of the descending proficiency program, extracted DNA from clinical samples was sent by the eight participating laboratories in different panels and analyzed by the NCR. In the ascending proficiency analysis, the sensitivity and specificity of the real-time PCR methods were 92.2% and 94.3%, respectively. The limit of detection of the different methods ranged between 0.1 and 1 fg/μl (0.2 to 2 CFU/μl). The nucleic acid extraction methods showed similar performances. During the descending proficiency analysis, performed with 126 samples, the result of the NCR for 15 samples (11.9%) was discordant with the result obtained by the source laboratory. Despite several initial differences, harmonization was easy and performances were homogeneous. However, the risk of false-positive results remains quite high, and we strongly recommend establishment of uniform quality control procedures performed regularly. PMID:19692562

  15. Proficiency program for real-time PCR diagnosis of Bordetella pertussis infections in French hospital laboratories and at the French National Reference Center for Whooping Cough and other Bordetelloses.

    PubMed

    Caro, Valérie; Guiso, Nicole; Alberti, Corinne; Liguori, Sandrine; Burucoa, Christophe; Couetdic, Gérard; Doucet-Populaire, Florence; Ferroni, Agnès; Papin-Gibaud, Sophie; Grattard, Florence; Réglier-Poupet, Hélène; Raymond, Josette; Soler, Catherine; Bouchet, Sylvie; Charreau, Sandrine; Couzon, Brigitte; Leymarie, Isabelle; Tavares, Nicole; Choux, Mathilde; Bingen, Edouard; Bonacorsi, Stéphane

    2009-10-01

    With the support of a ministerial program for innovative and expensive technologies, dedicated to the economic evaluation of laboratory diagnosis of pertussis by real-time PCR, external quality assessment for real-time IS481 PCR was carried out. Coordinated by the National Centre of Reference of Pertussis and other Bordetelloses (NCR), this study aimed to harmonize and to assess the performances of eight participating microbiology hospital laboratories throughout the French territory. Between January 2006 and February 2007, 10 proficiency panels were sent by the NCR (ascending proficiency program), representing a total of 49 samples and including eight panels to analyze and evaluate the global sensitivity and specificity of real-time PCR, one to assess the limit of detection, and one to evaluate nucleic acid extraction methods. As part of the descending proficiency program, extracted DNA from clinical samples was sent by the eight participating laboratories in different panels and analyzed by the NCR. In the ascending proficiency analysis, the sensitivity and specificity of the real-time PCR methods were 92.2% and 94.3%, respectively. The limit of detection of the different methods ranged between 0.1 and 1 fg/microl (0.2 to 2 CFU/microl). The nucleic acid extraction methods showed similar performances. During the descending proficiency analysis, performed with 126 samples, the result of the NCR for 15 samples (11.9%) was discordant with the result obtained by the source laboratory. Despite several initial differences, harmonization was easy and performances were homogeneous. However, the risk of false-positive results remains quite high, and we strongly recommend establishment of uniform quality control procedures performed regularly.

  16. External Quality Assessment for Tuberculosis Diagnosis and Drug Resistance in the European Union: A Five Year Multicentre Implementation Study

    PubMed Central

    Richter, Elvira; Ahmed, Nada; van der Werf, Marieke J.; Kodmon, Csaba; Drobniewski, Francis; Ruesch-Gerdes, Sabine

    2016-01-01

    Background External quality assurance (EQA) systems are essential to ensure accurate diagnosis of TB and drug-resistant TB. The implementation of EQA through organising regular EQA rounds and identification of training needs is one of the key activities of the European TB reference laboratory network (ERLTB-Net). The aim of this study was to analyse the results of the EQA rounds in a systematic manner and to identify potential benefits as well as common problems encountered by the participants. Methods The ERLTB-Net developed seven EQA modules to test laboratories’ proficiency for TB detection and drug susceptibility testing using both conventional and rapid molecular tools. All National TB Reference laboratories in the European Union and European Economic Area (EU/EEA) Member States were invited to participate in the EQA scheme. Results A total of 32 National TB Reference laboratories participated in six EQA rounds conducted in 2010–2014. The participation rate ranged from 52.9% - 94.1% over different modules and rounds. Overall, laboratories demonstrated very good proficiency proving their ability to diagnose TB and drug-resistant TB with high accuracy in a timely manner. A small number of laboratories encountered problems with identification of specific Non-tuberculous Mycobacteria (NTMs) (N = 5) and drug susceptibility testing to Pyrazinamide, Amikacin, Capreomycin, and Ethambutol (N = 4). Conclusions The European TB Reference laboratories showed a steady and high level of performance in the six EQA rounds. A network such as ERLTB-Net can be instrumental in developing and implementing EQA and in establishing collaboration between laboratories to improve the diagnosis of TB in the EU/EEA. PMID:27055064

  17. High frequency reference electrode

    DOEpatents

    Kronberg, James W.

    1994-01-01

    A high frequency reference electrode for electrochemical experiments comprises a mercury-calomel or silver-silver chloride reference electrode with a layer of platinum around it and a layer of a chemically and electrically resistant material such as TEFLON around the platinum covering all but a small ring or "halo" at the tip of the reference electrode, adjacent to the active portion of the reference electrode. The voltage output of the platinum layer, which serves as a redox electrode, and that of the reference electrode are coupled by a capacitor or a set of capacitors and the coupled output transmitted to a standard laboratory potentiostat. The platinum may be applied by thermal decomposition to the surface of the reference electrode. The electrode provides superior high-frequency response over conventional electrodes.

  18. High frequency reference electrode

    DOEpatents

    Kronberg, J.W.

    1994-05-31

    A high frequency reference electrode for electrochemical experiments comprises a mercury-calomel or silver-silver chloride reference electrode with a layer of platinum around it and a layer of a chemically and electrically resistant material such as TEFLON around the platinum covering all but a small ring or halo' at the tip of the reference electrode, adjacent to the active portion of the reference electrode. The voltage output of the platinum layer, which serves as a redox electrode, and that of the reference electrode are coupled by a capacitor or a set of capacitors and the coupled output transmitted to a standard laboratory potentiostat. The platinum may be applied by thermal decomposition to the surface of the reference electrode. The electrode provides superior high-frequency response over conventional electrodes. 4 figs.

  19. Results of an inter and intra laboratory exercise on the assessment of complex autosomal DNA profiles.

    PubMed

    Benschop, Corina C G; Connolly, Edward; Ansell, Ricky; Kokshoorn, Bas

    2017-01-01

    The interpretation of complex DNA profiles may differ between laboratories and reporting officers, which can lead to discrepancies in the final reports. In this study, we assessed the intra and inter laboratory variation in DNA mixture interpretation for three European ISO17025-accredited laboratories. To this aim, 26 reporting officers analyzed five sets of DNA profiles. Three main aspects were considered: 1) whether the mixed DNA profiles met the criteria for comparison to a reference profile, 2) the actual result of the comparison between references and DNA profiling data and 3) whether the weight of the DNA evidence could be assessed. Similarity in answers depended mostly on the complexity of the tasks. This study showed less variation within laboratories than between laboratories which could be the result of differences between internal laboratory guidelines and methods and tools available. Results show the profile types for which the three laboratories report differently, which informs indirectly on the complexity threshold the laboratories employ. Largest differences between laboratories were caused by the methods available to assess the weight of the DNA evidence. This exercise aids in training forensic scientists, refining laboratory guidelines and explaining differences between laboratories in court. Undertaking more collaborative exercises in future may stimulate dialog and consensus regarding interpretation. For training purposes, DNA profiles of the mixed stains and questioned references are made available. Copyright © 2016 The Chartered Society of Forensic Sciences. Published by Elsevier Ireland Ltd. All rights reserved.

  20. Comparison of the Sensititre YeastOne® dilution method with the Clinical Laboratory Standards Institute (CLSI) M27-A3 microbroth dilution reference method for determining MIC of eight antifungal agents on 102 yeast strains.

    PubMed

    Bertout, S; Dunyach, C; Drakulovski, P; Reynes, J; Mallié, M

    2011-02-01

    The Clinical Laboratory Standards Institute ([CLSI] formerly NCCLS) reference broth microdilution testing method (protocol M27-A3) was compared with a commercially available methods (Sensititre YeastOne(®)) by testing two quality control strains and 102 isolates of Candida sp. and Cryptococcus sp. against fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole, flucytosin, amphotericin B and caspofungin. Minimal inhibitory concentrations (MIC) endpoints were determined after 24h of incubation for Sensititre YeastOne(®) and after 24 and 48 h for CLSI microdilution method. Essential agreements between methods vary from 70.6 to 92.2%. Categorical agreements vary from 94.1% for 5FC to 72.6% for AMB. Sensititre YeastOne(®) reading appears to be useful for avoiding very major errors and this confirms the interest of this method for evaluating new antifungals activity in vitro.

  1. Measurement performance of reagent manufacturers by Centers for Disease Control and Prevention/Cholesterol Reference Method Laboratory Network lipid standardization specified for metabolic syndrome-focused health checkups program in Japan.

    PubMed

    Nakamura, Masakazu; Koyama, Isao; Iso, Hiroyasu; Sato, Shinichi; Okazaki, Mitsuyo; Kiyama, Masahiko; Shimamoto, Takashi; Konishi, Masamitsu

    2009-01-01

    This study was designed to clarify the current measurement performance of 7 reagent manufacturers for high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC) and triglycerides (TG) specified for the metabolic syndrome (MetS)-focused health checkups program in Japan. Twenty HDLC, 21 LDLC and 9 TG analytical reagent/instrument/calibrator systems (system), and combinations of reagent lots, instrument models and calibrator lots, underwent Centers for Disease Control and Prevention (CDC)/Cholesterol Reference Method Laboratory Network (CRMLN) lipid standardization. Eighty and 100% systems were requested to achieve an accuracy of within +/-1% and +/-2% of the reference value, so that a clinical laboratory can meet the CDC criteria. The CDC performance criteria of HDLC, LDLC and TG require an accuracy of within +/-5%, +/-4% and +/-5%, respectively. For HDLC, all 20 systems met the criteria. Fourteen (70.0%) and 18 (90.0%) systems were within +/-1% and +/-2%, respectively. For LDLC, 14 (66.7%) of 21 systems met the criteria, but 7 (33.3%) failed. Five (23.8%) and 17 (81.0%) systems were within +/-1% and +/-2%, respectively. For TG, 8 of 9 systems met the criteria. Two (22.2%) and 4 (44.4%) systems were within +/-1% and +/-2%, respectively. The minimum and maximum differences of a specified sample among manufacturers were 1.6 and 11.0 mg/dL for HDLC, 7.8 and 33.0 mg/dL for LDLC, and 2.8 and 27.4 mg/dL for TG, respectively. Homogeneous HDLC methods are acceptable for MetS, but further accuracy improvement of homogeneous LDLC and TG methods will be needed because of their poor performance.

  2. Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay using bench top flow cytometer for evaluation of sperm DNA fragmentation in fertility laboratories: protocol, reference values, and quality control.

    PubMed

    Sharma, Rakesh; Ahmad, Gulfam; Esteves, Sandro C; Agarwal, Ashok

    2016-02-01

    The purpose of this study is to provide a detailed protocol and quality control steps for measuring sperm DNA fragmentation (SDF) by terminal deoxynucleotidyl transferase deoxyuridine triphosphate (dUTP) nick end labeling (TUNEL) assay using a new bench top flow cytometer, determine the reference value of SDF, and assess sensitivity, specificity, and distribution of SDF in infertile men and controls with proven and unproven fertility. Semen specimens from 95 controls and 261 infertile men referred to a male infertility testing laboratory were tested for SDF by TUNEL assay using Apo-Direct kit and a bench top flow cytometer. Percentage of cells positive for TUNEL was calculated. Inter- and intraobserver variability was examined. TUNEL cutoff value, sensitivity, specificity, and distribution of different cutoff values in controls and infertile patients were calculated. The reference value of SDF by TUNEL assay was 16.8 % with a specificity of 91.6 % and sensitivity of 32.6 %. The positive and negative predictive values were 91.4 and 33.1 %, respectively. The upper limit of DNA damage in infertile men was significantly higher (68.9 %) than that in the controls (19.6 %). TUNEL assay using flow cytometry is a reproducible and easy method to determine SDF. At a cutoff point of 16.8 %, the test showed high specificity and positive predictive value. The results of this test could identify infertile men whose sperm DNA fragmentation does not contribute to their infertility and confirm that a man who tests positive is likely to be infertile due to elevated sperm DNA fragmentation.

  3. Advancements in NORM metrology - Results and impact of the European joint research project MetroNORM.

    PubMed

    Josef Maringer, Franz; Baumgartner, Andreas; Cardellini, Francesco; Cassette, Philippe; Crespo, Teresa; Dean, Julian; Wiedner, Hannah; Hůlka, Jiři; Hult, Mikael; Jerome, Simon; Kabrt, Franz; Kovář, Petr; Larijani, Cyrus; Lutter, Guillaume; Marouli, Maria; Mauring, Alexander; Mazánová, Monika; Michalik, Bogusław; Michielsen, Nathalie; Peyres, Virginia; Pierre, Sylvie; Pöllänen, Roy; Pommé, Stefaan; Reis, Mário; Stietka, Michael; Szücs, László; Vodenik, Branko

    2017-03-08

    The results of the three years European Metrology Research Programme's (EMRP) joint research project 'Metrology for processing materials with high natural radioactivity' (MetroNORM) are presented. In this project, metrologically sound novel instruments and procedures for laboratory and in-situ NORM activity measurements have been developed. Additionally, standard reference materials and sources for traceable calibration and improved decay data of natural radionuclides have been established.

  4. Rubidium marking technique for the European corn borer (Lepidoptera: Pyralidae) in corn

    SciTech Connect

    Legg, D.E.; Chiang, H.C.

    1984-04-01

    Laboratory and greenhouse experiments conducted in 1980 showed that rubidium (Rb) could be used to mark corn plants and emergent European corn borer (ECB), Ostrinia nubilalis (Huebner), moths. Rb had no adverse effects on pre-adult mortality, moth deformity, or fecundity. The best application method for marking ECB moths was an over-the-top + directed foliar spray to the corn plants. 14 references, 1 figure, 4 tables.

  5. Reference Services.

    ERIC Educational Resources Information Center

    Bunge, Charles A.

    1999-01-01

    Discusses library reference services. Topics include the historical development of reference services; instruction in library use, particularly in college and university libraries; guidance; information and referral services and how they differ from traditional question-answering service; and future concerns, including user fees and the planning…

  6. Reference Assessment

    ERIC Educational Resources Information Center

    Bivens-Tatum, Wayne

    2006-01-01

    This article presents interesting articles that explore several different areas of reference assessment, including practical case studies and theoretical articles that address a range of issues such as librarian behavior, patron satisfaction, virtual reference, or evaluation design. They include: (1) "Evaluating the Quality of a Chat Service"…

  7. Reference Assessment

    ERIC Educational Resources Information Center

    Bivens-Tatum, Wayne

    2006-01-01

    This article presents interesting articles that explore several different areas of reference assessment, including practical case studies and theoretical articles that address a range of issues such as librarian behavior, patron satisfaction, virtual reference, or evaluation design. They include: (1) "Evaluating the Quality of a Chat Service"…

  8. Reference Services.

    ERIC Educational Resources Information Center

    Bunge, Charles A.

    1999-01-01

    Discusses library reference services. Topics include the historical development of reference services; instruction in library use, particularly in college and university libraries; guidance; information and referral services and how they differ from traditional question-answering service; and future concerns, including user fees and the planning…

  9. Reference Revolutions.

    ERIC Educational Resources Information Center

    Mason, Marilyn Gell

    1998-01-01

    Describes developments in Online Computer Library Center (OCLC) electronic reference services. Presents a background on networked cataloging and the initial implementation of reference services by OCLC. Discusses the introduction of OCLC FirstSearch service, which today offers access to over 65 databases, future developments in integrated…

  10. Linguistic Competences of Learners of Dutch as a Second Language at the B1 and B2 Levels of Speaking Proficiency of the Common European Framework of Reference for Languages (CEFR)

    ERIC Educational Resources Information Center

    Hulstijn, Jan H.; Schoonen, Rob; de Jong, Nivja H.; Steinel, Margarita P.; Florijn, Arjen

    2012-01-01

    This study examines the associations between the speaking proficiency of 181 adult learners of Dutch as a second language and their linguistic competences. Performance in eight speaking tasks was rated on a scale of communicative adequacy. After extrapolation of these ratings to the Overall Oral Production scale of the Common European Framework of…

  11. Linguistic Competences of Learners of Dutch as a Second Language at the B1 and B2 Levels of Speaking Proficiency of the Common European Framework of Reference for Languages (CEFR)

    ERIC Educational Resources Information Center

    Hulstijn, Jan H.; Schoonen, Rob; de Jong, Nivja H.; Steinel, Margarita P.; Florijn, Arjen

    2012-01-01

    This study examines the associations between the speaking proficiency of 181 adult learners of Dutch as a second language and their linguistic competences. Performance in eight speaking tasks was rated on a scale of communicative adequacy. After extrapolation of these ratings to the Overall Oral Production scale of the Common European Framework of…

  12. IFCC international conventional reference procedure for the measurement of free thyroxine in serum: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group for Standardization of Thyroid Function Tests (WG-STFT)(1).

    PubMed

    Van Houcke, Sofie K; Van Uytfanghe, Katleen; Shimizu, Eri; Tani, Wataru; Umemoto, Masao; Thienpont, Linda M

    2011-08-01

    The IFCC Working Group for Standardization of Thyroid Function Tests proposes a candidate international conventional reference procedure (RMP) for measurement of the amount-of-substance concentration of free thyroxine in plasma/serum at physiological pH 7.40 and temperature (37.0°C). The unit for reporting measurement results is, by convention, pmol/L. The RMP is based on equilibrium dialysis isotope dilution-liquid chromatography/tandem mass spectrometry (ED-ID-LC/tandem MS). The rationale for proposing a conventional RMP is that, because of the physical separation step, it is unknown whether the measurement truly reflects the concentration of free thyroxine (FT4) in serum. Therefore, the ED part of the RMP has to strictly adhere to the following conditions: use of a dialysis buffer with a biochemical composition resembling the ionic environment of serum/plasma as closely as possible; buffering of the sample to a pH of 7.40 (at 37.0°C) before dialysis, however, without additional dilution; dialysis in a device with a dialysand/dialysate compartment of identical volume and separated by a membrane of regenerated cellulose and adequate cut-off; thermostatic control of the temperature during dialysis at 37.0°C±0.50°C. The c