Evaluation of the Innovance Immunoturbidimetric D-Dimer Assay for the Diagnosis of Disseminated Intravascular Coagulopathy (DIC) in different clinical settings

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Disseminated intravascular coagulation (DIC) remains a clinical challenge and a major cause of morbidity and mortality n different clinical situations. DIC is a clinical diagnosis supported by laboratory data but with no universally accepted diagnostic algorithm. However, the International Society on Thrombosis and Haemostasis (ISTH) recently proposed a DIC scoring system based on 4 laboratory parameters and the presence of a predisposing condition. Increase of a fibrin-related marker, such as D-dimer, represents a key element of the ISTH algorithm, which also scores elevations in the prothrombin time (PT) and reductions in the platelet count and fibrinogen concentration. A sensitive immunoturbidimetric D-dimer assay would probably provide an excellent sensitivity and negative predictive value for the diagnosis of DIC. The Innovance D-dimer assay is a new class of automated D-dimer test that is based on immunoturbidimetric techniques with a promising performance in terms of high sensitivity and specificity. Little is known about the performance of Innovance in the context of patient evaluation for suspected DIC in different clinical settings as proposed in this trial. Therefore, we are evaluating both the analytic and clinical performance of the Innovance (Dade Behring, Marbburg, Germany) immunoturbidimetric D-dimer assay in hospitalized patients not suspected of having DIC, and in patients who have had D-dimer assays ordered for suspected DIC. Because the measurement of D-dimer has not been harmonized among marketed assays, cutoff values for scoring D-dimer elevations in the ISTH algorithm (see table 1 and 2) need to be assay-specific. By using receiver operating characteristic (ROC) curve analysis, we will identify a prospective cutoff that maximizes sensitivity and specificity of the Innovance D-dimer assay. We are hoping by establishment of a cutoff value to compare the diagnostic performance of the Innovance D-dimer assay in the context of the ISTH scoring system. Furthermore, DIC is a serious complication of infection/sepsis, malignancy and in the acutely bleeding patient and it carries a considerable mortality rate, and once established it is difficult to reverse. Therefore it is crucial to establish a simple coagulation test like D-Dimer assay in order to predict the ocurrence of DIC.

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