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The IFCC reference measurement system for HbA(1)C: A 6-year progress report

Weykamp, Cas; John, W. Garry; Mosca, Andrea; Hoshino, Tadao; Little, Randie; Jeppsson, Jan-Olof LU ; Goodall, Ian; Miedema, Kor; Myers, Gary and Reinauer, Hans, et al. (2008) In Clinical Chemistry 54(2). p.240-248
Abstract
BACKGROUND: The IFCC Reference Measurement System for hemoglobin (Hb)A(1)c (IFCC-RM) has been developed within the framework of metrologic traceability and is embedded in a network of 14 reference laboratories. This paper describes the outcome of 12 intercomparison studies (periodic evaluations to control essential elements of the IFCC-RM). METHODS: Each study included: unknown samples (to test individual network laboratories); known samples (controls); recently manufactured calibrators (to check calculated assigned value); stored calibrators (to test stability) and a calibration-set (to calibrate the IFCC-RM). The unknown samples are measured by use of the IFCC-RM and the designated comparison methods [DCMs; the National Glycohemoglobin... (More)
BACKGROUND: The IFCC Reference Measurement System for hemoglobin (Hb)A(1)c (IFCC-RM) has been developed within the framework of metrologic traceability and is embedded in a network of 14 reference laboratories. This paper describes the outcome of 12 intercomparison studies (periodic evaluations to control essential elements of the IFCC-RM). METHODS: Each study included: unknown samples (to test individual network laboratories); known samples (controls); recently manufactured calibrators (to check calculated assigned value); stored calibrators (to test stability) and a calibration-set (to calibrate the IFCC-RM). The unknown samples are measured by use of the IFCC-RM and the designated comparison methods [DCMs; the National Glycohemoglobin Standardization Program (NGSP) in the US, Japanese Diabetes Society/Japanese Society for Clinical Chemistry (JDS/ JSCC) in Japan, and Mono-S in Sweden] are used to investigate the stability of the Master Equation (ME), the relationship between IFCC-RM and DCMs. RESULTS: A total of 105 IFCC-RM data sets were evaluated: 95 were approved, 5 were not, and for 5 no data were submitted. Trend analysis of the MEs, expressed as change in percentage HbA(1)c per year, revealed 0.000% (NGSP, not significant), -0.030%, (JDS/JSCC; significant) and -0.016% (Mono-S; not significant). Evaluation of long-term performance revealed no systematic change over time; 2 laboratories showed significant bias, 1 poor reproducibility. The mean HbA(1)c determined by laboratories performing mass spectrometry (MS) was the same as the mean determined by laboratories using capillary electrophoresis (CE), but the reproducibility at laboratories using CE was better. One batch of new calibrators was not approved. All stored calibrators were stable. CONCLUSION: A sound reference system is in place to ensure continuity and stability of the analytical anchor for HbA(1)c. (Less)
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published
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Clinical Chemistry
volume
54
issue
2
pages
240 - 248
publisher
American Association for Clinical Chemistry
external identifiers
  • wos:000252837800004
  • scopus:39749107290
ISSN
0009-9147
DOI
10.1373/clinchem.2007.097402
language
English
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yes
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30bea6a6-99db-493e-a9a3-deaf37f29fde (old id 1198763)
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2008-09-10 16:46:24
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@article{30bea6a6-99db-493e-a9a3-deaf37f29fde,
  abstract     = {BACKGROUND: The IFCC Reference Measurement System for hemoglobin (Hb)A(1)c (IFCC-RM) has been developed within the framework of metrologic traceability and is embedded in a network of 14 reference laboratories. This paper describes the outcome of 12 intercomparison studies (periodic evaluations to control essential elements of the IFCC-RM). METHODS: Each study included: unknown samples (to test individual network laboratories); known samples (controls); recently manufactured calibrators (to check calculated assigned value); stored calibrators (to test stability) and a calibration-set (to calibrate the IFCC-RM). The unknown samples are measured by use of the IFCC-RM and the designated comparison methods [DCMs; the National Glycohemoglobin Standardization Program (NGSP) in the US, Japanese Diabetes Society/Japanese Society for Clinical Chemistry (JDS/ JSCC) in Japan, and Mono-S in Sweden] are used to investigate the stability of the Master Equation (ME), the relationship between IFCC-RM and DCMs. RESULTS: A total of 105 IFCC-RM data sets were evaluated: 95 were approved, 5 were not, and for 5 no data were submitted. Trend analysis of the MEs, expressed as change in percentage HbA(1)c per year, revealed 0.000% (NGSP, not significant), -0.030%, (JDS/JSCC; significant) and -0.016% (Mono-S; not significant). Evaluation of long-term performance revealed no systematic change over time; 2 laboratories showed significant bias, 1 poor reproducibility. The mean HbA(1)c determined by laboratories performing mass spectrometry (MS) was the same as the mean determined by laboratories using capillary electrophoresis (CE), but the reproducibility at laboratories using CE was better. One batch of new calibrators was not approved. All stored calibrators were stable. CONCLUSION: A sound reference system is in place to ensure continuity and stability of the analytical anchor for HbA(1)c.},
  author       = {Weykamp, Cas and John, W. Garry and Mosca, Andrea and Hoshino, Tadao and Little, Randie and Jeppsson, Jan-Olof and Goodall, Ian and Miedema, Kor and Myers, Gary and Reinauer, Hans and Sacks, David B. and Slingerland, Robbert and Siebelder, Carla},
  issn         = {0009-9147},
  language     = {eng},
  number       = {2},
  pages        = {240--248},
  publisher    = {American Association for Clinical Chemistry},
  series       = {Clinical Chemistry},
  title        = {The IFCC reference measurement system for HbA(1)C: A 6-year progress report},
  url          = {http://dx.doi.org/10.1373/clinchem.2007.097402},
  volume       = {54},
  year         = {2008},
}