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.
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).


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).


CONCLUSIONS
In our cohort of patients, DD was less accurate than previously reported, with an upper estimate of the sensitivity of only 87%.
Ray
Patrick
P
Department of Emergency Medicine, Groupe Hospitalier Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, 75013 Paris, France. patrick.ray@psl.ap.hop-paris.fr
Bellick
Bensalem
B
Birolleau
Sophie
S
Marx
Jean-Sébastien
JS
Arock
Michel
M
Riou
Bruno
B
D000328:Adult; D000368:Aged; D003937:Diagnosis, Differential; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013923:Thromboembolism / Q000175:diagnosis*
D005338:Fibrin Fibrinogen Degradation Products