Comparison of the Simplify D-dimer assay performed at the bedside with a laboratory-based quantitative D-dimer assay for the diagnosis of pulmonary embolism in a low prevalence emergency department population

Emergency Medicine Journal : EMJ
M S RunyonJ A Kline

Abstract

The immunofiltration D-dimer assay could allow point-of-care testing for pulmonary embolism (PE). A study was undertaken to compare a clinician-performed qualitative D-dimer assay with the automated quantitative D-dimer test. A prospective observational study was conducted from January to October 2005 at an urban academic emergency department (ED). 1193 patients of mean (SD) age 47 (16) years (66% female) were enrolled. The study protocol combined pretest probability estimation, D-dimer testing by both a qualitative immunochromatographic assay (Simplify) performed at the point of care by 192 different clinicians and a quantitative D-dimer test performed in a CLIA-certified laboratory. The criterion standard was image-proven PE or deep venous thrombosis within 45 days after enrollment. To test interobserver agreement for the qualitative assay, two blinded observers independently read 841 Simplify cartridges. Of 1193 patients enrolled, 45 were PE+ (3.8%, 95% CI 2.8% to 5.0%). Qualitative results were available for 1169 (98%) and quantitative results were available for 1136 (95%). Comparison of the qualitative and quantitative D-dimer tests gave the following results: sensitivity 91% (95% CI 78% to 98%) vs 93% (95% CI 80% to 98%);...Continue Reading

Citations

Jul 22, 2009·AJR. American Journal of Roentgenology·Rajan T GuptaVictor F Tapson
Apr 11, 2012·Emergency Medicine Clinics of North America·David W Ouellette, Catherine Patocka
May 31, 2011·Annals of Emergency Medicine·Francis M FesmireUNKNOWN American College of Emergency Physicians
Oct 2, 2014·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Jeffrey A KlinePierre-Marie Roy
Apr 8, 2015·Journal of Thrombosis and Haemostasis : JTH·W A M LucassenH C P M van Weert
Mar 25, 2015·The Journal of Emergency Medicine·Jeffrey A Kline, Christopher Kabrhel
Oct 14, 2020·Journal of Thrombosis and Haemostasis : JTH·Federico GerminiKerstin de Wit

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