Randie R Little1, Robert I Wielgosz2, Ralf Josephs2, Tomoya Kinumi3, Akiko Takatsu3, Hongmei Li4, Daniel Stein5, Chris Burns6. 1. Department of Pathology and Anatomical Sciences, University of Missouri School of Medicine, Columbia, MO; LittleR@health.missouri.edu. 2. Bureau International des Poids et Mesures, Sèvres Cedex, France. 3. Bio-Medical Standards Group, National Metrology Institute of Japan, National Institute of Advanced Industrial Science and Technology, Ibaraki, Japan. 4. National Institute of Metrology, Beijing, China. 5. Division of Endocrinology and Metabolism, Diabetes Research and Training Center, Albert Einstein College of Medicine, Yeshiva University, Bronx, NY. 6. National Institute for Biological Standards and Control, South Mimms, UK.
Abstract
BACKGROUND: Assessment of endogenous insulin secretion by measuring C-peptide concentrations is widely accepted. Recent studies have shown that preservation of even small amounts of endogenous C-peptide production in patients with type 1 diabetes reduces risks for diabetic complications. Harmonization of C-peptide results will facilitate comparison of data from different research studies and later among clinical laboratory results at different sites using different assay methods. CONTENT: This review provides an overview of the general process of harmonization and standardization and the challenges encountered with implementing a reference measurement system for C-peptide. SUMMARY: Efforts to harmonize C-peptide results are described, including those by the National Institute of Diabetes and Digestive and Kidney Diseases-led C-peptide Standardization Committee in the US, activities in Japan, efforts by the National Institute for Biological Standards and Control in the UK, as well as activities led by the Bureau International des Poids et Mesures and the National Metrology Institute in China. A traceability scheme is proposed along with the next steps for implementation. Suggestions are made for better collaboration to optimize the harmonization process for other measurands.
BACKGROUND: Assessment of endogenous insulin secretion by measuring C-peptide concentrations is widely accepted. Recent studies have shown that preservation of even small amounts of endogenous C-peptide production in patients with type 1 diabetes reduces risks for diabetic complications. Harmonization of C-peptide results will facilitate comparison of data from different research studies and later among clinical laboratory results at different sites using different assay methods. CONTENT: This review provides an overview of the general process of harmonization and standardization and the challenges encountered with implementing a reference measurement system for C-peptide. SUMMARY: Efforts to harmonize C-peptide results are described, including those by the National Institute of Diabetes and Digestive and Kidney Diseases-led C-peptide Standardization Committee in the US, activities in Japan, efforts by the National Institute for Biological Standards and Control in the UK, as well as activities led by the Bureau International des Poids et Mesures and the National Metrology Institute in China. A traceability scheme is proposed along with the next steps for implementation. Suggestions are made for better collaboration to optimize the harmonization process for other measurands.
Authors: Randie R Little; Curt L Rohlfing; Alethea L Tennill; Richard W Madsen; Kenneth S Polonsky; Gary L Myers; Carla J Greenbaum; Jerry P Palmer; Eduard Rogatsky; Daniel T Stein Journal: Clin Chem Date: 2008-04-17 Impact factor: 8.327
Authors: Antoinette Moran; Brian Bundy; Dorothy J Becker; Linda A DiMeglio; Stephen E Gitelman; Robin Goland; Carla J Greenbaum; Kevan C Herold; Jennifer B Marks; Philip Raskin; Srinath Sanda; Desmond Schatz; Diane K Wherrett; Darrell M Wilson; Jeffrey P Krischer; Jay S Skyler; Linda Pickersgill; Eelco de Koning; Anette-G Ziegler; Bernhard Böehm; Klaus Badenhoop; Nanette Schloot; Jens Friis Bak; Paolo Pozzilli; Didac Mauricio; Marc Y Donath; Luis Castaño; Ana Wägner; Hans Henrik Lervang; Hans Perrild; Thomas Mandrup-Poulsen Journal: Lancet Date: 2013-04-05 Impact factor: 79.321
Authors: Karin Ekberg; Tom Brismar; Bo-Lennart Johansson; Per Lindström; Lisa Juntti-Berggren; Anders Norrby; Christian Berne; Hans J Arnqvist; Jan Bolinder; John Wahren Journal: Diabetes Care Date: 2007-01 Impact factor: 19.112
Authors: Jerry P Palmer; G Alexander Fleming; Carla J Greenbaum; Kevan C Herold; Lisa D Jansa; Hubert Kolb; John M Lachin; Kenneth S Polonsky; Paolo Pozzilli; Jay S Skyler; Michael W Steffes Journal: Diabetes Date: 2004-01 Impact factor: 9.461
Authors: Carla J Greenbaum; Thomas Mandrup-Poulsen; Paula Friedenberg McGee; Tadej Battelino; Burkhard Haastert; Johnny Ludvigsson; Paolo Pozzilli; John M Lachin; Hubert Kolb Journal: Diabetes Care Date: 2008-07-15 Impact factor: 19.112
Authors: William Hagopian; Robert J Ferry; Nicole Sherry; David Carlin; Ezio Bonvini; Syd Johnson; Kathryn E Stein; Scott Koenig; Anastasia G Daifotis; Kevan C Herold; Johnny Ludvigsson Journal: Diabetes Date: 2013-06-25 Impact factor: 9.461
Authors: Andrea Briones; Gustavo Martos; Magali Bedu; Tiphaine Choteau; Ralf D Josephs; Robert I Wielgosz; Maxim G Ryadnov Journal: iScience Date: 2022-04-25
Authors: Benjamin Y Owusu; Hannah Pflaum; Russell Garner; North Foulon; Thomas J Laha; Andrew N Hoofnagle Journal: J Mass Spectrom Adv Clin Lab Date: 2020-12-28