Referent d-dimer enzyme-linked immunosorbent assay testing is of limited value in the exclusion of thromboembolic disease: result of a practical study in an ED |
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| Authors: | Ray Patrick Bellick Bensalem Birolleau Sophie Marx Jean-Sébastien Arock Michel Riou Bruno |
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| Institution: | 1. Centre for Genomics and Child Health, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London E1 2AT, United Kingdom;2. Stem Cell Laboratory, National Bowel Research Centre, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 2 Newark Street, London E1 2AT, United Kingdom;3. Centre for Predictive in vitro Model, Queen Mary University of London, Mile End Road, London E1 4NS, United Kingdom;4. William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom;5. Rare Disease Research Unit, Pfizer, 610 Main Street, Cambridge, MA 02139, USA;6. UCL Great Ormond Street Institute of Child Health, 30 Guilford Street, London WC1N 1EH, United Kingdom;7. School of Biomedical Sciences, Stem Cell and Regenerative Medicine Consortium, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Hong Kong, China;8. NIHR Biomedical Research Centre at Great Ormond Street Hospital, Great Ormond Street, London, United Kingdom;1. AP-HP, Henri-Mondor Hospital, Department of Internal and Geriatric Medicine, Sud-Val-de-Marne Geriatric Oncology Unit, Créteil, France;2. AP-HP, Henri-Mondor Hospital, Departement of Drug Development, Clinical Pharmacology in Oncology, France;3. AP-HP, Henri-Mondor Hospital, Department of Pharmacy, Créteil, France;4. University Paris-Est, Paris Est Créteil University (UPEC), CEpiA (Clinical Epidemiology and Ageing), EA 7376-IMRB, Créteil, France;5. AP-HP, Henri-Mondor Hospital, Department of Public Health, Clinical Research Unit (URC-Mondor), Créteil, France;6. AP-HP, Henri-Mondor Hospital, Department of Medical Oncology, Créteil, France;7. AP-HP, Ambroise Paré Hospital, Department of Geriatrics, Boulogne-Billancourt, France;8. AP-HP, Cochin Hospital, Department of Medical Oncology, ARIANE, Paris, France;9. AP-HP, Hopital Europeen Georges Pompidou, Department of Geriatrics, Paris, France |
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| Abstract: | OBJECTIVE: The aim of this study was to assess in clinical practice the accuracy of a referent d-dimer enzyme-linked immunosorbent assay for the exclusion of venous thromboembolic disease (VTED). PATIENTS AND METHODS: An observational prospective study took place in an emergency department; 205 consecutive outpatients suspected of having VTED were included. Blood samples were collected at admission for VIDAS DD measurement. Venous thromboembolic disease was confirmed by standard clinical imaging. All patients were followed up at 3 months. RESULTS: Venous thromboembolic disease was confirmed in 57 patients (28%). The sensitivity and negative predictive value of a DD assay lower than 500 ng/mL were 78% (95% confidence interval = 67%-87%) and 84% (95% confidence interval = 73%-90%), respectively. Twelve patients had a false-negative DD with one or more of the following: (a) symptoms reported for more than 15 days (n = 2), (b) prior anticoagulation (n = 3), (c) distal VTED (n = 5), or (d) high clinical probability (n = 3). CONCLUSION: In our cohort of patients, DD was less accurate than previously reported, with an upper estimate of the sensitivity of only 87%. |
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