The quantitative measurement test is designed to aid in myocardial infarction diagnosis using human plasma samples.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to QuidelOrtho Corp for its Vitros hs Troponin I Reagent Pack, expanding the company’s cardiac testing menu for laboratories using Vitros immunodiagnostic systems.
The assay provides quantitative measurement of cardiac troponin I (cTnI) in human plasma samples using heparin anticoagulant to aid in diagnosing myocardial infarction. The test integrates with existing Vitros Systems workflows, which are built on dry-slide, MicroWell and INTELLICHECK technologies.
“Cardiovascular care depends on speed, accuracy, and confidence,” says Jonathan Siegrist, PhD, executive vice president of research and development and chief technology officer at QuidelOrtho, in a release. “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.”
Commercial Rollout Timeline
QuidelOrtho plans to begin commercial rollout for US laboratories operating Vitros Systems later this year. The San Diego-based company advises customers to contact their QuidelOrtho representative for ordering information, validation support, and technical documentation.
The clearance adds to QuidelOrtho’s cardiac testing portfolio as laboratories seek high-sensitivity troponin testing capabilities for emergency and acute care settings. High-sensitivity troponin assays can detect lower levels of the cardiac biomarker compared to conventional troponin tests, potentially enabling earlier detection of myocardial infarction.
“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,” says Siegrist in a release. “With this FDA clearance, laboratories running Vitros Systems can bring that capability to more patients consistently, when minutes matter.”
QuidelOrtho provides diagnostic solutions across clinical chemistry, immunoassay, immunohematology, and molecular testing markets, serving healthcare providers from point-of-care to hospital laboratory settings.
Photo caption: Vitros Immunodiagnostic Products hs Troponin I Assay
Photo credit: QuidelOrtho
