INNOVANCE D-Dimer AssayInnovation in D-dimer testing that goes beyond the expected

 

The INNOVANCE® D-Dimer Assay is a particle-enhanced immunoturbidimetric assay for the quantitative determination of cross-linked fibrin degradation products (D-dimers). The INNOVANCE D-Dimer Assay is indicated for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE. The INNOVANCE D-Dimer Assay can be used for the monitoring of the relative change in D-dimer concentration.1

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Features & Benefits


Stable reagents
  • Stable reagents (4 weeks at 2–8°C) allow economical operation.
  • Assay robustness combined with clinical efficiency eliminates the need for a dedicated D-dimer testing system.

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.

Validated diagnostic
  • Validated diagnostic sensitivity of ≥98% allows exclusion of DVT and PE.
  • Excellent clinical performance permits a broader spectrum of clinical diagnosis, monitoring, and follow-up.

Technical Specifications

8–15 µL
Required sample volume, depending on system application

1.41% - 5.3%
Within-device/lab CV (%) of INNOVANCE D-Dimer Control 1 on Sysmex CS-5100, CS-2500, and CA-660 Systems

150/300 tests per kit2
Number of tests per kit for small/large kit configuration

4 weeks
Stability after reconstitution at 2–8°C

0.19–35.2 mg/L FEU
Measuring range on Sysmex CS-5100, CS-2500, CA-660 Systems

 

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