Feasibility of standardization of serum C-peptide immunoassays with isotope-dilution liquid chromatography-tandem mass spectrometry

Clinical Chemistry
Diego Rodríguez CabaleiroLinda M Thienpont

Abstract

Serum C-peptide concentrations reflect pancreatic function in different clinical and diagnostic settings; however, the utility of C-peptide testing is limited by the lack of standardized commercial immunoassays. Standardization can best be done by split-sample comparison with a hierarchically higher reference measurement procedure with a set of native sera. For serum peptides, isotope-dilution liquid chromatography-mass spectrometry (ID-LC/MS) is recommended as a reference measurement procedure. We evaluated the analytical performance characteristics of an ID-LC/tandem MS procedure for measurement of serum C-peptide after a 2-step solid-phase extraction. To investigate the feasibility of this procedure for use in standardization, we also performed a method comparison with 3 representative commercial assays. The ID-LC/tandem MS procedure showed maximum within-run, between-run, and total CVs on dedicated sera (C-peptide concentrations, 1.6 and 4.0 mug/L) of 2.1%, 2.5%, and 2.9%, respectively; an accuracy of 94.6%-104.1%; a minimum trueness of 98.1% (95% confidence interval, 96.2%-100.0%), and limits of quantification and detection of 0.15 and 0.03 mug/L, respectively. Deming linear regression analysis of the method-comparison dat...Continue Reading

References

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Nov 27, 2004·Rapid Communications in Mass Spectrometry : RCM·Dietmar StöcklLinda M Thienpont
Nov 9, 2005·Rapid Communications in Mass Spectrometry : RCM·Diego Rodríguez-CabaleiroLinda M Thienpont

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Citations

Mar 13, 2014·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Tomoya KinumiAkiko Takatsu
Oct 12, 2010·International Journal of Legal Medicine·Frank MusshoffBurkhard Madea
Jan 29, 2016·Clinica Chimica Acta; International Journal of Clinical Chemistry·Steven W TaylorMichael J McPhaul
Apr 1, 2008·Clinical Biochemistry·Michael Vogeser, Christoph Seger
Jul 1, 2008·Proteomics. Clinical Applications·Glen L Hortin, Denis Sviridov
Dec 8, 2010·Proteomics. Clinical Applications·Paul E OranRandall W Nelson
Apr 12, 2016·Proteomics. Clinical Applications·Bassel SabbaghPeter Findeisen
Dec 31, 2009·Diabetes Care·Myrlene A StatenUNKNOWN Insulin Standardization Workgroup
Dec 3, 2016·PloS One·Annelien Van DalemUNKNOWN Belgian Diabetes Registry
Jun 9, 2017·Clinical Chemistry and Laboratory Medicine : CCLM·Melanie MooreChris Burns
Jan 31, 2007·Journal of Mass Spectrometry : JMS
Mar 3, 2007·Clinical Chemistry·Hsiao-Mei WiedmeyerJerry P Palmer
Apr 19, 2008·Clinical Chemistry·Randie R LittleDaniel T Stein

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