Evaluation of carbohydrate-deficient transferrin measurements on the V8 capillary electrophoresis system and comparison with the IFCC approved HPLC reference method and N-Latex immunonephelometric assay
-
Leo H.J. Jacobs
,
Riekie M. te Stroet
Abstract
Objectives
Carbohydrate-deficient transferrin (CDT) measurements are commonly used for the identification and follow-up of individuals suspected of chronic alcohol abuse. This study describes the analytical characteristics of the CDT assay on the Helena Biosciences V8 electrophoresis analyzer and compares its diagnostic performance to the International Federation of Clinical Chemistry and Laboratory Medicine approved high performance liquid chromatography (HPLC) method and the N-Latex CDT immunonephelometric assay.
Methods
The analytical performance of the V8 assay, including the linearity and the imprecision, was studied at two separate locations. Method comparison analysis was performed by studying the correlation, bias and agreement between the V8, HPLC and the N-Latex assays in 231 patient samples.
Results
The total imprecision ranged between 5.1 and 24.3% and was ≤13.1% for samples with concentrations above the clinical cut-off value (≥1.62%). The method comparisons revealed excellent correlations with r2≥0.97 for all comparisons. Measurements on the V8 showed a bias of −0.83 (−22.24%) and −0.40 (−12.26%) with the HPLC and N-Latex assays, respectively. The assays showed excellent agreements (Kappa scores ≥ 0.8) in classifying subjects with elevated CDT values. Receiver operating characteristic (ROC)-curve analysis, using the HPLC classification as reference, revealed areas under the ROC-curves of 0.981 (95% CI, 0.97–0.99) and 0.996 (0.99–1.00) for the N-Latex and V8 assays, respectively.
Conclusions
CDT measurements on the V8 assay are highly correlated with both the HPLC and the N-Latex assay and show excellent agreement in classifying subjects with elevated CDT values. Overall, the V8 CDT analysis is a robust, reliable and effective method to measure CDT concentrations in serum samples.
Research funding: The Helena Biosciences V8 CDT analyzer was provided to our laboratory for the duration of this study by Helena Biosciences Europa. Reagents and measurement costs for this study were kindly provided by Helena Biosciences Europe.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Ethical approval: The study was approved by the Institutional Scientific Research Review Committee Meander Medical Center.
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Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-0545).
© 2020 Walter de Gruyter GmbH, Berlin/Boston
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- Editorial
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- Review
- Re-examining ferritin-bound iron: current and developing clinical tools
- Opinion Papers
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