Production and certification of four frozen human serum certified reference materials containing creatinine and electrolytes

Ann Clin Biochem 2008;45:160-166
doi:10.1258/acb.2007.007126
© 2008 Association for Clinical Biochemistry

 

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Original Article


Romina P Barbagallo 1,
Nick Boley 1 ,
Gill Holcombe 1,
Sheila Merson 1,
Chris Mussell 1,
Caroline Pritchard 1,
Peter Stokes 1,
Steve Wood 1,
David Ducroq 2 and
Annette Thomas 2


1 Research and Technology Division, LGC Limited, Teddington TW11, 0LY, UK;
2 Reference Laboratory, WEQAS, Cardiff CF14 5WF, UK


Corresponding author: Nick Boley. Email: nick.boley{at}lgc.co.uk


Background: This paper describes the preparation, analysis and certificationof four frozen human serum certified reference materials (CRMs)containing creatinine and the electrolytes calcium, lithium,magnesium, potassium and sodium. These materials have been preparedto give concentrations of these analytes that cover the currentlyaccepted analytical range.

Methods: The analysis of the materials for certification purposes hasbeen carried out using methodology traceable to primary standards,and which is acceptable as a reference method. The certificationmethods include liquid chromatography-mass spectrometry (LC-MS)with exact-matching isotope dilution calibration (EM-IDMS) forcreatinine, inductively-coupled plasma optical emission spectroscopy(ICP-OES), ICP-MS and isotope-dilution inductively-coupled plasmamass spectroscopy (ID-ICP-MS) for the electrolytes.

Results: The uncertainties estimated for these certified values includea component from the characterization measurements, as wellas contributions from possible inhomogeneity and long-term instability.The certified values have been corroborated by measurementsobtained in a major UK External Quality Assessment scheme, whichhave, with the exception of the determination of creatinineat a particularly low concentration, given excellent agreement.

Conclusions: The materials are intended for use by pathology laboratories and manufacturers of in vitro diagnostic (IVD) kits for validationof existing routine methodology to a traceable standard, whichwill promote harmonization between the different methods, instrumentsand IVD kits used in these laboratories.

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