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.