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3rd July 2009

   

New High Sensitive Troponin T assay improving detection of myocardial injury

New High Sensitive Troponin T assay improving detection of myocardial injury The Elecsys® Troponin T high sensitive assay from Roche Diagnostics will allow laboratories to consolidate cardiac assays on a single integrated chemistry and immunoassay platform.

Elecsys® Troponin T high sensitive assay from Roche Diagnostics allows laboratories to consolidate cardiac assays on a single integrated chemistry and immunoassay platform

Roche Diagnostics is pleased to announce that the new Elecsys® Troponin T high sensitive (hs) assay, for use on cobas® and MODULAR Analytics serum work areas, is soon to be available to hospital laboratories in the UK and Ireland. This highly sensitive diagnostic assay has been developed to improve the detection of myocardial injury and to help identify risk of acute coronary syndromes, detecting Troponin T in the range of 0.003-10 ng/ml of serum or plasma.

Cardiac Troponins (Troponin T and Troponin I) are good indicators of myocardial injury due to their specificity for heart injury and because levels of these markers remain elevated in blood for an extended period of time. Even a small elevation in cardiac Troponin may indicate damage to the heart and require clinical intervention, and so new guidelines from the European Society of Cardiology (ESC) and the American College of Cardiology (ACC) recommend a highly sensitive Troponin assay with excellent precision in the low end values (10% or less total variation at the 99th percentile of the reference range)1.

The new Elecsys® Troponin T hs assay meets the precision recommendations in the ESC/ACC guidelines. The improved sensitivity of the assay is of great diagnostic and prognostic value, not only in patients with acute coronary syndromes, but also in stable patients with a variety of cardiac disorders. The sensitivity and precision of this new assay will enable more patients with ischaemic symptoms to be identified at an earlier stage, allowing earlier and more targeted treatment.

Although both Troponin T and Troponin I are good indicators of myocardial injury, the highly sensitive detection of Troponin T offered by the Elecsys® Troponin T hs assay is advantageous in patients with certain medical conditions, for example, in the risk assessment of chronic renal failure patients2 and in helping to select patients that suffer from acute coronary syndrome for more intensive therapy and intervention3.

The availability of the Elecsys® Troponin T hs assay will allow laboratories to consolidate their cardiac assays on a single integrated clinical chemistry and immunoassay platform (Serum Work Area). With 183 different assays, Roche offers the largest menu of tests available on an automated Serum Work Area platform. For further information about this extensive range, including the Elecsys® Troponin T hs assay, telephone the Roche Centralised Diagnostics team on 01444 256750


References:
1 Thygesen K., Alpert J.S., White H.D. Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. Eur. Heart. J. 2007;28:2525-2538; J. Am. Coll. Cardiol. 2007;50:2173-2195; Circulation 2007;116:2634-2653.
2 Helleskov Madsen L, Ladefoged S, Hildebrandt P, Atar D. Comparison of four different cardiac troponin assays in patients with end-stage renal disease on chronic haemodialysis. Acute Card. Care. 2008 10(3):173-180.
3 James S, Armstrong P, Califf R, Simoons ML, Venge P, Wallentin L, Lindahl B. Troponin T levels and risk of 30-day outcomes in patients with the acute coronary syndrome: prospective verification in the GUSTO-IV trial. Am. J. Med. 2003;115:178-184.


About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2008 sales by the Pharmaceuticals Division totalled 36.0 billion Swiss francs, and the Diagnostics Division posted sales of 9.7 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested nearly 9 billion Swiss francs in R&D in 2008. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.


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