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Next-generation troponin T test receives FDA clearance
Roche Diagnostics Corp. announced that the FDA has cleared its next-generation troponin T assay for use in patients presenting with suspected MI.
The blood test (Elecsys Troponin T Gen 5 STAT) can accurately detect lower levels of troponin and more rapidly aid in the diagnosis of patients with acute MI, the company stated in a press release.
The test has been available worldwide, with the exception of the United States, for the last 7 years.
According to the release, there are approximately 8 million ED consultations per year in the U.S. pertaining to suspected acute MI, but only 5% to 20% are actual acute MI, and fast diagnosis can reduce cardiac cell death in patients with MI.
“As an emergency doctor whose job is to make decisions on patients with chest pain, my ability to do this safely and accurately is driven by the sensitivity of the troponin assay,” Frank Peacock, MD, FACEP, from the Department of Emergency Medicine at the Baylor College of Medicine, Houston, TX, said in the release. “FDA clearance of this new [troponin T] assay is easily the best news in the last decade for emergency medicine patients presenting with chest pain.”
Disclosure: Peacock reports financial ties with Roche.
Perspective
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This is a much more sensitive iteration than the prior troponin T assay. It will detect more elevations of cardiac troponin T regardless of the etiology. However, these more modest increases are more apt to be non-ischemic heart disease, which often provides much larger troponin signals. The benefit for those with ischemic heart disease is that they will be detected more rapidly. Unfortunately, because the assay validation metrics are different in the U.S. than in Europe and the rest of the world, we will not be able to translate the criteria developed from so many studies to U.S. patients directly. Likely, however, the same principles will hold and we will be able to adapt some of the criteria to the metrics of this specific assay.
If clinicians are intelligent in how they utilize the assay, it will help them evaluate patients with possible ischemic heart disease more rapidly and more completely. If they are not intelligent in utilizing the assay, they could be overwhelmed with large numbers of patients with modest elevations that may be due to a cause such as structural heart disease or another non-ischemic cause which may be ancillary to a patient’s primary problem. It’s terribly important that clinicians understand not only the positive aspect of this advance but also the concept that one can’t consider every troponin elevation as indicative of severe underlying CAD that needs urgent intervention.
For patients, if the assays are used intelligently, this should facilitate triaging them into groups with ischemic heart disease vs. other CV problems, and should make evaluations more rapid. If we don’t do our due diligence and people aren’t educated about how best to use these assays, then it will cause a lot of unnecessary testing, which would be unfortunate.