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IFCC reference system for measurement of hemoglobin A(1c) in human blood and the National Standardization Schemes in the United States, Japan, and Sweden: A method-comparison study

Hoelzel, W; Weykamp, C; Jeppsson, Jan-Olof LU ; Miedema, K; Barr, JR; Goodall, I; Hoshino, T; John, WG; Kobold, U and Little, R, et al. (2004) In Clinical Chemistry 50(1). p.166-174
Abstract
Background: The national programs for the harmonization of hemoglobin (Hb)A(1c) measurements in the US [National Glycohemoglobin Standardization Program (NGSP)], Japan [Japanese Diabetes Society (JDS)/Japanese Society of Clinical Chemistry (JSCC)], and Sweden are based on different designated comparison methods (DCMs). The future basis for international standardization will be the reference system developed by the IFCC Working Group on HbA(1c) Standardization. The aim of the present study was to determine the relationships between the IFCC Reference Method (RM) and the DCMs. Methods: Four method-comparison studies were performed in 2001-2003. In each study five to eight pooled blood samples were measured by 11 reference laboratories of the... (More)
Background: The national programs for the harmonization of hemoglobin (Hb)A(1c) measurements in the US [National Glycohemoglobin Standardization Program (NGSP)], Japan [Japanese Diabetes Society (JDS)/Japanese Society of Clinical Chemistry (JSCC)], and Sweden are based on different designated comparison methods (DCMs). The future basis for international standardization will be the reference system developed by the IFCC Working Group on HbA(1c) Standardization. The aim of the present study was to determine the relationships between the IFCC Reference Method (RM) and the DCMs. Methods: Four method-comparison studies were performed in 2001-2003. In each study five to eight pooled blood samples were measured by 11 reference laboratories of the IFCC Network of Reference Laboratories, 9 Secondary Reference Laboratories of the NGSP, 3 reference laboratories of the JDS/JSCC program, and a Swedish reference laboratory. Regression equations were determined for the relationship between the IFCC RM and each of the DCMs. Results: Significant differences were observed between the HbA(1c) results of the IFCC RM and those of the DCMs. Significant differences were also demonstrated between the three DCMs. However, in all cases the relationship of the DCMs with the RM were linear. There were no statistically significant differences between the regression equations calculated for each of the four studies; therefore, the results could be combined. The relationship is described by the following regression equations: NGSP-HbA(1c) = 0.915(IFCC-HbA(1c)) + 2.15% (r(2) = 0.998); JDS/JSCC-HbA(1c) = 0.927(IFCC-HbA(1c)) + 1.73% (r(2) = 0.997); Swedish-HbA(1c) = 0.989(IFCC-HbA(1c)) + 0.88% (r(2) = 0.996). Conclusion: There is a firm and reproducible link between the IFCC RM and DCM HbA(1c) values. (C) 2004 American Association for Clinical Chemistry (Less)
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type
Contribution to journal
publication status
published
subject
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Clinical Chemistry
volume
50
issue
1
pages
166 - 174
publisher
American Association for Clinical Chemistry
external identifiers
  • pmid:14709644
  • wos:000188216900019
  • scopus:9144234059
ISSN
0009-9147
DOI
10.1373/clinchem.2003.024802
language
English
LU publication?
yes
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4692c368-822e-48cf-99d6-94b94d9da9f4 (old id 289800)
date added to LUP
2007-10-30 15:48:45
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2017-12-10 03:54:05
@article{4692c368-822e-48cf-99d6-94b94d9da9f4,
  abstract     = {Background: The national programs for the harmonization of hemoglobin (Hb)A(1c) measurements in the US [National Glycohemoglobin Standardization Program (NGSP)], Japan [Japanese Diabetes Society (JDS)/Japanese Society of Clinical Chemistry (JSCC)], and Sweden are based on different designated comparison methods (DCMs). The future basis for international standardization will be the reference system developed by the IFCC Working Group on HbA(1c) Standardization. The aim of the present study was to determine the relationships between the IFCC Reference Method (RM) and the DCMs. Methods: Four method-comparison studies were performed in 2001-2003. In each study five to eight pooled blood samples were measured by 11 reference laboratories of the IFCC Network of Reference Laboratories, 9 Secondary Reference Laboratories of the NGSP, 3 reference laboratories of the JDS/JSCC program, and a Swedish reference laboratory. Regression equations were determined for the relationship between the IFCC RM and each of the DCMs. Results: Significant differences were observed between the HbA(1c) results of the IFCC RM and those of the DCMs. Significant differences were also demonstrated between the three DCMs. However, in all cases the relationship of the DCMs with the RM were linear. There were no statistically significant differences between the regression equations calculated for each of the four studies; therefore, the results could be combined. The relationship is described by the following regression equations: NGSP-HbA(1c) = 0.915(IFCC-HbA(1c)) + 2.15% (r(2) = 0.998); JDS/JSCC-HbA(1c) = 0.927(IFCC-HbA(1c)) + 1.73% (r(2) = 0.997); Swedish-HbA(1c) = 0.989(IFCC-HbA(1c)) + 0.88% (r(2) = 0.996). Conclusion: There is a firm and reproducible link between the IFCC RM and DCM HbA(1c) values. (C) 2004 American Association for Clinical Chemistry},
  author       = {Hoelzel, W and Weykamp, C and Jeppsson, Jan-Olof and Miedema, K and Barr, JR and Goodall, I and Hoshino, T and John, WG and Kobold, U and Little, R and Mosca, A and Mauri, P and Paroni, R and Susanto, F and Takei, I and Thienpont, L and Umemoto, M and Wiedmeyer, HM},
  issn         = {0009-9147},
  language     = {eng},
  number       = {1},
  pages        = {166--174},
  publisher    = {American Association for Clinical Chemistry},
  series       = {Clinical Chemistry},
  title        = {IFCC reference system for measurement of hemoglobin A(1c) in human blood and the National Standardization Schemes in the United States, Japan, and Sweden: A method-comparison study},
  url          = {http://dx.doi.org/10.1373/clinchem.2003.024802},
  volume       = {50},
  year         = {2004},
}