VIDAS^® D-Dimer Exclusion™ II

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 Exclusion^TM 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 therapy^5,6.

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

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.