Validation of an Automated Immunoturbidimetric Assay for Measurement of Plasma D-Dimer

Verfasser / Beitragende:
[Mojca Božič, Mojca Stegnar]
Ort, Verlag, Jahr:
2003
Enthalten in:
Clinical Chemistry and Laboratory Medicine, 41/7(2003-07-21), 958-962
Format:
Artikel (online)
ID: 378879332
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024 7 0 |a 10.1515/CCLM.2003.146  |2 doi 
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245 0 0 |a Validation of an Automated Immunoturbidimetric Assay for Measurement of Plasma D-Dimer  |h [Elektronische Daten]  |c [Mojca Božič, Mojca Stegnar] 
520 3 |a The performance characteristics and diagnostic accuracy of a new rapid automated quantitative immunoturbidimetric D-dimer assay, Auto-Dimer (Biopool, Umeå, Sweden) were evaluated in a population of 135 outpatients with suspected deep-vein thrombosis of lower limb. Enzyme-linked immunosorbent assay was used as the reference method. The Auto-Dimer assay showed good reproducibility. The correlation between Auto-Dimer and enzyme-linked immunosorbent assay was high (r = 0.91, p < 0.05) and agreement in classifying patients above or below the cut-off was good (κ coefficient 0.74, 95 % CI 0.62-0.86). At a cut-off of 340 μg/l the sensitivity and specificity of Auto-Dimer were high (100% and 61%, respectively). These data show that Auto-Dimer is a reliable screening test for exclusion of deep-vein thrombosis. The assay could be included in prospective patient management studies in order to obtain further information on its clinical usefulness. 
540 |a Copyright © 2003 by Walter de Gruyter GmbH & Co. KG 
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690 7 |a Medical diagnosis  |2 nationallicence 
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700 1 |a Stegnar  |D Mojca  |4 aut 
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