Roche Elecsys® Troponin T-high sensitive

Faster diagnosis of Acute Myocardial Infarction

Roche Troponin T-high sensitive (cTnT-hs)

Accurate diagnosis of Acute Myocardial Infarction (AMI) is often difficult and time-consuming

 

  • Early diagnosis is critical, as every 30-minute delay between symptoms and treatment increases the 1-year mortality rate by 7.5%1
  • For NSTE-MI, the 1-year mortality rate is 11.6% vs. 9% for STE-MI2
  • Coronary heart disease is the number 1 cause of death in the Western world3
  • Detection of a rise and/or fall in troponin is the cornerstone of myocardial infarction diagnosis4

 

Early diagnosis of AMI with Roche Troponin T high sensitive assay using the T0/1-hour or 3-hour algorithm

 

  • The accelerated algorithm to rule-in/out AMI within 1 or 3-hour using Troponin T-high sensitive assay (TnT-hs) is endorsed by the 2015 European Society of Cardiology (ESC) guidelines for Acute Coronary Syndrome (ACS) without ST-elevation5
  • The performance of TnT-hs 0/1-hour ­algorithm is validated by three multicenter trials in over 3,038 patients and results demonstrate that >75 % of patients are triaged within 1 hour6,7,8
  • The high negative predictive value (99.1 % - 100 %) and the low 30-day-­mortality rate (0.0 % - 0.2 %) confirmed the safety of this approach for early discharge6,7,8

 

Introduction of Roche TnT-hs in routine practice helps to:

 

  • Reduce time to diagnosis and improve patient care9,10
  • Lower the need for cardiac stress testing by more than 30 %9
  • Shorten the length of stay in the emergency department by nearly 80 minutes to 2.1 hours and has the potential to contribute to cost savings9,10
  • More at-risk patients are identified ­without inappropriate increase in hospital resource utilisation11
cTnT-hs in routine practice

Consistent results between Roche CARDIAC POC Troponin T and Troponin T-hs laboratory platforms

 

Roche TnT-hs and POC TnT offer an evidence-based immediate rule-in cutoff (≈50ng/L) for AMI enabling appropriate treatment to begin sooner5,12

Consistent correlation

Roche TnT-hs meets the International Federation of Clinical Chemistry (IFCC) definition of high sensitivity Troponin test

 

The universal definition of myocardial infarction and the IFCC recommend using a troponin test that can measure the 99th percentile upper reference limit (URL) with an analytical precision ≤10% (% CV; coefficient of variation).4,13 The Roche TnT–hs test achieves less than 10 % CV at the 99th percentile URL defined at 14 ng/L and complies with this recommendation.14

In addition, the IFCC defines a high-sensitivity troponin test as one that can measure troponin above the Limit of Detection (LoD) in ≥50 % of healthy subjects.13 For example, a multicenter trial reports that 57 % of healthy subjects were measured with TnT-hs levels above 3 ng/L.14,15 Studies report LoD of 2.05 – 2.85 ng/L with the cobas e 601/e 602.15

This analytical performance results in significant clinical advantages to accelerate the accurate diagnosis of Acute Coronary Syndrome (ACS).5-11

Roche Troponin T-high sensitive (TnT-hs)

Roche Troponin T-high sensitive (TnT-hs)

  • Assay time

    9 minutes STAT assay

  • 99th percentile upper reference limit

    14 ng/L (pg/mL)

  • 10% CV precision

    13 ng/L (pg/mL)

  • Sample material

    Heparin, EDTA plasma and serum

References

 

  1. De Lucca G et al (2004). Circulation 109(10), 1223-5.
  2. Montalescot G et al (2007). Eur Heart J 28, 1409-17.
  3. Roger L V (2007). Med Clin North Am 91(4), 537-52.
  4. Thygesen, K. et al. (2012). J. Am. Coll Cardiol; 60:1581-98.
  5. Roffi, M. et al. (2015). Eur Heart J 2016; 37(3):267-315.
  6. Reichlin, T. et al. (2012). Arch Intern Med; 172(16):1211-8.
  7. Reichlin, T. et al. (2015). CMAJ; 187(8): E243-52.
  8. Mueller, C. et al. (2016). Annal Emerg Med.;68(1):76-87.
  9. Twerenbold, R. et al. (2016). Eur Heart J. 2016 Nov 21; 37(44):3324-3332.
  10. Ambavane, A et al. (2017), PLoS One 12(11), e0187662.
  11. Eggers, K.M. et al. (2016). Eur Heart J 2016 Aug 7;37(30):2417-24.
  12. Stengaard C et al (2013). Am J Cardiol 112, 1361-6.
  13. Apple, F.S. et al. (2015). Clin, Biochem.; 48(4-5):201-3.
  14. Roche Troponin T hs and Troponin T hs STAT package insert 2016-18.
  15. Saenger, A.K. et al. (2011). Clin Chim Acta; 412(9-10):748-54.