Oct. 2, 2019—Abbott announced that its Architect Stat High Sensitivity Troponin-I blood test has received clearance from the FDA. The test measures very low levels of troponin, which allows doctors to evaluate heart attack in patients within two to four hours of admission.
“This important milestone will allow U.S. physicians to utilize the advanced, proven capabilities of this blood test as they evaluate patients suspected of a heart attack,” Agim Beshiri, MD, Abbott’s senior medical director of global medical and scientific affairs, diagnostics, said in a company press release. “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.”
With this clearance, the blood test may be sold in the U.S. for use on Abbott’s fully automated Architect analyzer. Architect Stat High Sensitivity Troponin-I results should be used in conjunction with other diagnostic information such as electrocardiogram, clinical observations and information, and patient symptoms to aid in the diagnosis of heart attacks.