Diagnostic value of a new sensitive membrane based technique for instantaneous D-dimer evaluation in patients with clinically suspected deep venous thrombosis.
BACKGROUND
Plasma D-Dimer analysis, using ELISA assays, has demonstrated in previous studies a high sensitivity, suggesting its utility in excluding deep venous thrombosis (DVT).


OBJECTIVE
To assess the performance of a new rapid plasma D-Dimer ELISA measurement in suspected DVT patients with recent clinical signs, not exceeding one week.


METHODS
A prospective study of patients admitted for a suspected recent DVT. Contrast venography or compression ultrasonography were performed within 24 h of admission. A new membrane based ELISA technique, which uses an immunofiltration and two complementary monoclonal antibodies was tested. Results were expressed as positive or negative. A standard plasma D-Dimer ELISA measurement was also performed. D-Dimer performances were assessed at the end of the study.


RESULTS
265/448 patients had a proven DVT (72 distal, 193 proximal). The sensitivity of the instantaneous method in the diagnosis of overall DVT is 92 +/- 3.4% (95% CI), and specificity is 36.6 +/- 6.9%. Positive predictive value is 67.7 +/- 4.8% and negative predictive value is 76.1 +/- 8.9%. Sensitivity and negative predictive values reach 97.9 and 94.3% in the diagnosis of proximal DVT, but only 76.3 and 79.7% in the diagnosis of distal DVT. Similar results are observed with the standard ELISA method.


CONCLUSIONS
This new rapid plasma D-Dimer measurement appears highly sensitive, and could substitute the older ELISA methods. Both methods provide lower sensitivity in the case of a distal DVT location.
Leroyer
C
C
Department of Chest Diseases and Internal Medicine, Hôpital de la Cavale Blanche, Brest, France.
Escoffre
M
M
Le Moigne
E
E
Grimaux
M
M
Cagnioncle
O
O
Oger
E
E
Bressollette
L
L
Abgrall
J F
JF
Amiral
J
J
Mottier
D
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004797:Enzyme-Linked Immunosorbent Assay; D005069:Evaluation Studies as Topic; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D010690:Phlebography; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013924:Thrombophlebitis / Q000097:blood / Q000175:diagnosis* / Q000000981:diagnostic imaging; D013997:Time Factors; D014463:Ultrasonography
D005338:Fibrin Fibrinogen Degradation Products; D008567:Membranes, Artificial; D011933:Reagent Kits, Diagnostic; C036309:fibrin fragment D