QuidelOrtho Corporation, a global leader in in vitro diagnostics, has received FDA 510(k) clearance for its VITROS hs Troponin I Reagent Pack, known as the VITROS hs Troponin I Assay. This assay measures cardiac troponin I in human plasma to assist clinicians in diagnosing myocardial infarction. The FDA clearance allows laboratories using VITROS Systems to integrate high-sensitivity cardiac troponin testing into routine workflows, supporting timely and guideline-based decisions in emergency and acute care settings.

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Jonathan Siegrist, PhD, Executive Vice President of Research & Development and Chief Technology Officer at QuidelOrtho, emphasized the importance of speed, accuracy, and confidence in cardiovascular care. He stated that with the VITROS hs Troponin I Assay now cleared by the FDA, clinicians can quickly and reliably assess patients suspected of having a heart attack, while laboratories can deliver consistent, high-quality results. Siegrist noted that the assay enhances the company’s cardiac testing menu and reinforces its commitment to patient care by helping clinicians make faster and more confident decisions when minutes are critical.

The VITROS Systems are designed with dry-slide, MicroWell, and INTELLICHECK Technologies to provide reliable, efficient, and high-quality clinical results across laboratories worldwide. Siegrist added that every test result represents a person and their family, highlighting that the new assay enables laboratories to bring this life-saving capability to more patients. The commercial rollout for U.S. laboratories operating VITROS Systems is scheduled to begin later this year, and customers can contact their QuidelOrtho representative for ordering, validation, or technical support.

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Heart disease remains the leading cause of death in the United States for adults over 45 and affects most racial and ethnic groups. On average, someone in the U.S. dies from cardiovascular disease every 34 seconds, with more than 919,000 deaths recorded in 2023. High-sensitivity troponin assays such as VITROS hs Troponin I can improve outcomes by identifying heart attacks earlier, speeding up the rule-out process for low-risk patients, and reducing 30-day mortality by 12 percent and one-year mortality by 10 percent in patients with suspected acute coronary syndrome. Studies show that integrating high-sensitivity troponin testing enhances both the accuracy and efficiency of patient care, ultimately helping save lives.

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