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
(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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https://lup.lub.lu.se/record/1253780
- author
- Geistanger, Andrea ; Arends, Sabine ; Berding, Christoph ; Hoshino, Tadao ; Jeppsson, Jan-Olof LU ; Little, Randie ; Siebelder, Carla and Weykamp, Cas
- organization
- publishing date
- 2008
- 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
- 2016-04-01 11:38:43
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- 2022-02-10 19:24:39
@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}},
doi = {{10.1373/clinchem.2008.103556}},
volume = {{54}},
year = {{2008}},
}