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

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
› Author Affiliations
Further Information

Publication History

Received 23 June 1997

Accepted after revision 19 August 1997

Publication Date:
08 December 2017 (online)

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.

 
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