FDA has cleared the Architect Stat high-sensitivity troponin-I blood test from Abbott, Abbott Park, Ill, making the test available in the United States for use on Abbott’s Architect automated analyzer. One of the most researched troponin diagnostic tests, the technology can help doctors detect heart attacks faster and more accurately than contemporary troponin tests.
The agency’s clearance is particularly good news for women, according to Abbott, which notes that heart attacks in women are often misdiagnosed. Women are also less likely than men to receive aggressive diagnosis and treatment for cardiovascular disease, and they’re more likely to have different symptoms that warn of a heart attack. Because women often have lower levels of troponin protein than men, different cutoff measurements based on gender are required.
Abbott says that test results should be used in conjunction with other diagnostic information such as an electrocardiogram, clinical observations, and patient symptoms to aid in the diagnosis of heart attacks.
When people enter the emergency room with a suspected heart attack, doctors typically use a troponin blood test to help aid in their diagnosis. When the heart muscle has been damaged, troponin-I proteins are released from the heart and can be found at elevated levels in the blood. Abbott’s high-sensitivity troponin-I blood test measures very low levels of troponin, allowing doctors to evaluate heart attack in patients within 2 to 4 hours of admission.
“The addition of Abbott’s high-sensitivity troponin-I assay to the laboratory’s diagnostic testing menu is a great step forward to help laboratory scientists and clinicians better evaluate patients suspected of having a heart attack,” says Fred Apple, PhD, codirector of the clinical and forensic toxicology laboratory at Hennepin Healthcare/Hennepin County Medical Center, and professor of laboratory medicine and pathology at the University of Minnesota.
An estimated 840,000 Americans die of cardiovascular diseases each year, and heart disease remains the leading cause of death.1 Timing is a critical factor in helping doctors diagnose and treat those having a potential heart attack.
“Our research using this high-sensitivity assay has demonstrated it can provide doctors with the ability to detect or rule out a heart attack earlier,” says Apple. “This ability could help hospitals with more rapid triage and management of those diagnosed with a heart attack, as well as being able to safely discharge patients earlier on, resulting in savings to the healthcare system.”
Abbott’s test has been used in hospitals internationally and researched in more than 200 studies for its role in identifying heart disease and cardiac events, the company says. It was the first test outside the US to offer gender-specific cutoffs that allow doctors to more accurately diagnose heart attacks in women. A 2015 study found Abbott’s test uncovered twice as many heart attacks in women as standard troponin tests.2
Research at the University Heart Center Hamburg found that detecting a change in troponin levels using the high-sensitivity test over the first 3 hours after admission could facilitate an early diagnosis of heart attacks.3
“This important milestone will allow US physicians to utilize the advanced, proven capabilities of this blood test as they evaluate patients suspected of a heart attack,” says Agim Beshiri, MD, senior medical director for global medical and scientific affairs, diagnostics, at Abbott. “As one of the most widely researched high-sensitivity troponin tests, this technology could help address several challenges in emergency departments today, including overcrowding and more accurately identifying heart attacks in women.”
For more information, visit Abbott.
- Benjamin EJ, Muntner P, Alonso A, et al. Heart disease and stroke statistics, 2019 update: a report from the American Heart Association. Circulation. 2019;139(10):e56–e528; doi: 10.1161/cir.0000000000000659.
- Shah AS, Griffiths M, Lee K, et al. High sensitivity cardiac troponin and the under-diagnosis of myocardial infarction in women: prospective cohort study. BMJ. 2015;350:g7873; doi: 10.1136/bmj.g7873.
- Keller T, Zeller T, Ojeda F, et al. Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction. JAMA. 2011;306(24):2684–2693; doi: 10.1001/jama.2011.1896.