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Harmonization of Measurement Results of the Alcohol Biomarker Carbohydrate-Deficient Transferrin by Use of the Toolbox of Technical Procedures of the International Consortium for Harmonization of Clinical Laboratory Results

Weykamp, Cas; Wielders, Jos; Helander, Anders; Anton, Raymond F.; Bianchi, Vincenza; Jeppsson, Jan-Olof LU ; Siebelder, Carla; Whitfield, John B. and Schellenberg, Francois (2014) In Clinical Chemistry 60(7). p.945-953
Abstract
BACKGROUND: The need for equivalent results of routine measurement procedures for the alcohol biomarker carbohydrate-deficient transferrin (CDT) has been recognized by the IFCC. This article describes a project to harmonize CDT as conducted by an IFCC working group initiated for this purpose. METHODS: We used procedures for achieving harmonization as developed by the Consortium for Harmonization of Clinical Laboratory Results to assess the suitability of a candidate reference measurement procedure (cRMP), candidate reference materials (cRMs), and the success of efforts to achieve harmonization. RESULTS: CDT measurement procedures in routine use showed good reproducibility (CV 1.1%-2.8%) and linearity (r > 0.990) with variable slopes... (More)
BACKGROUND: The need for equivalent results of routine measurement procedures for the alcohol biomarker carbohydrate-deficient transferrin (CDT) has been recognized by the IFCC. This article describes a project to harmonize CDT as conducted by an IFCC working group initiated for this purpose. METHODS: We used procedures for achieving harmonization as developed by the Consortium for Harmonization of Clinical Laboratory Results to assess the suitability of a candidate reference measurement procedure (cRMP), candidate reference materials (cRMs), and the success of efforts to achieve harmonization. RESULTS: CDT measurement procedures in routine use showed good reproducibility (CV 1.1%-2.8%) and linearity (r > 0.990) with variable slopes (0.766 - 1.065) and intercepts (-0.34 to 0.92) compared to the cRMP. Heterogeneity after simulated harmonization was 4.7%. cRMs of frozen human native sera demonstrated commutability and 3-year stability for routine measurement procedures. The cRMP provided reproducible value assignment to cRMs with an expanded uncertainty (k = 2) of 0.03% at the 1.2% CDT level and 0.06% at the 4.4% CDT level. Harmonization efforts reduced the intermeasurement CV from 8.8% to 3.4%, allowed 99% recovery of the values assigned with the cRMP, and demonstrated 99% of results within the desirable allowable total error. Harmonization was less successful in samples with low CDT and high trisialo-transferrin concentrations. CONCLUSIONS: Harmonization of CDT is possible with frozen human native sera as cRMs with values assigned by use of the cRMP. We propose the cRMP as a candidate international conventional reference measurement procedure and cRMs as candidate international calibrators. (C) 2014 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
60
issue
7
pages
945 - 953
publisher
American Association for Clinical Chemistry
external identifiers
  • wos:000344778700012
  • scopus:84903728370
ISSN
0009-9147
DOI
10.1373/clinchem.2014.221531
language
English
LU publication?
yes
id
6fb22295-2469-41ea-b9dd-c307e99a0d18 (old id 4871844)
date added to LUP
2015-01-07 10:51:18
date last changed
2017-09-10 03:28:07
@article{6fb22295-2469-41ea-b9dd-c307e99a0d18,
  abstract     = {BACKGROUND: The need for equivalent results of routine measurement procedures for the alcohol biomarker carbohydrate-deficient transferrin (CDT) has been recognized by the IFCC. This article describes a project to harmonize CDT as conducted by an IFCC working group initiated for this purpose. METHODS: We used procedures for achieving harmonization as developed by the Consortium for Harmonization of Clinical Laboratory Results to assess the suitability of a candidate reference measurement procedure (cRMP), candidate reference materials (cRMs), and the success of efforts to achieve harmonization. RESULTS: CDT measurement procedures in routine use showed good reproducibility (CV 1.1%-2.8%) and linearity (r > 0.990) with variable slopes (0.766 - 1.065) and intercepts (-0.34 to 0.92) compared to the cRMP. Heterogeneity after simulated harmonization was 4.7%. cRMs of frozen human native sera demonstrated commutability and 3-year stability for routine measurement procedures. The cRMP provided reproducible value assignment to cRMs with an expanded uncertainty (k = 2) of 0.03% at the 1.2% CDT level and 0.06% at the 4.4% CDT level. Harmonization efforts reduced the intermeasurement CV from 8.8% to 3.4%, allowed 99% recovery of the values assigned with the cRMP, and demonstrated 99% of results within the desirable allowable total error. Harmonization was less successful in samples with low CDT and high trisialo-transferrin concentrations. CONCLUSIONS: Harmonization of CDT is possible with frozen human native sera as cRMs with values assigned by use of the cRMP. We propose the cRMP as a candidate international conventional reference measurement procedure and cRMs as candidate international calibrators. (C) 2014 American Association for Clinical Chemistry},
  author       = {Weykamp, Cas and Wielders, Jos and Helander, Anders and Anton, Raymond F. and Bianchi, Vincenza and Jeppsson, Jan-Olof and Siebelder, Carla and Whitfield, John B. and Schellenberg, Francois},
  issn         = {0009-9147},
  language     = {eng},
  number       = {7},
  pages        = {945--953},
  publisher    = {American Association for Clinical Chemistry},
  series       = {Clinical Chemistry},
  title        = {Harmonization of Measurement Results of the Alcohol Biomarker Carbohydrate-Deficient Transferrin by Use of the Toolbox of Technical Procedures of the International Consortium for Harmonization of Clinical Laboratory Results},
  url          = {http://dx.doi.org/10.1373/clinchem.2014.221531},
  volume       = {60},
  year         = {2014},
}