title: Comparison of six D-dimer methods in patients suspected of deep vein thrombosis.
abstract: We evaluated six D-dimer methods to determine their sensitivity, specificity, and negative predictive values (NPV) in symptomatic patients suspected of deep vein thrombosis (DVT). In patients suspected of DVT a whole blood D-dimer test (SimpliRED, Agen) was performed, and then tested using enzyme-linked immunosorbent assay (VIDAS D-Dimer, BioMerieux; Asserachrome D-Di, Stago International; Dimertest Gold, Agen) and automated immunoturbidometric methods (Advanced D-Dimer, Dade Behring; MiniQuant, Biopool). Each D-dimer method was independently compared with radiographic results to determine sensitivity and NPV. There were 151 patients enrolled in the study. Thirty-five (23.2%) patients had a positive Doppler ultrasound, with 26 proximal, eight distal, and one patient with both proximal and distal thrombus. Two patients (1.3%) had inconclusive studies and were excluded from the analyses. For all patients, the sensitivities for the rapid D-dimer methods were: SimpliRED, 82.3% [95% confidence interval (CI), 80.3-84.3%]; VIDAS D-Dimer, 91.4% (95% CI, 89.9-92.9%); MiniQuant D-Dimer, 96.3% (95% CI, 95.1-97.5%); and Advanced D-Dimer, 97.1% (95% CI, 96.3-97.9%). The sensitivity improved for SimpliRED (86.4%; 95% CI, 83.3-89.4%), VIDAS D-Dimer (95.5%; 95% CI, 85.0-100%), MiniQuant D-Dimer (100%; 95% CI, 96.9-100%) and Advanced D-Dimer (100%; 95% CI, 98.9-100%) in the inpatient population. The automated immunoturbidometric methods, the MiniQuant D-Dimer and Advanced D-Dimer, demonstrated comparable sensitivities and NPV with the VIDAS D-Dimer method in symptomatic patients suspected of DVT, which would suggest that these newer D-dimer methods could be used as part of the diagnostic algorithm for patients suspected of DVT.
authors.affiliation: Department of Pathology and Department of Surgery, University of California, Davis Medical Center, Sacramento, California, USA.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Gosselin
authors.forename: John T
authors.initials: JT
authors.lastname: Owings
authors.forename: Joshua
authors.initials: J
authors.lastname: Kehoe
authors.forename: John T
authors.initials: JT
authors.lastname: Anderson
authors.forename: Denis M
authors.initials: DM
authors.lastname: Dwyre
authors.forename: Robert C
authors.initials: RC
authors.lastname: Jacoby
authors.forename: Garth
authors.initials: G
authors.lastname: Utter
authors.forename: Edward C
authors.initials: EC
authors.lastname: Larkin
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009391:Nephelometry and Turbidimetry; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity; D020246:Venous Thrombosis / Q000175:diagnosis*
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; D011933:Reagent Kits, Diagnostic; C036309:fibrin fragment D