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Mojca Bo?i?, Mojca Stegnar

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

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 (? coefficient 0.74, 95 % CI 0.62–0.86). At a cut-off of 340 ?g/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.

Clinical Chemical Laboratory Medicine, Walter de Gruyter

Print ISSN: 1434-6621
Volume: 41, 07/2003
Pages: 958 - 962

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