Elecsys® Troponin T high sensitive (TnT-hs)
Improved performance - better clinical decisions
- In a clinical setting consistent with myocardial ischemia, detection of a rise and/or fall of troponin is the cornerstone of myocardial infarction diagnosis
- The Elecsys Troponin T high sensitive assay fulfills the guidelines of ACC/ESC* and NACB/AACC** in achieving less than 10 % coefficient of variation at the 99 percentile upper reference limit of the reference population
- The requirement results in significant advantages in the diagnostic of acute coronary syndrome:
- Enabling an earlier detection of an acute myocardial infarction (AMI) and an earlier rule-out and rule-in of AMI
- Increasing the number of patients correctly diagnosed with AMI thanks to higher sensitivity and better analytical precision
- Improving risk stratification of patients with elevated cTn levels with and without acute cardiac events
* ACC/ESC: American College of Cardiology/European Society of Cardiology
** NACB/AACC: National Academy of Clinical Biochemistry/Academy of the American Association for Clinical Chemistry
- Fully automated test
- Sample material: Heparin, EDTA plasma and serum
- STAT test: 9 minutes
- 99th percentile upper reference limit*: 14 ng/L (pg/mL)
- 10 % CV precision: 13 ng/L (pg/mL)
- Limit of detection: 5 ng/L (pg/mL)
- Limit of blank: 3 ng/L (pg/mL)
*Elecsys Troponin T high sensitive package insert
Earlier diagnosis with safe and reliable results
The Elecsys® Troponin T hs assay delivers benefits in a number of key areas:
Earlier diagnosis of NSTEMI
- Higher sensitivity enabling detection of more patients at risk
- High prognostic value for cardiac events in patients with renal failure
- Time to diagnosis shorter by almost 3 hours
- 20 % more patients identified with a final diagnosis of NSTEMI
- Test fulfills the guidelines of ACC/ESC* and NACB/AACC** in achieving less than 10% CV at the 99th percentile upper reference limit of the reference population
Safe and reliable results
- Particularly at lower levels
- Of acute and chronic myocardial damage that would be not discovered or only later with conventional cTn assays
- Between point-of-care devices for emergency testing and all cobas immunoassay analyzers in the central lab
Key benefit: Earlier diagnosis of AMI
Elecsys® cTnT-hs assay
cTnT-hs meets the ≤ 10% CV criteria at the 99th percentile upper reference limit and fulfills the new universal definition of AMI
Saenger AK, Katus, H; Melanson, S E; Panteghini, M; Venge, P; (2011) Multicenter analytical evaluation of a high-sensitivity troponin T assay. Clin Chim Acta 412(9-10), 748-54.
Chenevier-Gobeaux, C., Meune, C., Blanc, M.C., Cynober, L., Jaffray, P., Lefevre, G. (2011). Analytical evaluation of a high-sensitivity troponin T assay and its clinical assessment in acute coronary syndrome. Ann Clin Biochem 48(5), 452-8.
Third universal definition of Myocardial infarction. ESC/ACCF/AHA/WHF Task Force.
Thygesen, K., et al. (2012) J Am Coll Cardiol 60(16), 1581-98.
Eur Heart J 2012; 33:2551–67.
cTnT-hs implementation helps to diagnose Non ST elevation Myocardial infarction (NSTEMI) ~ 3 h earlier than conventional cTn assay and better identifies the earlier presenters at admission
Reichlin, T., Hochholzer, W., Bassetti, S., Steuer, S., Stetlzig, C., Hartwiger, S., Biedert, S., Schaub, N., Buerge, C., Potocki, M., Noveanu, M., Breidthardt, T., Twerenbold, R., Winkler, K., Bingisser, R., Mueller, C. (2009) Early diagnosis of myocardial infarction with sensitive cardiac troponin assays. NEJM 361(9), 858-67.
Giannitsis, E., Kurz, K., Hallermayer, K., Jarausch, J., Jaffe, A.S., Katus, H.A. (2010) Analytical validation of a high-sensitivity cardiac troponin T assay. Clin Chem 56(2), 254-61.
Biener, M., Mueller, M., Vafaie, M., Keller, T., Blankenberg, S., White, H., Katus, K., Giannitsis, E. (2013) Comparison of a 3-hour versus a 6-hour sampling-protocol using high-sensitivity cardiac troponin T for rule-out and rule-in of non-STEMI in an unselected emergency department population. Inter J Card 167(4), 1134-40.
cTnT-hs helps for a fast track rule-out of AMI
Hamm, C.W., et al. (2001) ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC).Authors/Task Force Members, Eur Heart J 32(23), 2999-3054.
Body, R., Carley, S., McDowell, G., Jaffe, A., France, M., Cruickshank, K., Wibberley, C., Nuttall, M., Mackway-Jones, K. (2011). Rapid exclusion of acute myocardial infarction in patients with undetectable troponin using a high-sensitivity assay. J Am Coll Cardiol 58, 1332-9.
Reichlin, T., Schindler, C., Drexler, B., Twerenbold, R., Reiter, M., Zellweger, C., Moehring, B., Ziller, R., Hoeller, R., Rubini Gimenez, M., Haaf, P., Potocki, M., Wildi, K., Balmelli, C., Freese, M., Stelzig, C., Freidank, H., Osswald, S., Mueller, C. (2012) One-hour rule-out and rule-in of acute myocardial Infarction using high-sensitivity cardiac troponin T. Arch Intern Med 172(16), 1211-8.
Conde, D., Costabel, J.P., Lambardi, F. (2013) Algorithm for probable acute coronary syndrome using high-sensitivity troponin T assay vs fourth-generation troponin T assay. Am J Emerg Med [0735-6757] 31(8), 1226 -1229
cTnT-hs values are highly predictive of unfavorable prognosis
Latini, R. et al. (2007) Prognostic value of very low plasma concentrations of troponin T in patients with stable chronic heart failure. Circulation 116 (11), 1242-9.
Omland, T. et al. (2009) A sensitive cardiac troponin T assay in stable coronary artery disease. NEJM 361(26), 2538-47.
de Lemos, J. et al. (2010) Association of troponin T detected with a highly sensitive assay and cardiac structure and mortality risk in the general population. JAMA 304(22), 2503-12.
Hasegawa, M., Ishii, J., Kitagawa, F., Kanayama, K., Takahashi, H., Ozaki, Y., Yuzawa, Y. (2013) Prognostic value of highly sensitive troponin T on cardiac events in patients with chronic kidney disease not on dialysis. Heart Vessels 28(4), 473-9.
Beatty, A., Ku, I., Christenson, R., DeFilippi, C., Schiller, N., Whooley, M. (2013) High-sensitivity cardiac troponin T levels and secondary events in outpatients with coronary heart disease from the Heart and Soul study. JAMA Intern Med 173(9), 763-9.