Author/Editor     Stegnar, Mojca; Božič, Mojca
Title     Određivanje koncentracije D-dimera različitim kvantitativnim testovima - vježba harmonizacije
Translated title     Determination of D-dimer by different quantitative assays - a harmonization exercise
Type     članek
Source     Biochem Med
Vol. and No.     Letnik 18, št. 2
Publication year     2008
Volume     str. 216-23
Language     cro
Abstract     Background: D-di mer determined by different as says shows considerable variability due to lack of standardization. We describe a harmonization exercise performed in an attempt to diminish this variabilityusing plasma samples with high D-di mer concentration. Materials and methods: Five laboratories participated with several different quantitative D-dimer as says: Vidas D-di mer Exclusion (Biomerieux), Auto-Dimer (Biopool), D-di mer Plus, Acute Care D-dimer (both Dade Behring) and Hemosil D-Dimer (Instrumentation Laboratory). For harmonization a set of six plasmas was prepared: normal pooled plasma and samples A-E, prepared by mixing normal poo ed plasma with in creasing parts (1, 2, 3, 8 and 14.7) of patient pooled plas ma with a high D-dimer concentration. For validation 15 plasma samples from patients with venous thromboembolism we reutilized. Results: Are ference regression line through the mean values of D-dimer in samples A-E was calculated and used to harmonize the results of the 15 validation samples. After harmonization the coefficients of variation improved considerably from 89% to 19% (mean values) for validation samples with high D-dimer concentration. For validation samples with low D-dimer concentration (normal or around cu t-o ff ) coefficients of variation even in creased from a mean value of 86% before harmonization to a mean value of 224% after harmonization. Conclusions: The harmonization procedure considerably decreased variability be tween different D-dimer as says in samples with a high D-dimer concentration. However, for samples wi th D-dimer concentration around cu t-o ff ,which is critical for clinical application, no improvement was observed.
Descriptors     BLOOD CHEMICAL ANALYSIS
DIMERIZATION
REFERENCE VALUES
QUALITY CONTROL