E M E R G E N C Y D I A G N O S T I C S S O L U T I O N

Get rapid results.Make reliable decisions.

PROCALCITONIND-DIMER TROPONIN NT-proBNP

PROCALCITONIND-DIMER TROPONIN NT-proBNP

from diagnosis, the seeds of better health

VIDAS® Emergency Diagnostics Solution

A Unique Panel

a Rapid and Flexible System+

Contribution of a Rapid Diagnostic Test Panel to Effective Triageof Emergency Department Patients presenting with Common Symptoms Contribution of a Rapid Diagnostic Test Panel to Effective Triage of Emergency Department Patients presenting with Common Symptoms

*Four of the most frequent symptoms in patients presenting to Hospital ED McCaig LF, Nawar EN. National Hospital Ambulatory Medical Care Survey: 2004 emergency department summary. Advance data from vital and health statistics; no 372. Hyattsville, MD: National Center for Health Statistics. 2006. HF: Heart Failure - ACS: Acute Coronary Syndromes - PE: Pulmonary Embolism

**For first day of admission to the ICU as aid to assess risk for progression of sepsis.

Infectious Non-Infectious HF

VIDASNT-proBNP

VIDAS®

B•R•A•H•M•S PCT**VIDASD-Dimer Exclusion™

VIDASTroponin I Ultra

VIDAS CK-MB

ACS

RESPIRATORY CARDIAC

NT-proBNP

Procalcitonin D-Dimer

Bacterial Viral Others

Troponin I

PE exclusion

CK-MB

Chest Pain - Shortness of Breath - Fever - Cough*

VIDAS® Emergency Diagnostics Panel

VIDAS® B R A H M S PCT®

VIDAS® D-DIMER EXCLUSION™

VIDAS® TROPONIN I ULTRA

VIDAS® NT-proBNP

When you need to be sure:

Suspicion of Heart Failure in Primary Care Patients3,4,5

1 Siebert U. et al. Am J Cardiol. 2006; 98:800-805 - 2 Januzzi J.L. et al. Am J Cardiol. 2008; 101 (Suppt.): 29A-38A - 3 Gustafsson F. et al. Heart Drug. 2003; 3: 141-1464 Hildebrandt P., Collinson P.O. Am J Cardiol. 2008; 101 (Suppl.): 25A-28A. - 5 Results are obtained in compliance with current VIDAS® NT-proBNP package insert (ref. 30449). ED: Emergency Department - NPV: Negative Predictive Value

Early diagnosis of heart failure (HF)

High clinical sensitivity and specificity to aid in the diagnosis of congestive heart failureCost-effective tool for ED patient management1

High specimen stability for reliable results

Early diagnosis of myocardial infarction (MI)

VIDAS® NT-proBNP

Acute dyspnea in ED patients2

Patient age < 75 years ≥ 75 years

NT-proBNP < 125 pg/mL ≥ 125 pg/mL < 450 pg/mL ≥ 450 pg/mLblood level

HF very unlikely HF likely HF very unlikely HF likely

Patient age < 50 years 50-75 years > 75 years

NT-proBNP < 300 pg/mL blood level Acute HF very unlikely (NPV = 98%)

> 450 pg/mL > 900 pg/mL > 1800 pg/mL Acute HF likely Acute HF likely Acute HF likely

High clinical sensitivity at the 99th percentile (< 0.01 µg/l) for early detection of MIPredicts increased risk for adverse cardiac events (MI or death) in patients with symptoms suggestive of ACS1

Compliant with International Guidelines

% Sensitivity 10% CV point: 76.3% 69.44% 0.11 µg/L

99th Percentile: 98.2% 97.22% 0.01 µg/L

% Specificity 10% CV point: 94.4% 96.24% 0.11 µg/L

99th Percentile: 95.3% 96.21% 0.01 µg/L

99th Percentile value3 0.01 µg/L

0.11 µg/L10% CV Cut-off value

Low-risk population (74%)for cardiac events Rate 5% (60 days)

High-risk population (26%)for cardiac events

Rate 40% (60 days)

0-6 hoursafter

admission

4-12 hoursafter first

blood draw

VIDAS® Troponin I Ultra

Orientation of Heart Failure Diagnosis using NT-proBNP

1 Apple F.S. et al. Clin Chim Acta. 2008; 390: 72-75 - 2 Data from VIDAS® Troponin I Ultra package insert (ref. 30448) - 3 Thygesen K. et al. Eur Heart J. 2007; 28: 2525-38ACS : Acute Coronary Syndrome - CV : Coefficient of Variation - cTnI: Cardiac Troponin I

cTnI decision level for MI3: the 99th percentile value of a normal reference population with optimal assay precision (total coefficient of variation) < 10%10% CV: the lowest cTnI concentration measured with a total coefficient of variation of 10%

Increased risk for cardiac events in suspected ACS patients with cTnI > 99th percentile on admission1

Clinical Performance of VIDAS® TNIU assay for patients presenting with symptoms suggestive of ACS1,2

FDA cleared for Exclusion of PE and DVT

Negative Predictive Value (NPV)

> 99%at a cut-off of

500 ng/mL

The Gold Standard Rapid automated ELISA test for exclusion of PE & DVT

VIDAS® D-Dimer Exclusion™

VIDAS® B R A H M S PCT®

Prognosis: risk assessment for progression to severe sepsis and septic shock

1 Perrier A, et al. Am J Med 2004; 116: 291-99 - 2 Stein P.D. et al. Am J Med 2006 ; 119: 1048-1055ELISA: Enzyme-Linked ImmunoSorbent Assay - DVT: Deep Vein Thrombosis - PE: Pulmonary Embolism - CUS: Compression Ultrasound - V/Q: Ventilation-perfusion - CT: Computed Tomography

www.procalcitonin.com adapted from Christ-Crain M. et al. Swiss Med Wkly 2005; 135:451-460 PCT: ProcalcitoninThe reference ranges above are provided for orientation purposes only.

A Combination of a sensitive D-Dimer assay and a Pre-Test Probability assessment allows rapid and safe exclusion of DVT/PE1,2

Procalcitonin - fast and highly specific increase in bacterial infection and sepsis

Clinical Decision Rule pre-test probability (PTP)

Low or intermediate

D-Dimer negative

STOP examination Continue examination

D-Dimer positive

High

Confidently rule out PE and DVT in 30-50% of suspected outpatients Disposition the patient -no further testing for VTE Efficient triage of patients Improved patient comfort

Follow-up with imaging procedures (CUS, V/Q scan, spiral CT scan) Other investigations for differential diagnosis

Healthy

0.05 0.5 2 10

Localinfections

Septic shock

Severesepsis

Systemicinfections(sepsis)

Clinical condition

PCT [ng/mL]

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bioMérieux, Inc.100 Rodolphe StreetDurham, NC 27712U.S.A.Tel: (800) 682 2666Fax: (800) 968 9494

www.biomerieux-usa.com

bioMérieux Canada, Inc.7815 Henri-Bourassa Boulevard WestVille St. Laurent (Québec)Canada H4R 2L8Tel: (1) 514 336 7321Fax: (1) 514 336 6450

A Solution adapted to Emergency Situations

VIDAS® Emergency Panel

Ease -of-use: Just load and go

Reliable system: MTBF over 2 years

Cost effective: Single-dose test, run only the test you need

Random Access: Stat testing capability

Quality results: ELISA methodology

Large menu for emergency testing

• Cardiac: Troponin I Ultra, CK-MB, Myoglobin, NT-proBNP

• Thrombosis: D-Dimer Exclusion™

• Infections: Procalcitonin

Procalcitonin D-DimerExclusion™

NT-proBNP Troponin IUltra

CK-MB

Code PCT DD2 PBNP TNIU CK-MB

Reference 304450-01 30442 30449-01 30448-01 30421-01

Tests/kit 60 60 60 60 30

Sample type(cap color coding)

plasma •(heparin)serum •

plasma •(citrated)

plasma •(heparin)serum •

plasma •(heparin)serum •

plasma •(heparin)EDTA •serum •

Sample volume 200 µl 200 µl 200 µl 200 µl 250 µl

Time to result 20 min 35 min 20 min 20 min 35 min

VIDAS protocol compatibility: Procalcitonin, NT-proBNP, Troponin I Ultra Test limitations must be taken into consideration in the clinical decision-making process.