926 resultados para Laboratories - Quality control
Resumo:
Recommendation for Oxygen Measurements from Argo Floats: Implementation of In-Air-Measurement Routine to Assure Highest Long-term Accuracy As Argo has entered its second decade and chemical/biological sensor technology is improving constantly, the marine biogeochemistry community is starting to embrace the successful Argo float program. An augmentation of the global float observatory, however, has to follow rather stringent constraints regarding sensor characteristics as well as data processing and quality control routines. Owing to the fairly advanced state of oxygen sensor technology and the high scientific value of oceanic oxygen measurements (Gruber et al., 2010), an expansion of the Argo core mission to routine oxygen measurements is perhaps the most mature and promising candidate (Freeland et al., 2010). In this context, SCOR Working Group 142 “Quality Control Procedures for Oxygen and Other Biogeochemical Sensors on Floats and Gliders” (www.scor-int.org/SCOR_WGs_WG142.htm) set out in 2014 to assess the current status of biogeochemical sensor technology with particular emphasis on float-readiness, develop pre- and post-deployment quality control metrics and procedures for oxygen sensors, and to disseminate procedures widely to ensure rapid adoption in the community.
Resumo:
This document is the Argo quality control manual for Dissolved oxygen concentration. It describes two levels of quality control: • The first level is the real-time system that performs a set of agreed automatic checks. • Adjustment in real-time can also be performed and the real-time system can evaluate quality flags for adjusted fields • The second level is the delayed-mode quality control system.
Resumo:
In April 2017, CMEMS plans to launch the WAVES NRT products. This document is focused in the automatic RTQC of the collected wave data. The validation procedure includes the delayed mode quality control of the data and will be specified in another guideline. To perform any kind of quality control to wave data, first it’s necessary to know the nature of the measurements and the analysis performed to those measurements to obtain the wave parameters. For that reason next chapter is dedicated to show the usual wave analysis and the different parameters and estimators obtained.
Resumo:
Dissertação de mestrado, Qualidade em Análises, Faculdade de Ciências e Tecnologia, Universidade do Algarve, 2014
Resumo:
The aim of this study is to perform a situational analysis of the Laboratory of pulp and paper-UNESP ITAPEVA for conducting proposal the accreditation according to ISO / IEC 17025:2005. The ISO / IEC 17025 establishes the criteria for those laboratories wishing to demonstrate their technical competence, which have an effective quality system and are able to generate technically valid results, establishing a single international standard for certifying the competence of laboratories to carry tests and / or calibrations, including sampling. The case study was conducted on laboratory Pulp and Paper Universidade Estadual Paulista (UNESP), campus Itapeva, where we compared the views of the technician responsible for the laboratory and a regular user. The generated conclusion is that the laboratory is unable to initiate an accreditation process, because it fails the requirements such as quality manual, register of subcontractors, research of customer satisfaction, schedule of internal audits, schedule for completion of critical analysis, profile of the functions required, functions current description, documentation of technical requirements for accommodation and environmental conditions, calibration programs, equipment calibration program, programs calibration standards and reports and / or certificate of test and / or calibration, that are in accordance with ISO / IEC 17025:2005, beyond that there is not the possibility to develop and implement a quality system without the commitment of everyone involved, regardless of the functional hierarchy
Resumo:
210 p.
Resumo:
Introduction: Amplicon deep-sequencing using second-generation sequencing technology is an innovative molecular diagnostic technique and enables a highly-sensitive detection of mutations. As an international consortium we had investigated previously the robustness, precision, and reproducibility of 454 amplicon next-generation sequencing (NGS) across 10 laboratories from 8 countries (Leukemia, 2011;25:1840-8).
Aims: In Phase II of the study, we established distinct working groups for various hematological malignancies, i.e. acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), and multiple myeloma. Currently, 27 laboratories from 13 countries are part of this research consortium. In total, 74 gene targets were selected by the working groups and amplicons were developed for a NGS deep-sequencing assay (454 Life Sciences, Branford, CT). A data analysis pipeline was developed to standardize mutation interpretation both for accessing raw data (Roche Amplicon Variant Analyzer, 454 Life Sciences) and variant interpretation (Sequence Pilot, JSI Medical Systems, Kippenheim, Germany).
Results: We will report on the design, standardization, quality control aspects, landscape of mutations, as well as the prognostic and predictive utility of this assay in a cohort of 8,867 cases. Overall, 1,146 primer sequences were designed and tested. In detail, for example in AML, 924 cases had been screened for CEBPA mutations. RUNX1 mutations were analyzed in 1,888 cases applying the deep-sequencing read counts to study the stability of such mutations at relapse and their utility as a biomarker to detect residual disease. Analyses of DNMT3A (n=1,041) were focused to perform landscape investigations and to address the prognostic relevance. Additionally, this working group is focusing on TET2, ASXL1, and TP53 analyses. A novel prognostic model is being developed allowing stratification of AML into prognostic subgroups based on molecular markers only. In ALL, 1,124 pediatric and adult cases have been screened, including 763 assays for TP53 mutations both at diagnosis and relapse of ALL. Pediatric and adult leukemia expert labs developed additional content to study the mutation incidence of other B and T lineage markers such as IKZF1, JAK2, IL7R, PAX5, EP300, LEF1, CRLF2, PHF6, WT1, JAK1, PTEN, AKT1, IL7R, NOTCH1, CREBBP, or FBXW7. Further, the molecular landscape of CLL is changing rapidly. As such, a separate working group focused on analyses including NOTCH1, SF3B1, MYD88, XPO1, FBXW7 and BIRC3. Currently, 922 cases were screened to investigate the range of mutational burden of NOTCH1 mutations for their prognostic relevance. In MDS, RUNX1 mutation analyses were performed in 977 cases. The prognostic relevance of TP53 mutations in MDS was assessed in additional 327 cases, including isolated deletions of chromosome 5q. Next, content was developed targeting genes of the cellular splicing component, e.g. SF3B1, SRSF2, U2AF1, and ZRSR2. In BCR-ABL1-negative MPN, nine genes of interest (JAK2, MPL, TET2, CBL, KRAS, EZH2, IDH1, IDH2, ASXL1) have been analyzed in a cohort of 155 primary myelofibrosis cases searching for novel somatic mutations and addressing their relevance for disease progression and leukemia transformation. Moreover, an assay was developed and applied to CMML cases allowing the simultaneous analysis of 25 leukemia-associated target genes in a single sequencing run using just 20 ng of starting DNA. Finally, nine laboratories are studying CML, applying ultra-deep sequencing of the BCR-ABL1 tyrosine kinase domain. Analyses were performed on 615 cases investigating the dynamics of expansion of mutated clones under various tyrosine kinase inhibitor therapies.
Conclusion: Molecular characterization of hematological malignancies today requires high diagnostic sensitivity and specificity. As part of the IRON-II study, a network of laboratories analyzed a variety of disease entities applying amplicon-based NGS assays. Importantly, the consortium not only standardized assay design for disease-specific panels, but also achieved consensus on a common data analysis pipeline for mutation interpretation. Distinct working groups have been forged to address scientific tasks and in total 8,867 cases had been analyzed thus far.
Resumo:
Molecular testing is becoming an important part of the diagnosis of any patient with cancer. The challenge to laboratories is to meet this need, using reliable methods and processes to ensure that patients receive a timely and accurate report on which their treatment will be based. The aim of this paper is to provide minimum requirements for the management of molecular pathology laboratories. This general guidance should be augmented by the specific guidance available for different tumour types and tests. Preanalytical considerations are important, and careful consideration of the way in which specimens are obtained and reach the laboratory is necessary. Sample receipt and handling follow standard operating procedures, but some alterations may be necessary if molecular testing is to be performed, for instance to control tissue fixation. DNA and RNA extraction can be standardised and should be checked for quality and quantity of output on a regular basis. The choice of analytical method(s) depends on clinical requirements, desired turnaround time, and expertise available. Internal quality control, regular internal audit of the whole testing process, laboratory accreditation, and continual participation in external quality assessment schemes are prerequisites for delivery of a reliable service. A molecular pathology report should accurately convey the information the clinician needs to treat the patient with sufficient information to allow for correct interpretation of the result. Molecular pathology is developing rapidly, and further detailed evidence-based recommendations are required for many of the topics covered here.
Resumo:
The identification of gasoline adulteration by organic solvents is not an easy task, because compounds that constitute the solvents are already in gasoline composition. In this work, the combination of Hydrogen Nuclear Magnetic Resonance ((1)H NMR) spectroscopic fingerprintings with pattern-recognition multivariate Soft Independent Modeling of Class Analogy (SIMCA) chemometric analysis provides an original and alternative approach to screening Brazilian commercial gasoline quality in a Monitoring Program for Quality Control of Automotive Fuels. SIMCA was performed on spectroscopic fingerprints to classify the quality of representative commercial gasoline samples selected by Hierarchical Cluster Analysis (HCA) and collected over a 6-month period from different gas stations in the São Paulo state, Brazil. Following optimized the (1)H NMR-SIMCA algorithm, it was possible to correctly classify 92.0% of commercial gasoline samples, which is considered acceptable. The chemometric method is recommended for routine applications in Quality-Control Monitoring Programs, since its measurements are fast and can be easily automated. Also, police laboratories could employ this method for rapid screening analysis to discourage adulteration practices. (C) 2010 Elsevier B.V. All rights reserved.
Resumo:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
Resumo:
Isotope screening is a simple test for determining the photosynthetic pathway used by plants. The scope of this work was to classify the photosynthetic type of some herbs and medicinal plants through studies of the carbon isotope composition (δ13C). Also, we propose the use of carbon isotope composition as a tool to control the quality of herbs and medicinal plants. For studies of δ13C, δ 13C‰ = [R (sample)/R (standard) - 1] × 10-3, dry leaves powdered in cryogenic mill were analyzed in a mass spectrometer coupled with an elemental analyzer for determining the ratio R = 13CO2/12CO2. In investigation of δ13C of 55 species, 23 botanical families, and 44 species possessed a C3 photosynthetic type. Six species found among the botanical families Euphorbiaceae and Poaceae were C4 plants, and 5 species found among the botanical families Agavaceae, Euphorbiaceae, and Liliaceae possessed CAM-type photosynthesis. Carbon isotope composition of plants can be used as quality control of herbs and medicinal plants, allowing the identification of frauds or contaminations. Also, the information about the photosynthetic type found for these plants can help in introducing and cultivating exotic and wild herbs and medicinal plants.
Resumo:
Considering how demand for quality assurance (QA) has grown in analytical laboratories, we show the trends in analytical science, illustrated through international standard ISO/IEC 17025, validation, measurements of uncertainty, and quality-control (QC) measures. A detailed review of the history of analytical chemistry indicates that these concepts are consistently used in laboratories to demonstrate their traceabilities and competences to provide reliable results. We propose a new approach for laboratory QA, which also develops a diagram to support routine laboratories (which generally apply a quality system, such as ISO/IEC 17025) or research laboratories (that have some difficult applying this international standard). This approach, called the Analytical Quality Assurance Cycle (AQAC), presents the major QA concepts and the relationships between these concepts in order to provide traceability and reliable results. The AQAC is a practical tool to support the trend towards QA in analytical laboratories. (C) 2012 Elsevier Ltd. All rights reserved.
Resumo:
The performance of high-resolution CZE for determination of carbohydrate-deficient transferrin (CDT) in human serum based on internal and external quality data gathered over a 10-year period is reported. The assay comprises mixing of serum with a Fe(III) ion-containing solution prior to analysis of the iron saturated mixture in a dynamically double-coated capillary using a commercial buffer at alkaline pH. CDT values obtained with a human serum of a healthy individual and commercial quality control sera are shown to vary less than 10%. Values of a control from a specific lot were found to slowly decrease as function of time (less than 10% per year). Furthermore, due to unknown reasons, gradual changes in the monitored pattern around pentasialo-transferrin were detected, which limit the use of commercial control sera of the same lot to less than 2 years. Analysis of external quality control sera revealed correct classification of the samples over the entire 10-year period. Data obtained compare well with those of HPLC and CZE assays of other laboratories. The data gathered over a 10-year period demonstrate the robustness of the high-resolution CZE assay. This is the first account of a CZE-based CDT assay with complete internal and external quality assessment over an extended time period.
Resumo:
Mode of access: Internet.