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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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