By Diagnostics World Staff
January 20, 2017 | Roche announced that it has received the 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test for patients with a suspected heart attack. With this clearance, Roche is the first IVD company in the U.S. to provide the next generation Troponin testing for patients as an aid in the diagnosis of myocardial infarction, enabling clinicians to more accurately identify patients experiencing a heart attack.
In a heart attack, early diagnosis and initiation of treatment can reduce the amount of cardiac cell death thus potentially saving and improving quality of lives. This next generation Troponin T test from Roche is able to provide accuracy at lower levels of troponin to aid in correctly identifying patients having an acute myocardial infarction (AMI).
Moreover, this next generation of TnT test from Roche has been available in the rest of the world for the past seven years during which time it has been rapidly adopted by clinicians and its clinical diagnostic utility is supported by more than 600 peer-reviewed publications.
The Elecsys Troponin T Gen 5 STAT test from Roche detects cardiac troponin, which is the preferred biomarker for the diagnosis of heart attack in clinical practice. In combination with an electrocardiogram (ECG) and signs of ischemia, troponin has become the gold standard as an aid in the diagnosis of heart attack. The higher sensitivity of the Roche TnT Gen 5 STAT assay, in conjunction with the rapid turnaround time of nine minutes, can significantly accelerate decision-making, and allows the detection of smaller infarctions thereby maximizing the potential for effective treatment.
With these clinical utilities and the automation advantages associated with Roche solutions, the Elecsys TnT Gen 5 STAT test can provide the confidence that healthcare professionals need to diagnose and manage patients in emergency settings and beyond.