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An evaluation of rapid D ‐dimer assays for the exclusion of deep vein thrombosis
Author(s) -
Gardiner Chris,
Pennaneac'h Coralie,
Walford Claire,
Machin Samuel J,
Mackie Ian J
Publication year - 2005
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2005.05394.x
Subject(s) - d dimer , medicine , deep vein , thrombosis , emergency department , predictive value , receiver operating characteristic , pre and post test probability , nuclear medicine , radiology , surgery , psychiatry
Summary We evaluated the performance of eight d ‐assays for the exclusion of deep vein thrombosis (DVT); Biopool AutoDimer, Biopool MiniQuant, bioMèrieux MDA d ‐Dimer, VIDAS, Dade Behring d ‐Dimer Plus, Trinity Biotech AMAX, NycoCard d ‐dimer and IL Test d ‐Dimer. The assays were evaluated both as stand‐alone tests, and in combination with pretest probability (PTP). d ‐dimer assays and PTP assessment were performed on 410 patients presenting to the emergency department with suspected acute DVT. DVT was diagnosed in 76 of 410 patients (18·5%) by compression ultrasound or other imaging techniques, as required. Receiver operator characteristics analysis established optimum cut‐off values and these were compared with manufacturer's cut‐off values where provided. As stand‐alone tests, the assays varied immensely regarding cut‐off value, negative predictive value (NPV 93–100%) and specificity (0–67%). At least one patient with confirmed DVT had a low d ‐dimer level by each method: to achieve 100% sensitivity it would be necessary to reduce cut‐off values to levels below clinical usefulness. When low d ‐dimer was used in combination with PTP, six of eight methods achieved ≥98% NPV, with a diagnosis of DVT excluded in 16–44% of patients without the requirement for diagnostic imaging. The highly variable diagnostic performance of these d ‐dimer assays means that some assays are unsuitable for certain diagnostic strategies. However, our data suggest that the combination of sensitive d ‐dimer assays with an assessment of PTP may be used to exclude a diagnosis of DVT.