Search Results - "Linko, Solveig"

Clinical decision limits as criteria for setting analytical performance specifications for laboratory tests by Rotgers, Emmi, Linko, Solveig, Theodorsson, Elvar, Kouri, Timo T.

“…•Biological, preanalytical and analytical variations form diagnostic variation, CVD.•Acceptable CVD were derived from clinically significant differences,…”
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An approach for determining allowable between reagent lot variation by van Schrojenstein Lantman, Marith, Çubukçu, Hikmet Can, Boursier, Guilaine, Panteghini, Mauro, Bernabeu-Andreu, Francisco A, Milinkovic, Neda, Mesko Brguljan, Pika, Linko, Solveig, Brugnoni, Duilio, O'Kelly, Ruth, Kroupis, Christos, Lohmander, Maria, Šprongl, Luděk, Vanstapel, Florent, Thelen, Marc

“…Clinicians trust medical laboratories to provide reliable results on which they rely for clinical decisions. Laboratories fulfil their responsibility for…”
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ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro -Diagnostics Regulation by Vanstapel, Florent J L A, Orth, Matthias, Streichert, Thomas, Capoluongo, Ettore D, Oosterhuis, Wytze P, Çubukçu, Hikmet Can, Bernabeu-Andreu, Francisco A, Thelen, Marc, Jacobs, Leo H J, Linko, Solveig, Bhattoa, Harjit Pal, Bossuyt, Patrick M M, Meško Brguljan, Pika, Boursier, Guilaine, Cobbaert, Christa M, Neumaier, Michael

“…The EU Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely…”
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Improving the laboratory result release process in the light of ISO 15189:2012 standard by Can Çubukçu, Hikmet, Vanstapel, Florent, Thelen, Marc, Bernabeu-Andreu, Francisco A., van Schrojenstein Lantman, Marith, Brugnoni, Duilio, Mesko Brguljan, Pika, Milinkovic, Neda, Linko, Solveig, Vaubourdolle, Michel, O'Kelly, Ruth, Kroupis, Christos, Lohmander, Maria, Šprongl, Luděk, Panteghini, Mauro, Boursier, Guilaine

“…The ISO 15189:2012 standard section 5.9.1 requires laboratories to review results before release, considering quality control, previous results, and clinical…”
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Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation by Roelofsen-de Beer, Roseri, Wielders, Jos, Boursier, Guilaine, Vodnik, Tatjana, Vanstapel, Florent, Huisman, Willem, Vukasović, Ines, Vaubourdolle, Michel, Sönmez, Çiğdem, Linko, Solveig, Brugnoni, Duilio, Kroupis, Christos, Lohmander, Maria, Šprongl, Luděk, Bernabeu-Andreu, Francisco, Meško Brguljan, Pika, Thelen, Marc

“…This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN…”
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Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element by Thelen, Marc, Vanstapel, Florent, Brguljan, Pika Meško, Gouget, Bernard, Boursier, Guilaine, Barrett, Edward, Kroupis, Christos, Lohmander, Maria, Šprongl, Luděk, Vodnik, Tatjana, Bernabeu-Andreu, Francisco, Vukasović, Ines, Sönmez, Çiğdem, Linko, Solveig, Brugnoni, Duilio, Vaubourdolle, Michel, Huisman, Willem, Panteghini, Mauro

“…ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological…”
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Analytical performance of the Iris iQ200 automated urine microscopy analyzer by Linko, Solveig, Kouri, Timo T., Toivonen, Eila, Ranta, Paivi H., Chapoulaud, Eric, Lalla, Martti

“…We evaluated the Iris iQ200 Automated Urine Microscopy Analyzer to find out if the instrument performed better than traditional visual bright field microscopy…”
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From a single analyzer to multiple instruments: The GUM approach by LINKO, Solveig

“…Assessment and expression of analytical quality have become novel spotlights in medical laboratories since accreditation began in the early 1990s, in Europe…”
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Internal audits in private medical laboratory practice: A Finnish experience in 1996-2000 by LINKO, Solveig

“…Internal audits inherently effect quality improvement, and concrete results can be expected by careful planning. As audits should improve the quality system in…”
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Evaluation of uncertainty of measurement in routine clinical chemistry--applications to determination of the substance concentration of calcium and glucose in serum by Linko, Solveig, Ornemark, Ulf, Kessel, Rüdiger, Taylor, Philip D P

“…We studied the uncertainty of measurement for the calcium and glucose (amount of) substance concentrations in serum. The evaluation follows a four-step…”
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Automated ion-selective measurement of lithium in serum. A practical approach to result-level verification in a two-way method validation by LINKO, Solveig

“…The Quality Assurance Department of Medix Diacor Labservice evaluated a two-way method validation procedure for serum lithium quantification in therapeutic…”
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Factors affecting the cytology outcome of Pap smears – a brief approach to internal quality control in private cytopathology laboratory practice Note by LINKO, SOLVEIG, TASKINEN, EERO, SARNA, SEPPO, KÄRKKÄINEN, PÄIVI

“…We evaluated the effect of intrauterine device (IUD), patient age and hormone replacement therapy (HRT) on cytology outcome in Pap smears together with the…”
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Factors affecting the cytology outcome of Pap smears – a brief approach to internal quality control in private cytopathology laboratory practiceNote by LINKO, SOLVEIG, TASKINEN, EERO, SARNA, SEPPO, KÄRKKÄINEN, PÄIVI

“…We evaluated the effect of intrauterine device (IUD), patient age and hormone replacement therapy (HRT) on cytology outcome in Pap smears together with the…”
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The effects of quality-management systems on external quality-assessment performance in Finnish clinical chemistry laboratories by SILOAHO, Maritta, LINKO, Solveig, PUHAKAINEN, Eino, NORDBERG, Ulla-Riitta

“…The effects of the implementation of quality-management systems and technological changes on the performance of 23 Finnish clinical chemistry laboratories were…”
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Factors affecting the cytology outcome of Pap smears - a brief approach to internal quality control in private cytopathology laboratory practice by LINKO, SOLVEIG, TASKINEN, EERO, SARNA, SEPPO, KÄRKKÄINEN, PÄIVI

“…We evaluated the effect of intrauterine device (IUD), patient age and hormone replacement therapy (HRT) on cytology outcome in Pap smears together with the…”
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Implementation of traceability and uncertainty in in-vitro diagnostic products: Results of the Roche workshop In Vitro Diagnostics Directive: Practical applications of uncertainty calculations by ANDERSSON, Johanna, COUCHER, Yvonne, KJER, Hans, LINKO, Solveig, ÖDLUND, Britt-Marie, VÖLKERT, Emil

“…The European Commission (EC) Directive on in vitro diagnostic medical devices requires—amongst other obligations—manufacturers to establish metrological…”
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Fluorometric measurement of urinary N-acetyl-beta-D-glucosaminidase and its correlation to uremia by Linko-Löppönen, S

“…A fluorometric endpoint method for determination of N-acetyl-beta-D-glucosaminidase (NAG, EC 3.2.1.30) activity in human urine is described. Random urine…”
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