VIDAS Emergency Diagnostics Solution (pdf) - bioMérieux

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%