title: Rapid detection of D-Dimers with mLabs® whole blood method for venous thromboembolism exclusion. Comparison with Vidas® D-Dimers assay.
abstract: BACKGROUND
  Easy to use point of care assays for D-Dimers measurement in whole blood from patients with clinical suspicion of venous thromboembolism (VTE) will facilitate the diagnostic strategy in the Emergency Department (ED) setting. We prospectively evaluated the diagnostic performance of the point-of-care mLabs® Whole Blood D-Dimers test and we compared it with the Vidas® D-Dimers assay.
  
  
  METHODS
  As part of the diagnostic algorithm applied in patients with clinical suspicion of VTE, the VIDAS® D-Dimers Test was prescribed by the emergency physician in charge. The mLabs® Whole Blood D-Dimers Test was used on the same samples. All patients had undergone exploration with the recommended imaging techniques for VTE diagnosis.
  
  
  RESULTS
  Both assays were performed, on 99 emergency patients (mean age was 65 years) with clinical suspicion of VTE. In 3% of patients, VTE was documented with a reference imaging technique. The Bland and Altman test showed significant agreement between the two methods. Both assays showed equal sensitivity and negative predictive value for VTE.
  
  
  CONCLUSIONS
  The mLabs whole blood assay is a promising point of care method for measurement of D-Dimers and exclusion of VTE diagnosis in the emergency setting which should be validated in a larger prospective study.
authors.affiliation: Service d'Hématologie Biologique Hôpital Tenon, Hôpitaux Universitaires Est Parisien, Assistance Publique Hôpitaux de Paris, Paris, France - grigorios.gerotziafas@tnn.aphp.fr.
authors.forename: Grigoris T
authors.initials: GT
authors.lastname: Gerotziafas
authors.forename: Patrick
authors.initials: P
authors.lastname: Ray
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Gkalea
authors.forename: Ahlem
authors.initials: A
authors.lastname: Benzarti
authors.forename: Amir
authors.initials: A
authors.lastname: Khaterchi
authors.forename: Claire
authors.initials: C
authors.lastname: Cast
authors.forename: Julie
authors.initials: J
authors.lastname: Pernet
authors.forename: Eleftheria
authors.initials: E
authors.lastname: Lefkou
authors.forename: Ismail
authors.initials: I
authors.lastname: Elalamy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D015415:Biomarkers / Q000097:blood; D019091:Critical Pathways; D004636:Emergency Service, Hospital; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010297:Paris; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000097:blood / Q000175:diagnosis* / Q000000981:diagnostic imaging; D015203:Reproducibility of Results; D054556:Venous Thromboembolism / Q000097:blood / Q000175:diagnosis* / Q000000981:diagnostic imaging; D020246:Venous Thrombosis / Q000097:blood / Q000175:diagnosis* / Q000000981:diagnostic imaging; D055815:Young Adult
chemical_list: D015415:Biomarkers; D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D