Utilize este identificador para referenciar este registo: http://hdl.handle.net/10400.18/2117
Título: A category 1 EQA scheme for comparison of laboratory performance and method performance: An international pilot study in the framework of the Calibration 2000 project
Autor: Jansen, Rob
Nuthar, Jassam
Thomas, Annette
Perich, Carmen
Fernandez-Calle, Pilar
Faria, Ana Paula
Correia, Helena
Barth, Julian
Weykamp, Cas
Cobbaert, Christa
Thelen, Marc
Ricós, Carmen
Palavras-chave: External Quality Assessment
Commutability
Biological Variation
Reference Method
Traceability
Harmonization
EQA
IVDD
In Vitro
Diagnostic Medical Devices Directive
Total Error
Data: 14-Nov-2013
Editora: Elsevier
Citação: Clin Chim Acta. 2014 May 15;432:90-8. doi: 10.1016/j.cca.2013.11.003. Epub 2013 Nov 14.
Resumo: INTRODUCTION: In the modern healthcare service, patients receive care in multiple hospitals and healthcare settings. Therefore, harmonization of results from different methods and instruments, both between and within laboratories, is of the utmost importance. The present pilot study aims to test the use of a Category 1 EQA scheme across four European countries by assessing the current level of equivalence of test results. METHOD: This work was led by the Dutch External Quality Assurance Scheme SKML and involved 28 laboratories from three regions in the UK, Spain and Portugal, and 120 laboratories from The Netherlands. A set of six commutable samples, targeted with reference methods, were circulated and 18 biochemistry analytes were tested. RESULTS AND CONCLUSIONS: The Total Error (TE) score, defined as the probability (%) that results are within the Total Error Acceptable (TEA) limits, for the eighteen analytes was calculated. Our data show that there is a need for further harmonization of laboratory data, in particular for electrolytes (calcium, chloride, magnesium, sodium), enzymes (ALT, amylase, AST, LDH), lipids (HDL-cholesterol), and for substrates (creatinine, total protein). Lack of performance consistency between instruments was seen for most analytes. The lack of harmonization is still present despite manufacturer claims of established traceability.
Peer review: yes
URI: http://hdl.handle.net/10400.18/2117
ISSN: 0009-8981
Versão do Editor: http://www.sciencedirect.com/science/article/pii/S0009898113004415
Aparece nas colecções:DEP - Artigos em revistas internacionais



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