205 resultados para external validation


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This paper argues that religious associations have a number of substantive rights when it comes to their external relations. It does so though comparing the position of the OSCE and the Council of Europe. This paper considers whether the emerging framework includes: (1) a right to legal entity status, (2) a right to establish and run charitable or educational institutions, (3) a right to privileges and substantive benefits and (4) a right to anything else. It concludes that the current developments are welcome because religious freedom has a collective aspect that is essential to the lives of many believers.

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A rapid analytical optical biosensor-based immunoassay was developed and validated for the detection of okadaic acid (OA) and its structurally related toxins from shellfish matrix. The assay utilizes a monoclonal antibody which binds to the OA group of toxins in order of their toxicities, resulting in a pseudofunctional assay. Single-laboratory validation of the assay for quantitative detection of OA determined that it has an action limit of 120 mu g/kg, a limit of detection of 31 mu g/kg, and a working range of 31-174 mu g/kg. The midpoint on the standard matrix calibration curve is 80 mu g/kg, half the current regulatory limit. Inter- and intra-assay studies of negative mussel samples spiked with various OA concentrations produced average coefficient of variation (CV) and standard deviation (SD) values of 7.9 and 10.1, respectively. The assay was also validated to confirm the ability to accurately codetect and quantify dinophysistoxin-1 (DTX-1), DTX-2, and DTX-3 from shellfish matrix. Alkaline hydrolysis was not required for the detection of DTX-3 from matrix. Excellent correlations with the data generated by the biosensor method and liquid chromatography/tandem mass spectrometry (LC/MS/MS) were obtained using a certified reference material (R-2 = 0.99), laboratory reference material, and naturally contaminated mussel samples (R-2 = 0.97). This new procedure could be used as a rapid screening procedure replacing animal-based tests for DSP toxins.

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This paper argues that, in the absence of indivisibilities, the expansion of an industry cannot generate economies of scale unless individual firms introduce the same change s in the way they carry out their activities. In the absence of some plausible focusing device, there is no good reason to expect this to happen.

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Contemporary medical science is reliant upon the rational selection and utilization of devices, and therefore, an increasing need has developed for in vitro systems aimed at replicating the conditions to which urological devices will be subjected to during their use in vivo. We report the development and validation of a novel continuous flow encrustation model based on the commercially available CDC biofilm reactor. Proteus mirabilis-induced encrustation formation on test biomaterial sections under varying experimental parameters was analyzed by X-ray diffraction, infrared- and Raman spectroscopy and by scanning electron microscopy. The model system produced encrusted deposits similar to those observed in archived clinical samples. Results obtained for the system are highly reproducible with encrustation being rapidly deposited on test biomaterial sections. This model will have utility in the rapid screening of encrustation behavior of biomaterials for use in urological applications. (C) 2010 Wiley Periodicals. Inc. J Biomed Mater Res Part B: Appl Biomater 93B: 128-140, 2010

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This output is an invited and refereed chapter in the second of the two book length outputs resulting from the EU HUMAINE grant and follow-on grants. The book is in the OUP Affective Science Series and is intended to provide a theoretically oriented state of the art model for those working in the area of affective computing. Each chapter provides a synthesis of a specific area and presents new data/findings/approaches developed by the author(s) which take the area further. This chapter is in the section on ‘Approaches to developing expression corpora and databases.’ The chapter provides a critical synthesis of the issues involved in databases for affective computing and introduces the SEMAINE SAL Database, developed as an integral part of the EU SEMAINE Project (The Sensitive Agent Project 2008-2011) which is an interdisciplinary project. The project aimed to develop a computer interface that would allow a human to interact with an artificial agent in an emotional manner.

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Loop-mediated isothermal amplification (LAMP) is an innovative technique that allows the rapid detection of target nucleic acid sequences under isothermal conditions without the need for complex instrumentation. The development, optimization, and clinical validation of a LAMP assay targeting the ctrA gene for the rapid detection of capsular Neisseria meningitidis were described. Highly specific detection of capsular N. meningitidis type strains and clinical isolates was demonstrated, with no cross-reactivity with other Neisseria spp. or with a comprehensive panel of other common human pathogens. The lower limit of detection was 6 ctrA gene copies detectable in 48 min, with positive reactions readily identifiable visually via a simple color change. Higher copy numbers could be detected in as little as 16 min. When applied to a total of 394 clinical specimens, the LAMP assay in comparison to a conventional TaqMan® based real-time polymerase chain reaction system demonstrated a sensitivity of 100% and a specificity of 98.9% with a ? coefficient of 0.942. The LAMP method represents a rapid, sensitive, and highly specific technique for the detection of N. meningitidis and has the potential to be used as a point-of-care molecular test and in resource-poor settings.

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A research element of the European Union (EU) sixth Framework project BioCop focused on the development of a surface plasmon resonance (SPR) biosensor assay for the detection of paralytic shellfish poisoning (PSP) toxins in shellfish as an alternative to the increasingly ethically unacceptable mouse bioassay. A biosensor assay was developed using both a saxitoxin binding protein and chip surface in tandem with a highly efficient simple extraction procedure. The present report describes the single laboratory validation of this immunological screening method, for this complex group of toxins with differing toxicities, according to the European Decision 2002/657/EC in conjunction with IUPAC and AOAC single laboratory validation guidelines. The different performance characteristics (detection capability CC beta, specificity/selectivity, repeatability, reproducibility, stability, and applicability) were determined in relation to the EU regulatory limit of 800 mu g of saxitoxin equivalents (STX eq) per kg of shellfish meat. The detection capability CC beta was calculated to be 120 mu g/kg. Intra-assay repeatability was found to be between 2.5 and 12.3% and interassay reproducibility was between 6.1 and 15.2% for different shellfish matrices. Natural samples were also evaluated and the resultant data displayed overall agreements of 96 and 92% with that of the existing AOAC approved methods of mouse bioassay (MBA) and high performance liquid chromatography (HPLC), respectively.

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Tiamulin (TIA) is an antimicrobial veterinary drug administered subtherapeutically to prevent swine dysentery and pneumonia. Due to its stability, crystalline structure, and water-soluble properties, TIA is a prime candidate for environmental monitoring. However, there are currently no screening methods available for TIA in environmental matrices, such as grass or ground water. In this paper, the development and validation of a screening method using optical SPR biosensor technology is presented. A solvent extraction was carried out on samples prior to analysis using the Biacore Q instrument. The limit of detection for the assay in grass and ground water was 10.8 ng/g and 2.4 ng/ml, respectively. In addition, the assay was shown to be of an acceptable standard with regard to both accuracy and reproducibility.