Siemens Healthineers recently announced that the U.S. Food and Drug Administration (FDA) cleared two of its High-Sensitivity Troponin I assays (TnIH). These assays are designed shorten the time doctors can diagnose a life-threatening heart attack. The FDA cleared the assays for the Atellica IM and ADVIA Centaur XP/XPT in vitro diagnostic analyzers from Siemens Healthineers.
According to WebMD, about 25% of all heart attacks occur without any previous warning signs. When the heart is damaged, it releases troponin into the bloodstream. Higher troponin level could be indicative of damage to the heart. Measured in nanograms per milliliter, a normal troponin level is below the 99th percentile in the blood test. Troponin results above this level may be indicative of heart damage or a heart attack.
The two new Siemens Healthineers TnIH assays are highly sensitive and can detect lower levels of troponin at greater precision at the 99th percentile, allowing the detection of smaller changes in a patient's troponin level as repeat testing occurs. By offering such greater precision to measure slight, yet critical changes in troponin levels, these assays offer physicians the ability to begin treatment sooner. Equipped with data to properly triage patients sooner or to exclude myocardial infarctions, the assays can help support testing initiatives tied to improving patient experience.
These assays can help reduce emergency room overcrowding. They will allow emergency physicians to do a more efficient job at triaging patients to receive the proper level of care and to discharge the patients who do not need to stay in the emergency department, which can reduce the nation's healthcare costs.
A recognized worldwide leader in cardio vascular disease (CVD) testing, Siemens Healthineers is the only company offering multiple solutions for cardiac troponin I (cTnI) testing that meets the current guidelines for MI diagnosis. Other manufacturers offering Troponin-I assays include Abbott Laboratories and Beckman Coulter.