VIDAS Emergency Diagnostics Solution (pdf) - bioMérieux

EMERGENCY DIAGNOSTICS SOLUTION
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 Emergency Department of a Rapid Patients Diagnostic presenting Test Panel with to Common Effective Symptoms Triage of
Emergency Department Patients presenting with Common Symptoms
Chest Pain - Shortness of Breath - Fever - Cough*
RESPIRATORY
CARDIAC
Infectious Non-Infectious HF
NT-proBNP
ACS
Troponin I
Bacterial Viral PE exclusion Others
Procalcitonin
VIDAS ®
B•R•A•H•M•S PCT**
D-Dimer
VIDAS
D-Dimer Exclusion
VIDAS
NT-proBNP
VIDAS
Troponin I Ultra
CK-MB
VIDAS CK-MB
**For first day of admission to the ICU as aid to assess risk for progression of sepsis.
*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

VIDAS ® BRAHMS 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
Early diagnosis of heart failure (HF)
High clinical sensitivity and specificity to aid in the diagnosis of congestive heart failure
Cost-effective tool for ED patient management 1
High specimen stability for reliable results
Orientation of Heart Failure Diagnosis using NT-proBNP
Acute dyspnea in ED patients 2
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
Suspicion of Heart Failure in Primary Care Patients 3,4,5
Patient age < 75 years ≥ 75 years
NT-proBNP < 125 pg/mL ≥ 125 pg/mL < 450 pg/mL ≥ 450 pg/mL
blood level
HF very unlikely HF likely HF very unlikely 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
Early diagnosis of myocardial infarction (MI)
High clinical sensitivity at the 99 th percentile (< 0.01 µg/l) for early detection of MI
Predicts increased risk for adverse cardiac events (MI or death) in patients with symptoms suggestive of ACS 1
Compliant with International Guidelines
Clinical Performance of VIDAS ® TNIU assay for
patients presenting with symptoms suggestive of ACS 1,2
0-6 hours
after
admission
4-12 hours
after first
blood draw
% Sensitivity 10% CV point: 76.3% 69.44%
0.11 µg/L
99 th Percentile: 98.2% 97.22%
0.01 µg/L
% Specificity 10% CV point: 94.4% 96.24%
0.11 µg/L
99 th Percentile: 95.3% 96.21%
0.01 µg/L
Increased risk for cardiac events in suspected ACS
patients with cTnI > 99 th percentile on admission 1
Low-risk population (74%)
for cardiac events
Rate 5% (60 days)
99 th Percentile value 3
0.01 µg/L
High-risk population (26%)
for cardiac events
Rate 40% (60 days)
0.11 µg/L
10% CV Cut-off value
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
cTnI decision level for MI 3 : the 99 th 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%

VIDAS ® BRAHMS PCT ®
Prognosis: risk assessment for progression to severe sepsis and septic shock
Procalcitonin - fast and highly specific increase in bacterial infection and sepsis
PCT [ng/mL]
0.05 0.5 2 10
Clinical
condition
Healthy
Local
infections
Systemic
infections
(sepsis)
Severe
sepsis
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
The Gold Standard
Rapid automated ELISA test for exclusion of PE & DVT
A Combination of a sensitive D-Dimer assay and a Pre-Test Probability
assessment allows rapid and safe exclusion of DVT/PE 1,2
Clinical Decision Rule
pre-test probability (PTP)
D-Dimer negative
Low or intermediate
High
D-Dimer positive
FDA cleared
for Exclusion
of PE and DVT
STOP examination
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
Continue examination
Follow-up with imaging
procedures (CUS, V/Q scan,
spiral CT scan)
Other investigations for
differential diagnosis
Negative Predictive
Value (NPV)
> 99%
at a cut-off of
500 ng/mL
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
D-Dimer
Exclusion
NT-proBNP
Troponin I
Ultra
CK-MB
Code PCT DD2 PBNP TNIU CK-MB
© 2008 BIOMÉRIEUX, INC. • BIOMÉRIEUX, THE BLUE LOGO, VIDAS AND EXCLUSION ARE USED AND/OR REGISTERED AND PROTECTED TRADEMARKS BELONGING TO BIOMÉRIEUX SA OR ONE OF ITS SUBSIDIARIES • PRINTED IN U.S.A. • VID-045-08
Reference 304450-01 30442 30449-01 30448-01 30421-01
Tests/kit 60 60 60 60 30
Sample type
(cap color coding)
Ease -of-use:
Just load and go
Reliable system:
MTBF over 2 years
Cost effective:
Single-dose test,
run only the test
you need
bioMérieux, Inc.
100 Rodolphe Street
Durham, NC 27712
U.S.A.
Tel: (800) 682 2666
Fax: (800) 968 9494
www.biomerieux-usa.com
A Solution adapted to Emergency Situations
Random Access:
Stat testing capability
Quality results:
ELISA methodology
plasma •
(heparin)
serum •
plasma •
(citrated)
bioMérieux Canada, Inc.
7815 Henri-Bourassa Boulevard West
Ville St. Laurent (Québec)
Canada H4R 2L8
Tel: (1) 514 336 7321
Fax: (1) 514 336 6450
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.
Large menu for emergency testing
• Cardiac: Troponin I Ultra, CK-MB,
Myoglobin, NT-proBNP
• Thrombosis: D-Dimer Exclusion
• Infections: Procalcitonin