Harmonization of Measurement Results of the Alcohol Biomarker Carbohydrate- Deficient Transferrin by Use of the Toolbox of Technical Procedures of the.
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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
C. Weykamp, J. Wielders, A. Helander, R.F. Anton, V. Bianchi, J.-O. Jeppsson, C. Siebelder, J.B. Whitfield, and F. Schellenberg on behalf of the IFCC Working Group on Standardization of Carbohydrate-Deficient Transferrin
Table 1. Samples in the Study. For the Assessment part of the study two batches of frozen candidate reference materials (cRMs) and 3 batches of lyophilized candidate reference materials were included. To monitor the success of the harmonization effort one batch of frozen candidate reference material and 27 single donation specimens of patients were included in the study. cRMP, candidate reference method procedure.
Table 2. Harmonization Potential. A first requirement for harmonization is that the routine tests to be harmonized have the potential to be harmonized. The results in this table show that the reproducibility, the linearity and the heterogeneity of the respective tests are good enough to allow harmonization.
Fig. 1. Bland–Altman plots for commutability. Commutability of the 3 batches of lyophilized cRMs (Lyo cRM 2, 3, 4) and 1 batch of frozen cRMs (Fro cRM 2) for the routine MPs. CDT concentrations in IFCC CDT units are on the x-axis. Differences in CDT between the respective routine MPs and the cRMP in IFCC CDT units are on the y-axis.
Table 3. Targeting reference materials. Successful use of reference materials requires that it is possible to assign reliable target values. The results in table 3 show that it is possible to target the reference materials for CDT with a network of 6 reference laboratories operating the reference method: the targeting is reproducible and the uncertainty is low.
Table 4. Success of harmonization of CDT routine measurement procedures (MPs): inter-method CV and recovery target values after calibration with frozen cRMs.
CDT Results can be harmonized There is harmonization potential Reference materials available Reference method available Manufacturers expressed intention to harmonize Success demonstrated
Toolbox of the ICHCLR is efficient As demonstrated in the process of harmonizing CDT