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VIDAS® D-Dimer Exclusion™ II

Safe exclusion of Venous Thromboembolism

VIDAS® D-Dimer Exclusion™ II is a highly-sensitive automated D-Dimer assay. In conjunction with assessment of clinical pretest probability, it allows safe exclusion of deep vein thrombosis (DVT) and pulmonary embolism (PE) in both low and intermediate suspected outpatient risk groups in just 20 minutes.

  • Over 99% sensitivity and negative predictive value (NPV)
  • First automated assay to obtain FDA clearance for safe VTE exclusion
  • Most tested and referenced D-Dimer assay available
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VIDAS® D-Dimer Exclusion™ II is an automated test for the immunoenzymatic determination of fibrin degradation products in human plasma. Combined with pretest probability (PTP) scores, it can safely be used to exclude both PE and DVT in suspected patients attending the emergency department (ED) with common symptoms such as chest pain and dyspnea1. Due to its high sensitivity and negative predictive value, VIDAS® D-Dimer Exclusion™ II enables safe exclusion of up to 50% of outpatients, leading to a significant reduction in the global cost of diagnosis2.

Testing strategy

According to international guidelines*, there are two essential steps for cost-efficient and safe exclusion of VTE:

  1. Clinical Assessment: use of validated pre-test probability (PTP) scores to classify patients into low, intermediate or high risk for VTE
  2. Use of a high-sensitivity D-Dimer assay to enable safe exclusion of VTE in patients in low and intermediate risk groups.

 

Click to enlarge 

Contemporary algorithm for safe DVT and PE exclusion 
Adapted from Bounameaux H and Perrier A. Hematol J 2003; 4: 97-103.

 

Test benefits

1. Compliant with CLSI guidelines*:

  • High sensitivity and NPV**, enabling safe VTE exclusion of both low and intermediate risk patients corresponding to approximately 50% of outpatient population presenting with symptoms
  • Results: reduced imaging, cost savings and rapid turn-around of emergency patients

 

2. Rapid 20 minutes test result fitting into emergency time requirements and rapid patient triage

3. Streamlined laboratory workflow and cost control

  • Calibration only once a month
  • No test warm-up period
  • Easy-to-perform reconstitution of the calibrators and controls using distilled water

Extensive clinical validation

  • Included in 7 prospective outcome studies / over 8,000 patients enrolled (suspected PE)3
  • 3-month follow-up in 2,166 patients with low/intermediate PTP and normal D-dimer3
  • Failure rate: 0.14% (NPV 99.9%)3
  • Currently used in several major outcome studies (REVERSE5 & ADJUST)

VIDAS® Emergency range

VIDAS® D-DIMER Exclusion™ II is a key component of the VIDAS Emergency range, which also includes markers of cardiac necrosis, heart failure and severe bacterial infections.

The VIDAS solution allowing 24/7 on-demand testing is particularly adapted to emergency conditions and rapid patient triage.

* See RESOURCES

** See package insert for performance details

References:

  1. Huisman MV, Klok FA. J Thromb Haemost. 2013;11:412-22
  2. Righini M, et al. J Thromb Haemost 2007;5:1869-7
  3. Carrier M, et al. Thromb Haemost. 2009;101:886-92
  4. Ceriani E, et al. J Thromb Haemost. 2010;8:957-70
  5. Rodger MA, et al. CMAJ. 2008; 179: 417-26

 

Technical specifications for VIDAS® D-Dimer Exclusion™ II
Reference 30455
Tests / kit 60
Intended Use Indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE.
Clinical performance

Sensitivity: 99% (95.1-100) / NPV: 99% (95.8-100)
Time to result 20 minutes
Results Quantitative / Cut-off = 500 ng/mL (FEU*)
Sample type Plasma
Sample volume 200µl
Calibration 1 level (included) every 28 days

* FEU = Fibrinogen equivalent unit (500 ng FEU/mL = 250 ng D-dimer/mL)

 

Find more technical details on www.myvidas.com.

Consult your local bioMérieux representative for product availability in your country.

Guidelines

Clinical and Laboratory Standards Institute (CLSI). Quantitative D-dimer for the exclusion of venous thromboembolic disease; approved guideline. CLSI document H59-A. CLSI, Wayne, PA, USA, 2011.
 

Related Publications

Tools & Resources

  • Venous Thromboembolism Forum. Latest advances in the diagnosis and prognosis of venous thromboembolism. Report from the meeting of an expert group. Annecy, France, November 13, 2012.
  • D-Dimer Decisional Algorithm slide ruler
  • PTP scoring pad

These resources can be downloaded from www.myvidas.com. Register now!

Useful Links

Find out more about DVT: http://www.clotconnect.org/

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