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
(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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https://lup.lub.lu.se/record/4871844
- author
- Weykamp, Cas ; Wielders, Jos ; Helander, Anders ; Anton, Raymond F. ; Bianchi, Vincenza ; Jeppsson, Jan-Olof LU ; Siebelder, Carla ; Whitfield, John B. and Schellenberg, Francois
- organization
- publishing date
- 2014
- 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
- pmid:24691685
- ISSN
- 0009-9147
- DOI
- 10.1373/clinchem.2014.221531
- language
- English
- LU publication?
- yes
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- 6fb22295-2469-41ea-b9dd-c307e99a0d18 (old id 4871844)
- date added to LUP
- 2016-04-01 11:09:25
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- 2022-04-05 00:38:52
@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}},
doi = {{10.1373/clinchem.2014.221531}},
volume = {{60}},
year = {{2014}},
}