Observer and biological variation of a rapid whole blood D-dimer test

F. Turkstra, E. J. van Beek, H. R. Büller

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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
Original languageEnglish
Pages (from-to)91-93
JournalThrombosis and haemostasis
Issue number1
Publication statusPublished - 1998

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