חברת אילקס שמחה להודיע על השקת ערכה חדשה לבדיקת טרופונין במכשיר ה- :Vidas
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1 3 באפריל, 1026 לקוחות נכבדים, הנדון: קיט חדש VIDAS High sensitive Troponin I חברת אילקס שמחה להודיע על השקת ערכה חדשה לבדיקת טרופונין במכשיר ה- :Vidas.Vidas High sensitive Troponin I נתוני הספרות המקצועית מלמדים כי שימוש בבדיקה זו ישפר את היכולת לאתר התקפי לב, ויביא לשיפור הטיפול הרפואי המבוצע כיום. הודות לשינויים שבוצעו בערכה, פרק הזמן בין סידרת מדידות עוקבות של טרופונין לנבדק מתקצר באופן ניכר ( במקום 6-9 שעות ל- 3 שעות בלבד(. בהתאם לקריטריונים של requirements) ESC 2015 (analytical & clinical ההדירות )CV%( באחוזון ה- 99, הינה 7% )קריטריון אנליטי(. בנוסף מוצע אלגוריתם ל rapid rule-in/rule-out )קריטריון קליני(. האלגוריתם החדש המוצע: T0 = ctn concentration on admission T2h = ctn concentration 2 hours after admission * Data from validation study in 592 patients ** Difference in ctn concentration *** Negative Predictive Value **** Positive Predictive Value
2 להלן מאפייני הערכה החדשה: לתשומת ליבכם, היחידות השתנו מ- µg/l ל-.(ng/L) הערכה הנוכחית תהיה זמינה עד סוף יולי ערוץ התקשורת של הקיט החדש TNHS מצ"ב מידע מחברת BioM erieux בברכה, עילית ליזרמן, מנהלת מוצר אילקס מדיקל
3 New High sensitive Troponin I Delivering a diagnosis in only 2 hours
4 Did you know? Worldwide 16 million people die annually of cardiovascular diseases, specifically heart attacks or stroke (1) Expected prevalence of acute myocardial infarction (MI) in chest pain patients in the ED (3) 5-10% STEMI* 15-20% NSTEMI** Chest pain is among the top 10 reasons to visit an emergency department (ED), accounting for about 5% of all ED visits (2) Deliver high performance Intended use: l Aid in the diagnosis of myocardial infarction. 19 ng/l The 99 th percentile has been defined at 19 ng/l CV = 7 At the 99 th percentile High sensitive Troponin I l Aid in the risk stratification of patients with symptoms suggestive of ACS with respect to relative risk of allcause mortality and major adverse cardiac events (MACE) consisting of MI and revascularization, at 30 days. Optimize the management of ACS *** with high sensitivity troponins (4) Accelerate patient triage with high diagnostic accuracy in only 2 hours l 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. l ctn has become a continuous variable with accurate measurement below the 99 th 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. Diagnosis l Mandatory tool, in addition to clinical assessment and ECG, to make a definitive diagnosis of acute MI. l Serial measurement to differentiate acute from chronic cardiac myocyte damage. Level of ctn Normal levels Onset of myocardial infarction T = 0 h Ischemia or Micronecrosis T = 6 h Necrosis Conventional generations of ctn assays Conventional cut-off (10% CV) 99 th percentile Time Risk stratification High-sensitivity ctn assays Additional tool in risk stratification to guide therapeutic decision making. T0 < 2 ng/l or T0 and T2h < 6 ng/l RULE-OUT (54.6%) Sensitivity 97.7% NPV*** 99.4% Patients with suspected NSTEMI* Others OBSERVATIONAL ZONE (29.6%) AMI prevalence 8.6% T0 100 ng/l or ** T2h-T0 10 ng/l RULE-IN (15.8%) Specificity 95.2% PPV**** 74.5% l Algorithm based on admission values and absolute changes within the first 2 hours. l Delivers a diagnosis - safe rule-out and accurate rule-in - of acute MI (NSTEMI) in the vast majority (70%) of suspected chest pain patients. l Shortens the time needed to triage chest pain patients in the ED (will obviate the need for prolonged monitoring with frequent serial blood sampling). * ST segment elevation myocardial infarction ** Non ST segment elevation myocardial infarction *** Acute Coronary Syndrome * Data from validation study in 592 patients ** Difference in ctn concentration *** Negative Predictive Value **** Predictive Positive Value
5 12-15 / /008/GB/A / Document and/or pictures not legally binding. Modifications by biomérieux can be made without prior notice / BIOMÉRIEUX, the blue logo and VIDAS are used, pending and/or registered trademarks belonging to biomérieux, or one of its subsidiaries or one of its companies. Any other trademark is the property of its respective owner. VIDAS apparatus is a used, pending and/or registered designs belonging to biomérieux or one of its subsidiaries or one of its companies / biomérieux S.A. RCS Lyon / Printed in France / THERA Conseil / RCS Lyon B Available on instruments of the VIDAS VIDAS, mini VIDAS and VIDAS 3 VIDAS High sensitive Troponin I Reference number Tests / kit 60 Time to result Sample type 20 min Serum, Plasma (Li Hep) Sample volume 200 µl Units Measuring range Limit of quantification (LoQ) Limit of detection (LoD) Limit of blank (LoB) Precision (99 th percentile for the global healthy population) Calibrators & Controls frequency REFERENCES 1. Lozano R, et al. Lancet.2012;380: Bandstein N, et al. J Am Coll Cardiol. 2014;63: Mueller C, et al. Eur Heart J Aug 29. pii: ehv409. [Epub ahead of print] 4. Roffi M, et al. Eur Heart J Aug 29. pii: ehv320. [Epub ahead of print] Discover the VIDAS community and become a member by registering on biomérieux S.A Marcy l Etoile France Tel. : + 33 (0) Fax : +33 (0) ng/l ng/l ng/l ng/l ng/l 19 ng/l ; CV = 7.0% 28 days CARDIAC PANEL High sensitive Troponin I, NT-proBNP2, Galectin-3, CK-MB, Myoglobin, Digoxin family:
hs-c Tn I high sensitivity troponin I <17 min
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