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 P.M.; Helander, Anders; Anton, Raymond F.; Bianchi, Vincenza; Jeppsson, Jan‐Olof; Siebelder, Carla; Whitfield, John B.; Schellenberg, François

doi:10.1373/clinchem.2014.221531

Cited by 28 publications

(23 citation statements)

References 21 publications

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“…However, the harmonization procedure recently proposed by IFCC-WG-CDT across CDT routine measurement procedures [26] should reduce the bias between the two methods and improve CDT reporting.…”

Section: Discussionmentioning

confidence: 99%

First evaluation of a multi-capillary electrophoresis CDT assay on Helena Biosciences' V8 analyser

Marinova

Artusi

Baggio

et al. 2014

Clinical Biochemistry

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Section: Discussionmentioning

confidence: 99%

First evaluation of a multi-capillary electrophoresis CDT assay on Helena Biosciences' V8 analyser

Marinova

Artusi

Baggio

et al. 2014

Clinical Biochemistry

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“…Harmonization of the assay obviously is important. The Calibration 2.000 project and co-workers of it contributed both to harmonization [64,65] and to the development of a reference method [63].…”

Section: Endocrinology Binding Assays Vitaminsmentioning

confidence: 99%

The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability

Jansen

Cobbaert

Weykamp

et al. 2018

Clinical Chemistry and Laboratory Medicine (CCLM)

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Calibration 2.000 was initiated 20 years ago for standardization and harmonization of medical tests. The program also intended to evaluate adequate implementation of the In Vitro Diagnostics (IVD) 98/79/EC directive, in order to ensure that medical tests are fit-for-clinical purpose. The Calibration 2.000 initiative led to ongoing verification of test standardization and harmonization in the Netherlands using commutable external quality assessment (EQA)-tools and a type 1 EQA-design, where feasible. National support was guaranteed by involving all laboratory professionals as well as laboratory technicians responsible for EQA and quality officers. A category 1 EQA-system for general chemistry analytes, harmonizers for specific analytes like hGH and IGF-1, and commutable materials for other EQA-sections have been developed and structurally introduced in the EQA-schemes. The type 1 EQA-design facilitates the dialogue between individual specialists in laboratory medicine and the IVD-industry to reduce lot-to-lot variation and to improve standardization. In such a way, Calibration 2.000 sheds light on the metrological traceability challenges that we are facing and helps the laboratory community to get the issues on the table and resolved. The need for commutable trueness verifiers and/or harmonizers for other medical tests is now seen as paramount. Much knowledge is present in the Netherlands and for general chemistry, humoral immunology and protein chemistry, a few endocrinology tests, and various therapeutic drug monitoring (TDM) tests, commutable materials are available. Also the multi sample evaluation scoring system (MUSE) and the category 1 EQA-design offer many possibilities for permanent education of laboratory professionals to further improve the between and within laboratory variation and the test equivalence.

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“…Weykamp et al recently reported on their efforts toward the harmonization of carbohydrate-deficient transferrin (CDT) measurements in serum (1 ). Alcohol biomarkers play a key role in the identification of alcohol abuse, a chronic disorder with enormous health and legal implications.…”

Section: Combining Serum Carbohydrate-deficient Transferrin and Hair mentioning

confidence: 99%

Combining Serum Carbohydrate-Deficient Transferrin and Hair Ethyl Glucuronide to Provide Optimal Information on Alcohol Use

Neels¹,

Yegles

Dom

et al. 2014

Clinical Chemistry

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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

Cited by 28 publications

References 21 publications

First evaluation of a multi-capillary electrophoresis CDT assay on Helena Biosciences' V8 analyser

First evaluation of a multi-capillary electrophoresis CDT assay on Helena Biosciences' V8 analyser

The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability

Combining Serum Carbohydrate-Deficient Transferrin and Hair Ethyl Glucuronide to Provide Optimal Information on Alcohol Use

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