title: The performance of quantitative D-dimer assays in laboratory routine.
abstract: Assessment of D-dimer in plasma is routinely used for the exclusion of venous thrombosis and the monitoring of hypercoagulability. Little information is available about the performance of D-dimer assays in clinical laboratories examined by external quality assessment schemes. We obtained results from 423 laboratories measuring plasma pools from patients with elevated D-dimer levels mixed with human normal plasma. The results from five samples were reported containing D-dimer from the lower normal range up to a 20-fold increased level. In addition, information about the assignment of a cut-off point and the medical need to apply these assays was obtained by standardized questionnaire. Participants reported results and additional information from 20 different assays. Lack of standardization regarding the calibration concepts obstructs comparability of results. Results in one sample varied up to 20-fold between the assays applied. In addition, a high variability was reported around the cut-off values introduced for the exclusion of venous thrombosis and pulmonary embolism. As a consequence, generally accepted cut-off values cannot be established. For cut-off assignment, 62% of participants used the kit insert but also 14% used local validation. In conclusion, standardization or at least harmonization of D-dimer assays is necessary to ensure comparability of D-dimer plasma levels measured in clinical routine.
authors.affiliation: INSTAND e.V., Düsseldorf, Germany. mispannagl@t-online.de
authors.forename: Michael
authors.initials: M
authors.lastname: Spannagl
authors.forename: Frits
authors.initials: F
authors.lastname: Haverkate
authors.forename: Hans
authors.initials: H
authors.lastname: Reinauer
authors.forename: Piet
authors.initials: P
authors.lastname: Meijer
mesh_terms: D001774:Blood Chemical Analysis; D019411:Clinical Laboratory Techniques / Q000592:standards; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis* / Q000592:standards; D006801:Humans; D011655:Pulmonary Embolism; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D020246:Venous Thrombosis / Q000097:blood* / Q000175:diagnosis
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D