High-sensitivity troponin I blood test cleared by FDA
Abbott announced that a high-sensitivity troponin I blood test used to detect MI has received FDA clearance.
The blood test (Architect Stat) can detect very low levels of troponin, which allows physicians to assess patients within 2 to 4 hours of admission, according to a press release from the company. Results of the test are not affected by biotin interference, which is important as biotin supplements grow in popularity, according to the release.
“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,” Fred. S. Apple, PhD, DABCC, co-director of the Clinical and Forensic Toxicology Laboratory at Hennepin Healthcare/Hennepin County Medical Center in Minneapolis and professor of laboratory medicine and pathology at the University of Minnesota in Minneapolis, said in the release.
The blood test was utilized in more than 200 studies to identify cardiac events and heart disease, according to the release.
“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, senior medical director of global medical and scientific affairs at Abbott, said in the 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.”
Disclosures: Beshiri is an employee of Abbott. Apple reports he is on the board of directors for HyTest Ltd; an associate editor for Clinical Chemistry, on the advisory board for Brava Dx, Instrumentation Laboratory, LumiraDx and Siemens Healthineers; consults for Banyan Biomarkers; receives honorarium for speaking at industry conferences from Abbott Diagnostics and Siemens Healthineers; and is a principal investigator on industry-funded grants on cardiac biomarkers through Hennepin Healthcare Research Institute for Abbott Diagnostics, Abbott POC, BD, Beckman Coulter, Davita, ET Healthcare, Ortho-Clinical Diagnostics, Roche Diagnostics and Siemens Healthineers.