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    Poster Networking

    Venous Thromboembolism

    Poster Networking Session

    PB1013 - Evaluation of the diagnostic performance of three D-dimer assays in patients with suspected deep vein thrombosis

    Monday, June 26, 2023
    18:30 – 19:30 ET
    Room: Exhibition
    Background: D-dimer is a central element in the diagnostic work-up of deep vein thrombosis (DVT).

    Aims: We aimed to evaluate the performance of three D-dimer assays: Tina-quant Gen. 2 (Roche Diagnostics), INNOVANCE D-dimer (Siemens Healthcare Diagnostics), and STA-Liatest D-Di Plus (Diagnostica Stago) in the exclusion of DVT.

    Methods: Samples (n=1097) and clinical data were acquired from a prospective outcome study (Rivaroxaban for Scheduled Work-up of Deep Vein Thrombosis – the Ri-Schedule), which included patients referred to the emergency department with suspected DVT. D-dimer was determined by STA-Liatest. Patients with D-dimer ≥ 0.5 µg/mL FEU, as stand-alone, were referred for compression ultrasonography (CUS) to confirm/exclude DVT, and were followed up for 90 days. Blood samples were analyzed by Tina-quant and INNOVANCE assays. The diagnostic performances of the three assays were investigated.

    Results: Using fixed cut-off ≥ 0.5 µg/mL FEU, positive D-dimer was found in 775 patients (70.6%) with STA-Liatest, 730 patients (66.5%) with Tina-quant, and 811 (73.9%) with INNOVANCE. DVT was confirmed by CUS in 210 (27.1% of patients with positive D-dimer with STA-Liatest). Of those, nine (4.3%) had negative D-dimer ( < 0.5 µg/mL) with at least one of the three assays yielding a failure rate of 1.2% (95% CI 0.3–3.2) with STA-Liatest, 2.2% (95 % CI 0.9–4.3) with Tina-quant, and 2.1% (95% CI 0.8–4.6) with INNOVANCE. The sensitivity and negative predictive value (NPV) for Tina-quant were 96.2% and 97.8%, for INNOVANCE 97.1% and 97.9%, and for STA-Liatest 98.1% and 98.8% respectively. The efficiency to exclude DVT based on D-dimer as a stand-alone test was 33.5% for Tina-quant, 29.4% for STA-Liatest, and 26.1% for INNOVANCE (Table 1).

    Conclusion(s): The three D-dimer assays Tina-quant, INNOVANCE, and STA-Liatest showed good performances with sensitivity > 96% and NPV > 97%. The efficiency to exclude DVT varied and was highest for Tina-quant, whereas the failure rate was lowest for STA-Liatest.