E M E R G E N C Y

D IAG N O ST I C S

S O L U T I O N

PROCALCITONIN D-DIMER TROPONIN NT-proBNP

Get rapid results.

Make reliable decisions.

from diagnosis, the seeds of better health

A Unique Panel a Rapid and Flexible System

+

VIDAS Emergency Diagnostics Solution

Contribution of a Rapid Diagnostic Test Panel to Effective Triage of Contribution of a RapidPatients presenting with Common Symptoms Emergency Department Diagnostic Test Panel to Effective Triage of Emergency Department Patients presenting with Common Symptoms
Chest Pain - Shortness of Breath - Fever - Cough*

RESPIRATORY
Infectious
Bacterial Viral

CARDIAC
HF NT-proBNP
VIDAS NT-proBNP

Non-Infectious
PE exclusion Others

ACS Troponin I
VIDAS Troponin I Ultra

Procalcitonin
VIDAS BRAHMS PCT**

D-Dimer
VIDAS D-Dimer Exclusion

CK-MB
VIDAS CK-MB
*Four of the most frequent symptoms in patients presenting to Hospital ED
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.

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.

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:

VIDAS Emergency Diagnostics Panel

VIDAS

NT-proBNP
failure (HF)

Early diagnosis of heart

High clinical sensitivity and specificity to aid in the diagnosis of congestive heart failure Cost-effective tool for ED patient management1 High specimen stability for reliable results

Orientation of Heart Failure Diagnosis using NT-proBNP

Acute dyspnea in ED patients2
Patient age NT-proBNP blood level > 450 pg/mL Acute HF likely < 50 years 50-75 years < 300 pg/mL Acute HF very unlikely (NPV = 98%) > 900 pg/mL Acute HF likely > 1800 pg/mL Acute HF likely > 75 years

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

Patient age NT-proBNP blood level < 75 years < 125 pg/mL HF very unlikely

75 years
125 pg/mL
HF likely < 450 pg/mL HF very unlikely

450 pg/mL
HF likely

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: 141-146 4 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

VIDAS

Troponin I Ultra
infarction (MI)
Increased risk for cardiac events in suspected ACS patients with cTnI > 99th percentile on admission1
99th Percentile value3 0.01 g/L

Early diagnosis of myocardial

High clinical sensitivity at the 99th percentile (< 0.01 g/l) for early detection of MI Predicts increased risk for adverse cardiac events (MI or death) in patients with symptoms suggestive of ACS1 Compliant with International Guidelines
Clinical Performance of VIDAS TNIU assay for patients presenting with symptoms suggestive of ACS1,2
0-6 hours after admission % Sensitivity 10% CV point: 0.11 g/L 99th Percentile: 0.01 g/L % Specificity 10% CV point: 0.11 g/L 99th Percentile: 0.01 g/L 76.3% 98.2% 94.4% 95.3% 4-12 hours after first blood draw 69.44% 97.22% 96.24% 96.21% 0.11 g/L 10% CV Cut-off value
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%

Low-risk population (74%)

for cardiac events Rate 5% (60 days)

High-risk population (26%)

for cardiac events Rate 40% (60 days)

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: 2525-38 ACS : Acute Coronary Syndrome - CV : Coefficient of Variation - cTnI: Cardiac Troponin I

VIDAS

B R A H M S PCT
Procalcitonin - fast and highly specific increase in bacterial infection and sepsis

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

PCT [ng/mL] Clinical condition

0.05 Healthy

0.5 Local infections

2 Systemic infections (sepsis) Severe sepsis

10 Septic shock

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

VIDAS

D-Dimer Exclusion
PE & DVT

The Gold Standard

Rapid automated ELISA test for exclusion of

A Combination of a sensitive D-Dimer assay and a Pre-Test Probability assessment allows rapid and safe exclusion of DVT/PE1,2
Clinical Decision Rule pre-test probability (PTP) Low or intermediate High

FDA cleared
for Exclusion of PE and DVT

D-Dimer negative STOP examination

D-Dimer positive Continue examination

Negative Predictive Value (NPV)

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

> 99% 500 ng/mL

at a cut-off of

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

VIDAS Emergency Panel

Procalcitonin
Code
2008 BIOMRIEUX, INC. BIOMRIEUX, THE BLUE LOGO, VIDAS AND EXCLUSION ARE USED AND/OR REGISTERED AND PROTECTED TRADEMARKS BELONGING TO BIOMRIEUX SA OR ONE OF ITS SUBSIDIARIES PRINTED IN U.S.A. VID-045-08

D-Dimer Exclusion
DD2 30442 60 plasma (citrated)

NT-proBNP
PBNP 30449-01 60 plasma (heparin) serum 200 l 20 min

Troponin I Ultra
TNIU 30448-01 60 plasma (heparin) serum 200 l 20 min

CK-MB
CK-MB 30421-01 30 plasma (heparin) EDTA serum 250 l 35 min

PCT 304450-01 60 plasma (heparin) serum 200 l 20 min

Reference Tests/kit Sample type (cap color coding)

Sample volume Time to result

200 l 35 min

VIDAS protocol compatibility: Procalcitonin, NT-proBNP, Troponin I Ultra

Test limitations must be taken into consideration in the clinical decision-making process.

A Solution adapted to Emergency Situations

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
bioMrieux, Inc. 100 Rodolphe Street Durham, NC 27712 U.S.A. Tel: (800) 682 2666 Fax: (800) 968 9494 bioMrieux Canada, Inc. 7815 Henri-Bourassa Boulevard West Ville St. Laurent (Qubec) Canada H4R 2L8 Tel: (1) 514 336 7321 Fax: (1) 514 336 6450

Large menu for emergency testing Cardiac: Troponin I Ultra, CK-MB, Myoglobin, NT-proBNP Thrombosis: D-Dimer Exclusion Infections: Procalcitonin

www.biomerieux-usa.com