Observer and Biological Variation of a Rapid Whole Blood D-Dimer Test

Franktien Turkstra; Edwin J. R. van Beek; Harry R. Büller

doi:10.1055/s-0037-1614226

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1998; 79(01): 91-93
DOI: 10.1055/s-0037-1614226

Review Article

Schattauer GmbH

Observer and Biological Variation of a Rapid Whole Blood D-Dimer Test

Authors

Franktien Turkstra

From the Academic Medical Center, University of Amsterdam, Center for Haemostasis, Thrombosis, Atherosclerosis and Inflammation Research, Amsterdam, The Netherlands
Edwin J. R. van Beek

From the Academic Medical Center, University of Amsterdam, Center for Haemostasis, Thrombosis, Atherosclerosis and Inflammation Research, Amsterdam, The Netherlands
Harry R. Büller

From the Academic Medical Center, University of Amsterdam, Center for Haemostasis, Thrombosis, Atherosclerosis and Inflammation Research, Amsterdam, The Netherlands

Abstract

Summary

In consecutive patients with suspected venous thromboembolism the interobserver variability of the SimpliRED D-dimer test was evaluated by two observers who independently scored one plate, the between assay variation was performed simultaneously by a third independent observer, who assessed a second plate. The biological variation was studied, 1-4 hours later by an independent evaluation.

A total of 155 patients entered the study, venous thromboembolism was present in 42 patients (28%). The interobserver variability was 2/83 samples, with a kappa of 0.95 (95% confidence interval 0.88-1.0). The between assay variation was 2/98, with a kappa value of 0.96 (95% confidence interval 0.90-1.0). When testing the biological variation the observers disagreed in 2 of 69 patients (3%).

The SimpliRED D-dimer assay has a good to excellent interobserver variability, between assay variation and reproducibility.

Full Text

References

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