Repository logo
 
Publication

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

2013-11-14Journal article Restricted access
Simple item page
dc.contributor.authorJansen, Rob
dc.contributor.authorNuthar, Jassam
dc.contributor.authorThomas, Annette
dc.contributor.authorPerich, Carmen
dc.contributor.authorFernandez-Calle, Pilar
dc.contributor.authorFaria, Ana Paula
dc.contributor.authorCorreia, Helena
dc.contributor.authorBarth, Julian
dc.contributor.authorWeykamp, Cas
dc.contributor.authorCobbaert, Christa
dc.contributor.authorThelen, Marc
dc.contributor.authorRicós, Carmen
dc.date.accessioned2014-03-13T15:04:59Z
dc.date.available2014-03-13T15:04:59Z
dc.date.issued2013-11-14
dc.description.abstractINTRODUCTION: 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.por
dc.identifier.citationClin Chim Acta. 2014 May 15;432:90-8. doi: 10.1016/j.cca.2013.11.003. Epub 2013 Nov 14.por
dc.identifier.issn0009-8981
dc.identifier.otherdoi: 10.1016/j.cca.2013.11.003
dc.identifier.urihttp://hdl.handle.net/10400.18/2117
dc.language.isoengpor
dc.peerreviewedyespor
dc.publisherElsevierpor
dc.relation.publisherversionhttp://www.sciencedirect.com/science/article/pii/S0009898113004415por
dc.subjectExternal Quality Assessmentpor
dc.subjectCommutabilitypor
dc.subjectBiological Variationpor
dc.subjectReference Methodpor
dc.subjectTraceabilitypor
dc.subjectHarmonizationpor
dc.subjectEQApor
dc.subjectIVDDpor
dc.subjectIn Vitropor
dc.subjectDiagnostic Medical Devices Directivepor
dc.subjectTotal Errorpor
dc.titleA category 1 EQA scheme for comparison of laboratory performance and method performance: An international pilot study in the framework of the Calibration 2000 projectpor
dc.typejournal article
dspace.entity.typePublication
oaire.citation.titleClinica Chimica Actapor
rcaap.rightsrestrictedAccesspor
rcaap.typearticlepor

Files

Original bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
International pilot study in the framework of the calibration 2000 project.pdf
Size:
1.86 MB
Format:
Adobe Portable Document Format
Download
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
1.71 KB
Format:
Item-specific license agreed upon to submission
Description:
Download

Collections

DEP - Artigos em revistas internacionais