High-Sensitivity Troponin I Assay Aids in Diagnosis of Myocardial Infarction

Heart disease remains the leading cause of death for adults over 45 in the United States, accounting for nearly one in three deaths. In 2023 alone, 919,032 Americans died from cardiovascular disease — that’s one death every 34 seconds. Early detection of cardiac events is therefore critical to improving survival outcomes and reducing long-term complications.

High-sensitivity troponin assays detect cardiac injury earlier than conventional tests, allowing clinicians to identify heart attacks sooner, rule out low-risk patients more safely, and make faster, guideline-based decisions in emergency and acute settings. Studies show that implementing hs troponin testing can reduce 30-day mortality by 12% and 1-year mortality by 10% among patients with suspected acute coronary syndrome (ACS). Now, a novel assay enables high-sensitivity troponin I measurement to aid in the diagnosis of myocardial infarction.

Image: The VITROS hs Troponin I Assay is designed for use on VITROS Systems (Photo courtesy of QuidelOrtho)

QuidelOrtho Corporation’s (San Diego, CA, USA) VITROS hs Troponin I Reagent Pack (VITROS hs Troponin I Assay) quantitatively measures cardiac troponin I (cTnI) levels in human plasma to aid in the diagnosis of myocardial infarction (heart attack). The assay is designed for use on VITROS Systems, which are built on QuidelOrtho’s dry-slide, MicroWell, and INTELLICHECK technologies, ensuring workflow efficiency, reliability, and high-quality clinical results across global laboratories. The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the VITROS hs Troponin I Reagent Pack, which will be commercially rolled out for U.S. laboratories operating VITROS Systems later this year.

"Cardiovascular care depends on speed, accuracy and confidence," said Jonathan Siegrist, PhD, Executive Vice President of Research & Development & Chief Technology Officer. "With FDA clearance of our VITROS hs Troponin I Assay, clinicians using VITROS Systems can access high-sensitivity cardiac troponin testing that fits seamlessly into existing workflows and supports timely, guideline-aligned decision-making in emergency and acute settings."

"Behind every test result is a person and a family. As part of our ongoing commitment to our clinically impactful cardiac menu, our VITROS hs Troponin I Assay can help clinicians evaluate suspected heart attacks with speed and confidence. With this FDA clearance, laboratories running VITROS Systems can bring that capability to more patients consistently, when minutes matter," added Siegrist.