Cechy i korzyści
Excellent clinical performance
- NEW! For use in DIC assessment. Cutoffs:1,2 Increased (2 points): 4.0 mg/L FEU, strongly increased (3 points): 13.0 mg/L FEU.
- Validated negative predictive value of ≥99.5% allows exclusion of DVT and PE, using a cut-off of 0.5 mg/L FEU across Siemens Healthineers and Sysmex systems.3,4
- Proven performance evaluated and verified across 24 sites and > 3300 samples (number of outpatients suspected of PE:1834 and DVT:1539), and under a set of inclusion/exclusion criteria reflecting real-life conditions.
- Excellent clinical performance permits a broader spectrum of clinical diagnosis, monitoring, and follow-up.
Fast turnaround time
- Fast turnaround time (11 minutes or less) improves daily throughput to enhance efficiency.
- Efficient, fully automated processing for reduced manual preparation and sample dilution.
- Calibration curve stability of up to 12 months.
- Assay robustness combined with clinical efficiency eliminates the need for a dedicated D-dimer testing system.
0.19-35.20 mg/L FEU
Total measuring range on Atellica® COAG 3601
or Sysmex® CS, CN1, and CA Systems
160/310 tests per kit5
INNOVANCE D-Dimer assay kit components
The assay consists of several components and can be ordered as a test kit.
INNOVANCE D-Dimer Buffer
Description: Buffered solution with stabilizers (ready-to-use liquid)
Available on Siemens Healthineers and Sysmex Systems
INNOVANCE D-Dimer assay applications are available on Atellica COAG 3601 and BCS XP Systems from Siemens Healthineers and Sysmex CN-3000/60001, CS-2500/5100, and CA-660 Systems. For details on available assay applications or order information, download a copy of the hemostasis reagent portfolio catalog.
D-dimer testing—a cornerstone in your coagulation lab
D-dimer testing is a cornerstone of the coagulation lab. Besides its most important clinical use — the exclusion of venous thromboembolism (VTE) — and all the factors influencing specificity and sensitivity of D-dimer assays, elevated D-dimer levels play a pivotal role in many other diseases and conditions, such as severe infections (e.g., COVID-19), and in a wide variety of pro-thrombotic diseases. The INNOVANCE D-Dimer assay can be applied in different clinical settings, such as, but not limited to:
Exclusion of deep vein thrombosis (DVT) and pulmonary embolism (PE)
D-dimer testing has become a powerful tool in clinical practice for use in outpatients with suspected deep vein thrombosis (DVT) or pulmonary embolism (PE), in conjunction with clinical prediction rules (CPR) or clinical decision rules (CDR), e.g., the Wells score or YEARS algorithm.6,7,8,9
Diagnosis or monitoring of DIC
DIC describes a condition in which blood clots form throughout the body. Well-established scoring systems include the determination of D-dimer level, platelet count, fibrinogen level, and prothrombin time (PT) and are useful for the diagnosis of DIC and monitoring its progression.1,2,10