Clinical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay

Alan H. Wu, Department of Laboratory Medicine, University of California, San Francisco, CA, United States.
Simon A. Mahler, Departments of Emergency Medicine, Epidemiology and Prevention, and Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC, United States.
Stacey L. House, Department of Emergency Medicine, Washington University School of Medicine, St. Louis, MO, United States.
Saeed A. Jortani, Department of Pathology and Laboratory Medicine, University of Louisville School of Medicine, Louisville, KY, United States.
Michael H. Creer, Department of Laboratory Medicine and Pathology, Penn State University Hershey Medical Center, Hershey, PA, United States.
Kristin L. Rising, Department of Emergency Medicine, Thomas Jefferson University Hospital, Philadelphia, PA, United States.
Jason J. Bischof, Department of Emergency Medicine, College of Medicine, Ohio State University Wexner Medical Center, Columbus, OH, United States.
Chad Crystal, ERA Health Research, Redmond, WA, United States.
Gary F. Headden, Department of Emergency Medicine, Medical University of South Carolina Charleston, SC, United States.
Fred S. Apple, Department of Laboratory Medicine and Pathology, Cardiac Biomarker Trials Laboratory, Hennepin Healthcare Research Institute, Minneapolis, MN, United States.
Nicholas E. Harrison, Indiana University Department of Emergency Medicine, Indiana University Health Methodist Hospital, Indianapolis, IN, United States.
Andrew C. Meltzer, Department of Emergency Medicine, George Washington University Hospital, Washington, DC, United States.
Justin T. Baca, Department of Emergency Medicine, University of New Mexico Hospital, Albuquerque, NM, United States.
Brian Tiffany, Department of Emergency Medicine, Dignity Health Chandler Regional Medical Center, Chandler, AZ, United States.
Mark Sochor, Department of Emergency Medicine, University of Virginia Health System, Charlottesville, VA, United States.
Grace U. Pentecostes, Abbott Point of Care Diagnostics, Clinical Affairs, Princeton, NJ, United States.
Katrina P. Di Tullio, Abbott Point of Care Diagnostics, Clinical Affairs, Ottawa, ON, Canada.
Manish S. Gupta, Abbott Point of Care Diagnostics, Clinical Affairs, Santa Clara, CA, United States.
Adam J. Singer, Department of Emergency Medicine, Stony Brook University Hospital, Renaissance School of Medicine at Stony Brook University, Stony Brook, NY, United States.
James L. Januzzi, Department of Medicine, Division of Cardiology, Massachusetts General Hospital, Boston, MA, United States.

Document Type

Journal Article

Publication Date

10-28-2025

Journal

The journal of applied laboratory medicine

DOI

10.1093/jalm/jfaf152

Abstract

BACKGROUND: High-sensitivity cardiac troponin (hs-cTn) assays performed in the central laboratory have long turnaround times. This study evaluates the clinical performance of a novel bedside point-of-care (POC) hs-cTnI assay (i-STAT® hs-TnI) to aid in the diagnosis of myocardial infarction (MI). METHODS: A prospective multisite cohort study involving emergency department (ED) patients with symptoms suggestive of acute coronary syndrome was conducted at 28 sites across the United States. Serial whole blood samples were collected at 0-1 h and >1-3 h from ED presentation. Primary outcome was MI or non-MI. Sensitivity, specificity, and negative predictive value (NPV) for MI were calculated with 97.5% lower confidence limits (LCL) using the female, male, and overall 99th percentile upper reference limit (URL, 13, 28, and 21 ng/L, respectively). Post hoc analysis was also conducted for initial measurements below the limit of quantification (LoQ, 2.9 ng/L) and <5.0 ng/L. RESULTS: The cohort included 3582 patients, median age 59 y, 64% female. MI incidence was 8.6%. Sensitivity and specificity at >1-3 h were 96.6% (LCL 91.7%) and 82.1% (80.2%) using the female URL; 90.7% (LCL 84.1%) and 83.9% (LCL 81.4%) using the male URL; and 92.4% (LCL 88.3%) and 85.6% (LCL 84.2%) using the overall URL. NPVs for MI of initial hs-cTnI measurements

Department

Emergency Medicine

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