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Statistical methods for monitoring the relationship between the IFCC reference measurement procedure for hemoglobin A(1c) and the designated comparison methods in the United States, Japan, and Sweden

Geistanger, Andrea; Arends, Sabine; Berding, Christoph; Hoshino, Tadao; Jeppsson, Jan-Olof LU ; Little, Randie; Siebelder, Carla and Weykamp, Cas (2008) In Clinical Chemistry 54(8). p.1379-1385
Abstract
BACKGROUND: The American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD)/International Diabetes Federation GDFAFCC Consensus Statement on the worldwide standardization of HbA(1c) states that"...[HbA(1c)] results are to be reported world-wide in IFCC units...and derived NGSP units...,using the IFCC-NGSP master equation." METHODS: We describe statistical methods to evaluate and monitor the relationships as expressed in master equations (MEs) between the IFCC Reference Measurement procedure (IFCC-RM) and designated comparison methods (DCMs) [US National Glycohemoglobin Standardization Program (NGSP), Japanese Diabetes Society/Japanese Society for Clinical Chemistry (JDS/JSCC), and Mono-S in Sweden]. We applied... (More)
BACKGROUND: The American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD)/International Diabetes Federation GDFAFCC Consensus Statement on the worldwide standardization of HbA(1c) states that"...[HbA(1c)] results are to be reported world-wide in IFCC units...and derived NGSP units...,using the IFCC-NGSP master equation." METHODS: We describe statistical methods to evaluate and monitor the relationships as expressed in master equations (MEs) between the IFCC Reference Measurement procedure (IFCC-RM) and designated comparison methods (DCMs) [US National Glycohemoglobin Standardization Program (NGSP), Japanese Diabetes Society/Japanese Society for Clinical Chemistry (JDS/JSCC), and Mono-S in Sweden]. We applied these statistics, including uncertainty calculations, to 12 studies in which networks of reference laboratories participated, operating the IFCC-RM and DCMs. RESULTS: For NGSP and Mono-S, slope, intercept, and derived percentage HbA(1c) at the therapeutic target show compliance with the respective MEs in all 12 studies. For JDS/JSCC, a slight deviation is seen in slope and derived percentage HbA(1c) in 2 of the 12 studies. Using the MEs, the uncertainty in an assigned value increases from 0.42 mmol/mol HbA(1c) (IFCC-RM) to 0.47 (NGSP), 0.49 (JDS/JSCC), and 0.51 (Mono-S). CONCLUSIONS: We describe sound statistical methods for the investigation of relations between networks of reference laboratories. Application of these statistical methods to the relationship between the JFCC-RM and DCMs in the US, Japan, and Sweden shows that they are suitable for the purpose, and the results support the applicability of the ADA/EASD/lDF/lFCC Consensus Statement on HbA1c measurement. (C) 2008 American Association for Clinical Chemistry. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Clinical Chemistry
volume
54
issue
8
pages
1379 - 1385
publisher
American Association for Clinical Chemistry
external identifiers
  • wos:000258090100016
  • scopus:48949103005
ISSN
0009-9147
DOI
10.1373/clinchem.2008.103556
language
English
LU publication?
yes
id
fbaca357-dd41-46ac-ae67-e20cbbca25d3 (old id 1253780)
date added to LUP
2008-10-28 14:15:27
date last changed
2017-05-28 03:30:01
@article{fbaca357-dd41-46ac-ae67-e20cbbca25d3,
  abstract     = {BACKGROUND: The American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD)/International Diabetes Federation GDFAFCC Consensus Statement on the worldwide standardization of HbA(1c) states that"...[HbA(1c)] results are to be reported world-wide in IFCC units...and derived NGSP units...,using the IFCC-NGSP master equation." METHODS: We describe statistical methods to evaluate and monitor the relationships as expressed in master equations (MEs) between the IFCC Reference Measurement procedure (IFCC-RM) and designated comparison methods (DCMs) [US National Glycohemoglobin Standardization Program (NGSP), Japanese Diabetes Society/Japanese Society for Clinical Chemistry (JDS/JSCC), and Mono-S in Sweden]. We applied these statistics, including uncertainty calculations, to 12 studies in which networks of reference laboratories participated, operating the IFCC-RM and DCMs. RESULTS: For NGSP and Mono-S, slope, intercept, and derived percentage HbA(1c) at the therapeutic target show compliance with the respective MEs in all 12 studies. For JDS/JSCC, a slight deviation is seen in slope and derived percentage HbA(1c) in 2 of the 12 studies. Using the MEs, the uncertainty in an assigned value increases from 0.42 mmol/mol HbA(1c) (IFCC-RM) to 0.47 (NGSP), 0.49 (JDS/JSCC), and 0.51 (Mono-S). CONCLUSIONS: We describe sound statistical methods for the investigation of relations between networks of reference laboratories. Application of these statistical methods to the relationship between the JFCC-RM and DCMs in the US, Japan, and Sweden shows that they are suitable for the purpose, and the results support the applicability of the ADA/EASD/lDF/lFCC Consensus Statement on HbA1c measurement. (C) 2008 American Association for Clinical Chemistry.},
  author       = {Geistanger, Andrea and Arends, Sabine and Berding, Christoph and Hoshino, Tadao and Jeppsson, Jan-Olof and Little, Randie and Siebelder, Carla and Weykamp, Cas},
  issn         = {0009-9147},
  language     = {eng},
  number       = {8},
  pages        = {1379--1385},
  publisher    = {American Association for Clinical Chemistry},
  series       = {Clinical Chemistry},
  title        = {Statistical methods for monitoring the relationship between the IFCC reference measurement procedure for hemoglobin A(1c) and the designated comparison methods in the United States, Japan, and Sweden},
  url          = {http://dx.doi.org/10.1373/clinchem.2008.103556},
  volume       = {54},
  year         = {2008},
}