title: Diagnostic value of a new sensitive membrane based technique for instantaneous D-dimer evaluation in patients with clinically suspected deep venous thrombosis.
abstract: 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.
authors.affiliation: Department of Chest Diseases and Internal Medicine, Hôpital de la Cavale Blanche, Brest, France.
authors.forename: C
authors.initials: C
authors.lastname: Leroyer
authors.forename: M
authors.initials: M
authors.lastname: Escoffre
authors.forename: E
authors.initials: E
authors.lastname: Le Moigne
authors.forename: M
authors.initials: M
authors.lastname: Grimaux
authors.forename: O
authors.initials: O
authors.lastname: Cagnioncle
authors.forename: E
authors.initials: E
authors.lastname: Oger
authors.forename: L
authors.initials: L
authors.lastname: Bressollette
authors.forename: J F
authors.initials: JF
authors.lastname: Abgrall
authors.forename: J
authors.initials: J
authors.lastname: Amiral
authors.forename: D
authors.initials: D
authors.lastname: Mottier
mesh_terms: 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
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; D008567:Membranes, Artificial; D011933:Reagent Kits, Diagnostic; C036309:fibrin fragment D