The U.S. Food and Drug Administration (FDA) recently approved a next-generation troponin assay, Roche’s TnT Gen 5 Stat, which is a highly sensitive cardiac troponin. Allan Jaffe, M.D., Consultant and Chair of Mayo Clinic’s Division of Clinical Core Laboratory Services, with a joint appointment in the Division of Cardiovascular Diseases, spoke with CAP Today about what the assay means from a pathology and cardiology perspective.
"There is a reluctance by cardiologists to move forward," says Dr. Jaffe, "The reality is that when you use high-sensitivity troponin, you’re going to have a lot more elevations. Cardiologists are concerned that many of the low-level elevations could be due to structural heart disease or other types of nonischemic etiologies that exist in many critically ill patients."
On the other hand, according to Dr. Jaffe, the emergency department's philosophy is to be concerned about not missing something. As a result, ED staff have a tendency to admit a lot of people if they don't know what to do, which ultimately affects the cardiologist.
"Whether it’s right or wrong, the cardiologists’ point of view is, 'What do we do with these people? Do they all need angiograms?'" says Dr. Jaffe, who is also a Professor of Laboratory Medicine and Pathology and a Professor of Medicine at Mayo Clinic, noting that troponin as a marker is not specific for ischemic heart disease. And as testing increases, so do costs, potential morbidities, and fear.
However, the use of the higher-sensitivity assay does have many clinicians excited. Dr. Jaffe commented, "The time to do it is now. Don’t miss the chance. This assay will add a tremendous amount of benefit when it’s implemented."
In the article, Dr. Jaffe also discussed a paper he recently coauthored, addressing the issues and controversies related to use of the higher-sensitivity assay. The paper suggests using sex-specific 99th percentile upper-reference limit values and a two-hour rule-out strategy.
Among other clinicians, Dr. Jaffe is excited about the test's potential, "This assay will allow people to move out of the emergency department much more quickly. Rule-outs will be more secure. Rule-ins will be more secure. But only if we educate people in how to use it properly. Not only does the lab have to provide appropriate materials, but our colleagues have to be open-minded and willing to listen and deal with the information we’re trying to provide. We do that, and it will be a win-win, and everybody will be happy."