Title
A model for the harmonisation of test results of different quantitative D-dimer methods
Author
TNO Kwaliteit van Leven TNO Preventie en Gezondheid
Meijer, P.
Haverkate, F.
Kluft, C.
Moerloose, P.de
Verbruggen, B.
Spannagl, M.
Publication year
2006
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. © 2006 Schattauer GmbH, Stuttgart.
Subject
Commutability
D-dimer
Harmonisation
Linear regression
D dimer
Biological Markers
Blood Coagulation Disorders
Fibrin Fibrinogen Degradation Products
Humans
Immunoassay
Models, Biological
Regression Analysis
Reproducibility of Results
To reference this document use:
http://resolver.tudelft.nl/uuid:8468f5ae-c7e7-4a2b-906b-6b2035924cd6
DOI
https://doi.org/10.1160/th05-01-0042
TNO identifier
239156
ISSN
0340-6245
Source
Thrombosis and Haemostasis, 95 (95), 567-572
Document type
article