Analytic validation and clinical evaluation of the STA LIATEST immunoturbidimetric D-dimer assay for the diagnosis of disseminated intravascular coagulation.
To evaluate the diagnostic performance of a quantitative, immunoturbidimetric D-dimer assay and compare it with other components of the proposed International Society on Thrombosis and Haemostasis disseminated intravascular coagulation (DIC) diagnostic algorithm, we retrospectively analyzed the D-dimer, platelet count, prothrombin time, and fibrinogen results for all eligible hospitalized patients (n = 241) who had a D-dimer assay ordered during a 12-month period. A receiver operating characteristic (ROC) curve constructed from the maximum D-dimer measurement for all patients was significant (P < .001) with an area under the curve (AUC) of 0.94. The ROC curves of the other tests were each significant (P < .001), but the AUCs of the prothrombin time (0.74), fibrinogen level (0.70), and platelet count (0.67) did not approach that of the D-dimer. A D-dimer cutoff of 8.2 microg/mL (8,200 microg/L) optimized sensitivity and negative predictive value for the total population and patients with a predisposing condition. Validation against 286 additional patients in a separate analysis verified the diagnostic performance of the aforementioned cutoff. A sensitive, immunoturbidimetric D-dimer assay, by itself provides excellent sensitivity and negative predictive value for the diagnosis of DIC.
Department of Pathology, University of Utah Health Sciences Center, Salt Lake City 84132-2501, USA.
Christopher M
CM
Lehman
Lori W
LW
Wilson
George M
GM
Rodgers
D000328:Adult; D000465:Algorithms; D019540:Area Under Curve; D004211:Disseminated Intravascular Coagulation / Q000175:diagnosis*; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D005340:Fibrinogen / Q000032:analysis; D006801:Humans; D007118:Immunoassay; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D011237:Predictive Value of Tests; D011517:Prothrombin Time; D012372:ROC Curve; D012016:Reference Values; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D; D005340:Fibrinogen