Source:http://linkedlifedata.com/resource/pubmed/id/16525589
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
3
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pubmed:dateCreated |
2006-3-9
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pubmed:abstractText |
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.
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pubmed:commentsCorrections | |
pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Mar
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pubmed:issn |
0340-6245
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
95
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
567-72
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pubmed:meshHeading |
pubmed-meshheading:16525589-Biological Markers,
pubmed-meshheading:16525589-Blood Coagulation Disorders,
pubmed-meshheading:16525589-Fibrin Fibrinogen Degradation Products,
pubmed-meshheading:16525589-Humans,
pubmed-meshheading:16525589-Immunoassay,
pubmed-meshheading:16525589-Models, Biological,
pubmed-meshheading:16525589-Regression Analysis,
pubmed-meshheading:16525589-Reproducibility of Results
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pubmed:year |
2006
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pubmed:articleTitle |
A model for the harmonisation of test results of different quantitative D-dimer methods.
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pubmed:affiliation |
ECAT Foundation, Leiden, The Netherlands. P.Meijer@ecat.nl
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pubmed:publicationType |
Journal Article
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