delivering a diagnosis in only 2 hours · vidas® high sensitive troponin l delivering a diagnosis...
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VIDAS®
High sensitive Troponin l Delivering a diagnosis in only 2 hours
bioMérieux S.A. • 69280 Marcy l’Etoile • France • Tel.: + 33 (0)4 78 87 20 00 • Fax: +33 (0)4 78 87 20 90www.biomerieux.com • www.biomerieux-diagnostics.com
Did you know?Worldwide 16 million people die annually of cardiovascular diseases, speci� cally heart attacks or stroke (1)
Chest pain is among the top 10 reasons to visit an emergency department (ED), accounting for about 5% of all ED visits (2)
Expected prevalence of acute myocardial infarction (MI) in chest pain patients in the ED (3)
5-10%STEMI
15-20% NSTEMI
VIDAS®
High sensitiveTroponin I Deliver high performance
∆: Di� erence in cTn concentration NPV: Negative Predictive Value PPV: Predictive Positive Value
Accelerate patient triage withhigh diagnostic accuracy in only 2 hours
INTENDED USE:● Aid in the diagnosis of myocardial infarction. ● Aid in the risk strati� cation of patients with
symptoms suggestive of ACS with respect to relative risk of all-cause mortality and major adverse cardiac events (MACE) consisting of MI and revascularization, at 30 days.
● Algorithm based on admission values and absolute changes within the � rst 2 hours.● Delivers a diagnosis - safe rule-out and accurate rule-in - of acute MI (NSTEMI) in the vast
majority (70%) of suspected chest pain patients.● Shortens the time needed to triage chest pain patients in the ED (will obviate the need for
prolonged monitoring with frequent serial blood sampling).
The 99th percentile
has been de� nedat 19 ng/L
19ng/L
At the 99th
percentile
%CV 7Optimize the management of ACS
with high sensitivity troponins (4)
● New generation of highly sensitive troponin (cTn) assays allows earlier detection of acute MI, with shortening of time window for serial measurement to 3 hours.
● cTn has become a continuous variable with accurate measurement below the 99th percentile as well as small absolute changes within one or two hours. This has enabled development of algorithms for reliable rule-out and rule-in of acute MI within 2 hours.
ST – segment elevation myocardial infarctionNon – ST – segment elevation myocardial infarctionAcute Coronary Syndrome
DIAGNOSIS ● Mandatory tool, in addition to clinical
assessment and ECG, to make a de� nitive diagnosis of acute MI.
● Serial measurement to di� erentiate acute from chronic cardiac myocyte damage.
RISK STRATIFICATION ● Additional tool in risk strati� cation
to guide therapeutic decision making.
AT PRESENTATION T0 Measurement of VIDAS HsTnI
RULE-OUT
RULE-OUT(54.6%)
Sensitivity 97.7% NPV 99.4%
OBSERVATIONAL ZONE
OBSERVATIONAL ZONE(29.6%)
AMI prevalence8.6%
RULE-IN
RULE-IN(15.8%)
Speci� city 95.2%PPV 74.5%
< 2 ng/L
< 6 ng/L
≥ 2 ng/L
Others ≥ 10 ng/L
< 100 ng/L ≥ 100 ng/L
T0 AND T2h ∆ T2h - T0
PATIENTS WITH SUSPECTED NSTEMI(5)
AT 2 HOURS T2h Re-test VIDAS HsTnI
Level of cTn
Onset ofmyocardial infarction
Normal levels NecrosisTime
High-sensitivity cTn assays
Conventional generationsof cTnassays
Conventional cut-o� (10% CV)
99th percentile
Ischemia orMicro-
necrosis T = 6 hT = 0 h
VIDAS®
High sensitive Troponin l Delivering a diagnosis in only 2 hours
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AVAILABLE ON VIDAS®
INSTRUMENTS:VIDAS®, MINI VIDAS® AND VIDAS® 3
Reference number 415386
Tests / kit 60
Time to result 20 min
Sample type Serum, Plasma (Li Hep)
Sample volume 200 µL
Units ng/L
Reportable measuring range 1.5 – 40 000 ng/L
Limit of quantifi cation (LoQ)Limit of detection (LoD)Limit of blank (LoB)
2.9-4.9 ng/L1.3-3.2 ng/L0.0-1.9 ng/L
Precision (99th percentile for the global healthy population) 19 ng/L ; CV = 7.0%
Calibrators & Controls frequency 28 days
VIDAS® High sensitive Troponin I
VIDAS® off ers your lab simplicity and productivity. It will enhance your workfl ow, allowing you to handle batch series while maintaining specifi c management of emergency tests.
REFERENCES1. Lozano R, et al. Lancet.2012;380:2095-128.2. Bandstein N, et al. J Am Coll Cardiol. 2014;63:2569-78.3. Mueller C, et al. Eur Heart J. 2015 Aug 29. pii: ehv409. 4. Roffi M, et al. Eur Heart J. 2015 Aug 29. pii: ehv320.5. Lindahl B, et al. Heart. 2017;103:125-131
CARDIAC PANELl High sensitive Troponin Il NT-proBNP2l Galectin-3l CK-MBl Myoglobinl Digoxin
bioMérieux S.A. • 69280 Marcy l’Etoile • France • Tel.: + 33 (0)4 78 87 20 00 • Fax: +33 (0)4 78 87 20 90www.biomerieux.com • www.biomerieux-diagnostics.com
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