title: New combinational assay using soluble fibrin and d-dimer determinations: a promising strategy for identifying patients with suspected venous thromboembolism.
abstract: OBJECTIVE
  To establish a new and reliable assay for quantification of the soluble fibrin (SF) in combination with that of D-dimer for early diagnosis of venous thromboembolism.
  The SF assay is based on D-dimer generated after incubation of plasma with tissue-type plasminogen activator (t-PA). SF and standard D-dimer assays, run in blind, were used to test 119 untreated outpatients with clinically suspected deep-vein thrombosis (DVT, 49 patients) or pulmonary embolism (PE, 70 patients) consulting at the emergency unit of the hospital. Thromboses were confirmed by current imaging methods such as ultrasonography, scintigraphy, computed tomographic pulmonary angiography (CTPA) and ventilation/perfusion scan.
  
  
  RESULTS
  SF assay was validated in 270 healthy volunteers [51.8% males; mean age years ± SD: 41±13; age range 19 to 65]. Among these normal plasmas, SF levels were ≤200 ng/mL in 97.8% of them, and 200-250 ng/mL in the remainder [26-46 years old; 50% males]. ROC curves were used to determine the SF cut-off value for plasma SF positivity, which was found to be 300 ng/mL. In patients with suspected venous thromboembolism, SF sensitivities for DVT and PE (92% and 94%, respectively) were comparable to those of D-dimer (96% and 94%), whereas SF specificities (86% and 95%) were higher than those of D-dimer (50% and 54%). Positive-predictive values for SF (89% and 94%) were again higher than those of D-dimer (70% and 65%) in DVT and PE. The amount of circulating SF normalized rapidly after anticoagulant therapy.
  
  
  CONCLUSIONS
  Results from this small group of patients suggest that the evaluation of plasma SF, in combination with that of D-dimer, represents a potentially useful tool for the early diagnosis of venous thromboembolism, provided that the patients have not been treated previously by anticoagulants.
authors.affiliation: Service d'Onco-Hématologie, Hôtel-Dieu, Paris, France; Université Paris Diderot Paris-7, UMR INSERM U965, Paris, France.
authors.forename: Shahsoltan
authors.initials: S
authors.lastname: Mirshahi
authors.affiliation: Laboratoire d'Hématologie, Hôpital Lariboisière, Paris, France; Laboratoire MERCI, Faculté de Médecine et Pharmacie, Rouen, France.
authors.forename: Claudine
authors.initials: C
authors.lastname: Soria
authors.affiliation: Service de Pneumologie, Hôpital de Neuilly, Neuilly, France.
authors.forename: Basile
authors.initials: B
authors.lastname: Kouchakji
authors.affiliation: Service des Urgences, Hôtel-Dieu, Paris, France.
authors.forename: Gérald
authors.initials: G
authors.lastname: Kierzek
authors.affiliation: Hôpital Charles-Nicolle, Rouen, France.
authors.forename: Jeanne Yvonne
authors.initials: JY
authors.lastname: Borg
authors.affiliation: Hôpital Charles-Nicolle, Rouen, France.
authors.forename: Rémi
authors.initials: R
authors.lastname: Varin
authors.affiliation: Service d'Onco-Hématologie, Hôtel-Dieu, Paris, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Chidiac
authors.affiliation: Laboratoire d'Hématologie, Hôpital Lariboisière, Paris, France.
authors.forename: Ludovic
authors.initials: L
authors.lastname: Drouet
authors.affiliation: Service d'Onco-Hématologie, Hôtel-Dieu, Paris, France; Université Paris Diderot Paris-7, UMR INSERM U965, Paris, France.
authors.forename: Massoud
authors.initials: M
authors.lastname: Mirshahi
authors.affiliation: Service d'Onco-Hématologie, Hôtel-Dieu, Paris, France; Université Paris Diderot Paris-7, UMR INSERM U965, Paris, France.
authors.forename: Jeannette
authors.initials: J
authors.lastname: Soria
mesh_terms: D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D001774:Blood Chemical Analysis / Q000379:methods* / Q000592:standards; D042241:Early Diagnosis; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000737:chemistry* / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011655:Pulmonary Embolism / Q000097:blood / Q000175:diagnosis; D012016:Reference Values; D015203:Reproducibility of Results; D012995:Solubility; D010959:Tissue Plasminogen Activator / Q000494:pharmacology; D054556:Venous Thromboembolism / Q000097:blood* / Q000175:diagnosis* / Q000188:drug therapy; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D; D010959:Tissue Plasminogen Activator