Determinants of plasma fibrin D-dimer sensitivity for acute pulmonary embolism as defined by pulmonary angiography.

BACKGROUND: The reported operating characteristics of the plasma fibrin D-dimer level for the diagnosis of acute pulmonary embolism vary widely. OBJECTIVE: To determine the sensitivity, specificity, predictive value, and clinical utility of the D-dimer for the diagnosis of pulmonary embolism, and to describe the effect of D-dimer assay method (enzyme-linked immunosorbent assay [ELISA], latex agglutination, membrane ELISA) and discriminate level, patient location at onset, comorbid disease, duration and intensity of concurrent heparin administration, and duration of symptoms on these operating characteristics. DESIGN: Prospective laboratory investigation. SETTING: Community and tertiary care teaching hospital. PATIENTS: Consecutive patients with suspected acute pulmonary embolism referred for pulmonary angiography from April 1993 through March 1996. MEASUREMENTS: Baseline characteristics, the duration and intensity of heparin anticoagulation, the time interval between symptom onset and plasma D-dimer testing, pulmonary angiography, and the D-dimer level on the day of pulmonary angiography. RESULTS: Of 105 consenting patients, 33 (31%) had a positive pulmonary angiogram. The D-dimer sensitivity/ negative predictive value for the ELISA, latex agglutination (American Bioproducts Co/Diagnostica Stago and Biopool International), and membrane ELISA were 100%/100%, 94%/94%, 100%/100%, and 97%/96%, respectively, at a discriminate level of 250 microg/L or less. The clinical utility, defined as the prevalence of a negative test, ranged from 17% to 33%. D-dimer sensitivity was unaffected by patient location at onset, comorbid disease, or heparin therapy but was inversely related to the duration of symptoms. CONCLUSIONS: The sensitivity of the plasma fibrin D-dimer for the diagnosis of pulmonary embolism depends on the assay method, the assay-specific discriminate level, and the duration of symptoms. At the appropriate discriminate level, the plasma D-dimer is a sensitive but nonspecific test for the diagnosis of pulmonary embolism.