An approach for determining allowable between reagent lot variation

Autor: Marith van Schrojenstein Lantman, Hikmet Can Çubukçu, Guilaine Boursier, Mauro Panteghini, Francisco A. Bernabeu-Andreu, Neda Milinkovic, Pika Mesko Brguljan, Solveig Linko, Duilio Brugnoni, Ruth O’Kelly, Christos Kroupis, Maria Lohmander, Luděk Šprongl, Florent Vanstapel, Marc Thelen

Publikováno v: Clinical Chemistry and Laboratory Medicine, 60, 5, pp. 681-688
Clinical Chemistry and Laboratory Medicine
Clinical Chemistry and Laboratory Medicine, 60, 681-688

Clinicians trust medical laboratories to provide reliable results on which they rely for clinical decisions. Laboratories fulfil their responsibility for accurate and consistent results by utilizing an arsenal of approaches, ranging from validation a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::75084fe329802ffbc193347c1b57eaab

Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element

Autor: Duilio Brugnoni, Guilaine Boursier, Bernard Gouget, Luděk Šprongl, Pika Mesko Brguljan, E. Barrett, Francisco Bernabeu-Andreu, Christos Kroupis, Cen standards, Solveig Linko, Michel Vaubourdolle, Mauro Panteghini, Tatjana Vodnik, Florent Vanstapel, Çiğdem Sönmez, Willem Huisman, Maria Lohmander, Marc H M Thelen, Ines Vukasović

Publikováno v: Clinical chemistry and laboratory medicine, vol. 57, no. 4, pp. 459-464, 2019.

ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceabili

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dcba1d58596ef2c600d31b913e295189
https://pubmed.ncbi.nlm.nih.gov/30511927

The effects of quality-management systems on external quality-assessment performance in Finnish clinical chemistry laboratories

Autor: Ulla-Riitta Nordberg, Maritta Siloaho, Eino Puhakainen, Solveig Linko

Publikováno v: Accreditation and Quality Assurance. 11:238-245

The effects of the implementation of quality-management systems and technological changes on the performance of 23 Finnish clinical chemistry laboratories were studied in external quality-assessment (EQA) schemes organized by Labquality Ltd., Finland

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::fa15a856c9459536c04bf556743d111c
https://doi.org/10.1007/s00769-006-0148-2

Implementation of traceability and uncertainty in in-vitro diagnostic products?Results of the Roche workshop ?In Vitro Diagnostics Directive?: Practical applications of uncertainty calculations

Autor: Johanna Andersson, Hans Kjer, Solveig Linko, Britt-Marie Ödlund, Yvonne Couchér, Emil Völkert

Publikováno v: Accreditation and Quality Assurance. 9:47-51

The European Commission (EC) Directive on in vitro diagnostic medical devices requires—amongst other obligations—manufacturers to establish metrological traceability of values assigned to calibrators to available measurement procedures and/or ava

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5c6cc0d11d899803507a4439561989d6
https://doi.org/10.1007/s00769-003-0720-y

Determination of testosterone in serum by liquid chromatography-tandem mass spectrometry

Autor: Esa Hämäläinen, Outi Itkonen, Ursula Turpeinen, Solveig Linko

Publikováno v: Scandinavian journal of clinical and laboratory investigation. 68(1)

Commercial direct immunoassays for serum testosterone sometimes result in inaccuracies in samples from women and children, leading to misdiagnosis and inappropriate treatment. The diagnosis of male hypogonadism also requires an accurate testosterone

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8f0a82a50afa436828f3c34fad324aed
https://pubmed.ncbi.nlm.nih.gov/17852804