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- VIDAS® D-Dimer Exclusion II
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
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.
According to international guidelines*, there are two essential steps for cost-efficient and safe exclusion of VTE:
- Clinical Assessment: use of validated pre-test probability (PTP) scores to classify patients into low, intermediate or high risk for VTE
- Use of a high-sensitivity D-Dimer assay to enable safe exclusion of VTE in patients in low and intermediate risk groups.
Contemporary algorithm for safe DVT and PE exclusion
Adapted from Bounameaux H and Perrier A. Hematol J 2003; 4: 97-103.
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 theVIDAS® 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
- Huisman MV, Klok FA. J Thromb Haemost. 2013;11:412-22
- Righini M, et al. J Thromb Haemost 2007;5:1869-7
- Carrier M, et al. Thromb Haemost. 2009;101:886-92
- Ceriani E, et al. J Thromb Haemost. 2010;8:957-70
- Rodger MA, et al. CMAJ. 2008; 179: 417-26
|Technical specifications for VIDAS® D-Dimer Exclusion™ II|
|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.|
Sensitivity: 99% (95.1-100) / NPV: 99% (95.8-100)
|Time to result||20 minutes|
|Results||Quantitative / Cut-off = 500 ng/mL (FEU*)|
|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.
- Huisman MV, Klok FA. Diagnostic management of acute deep vein thrombosis and pulmonary embolism. J Thromb Haemost. 2013;11:412-22.
- Ceriani E, Combescure C, Le Gal G, Nendaz M, Perneger T, Bounameaux H, Perrier A, Righini M. Clinical prediction rules for pulmonary embolism: a systematic review and metaanalysis. J Thromb Haemost. 2010;8:957-70.
- Carrier M, Righini M, Djurabi RK, Huisman MV, Perrier A, Wells PS, Rodger M, Wuillemin WA, Le Gal G. VIDAS D-dimer in combination with clinical pre-test probability to rule out pulmonary embolism. A systematic review of management outcome studies. Thromb Haemost. 2009;101:886-92.
- Rodger MA, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Solymoss S, Crowther M, Perrier A, White R, Vickars L, Ramsay T, Betancourt MT, Kovacs MJ. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008;179:417-26.
- Di Nisio M, Squizzato A, Rutjes AW, Büller HR, Zwinderman AH, Bossuyt PM. Diagnostic accuracy of D-dimer test for exclusion of venous thromboembolism: a systematic review. J Thromb Haemost. 2007;5:296-304.
- Righini M, Nendaz M, Le Gal G, Bounameaux H, Perrier A. Influence of age on the costeffectiveness of diagnostic strategies for suspected pulmonary embolism. J Thromb Haemost. 2007;5:1869-77.
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
Find out more about DVT: http://www.clotconnect.org/
Please consult your local bioMérieux representative for product availability in your country