A new method for measuring D-dimer using immunoturbidometry: a study of 255 patients with suspected pulmonary embolism and deep vein thrombosis.
D-Dimer testing has been suggested as a non-invasive method for the exclusion of pulmonary embolism (PE) and deep vein thrombosis (DVT). In this study, we compared a new method, the Miniquant D-dimer (Biopool International, Ventura, California, USA) to other previously validated D-dimer methods used for the purpose. Patients who were undergoing a definitive diagnostic study for thromboembolism had a blood sample drawn at that time. A whole-blood D-dimer (SimpliRed; Agen Biomedical Ltd, Brisbane, Australia) test was performed, and residual plasma was frozen and later analyzed using two enzyme-linked immunosorbent assay (ELISA) methods (D-dimer Gold; Agen, and Asserachrome D-Di; Stago International, Parsippany, New Jersey, USA) and the Miniquant D-dimer. Once all samples were analyzed, the correlation and accuracy of the Miniquant was compared with the ELISA method using Spearman's regression and Dunn's multiple paired comparison. All D-dimer methods were compared with radiographic studies. The data was analyzed collectively and segregated into in-patient (n = 112) and out-patient (n = 143) populations. The Miniquant D-dimer sensitivity, specificity and negative predictive value (NPV) for all patients were 95, 21, and 94% for DVT, and 100, 26, and 100% for PE. This new D-dimer method demonstrates acceptable sensitivity in patients with PE and DVT and, based on the high NPV of this method, it can be used for the exclusion of thromboembolism.
Gosselin
R C
RC
Department of Pathology, University of California, Davis, Medical Center, Sacramento 95817, USA.
Owings
J T
JT
Utter
G H
GH
Jacoby
R C
RC
Larkin
E C
EC
D000328:Adult; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008875:Middle Aged; D011655:Pulmonary Embolism / Q000097:blood / Q000175:diagnosis; D013924:Thrombophlebitis / Q000097:blood / Q000175:diagnosis
D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D