Evaluation of a new rapid D-dimer assay for clinically suspected deep venous thrombosis (Liatest D-dimer).
In previous studies, enzyme-linked immunosorbent assays (ELISA) for plasma D-dimer analysis have demonstrated high sensitivity, suggesting their potential usefulness in excluding deep venous thrombosis (DVT). We evaluated the usefulness of a new D-dimer test (Liatest D-dimer) for suspected DVT in a prospective study of patients admitted to the hospital because of recent (not exceeding 1 week before admission) clinical signs. Contrast venography or compression ultrasonography or both were performed within 24 hours of admission. A new quantitative determination of D-dimer concentration using a suspension of microlatex particles coated with specific antibodies was tested. A standard plasma D-dimer ELISA measurement was also performed. Of 464 patients, 276 had a proven DVT (distal, 74; proximal, 202). For a cutoff level of 400 ng/mL, sensitivity of the Liatest method in the diagnosis of overall DVT was 94.6% (95% confidence interval, 92.0%-97.0%), and the specificity was 35% (95% confidence interval, 28%-42%). The sensitivity and negative predictive value were 98.5% and 95.6%, respectively, in the diagnosis of proximal DVT, but only 83.8% and 84.6%, respectively, in the diagnosis of distal DVT. This new rapid Liatest D-dimer assay seems to be highly sensitive and could replace the ELISA method in excluding patients with proximal DVT. Both methods provide lower sensitivity for distal DVT.
Escoffre-Barbe
M
M
Department of Haematology, Hôpital de la Cavale Blanche, Brest, France.
Oger
E
E
Leroyer
C
C
Grimaux
M
M
Le Moigne
E
E
Nonent
M
M
Bressollette
L
L
Abgrall
J F
JF
Soria
C
C
Amiral
J
J
Ill
P
P
Clavier
J
J
Mottier
D
D
D001322:Autoanalysis; D004797:Enzyme-Linked Immunosorbent Assay; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007840:Latex; D008863:Microspheres; D010690:Phlebography; D011446:Prospective Studies; D012372:ROC Curve; D012680:Sensitivity and Specificity; D013924:Thrombophlebitis / Q000175:diagnosis*; D014463:Ultrasonography
D005338:Fibrin Fibrinogen Degradation Products; D007840:Latex; C036309:fibrin fragment D