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
  • Only assay validated for use in the HERDOO2  clinical decision rule to help guide duration of anticoagulant therapy in women with unprovoked VTE
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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. The use of an age-adjusted cut-off for patients with suspected PE improves assay specificity for PE exclusion in elderly patients7.

VIDAS® D-Dimer ExclusionTM II is the only test validated for use in the HERDOO2 clinical decision rule, allowing clinicians to safely discontinue anticoagulants in more than half of women with unprovoked VTE. These patients can be spared the burden of extended exposure to blood thinners6.

Testing strategy for VTE exclusion

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.

Diagnostic algorithm for suspected DVT or PE in outpatients

 

For patients with suspected PE, the use of an age-adjusted cut-off compared to a single clinical cut-off allows safe exclusion of the disease in a much larger proportion of suspected outpatients, particularly in the elderly, and enables to reduce the number of imaging tests required7

Optimal D-dimer cut-off for PE exclusion by age

 

 

Guiding the duration of therapy

The VIDAS® D-Dimer Exclusion™ II assay is part of the HERDOO2 clinical decision rule. This new rule helps clinicians to confidently identify about 1 in 4 unprovoked VTE patients who are at sufficiently low risk of a recurrent VTE event that they may discontinue oral anticoagulants after short-term therapy5,6.

The HERDOO2 decision rule integrates D-dimer measurement with clinical and demographic predictors. The annual VTE recurrence risk in women with 0 or 1 of the HERDOO predictors appears sufficiently low (<3%) to justify safe discontinuation of oral anticoagulation after the initial duration of 5-12 months.

Only the VIDAS® D-Dimer Exclusion™ II test was used in the derivation and validation of the HERDOO2 clinical decision rule. As D-dimer assays are not standardized, it is not possible to safely use another D-dimer test in this rule.

“Using the HERDOO2 rule, over half of women with unprovoked VTE can safely discontinue anticoagulants and be spared the burdens, costs, and risks of lifelong anticoagulation. This finding is potentially practice-changing.”
Dr Marc Rodger, Ottawa Hospital and University of Ottawa (Canada), Investigator of the REVERSE studies (REcurrent VEnous thromboembolism Risk Stratification Evaluation)

 

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

Assay sensitivity – VIDAS D-Dimer

 

2. Rapid 20 minute 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
  • Used in major outcome studies REVERSE I5, REVERSE II6 & ADJUST-PE7.

VIDAS® Emergency range

VIDAS® D-Dimer Exclusion™ II is a key component of theVIDAS® Emergency range, which also includes markers of cardiac injury, 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
  6. Rodger MA, et al. BMJ. 2017 Mar 17;356:j1065.
  7. Righini M, et al. JAMA. 2014;311:1117-24.

 

Technical specifications for VIDAS® D-Dimer Exclusion II
Reference 30455-02
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.
Indicated for use in the HERDOO2 clinical decision rule to assess the risk of recurrence of venous thromboembolism (VTE) in women with a first unprovoked VTE.
Clinical performance Sensitivity: 99% (95.1-100) / NPV: 99% (95.8-100)
Time to result 20 minutes
Results Quantitative
To exclude VTE in combination with clinical pretest probability assessment:
For DVT:
cut-off = 500 ng/mL (FEU*)
For PE:
< 50 years: cut-off = 500 ng/mL
≥ 50 years: cut-off = age x 10 ng/mL
To aid in evaluating the VTE recurrence rate in women with a first unprovoked VTE, in order to guide the duration of oral anticoagulant therapy (part of the HERDOO2 clinical decision rule):
cut-off = 250 ng/mL
Sample type Plasma (Cit.)
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

Education

Flyers

Webcasts

Learn more about the diagnosis and management of patients with VTE:

  • Diagnostic Management of Patients with Acute Deep Vein Thrombosis or Pulmonary Embolism | Presented by Prof. Menno Huisman from the Department of Thrombosis and Hemostasis at Leiden University Medical Center (Netherlands)
  • D-Dimer as an Aid to Guide the Duration of Oral Anticoagulant Therapy in Unprovoked VTE | Series presented by Dr Marc Rodger, Chief/Chair, Hematology and Senior Scientist at the Ottawa Hospital Research Institute (Canada), including 3 episodes:
    • An unmet clinical need
    • The “Men Continue and HERDOO2 Clinical Decision Rule”
    • Validation of the “Men Continue and HERDOO2 Clinical Decision Rule”

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Useful Links

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

Please consult your local bioMérieux representative for product availability in your country

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