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DOI: 10.1055/s-0037-1614226
Observer and Biological Variation of a Rapid Whole Blood D-Dimer Test
Publication History
Received
23 June 1997
Accepted after revision
19 August 1997
Publication Date:
08 December 2017 (online)
![](https://www.thieme-connect.de/media/10.1055-s-00035024/199801/lookinside/thumbnails/10-1055-s-0037-1614226-1.jpg)
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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