Titre du document / Document title

A model for the harmonisation of test results of different quantitative D-dimer methods

Auteur(s) / Author(s)

MEIJER Piet ^{(1 2)} ; HAVERKATE Frits ⁽¹⁾ ; KLUH Cornelis ⁽²⁾ ; DE MOERLOOSE Philippe ⁽³⁾ ; VERBRUGGEN Bert ⁽⁴⁾ ; SPANNAGL Michael ^{(5 6)} ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ ECAT Foundation, Leiden, PAYS-BAS
⁽²⁾ TNO Prevention and Health, Leiden, PAYS-BAS
⁽³⁾ University Hospital, Geneva, SUISSE
⁽⁴⁾ Academic Medical Center St. Radboud, Nijmegen, PAYS-BAS
⁽⁵⁾ University Hospital, Munich, ALLEMAGNE
⁽⁶⁾ Instand, Düsseldorf, ALLEMAGNE

Résumé / Abstract

The numerical test results of different D-dimer assays vary widely. Because of the complexity of the analyte of target as well as the variability in specificity of different D-dimer assays, only harmonisation of the test results seems to be feasible.The use of a single conversion factor does not take into account for several methods the lack of commutability between test results and consensus values at different D-dimer levels.This is probably related to the mutually different response of methods to high and low levels.We therefore designed a harmonisation model based on the transformation of a method-specific regression line to a reference regression line. We used the data for the measurement of a set of plasma samples with different D-dimer levels by 353 different laboratories using 7 of the most frequently used quantitative D-dimer methods. For each method we calculated the method-specific consensus value for each sample.The overall median value was also estimated. Per method linear regression was applied throughout the method-specific consensus values using the amount of patient pooled plasma added to the different plasma samples as the independent variable. The line through the overall median values of all 7 methods was used as the reference line. Harmonisation between the methods was obtained by transformation of the method-specific regression line to the reference line.This harmonisation resulted in a reduction of the variability between the method-specific consensus values from about 75% to about 5.5%. Clinical validation of this concept had shown significant improvement of the test result comparability.We conclude that this model is a feasible approach in the harmonisation of D-dimer methods. If the harmonisation procedure is included in the calibration procedure by the manufacturers, customers will automatically obtain harmonised test results.

Revue / Journal Title

Thrombosis and haemostasis   ISSN 0340-6245   CODEN THHADQ 

Source / Source

2006, vol. 95, n^o3, pp. 567-572 [6 page(s) (article)] (18 ref.)

Langue / Language

Anglais

Editeur / Publisher

Schattauer, Stuttgart, ALLEMAGNE  (1976) (Revue)

Mots-clés anglais / English Keywords

Linear regression ; Method ; D dimer ; Quantitative analysis ; Model test ;

Mots-clés français / French Keywords

Régression linéaire ; Méthode ; Dimère D ; Analyse quantitative ; Essai sur modèle ;

Mots-clés espagnols / Spanish Keywords

Regresión lineal ; Método ; Dímero D ; Análisis cuantitativo ; Ensayo sobre modelo ;

Mots-clés d'auteur / Author Keywords

D-dimer ; harmonisation ; linear regression ; commutability ;

Localisation / Location

INIST-CNRS, Cote INIST : 10255, 35400013305975.0260