Diagnostic accuracy of D-dimer test for exclusion of venous thromboembolism: a systematic review

BACKGROUND: The reported diagnostic accuracy of the D-dimer test for exclusion ofdeep vein thrombosis (DVT) and pulmonary embolism (PE) varies. It is unknown towhat extent this is due to differences in study design or patient groups, or togenuine differences between D-dimer assays.METHODS: Studies evaluating the diagnostic accuracy of the D-dimer test in thediagnosis of venous thromboembolism were systematically searched for in theMEDLINE and EMBASE databases up to March 2005. Reference lists of all includedstudies and of reviews related to the topic of the present meta-analysis weremanually searched for other additional potentially eligible studies. Tworeviewers independently extracted study characteristics using standardized forms.RESULTS: In total, 217 D-dimer test evaluations for DVT and 111 for PE wereanalyzed. Several study design characteristics were associated with systematicdifferences in diagnostic accuracy. After adjustment for these features, thesensitivities of the D-dimer enzyme-linked immunofluorescence assay (ELFA) (DVT96%; PE 97%), microplate enzyme-linked immunosorbent assay (ELISA) (DVT 94%; PE95%), and latex quantitative assay (DVT 93%; PE 95%) were superior to those ofthe whole-blood D-dimer assay (DVT 83%; PE 87%), latex semiquantitative assay(DVT 85%; PE 88%) and latex qualitative assay (DVT 69%; PE 75%). The latexqualitative and whole-blood D-dimer assays had the highest specificities (DVT99%, 71%; PE 99%, 69%).CONCLUSIONS: Compared to other D-dimer assays, the ELFA, microplate ELISA andlatex quantitative assays have higher sensitivity but lower specificity,resulting in a more confident exclusion of the disease at the expense of moreadditional imaging testing. These conclusions are based on the most up-to-dateand extensive systematic review of the topic area, including 184 articles, with328 D-dimer test evaluations.