title: The performance of STA-Liatest D-dimer assay in out-patients with suspected pulmonary embolism.
abstract: Several studies have shown that D-dimer can reliably rule out pulmonary embolism (PE) in out-patients. However, various assays have different sensitivities and specificities to detect thrombosis. Our aim was to evaluate the performance of STA-Liatest D-Di in out-patients referred for suspected PE in a prospective outcome study. 495 consecutive patients referred to Østfold Hospital Trust-Fredrikstad, Norway for suspected PE between February 2002 and December 2003, were recruited in a study evaluating a decision-based algorithm combining clinical probability (CP), D-dimer, and multi-slice computer tomography (MSCT). D-dimer was performed as a first step test. No further testing was carried out in patients with D-dimer < or =0.4 mg/l and low/intermediate CP. The remaining patients proceeded to MSCT. All patients were followed up for 3 months to assess the 3-month thromboembolic risk. The final cohort consisted of 432 patients. PE was diagnosed in 102 (23%) patients. At a D-dimer cut-off point of 0.4 mg/l the tests had the highest sensitivity (100%) and specificity (36%). It safely ruled out PE in 120 (28%) patients. Kappa-coefficients for comparisons versus VIDAS and Asserachrom showed good concordance. STA-Liatest is a reliable and effective assay that can safely rule out PE in out-patients with a performance comparable with that of enzyme-linked immunosorbent assay-based d-dimer levels.
authors.affiliation: Department of Medicine, Østfold Hospital Trust, Fredrikstad, Norway. waleed.ghanima@so-hf.no
authors.forename: W
authors.initials: W
authors.lastname: Ghanima
authors.forename: M
authors.initials: M
authors.lastname: Abdelnoor
authors.forename: M-C
authors.initials: MC
authors.lastname: Mowinckel
authors.forename: P M
authors.initials: PM
authors.lastname: Sandset
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D000911:Antibodies, Monoclonal / Q000276:immunology; D015415:Biomarkers / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D004812:Epidemiologic Methods; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009391:Nephelometry and Turbidimetry / Q000379:methods; D011655:Pulmonary Embolism / Q000175:diagnosis* / Q000000981:diagnostic imaging; D014057:Tomography, X-Ray Computed
chemical_list: D000911:Antibodies, Monoclonal; D015415:Biomarkers; D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D