title: Evaluation of the Stratus CS Acute Care D-dimer assay (DDMR) using the Stratus CS STAT Fluorometric Analyzer: a prospective multisite study for exclusion of pulmonary embolism and deep vein thrombosis.
abstract: BACKGROUND
  D-dimer testing is an integral part of the diagnostic algorithm in excluding patients with venous thromboembolism. In this study, we prospectively evaluated the Stratus DDMR D-dimer test in patients suspected of pulmonary embolism (PE) and deep vein thrombosis (DVT).
  
  
  METHODS
  Patients suspected of venous thromboembolism were prospectively enrolled at four different clinical sites, with sodium citrate and lithium heparin plasma was tested using the DDMR D-dimer test on the Stratus CS analyzer.
  
  
  RESULTS
  1,012 patients were enrolled for analysis, with 85/603 (14.1%) patients with PE and 80/443 (18.1%) with DVT, and four of the patients (0.4%) with PE and DVT. For the samples collected in 3.2% sodium citrate, the DDMR method had a sensitivity, specificity, and negative predictive value for VTE of 98.0%, 38.1%, and 99.1%, respectively. For the samples collected in lithium heparin, the DDMR method had a sensitivity, specificity, and negative predictive value (NPV) for VTE of 98.9%, 28.8%, and 99.4%, respectively. In PE, DDMR testing on citrate plasma had a sensitivity, specificity, and NPV of 98.8%, 39.5%, and 99.6%, respectively, while heparin samples had a sensitivity, specificity, and NPV for PE of 98.0%, 28.4%, and 99.1%, respectively. In DVT, citrate plasma had a sensitivity, specificity, and NPV for DVT of 97.5%, 32.0%, and 98.3%, respectively, while heparin samples had a sensitivity, specificity, and NPV for DVT of 100%, 27.8%, and 100%, respectively.
  
  
  CONCLUSIONS
  The Stratus CS DDMR D-dimer can be used in those patients with non-high clinical pre-test probability for the exclusion of PE.
authors.affiliation: University of California, Davis Health System, Sacramento, CA 95817, USA.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Gosselin
authors.forename: Jogin R
authors.initials: JR
authors.lastname: Wu
authors.forename: Kandice
authors.initials: K
authors.lastname: Kottke-Marchant
authors.forename: Dirk
authors.initials: D
authors.lastname: Peetz
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Christie
authors.forename: Heidrun
authors.initials: H
authors.lastname: Muth
authors.forename: Edward
authors.initials: E
authors.lastname: Panacek
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D005470:Fluorometry / Q000295:instrumentation / Q000379:methods / Q000592:standards; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods / Q000592:standards; D008875:Middle Aged; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000097:blood* / Q000175:diagnosis; D020246:Venous Thrombosis / Q000097:blood* / Q000175:diagnosis; D055815:Young Adult
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D