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Post-standardization of routine creatinine assays: are they suitable for clinical applications

2017-05Journal article Restricted access
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dc.contributor.authorJassam, Nuthar
dc.contributor.authorWeykamp, Cas
dc.contributor.authorThomas, Annette
dc.contributor.authorSecchiero, Sandra
dc.contributor.authorSciacovelli, Laura
dc.contributor.authorPlebani, Mario
dc.contributor.authorThelen, Marc
dc.contributor.authorCobbaert, Christa
dc.contributor.authorPerich, Carmen
dc.contributor.authorRicós, Carmen
dc.contributor.authorPaula, Faria A.
dc.contributor.authorBarth, Julian H.
dc.date.accessioned2018-03-22T18:50:26Z
dc.date.available2018-03-22T18:50:26Z
dc.date.issued2017-05
dc.description.abstractIntroduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239  μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100  μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility. We believe that clinical laboratories and manufacturers should work together to phase out the use of relatively non-specific Jaffe methods and replace them with more specific methods that are enzyme based.pt_PT
dc.description.sponsorshipA fund was received from Roche for the UK part of this study.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationAnn Clin Biochem. 2017 May;54(3):386-394. doi: 10.1177/0004563216664541. Epub 2016 Aug 5.pt_PT
dc.identifier.doi10.1177/0004563216664541pt_PT
dc.identifier.issn0004-5632
dc.identifier.urihttp://hdl.handle.net/10400.18/5454
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherSAGE Publications/Association for Clinical Biochemistrypt_PT
dc.relation.publisherversionhttp://journals.sagepub.com/doi/abs/10.1177/0004563216664541?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed&pt_PT
dc.subjectAcute Kidney Injurypt_PT
dc.subjectArtifactspt_PT
dc.subjectBiomarkerspt_PT
dc.subjectBlood Glucosept_PT
dc.subjectColorimetrypt_PT
dc.subjectCreatininept_PT
dc.subjectEnzyme Assayspt_PT
dc.subjectEuropean Unionpt_PT
dc.subjectGlomerular Filtration Ratept_PT
dc.subjectHumanspt_PT
dc.subjectObserver Variationpt_PT
dc.subjectRenal Insufficiency, Chronicpt_PT
dc.subjectReproducibility of Resultspt_PT
dc.subjectSensitivity and Specificitypt_PT
dc.subjectAssociation for Clinical Biochemistrypt_PT
dc.subjectAvaliação Externa da Qualidadept_PT
dc.titlePost-standardization of routine creatinine assays: are they suitable for clinical applicationspt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage394pt_PT
oaire.citation.issue3pt_PT
oaire.citation.startPage386-394pt_PT
oaire.citation.titleAnnals of Clinical Biochemistrypt_PT
oaire.citation.volume54pt_PT
rcaap.rightsembargoedAccesspt_PT
rcaap.typearticlept_PT

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