D-Dimer Exclusion™II - Please visit us at www.biomerieux

E M E R G E N C Y
D-Dimer Exclusion™ II
THE GOLD STANDARD
JUST GOT FASTER
© 2013 BIOMÉRIEUX, INC. • BIOMÉRIEUX, THE BLUE LOGO, VIDAS AND D-DIMER EXCLUSION ARE USED AND/OR REGISTERED AND PROTECTED TRADEMARKS BELONGING TO BIOMÉRIEUX SA OR ONE OF ITS SUBSIDIARIES • PRINTED IN U.S.A. • VID-038-13
Are you using the right D-Dimer test to
SAFELY EXCLUDE outpatients with suspected VTE*?
Due to the relatively low disease prevalence in outpatients (20% or less),
D-Dimer testing plays a major role in rapid triage resulting in safe exclusion of up to
50% of patients with suspected VTE presenting to the emergency department. 1,2
Accurate, early diagnosis of VTE (DVT/PE*) is critical to prevent complications and risk of death.
2 ESSENTIAL STEPS FOR COST-EFFICIENT AND SAFE EXCLUSION OF VTE
1,2
n STEP 1: CLINICAL ASSESSMENT: use of validated pre-test probability (PTP) scores - e.g. the Revised Geneva score (PE) or
the Wells scores (DVT/PE) - to classify patients as having low, intermediate or high risk for VTE. 3,4,5
n S TEP 2: D-DIMER TESTING: use of a high-sensitivity assay to enable safe exclusion of VTE in Low & Intermediate patient
risk groups, thereby avoiding an unacceptable rate of missed diagnoses. 6
CLSI H59-A RECOMMENDATIONS
FOR EXCLUSION OF VTE
Sensitivity
and
95% lower limit of
one-sided CI
Negative predictive
value (NPV)
and
95% lower limit of
one-sided CI
> 97%
> 90%
VIDAS® D-DIMER
EXCLUSION™ II
ASSAY SENSITIVITY AND MISSED DIAGNOSES
PER 100 D-DIMER SCREENS
100%
> 94.2%
(Low & intermediate PTP)
> 98%
> 95%
100%
> 95.8%
(Low & intermediate PTP)
Low risk
Imprecision (CV)
CV < 7.5%
CV < 6%
PATIENTS
Intermediate risk
without VTE
MISSED DIAGNOSES
High risk
with VTE
Assay A (Se 99%)
Assay B (Se 95%)
Assay C (Se 88%)
D-dimer is not recommended for exclusion in High PTP group
VIDAS® D-Dimer Exclusion™ II, with sensitivity >99% [95.1-100%] 8, combined with PTP,
safely excludes DVT/PE in both Low & Intermediate PTP groups
Get the ORIGINAL quality you trust…
• 7 prospective outcome studies (>8,000 patients
enrolled) with 3-month follow-up in 2,166 patients
with low/intermediate PTP and normal D-dimer:
failure rate 0.14% (NPV 99.9%) 9
… with faster time-to-result (20 min.)
TECHNICAL SPECIFICATIONS 8
Reference / Code
30455-01 / DEXII
Tests/kit
60 tests
Time to result
20 minutes
Results
Quantitative; Cut-off = 500 ng/mL (FEU) **
Sample type / volume
Plasma (citrate) / 200 µl
Calibration
1 level (included) every 28 days
Measuring range / linearity
45 – 10,000 ng/mL (FEU)
Standardized against
VIDAS D-Dimer Exclusion 8
bioMérieux, Inc.
100 Rodolphe Street
Durham, NC 27712
U.S.A.
Tel: (800) 682 2666
Fax: (800) 968 9494
et al. Ann Intern Med. 2006;144:165-71. n 6. Wayne PA. CLSI document H59-A. Clinical and Laboratory Standards Institute,
www.biomerieux-usa.com
n
* VTE = Venous Thromboembolism ; DVT = Deep Vein Thrombosis ; PE = Pulmonary Embolism ; ** CLSI alignment6
n
1. Righini M, et al. J Thromb Haemost. 2007;5:1869-7. n 2. Ten Cate-Hoek AJ, et al. J Thromb Haemost. 2005;3:2465-70.
n
3. Wells PS, et al. N Engl J Med. 2003;349:1227-35. n 4. Wells PS, et al. Thromb Haemost. 2000;83:416-20. n 5. Le Gal G,
PA, USA, 2011. n 7. Ceriani E, et al. J Thromb Haemost. 2010;8:957-70 n 8. VIDAS D-Dimer Exclusion II package insert.
9. Carrier M, et al. Thromb Haemost. 2009;101:886-92.