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![Page 1: CUS - bioMérieux€¦ · CUS, Helical CT Continue Testing. Just One Test. A Clear Answer. The Right Choice. This single, rapid ELISA offers a range of benefits for the Emergency](https://reader033.vdocuments.us/reader033/viewer/2022060220/5f06fe397e708231d41ac2c9/html5/thumbnails/1.jpg)
Does it Take toHow Many Tests
Exclude PE and DVTConfidence?with
V/Q Scan,
D-dimer,
Venography,
Helical CT,
CUS...
PulmonaryAngiography,
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With a single test, it’s now possible to confidently rule out a
diagnosis of Pulmonary Embolism (PE) or Deep Vein Thrombosis
(DVT) in low- and moderate-risk patients who visit your
Emergency Department.1
And you can do it both quickly and easily because
VIDAS® D-Dimer Exclusion™ is a rapid, automated
enzyme-linked immunosorbent assay (ELISA) that
provides results in less than an hour.1
So instead of dealing with additional time-consuming and
inconvenient tests that delay decision making, you can streamline
your diagnostic algorithm and get to the point of exclusion
quicker. With all of the confidence you need to make the
appropriate diagnostic decision.
VIDAS® D-Dimer Exclusion™
Just One.
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Not All D-dimer Assays are Created Equal.
D-dimer assays vary widely in both sensitivity and negative predictive
value (NPV). Simply put, a D-dimer assay with the highest sensitivity
and NPV will provide the most accurate results.
The ELISA D-dimer assay is considered to be the gold standard and
has the most published studies supporting it. Other D-dimer assays
have reported sensitivities as low as 79%7, with NPVs as low as
83%8. These numbers are critical, because for each 1% increase in
NPV, the risk of undiagnosed PE or DVT decreases.
It’s a DecisionYou Can Trust.The weight of the evidence clearly shows that youcan be confident in your decision when usingVIDAS® D-Dimer Exclusion™ to rule out a diagnosis ofPE or DVT in low- and moderate-risk outpatients.
Management studies show that as many as 75% of
outpatients who present to Emergency Departments with
suspected PE and DVT are negative for these conditions.2,3
For approximately 30%2,4 to 50%5,6 of this group, a
pre-test probability (PTP) assessment of low or moderate
risk and a negative result from the VIDAS D-Dimer Exclusion
assay is all you need to quickly exclude further diagnostic
procedures.1,4
Quickly and Confidently Rule OutMore than 1/3 of Presenting Patients.
VIDAS D-Dimer Exclusion enables you to exclude low- and
moderate-risk outpatients quickly, easily and with confidence,
using a simple decision process.
A New Diagnostic Algorithm.
Studies show that ED patients with a normal
(<500 ng/ml) VIDAS D-Dimer Exclusion
result and a low or moderate PTP
score can be excluded from
further testing.1,2,4
50 Studies & Over 11,000 Patients:What Does It AllAdd Up To?
VIDAS®
D-DimerExclusion™
The Gold StandardRapid ELISA.
LowScore
on Clinical Pre-testProbabilityAssessment
MediumScore
on Clinical Pre-testProbabilityAssessment
- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -
>99%Negative Test Result
at a cut-off of 500 ng/ml1. Proven in morethan 50 published peer-reviewed studies
with greater than 11,000 patients,including five prospective
management trials.
Negative Predictive Value (NPV)
- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - -
Case Closed.Disposition the Patient.
when used in conjunction with a pre-testprobability model at a cut-off
of 500 ng/ml1.
FDACLEARED
for Exclusion of PE and DVT
as
NPVRISK
+ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + +
PositiveTest Result
VIDAS D-Dimer Exclusionequal to or above
500 ng/ml.
+ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + + + + + + + ++ + + + + + + + + + + + + + + + + + + + + + + +
Pulmonary Angiography,V/Q Scan, Venography,
CUS, Helical CT
ContinueTesting
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Just One Test.A Clear Answer.The Right Choice.
This single, rapid ELISA offers a range of benefits for the Emergency Department as well asother hospital ancillary departments.
• Save time, with stat results in under an hour, 24/7
• Close patient cases and free up beds quicker
• Save resources by eliminating unnecessary diagnostic and radiologic testing
• Reduce risk by using the most clinically proven D-dimer assay
• Improve overall efficiency in the ED
“Automated ELISA D-dimer exclusion testing is quickly becoming a widely accepted
method for ruling out VTE in the ED. A negative D-dimer test result can prevent patients
from undergoing invasive and painful testing procedures and reduce the need for costly
confirmatory tests in a significant number of patients.”
Dr. Douglas M. Hill, Co-Director Emergency DepartmentNorth Suburban Medical Center, Thornton, CO
Performfewer invasive
diagnosticprocedureson patients
Providequicker dispositionfor patients who
don’t havePE or DVT
Discover the confidence toexclude with a single test –VIDAS D-Dimer Exclusion.
And send patients home sooner. www.biomerieux-usa.com/ddimer
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1. VIDAS D-Dimer Exclusion Package Insert, No. rev. 2004/06/08.
2. Perrier A, et al. Non-invasive diagnosis of venous thromboembolism in outpatients. Lancet.1999; 353: 190-195.
3. Hirsch J, Lee A. Blood. 2002; 99: 3102-3110.
4. Perrier A, et al. Diagnosing Pulmonary Embolism in Outpatients with Clinical Assessment, D-Dimer Measurement,
Venous Ultrasound, and Helical Computed Tomography: A multicenter Management Study, American Journal of
Medicine. 2004; 116: 291-299.
5. Beltran S, et al. Economic Study, Piedmont Hospital, Atlanta, 2001.
6. Kruip M. Use of a Clinical Decision Rule in Combination with D-Dimer Concentration in Diagnostic Workup of Patients
with Suspected PE, Archives of Internal Medicine, 2002; 162: 1631-354.
7. Stein P, et al. D-Dimer for the Exclusion of Acute Venous Thrombosis and Pulmonary Embolism, A Systematic Review,
Annals of Internal Medicine, 2004; 140: 589-602.
8. Bounameaux H, et al. D-dimer testing in suspected venous thromboembolism: an update. QJM 1997; 90: 437-442.
Ask For It By Name.
The proven standard of care to safely exclude PE and DVTin low– and moderate–risk patients
bioMérieux, Inc.100 Rodolphe StreetDurham, NC 27712U.S.A.Tel: (800) 682-2666Fax: (800) 968-9494
bioMérieux Canada, Inc.7815 Henri-Bourassa Boulevard WestSt. Laurent (Québec)Canada H4S 1P7Tel: (514) 336-7321Fax: (514) 807-00151-800-361-7321 ext. 221
www.biomerieux-usa.com
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