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  • 1.
    Andersson, H O
    RISE, SP – Sveriges Tekniska Forskningsinstitut.
    Relevant elements of laboratory competence1998Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 3, nr 7, s. 281-283Artikel i tidskrift (Övrigt vetenskapligt)
  • 2.
    Andersson, H O
    RISE, SP – Sveriges Tekniska Forskningsinstitut.
    The 20th Nordic conference on metrology and calibration1999Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 4, nr 7, s. 313-Artikel i tidskrift (Övrigt vetenskapligt)
  • 3.
    Andersson, H O
    RISE, SP – Sveriges Tekniska Forskningsinstitut, SP Bygg och Mekanik, Säkerhet och Funktion.
    The rational use of proficiency tests and intercomparisons1998Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 3, nr 6, s. 224-226Artikel i tidskrift (Övrigt vetenskapligt)
  • 4.
    Barwick, Vicki
    et al.
    LGC Ltd, UK.
    Ellison, Stephen L. R.
    LGC Ltd, UK.
    Gjengedal, Elin
    NTNU Norwegian University of Life Sciences, Norway.
    Magnusson, Bertil
    RISE - Research Institutes of Sweden, Biovetenskap och material, Kemi och material.
    Molinier, Olivier
    Aglae, France.
    Patriarca, Marina
    Istituto Superiore di Sanità, Italy.
    Sibbesen, Lorens
    LAB Quality International, Denmark.
    Vanlaethem, Nicole
    Classes Moyennes et Energie, Belgium.
    Vercruysse, Isabelle
    Belab, Belgium.
    Method validation in analytical sciences: discussions on current practice and future challenges2017Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 22, nr 5, s. 253-263Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Eurachem held a workshop on method validation in analytical sciences in Gent, Belgium, on 9–10 May 2016. A summary of the working group discussions is provided here. The discussions covered a range of issues concerned with current practice and future challenges in method validation, i.e. setting requirements for a method to be validated; planning validation studies; validation of qualitative and semi-quantitative methods; validation of multi-parameter methods; determination of trueness/bias; assessment of working range; validation in microbiology; and method validation under flexible scope of accreditation. Delegates (129) from 24 different countries and from different backgrounds, e.g. from both public and private laboratories, laboratory associations, accreditation bodies and universities, attended the working groups, thus providing opportunities to collect a variety of views and experiences as well as to identify potential gaps in current guidance and regulations. While the practicalities of assessing method performance characteristics are generally well understood, the issue of setting requirements for those characteristics beforehand is less straightforward. Although a number of documents addressing the principles of method validation are available, guidance on dealing with more complex and ‘non-ideal’ situations, as well as examples of good practice, would be welcomed and greater harmonisation of approaches was deemed necessary. There remains a need for guidance on both the concepts that apply to ‘qualitative’ or ‘nominal’ test methods and on the practical implementation of validation studies in such cases.

  • 5.
    Dybkaer, R, Örnemark U et al
    Organisk kemi (Kmo).
    Traceability in laboratory medicine. A necessity1999Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 4, nr 8, s. 349-351Artikel i tidskrift (Övrigt vetenskapligt)
  • 6. Hansen, JB
    et al.
    Grøn, C
    Lund, U
    Magnusson, B
    YKI – Ytkemiska institutet.
    Nordbotten, A
    Oberender, A
    Uncertainty from sampling: Workshop to launch a Nordtest handbook on sampling uncerainty estimation using a robust procedure based on a higher target value of uncertainty2007Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 12, s. 377-381Artikel i tidskrift (Refereegranskat)
  • 7.
    Hedman, Johannes
    et al.
    Swedish National Forensic Centre, Sweden ; Lund University, Sweden.
    Lavander, Moa
    National Food Agency, Sweden.
    Salomonsson, Emelie N.
    Swedish Defence Research Agency, Sweden.
    Jinnerot, Tomas
    National Veterinary Institute, Sweden.
    Boiso, Lina
    Swedish National Forensic Centre, Sweden.
    Magnusson, Bertil
    RISE - Research Institutes of Sweden, Biovetenskap och material, Kemi och material.
    Rådström, Peter
    Lund University, Sweden.
    Validation guidelines for PCR workflows in bioterrorism preparedness, food safety and forensics2018Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 23, nr 3, s. 133-144Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    The polymerase chain reaction (PCR) is the backbone of contemporary DNA/RNA analysis, ideally enabling detection of one or just a few target molecules. However, when analysing food or forensic samples the analytical procedure is often challenged by low amounts of poor quality template molecules and complex matrices. Applying optimised and validated methods in all steps of the analysis workflow, i.e. sampling, sample treatment, DNA/RNA extraction and PCR (including reverse transcription for RNA analysis), is thus necessary to ensure the reliability of analysis. In this paper, we describe how in-house validation can be performed for the different modules of the diagnostic PCR process, providing practical examples as tools for laboratories in their planning of validation studies. The focus is analysis of heterogeneous samples with interfering matrices, with relevance in food testing, forensic DNA analysis, bioterrorism preparedness and veterinary medicine. Our objective is to enable rational in-house validation for reliable and swift quality assurance when results are urgent, for example in the event of a crisis such as a foodborne outbreak or a crime requiring the analysis of a large number of diverse samples. To that end, we explain the performance characteristics associated with method validation from a PCR and biological sample matrix perspective and suggest which characteristics to investigate depending on the type of method to be validated. Also, we include a modular approach to validation within the PCR workflow, aiming at efficient validation and a flexible use of methods.

  • 8.
    Johnson, Erland
    et al.
    RISE., SP – Sveriges Tekniska Forskningsinstitut, SP Sveriges tekniska forskningsinstitut, SP – Sveriges Tekniska Forskningsinstitut / Hållfasthet (BMh).
    Johansson, Klas
    RISE., SP – Sveriges Tekniska Forskningsinstitut, SP Sveriges tekniska forskningsinstitut, SP – Sveriges Tekniska Forskningsinstitut / Hållfasthet (BMh).
    Svensson, Thomas
    RISE., SP – Sveriges Tekniska Forskningsinstitut, SP Sveriges tekniska forskningsinstitut, SP – Sveriges Tekniska Forskningsinstitut / Hållfasthet (BMh).
    Holmgren, Magnus
    RISE., SP – Sveriges Tekniska Forskningsinstitut.
    Reflections regarding uncertainty of measurement, on the results of a Nordic fatigue test interlaboratory comparison2005Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 10, nr 5, s. 208-213Artikel i tidskrift (Refereegranskat)
  • 9.
    Magnusson, Bertil
    SP - Sveriges Tekniska Forskningsinstitut / Oorganisk kemi (Kmoo).
    Key challenges in internal quality control: Eurachem training course and workshop held in Berlin2013Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 18, nr 4, s. 269-270Artikel i tidskrift (Refereegranskat)
  • 10.
    Magnusson, Bertil
    SP - Sveriges Tekniska Forskningsinstitut / Oorganisk kemi (Kmoo).
    Methodology in internal quality control of chemical analysis2013Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 18, nr 4, s. 271-278Artikel i tidskrift (Refereegranskat)
  • 11.
    Magnusson, Bertil
    Oorganisk kemi (Kmoo).
    Uncertainty of standard addition experiments: A novel approach to include the uncertainty associated with the standard in the model equation2012Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 17, nr 2, s. 129-138Artikel i tidskrift (Refereegranskat)
  • 12.
    Magnusson, Bertil
    SP - Sveriges Tekniska Forskningsinstitut / Oorganisk kemi (Kmoo).
    Use of characteristic functions derived from proficiency testing data to evaluate measurement uncertainties2012Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 17, nr 4, s. 399-403Artikel i tidskrift (Refereegranskat)
  • 13.
    Magnusson, Bertil
    et al.
    RISE., SP – Sveriges Tekniska Forskningsinstitut, SP Sveriges tekniska forskningsinstitut, SP – Sveriges Tekniska Forskningsinstitut / Oorganisk kemi (Kmoo).
    Ellisson, S. L. R.
    LGC, UK.
    Patriarca, M.
    Istituto Superiore di Sanita, Italy.
    Impact of Eurachem 25 years of activity2014Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 19, nr 2, s. 59-64Artikel i tidskrift (Refereegranskat)
  • 14.
    Pereira, Paulo
    et al.
    Portuguese Institute of Blood and Transplantation, Portugal.
    Magnusson, Bertil
    RISE., SP – Sveriges Tekniska Forskningsinstitut, SP Kemi Material och Ytor, Kemi.
    Theodorsson, Elvar
    Linköping University, Sweden.
    Westgard, James O.
    University of Wisconsin, US.
    Encarnação, Pedro
    Catholic University of Portugal, Portugal.
    Measurement uncertainty as a tool for evaluating the ‘grey zone’ to reduce the false negatives in immunochemical screening of blood donors for infectious diseases2016Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 21, nr 1, s. 25-32Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    The risk of misclassifying infected individuals as healthy constitutes a crucial challenge when screening blood donors by means of immunoassays. This risk is especially challenging when the numerical results are close to the clinical decision level, i.e. in the ‘grey zone’. The concept of using measurement uncertainty for evaluating the ‘grey zone’ has previously not been systematically applied in this context. This article explains methods, models and empirical (top-down) approaches for the calculation of measurement uncertainty using results from a blood bank according to the internationally accepted GUM principles, focusing on uncertainty sources in the analytical phase. Of the different approaches available, the intralaboratory empirical approaches are emphasised since modelling (bottom-up) approaches are impracticable due to the lack of reliable model equations for immunoassays. Different methods are applied to estimate the measurement uncertainty for the Abbott Prism® HCV immunoassay. The expanded uncertainty obtained at the clinical decision level from the intralaboratory empirical approach was 36 %. The estimated uncertainty was used to set acceptance and rejection zones following the procedure set in the Eurachem guideline, emphasising the need to minimise the occurrence of false negatives.

  • 15.
    Taylor, PDP
    et al.
    Organisk kemi (Kmo).
    Örnemark, U
    Organisk kemi (Kmo).
    Interlaboratory programmes: The international measurement evaluation programme1997Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 2, nr 5, s. 265-Artikel i tidskrift (Övrigt vetenskapligt)
  • 16.
    Theodorsson, Elvar
    et al.
    Linköping University, Sweden.
    Magnusson, Bertil
    RISE - Research Institutes of Sweden, Biovetenskap och material, Kemi och material.
    Full method validation in Clinical chemistry2017Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 22, nr 5, s. 235-246Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Clinical chemistry is subject to the same principles and standards used in all branches of metrology in chemistry for validation of measurement methods. The use of measuring systems in clinical chemistry is, however, of exceptionally high volume, diverse and involves many laboratories and systems. Samples for measuring the same measurand from a certain patient are likely to encounter several measuring systems over time in the process of diagnosis and treatment of his/her diseases. Several challenges regarding method validation across several laboratories are therefore evident, but rarely addressed in current standards and accreditation practices. The purpose of this is paper to address some of these challenges, making a case that appropriate conventional method validation performed by the manufacturers fulfils only a part of the investigation needed to show that they are fit for purpose in different healthcare circumstances. Method validation across several laboratories using verified commercially available measuring systems can only be performed by the laboratories—users themselves in their own circumstances, and need to be emphasised more by the laboratories themselves and accreditation authorities alike.

  • 17.
    van Nevel, L
    et al.
    Organisk kemi (Kmo).
    Örnemark, U
    Organisk kemi (Kmo).
    The International Measurement Evaluation Programme (IMEP): Full graphical presentation of results from IMEP-6 "Trace elements in water" on the Springer-Verlags Website1998Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 3, nr 11, s. 444-446Artikel i tidskrift (Övrigt vetenskapligt)
  • 18.
    Örnemark, Ulf
    RISE, SP – Sveriges Tekniska Forskningsinstitut.
    Bridging cultural gaps in quality assurance2001Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 6, nr 5, s. 138-139Artikel i tidskrift (Övrigt vetenskapligt)
  • 19.
    Örnemark, Ulf
    RISE, SP – Sveriges Tekniska Forskningsinstitut.
    Proficiency testing in analytical chemistry, microbiology and laboratory medicine: Working group discussions on current status, problems and future directions2001Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 6, nr 5, s. 140-146Artikel i tidskrift (Övrigt vetenskapligt)
  • 20. Örnemark, Ulf
    The International Measurement Evaluation Programme (IMEP) IMEP-6 Trace elements in water1999Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 3, nr 2, s. 56-68Artikel i tidskrift (Övrigt vetenskapligt)
  • 21.
    Örnemark, Ulf
    RISE, SP – Sveriges Tekniska Forskningsinstitut.
    The IRMM International Measurement Evaluation Programme (IMEP) IMEP-7: Inorganic components in human serum1999Ingår i: Accreditation and Quality Assurance, ISSN 0949-1775, E-ISSN 1432-0517, Vol. 4, nr 11, s. 463-472Artikel i tidskrift (Övrigt vetenskapligt)
1 - 21 av 21
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