Validation of a 0/2-Hour Point-Of-Care High Sensitivity Troponin Algorithm: A Multisite US Study.

Abstract

A 0/2-h algorithm for the i-STAT point-of-care (POC) high sensitivity troponin I (hs-cTnI) assay was recently derived in Australia. The objective of this study was to validate and optimize the performance of the 0/2-h algorithm in a multisite U.S. Emergency Department (ED) cohort. A prospective cohort study was conducted at three U.S. EDs (February-September 2025). Adults without STEMI and at least one hs-cTnI ordered were accrued. Blood samples were collected simultaneously for POC hs-cTnI measurement on an i-STAT 1 analyzer (Abbott Laboratories) and central laboratory hs-cTnI measurement (Beckman Coulter). The primary outcome was index myocardial infarction (MI), adjudicated by experts using clinical hs-cTnI measures. Diagnostic performance of the Australian 0/2-h algorithm was assessed by calculating negative and positive predictive values (NPV, PPV) with associated 95% confidence intervals. Efficacy, defined as the proportion of patients classified into the rule-out zone, was calculated. Algorithm optimization tested modified cut points to increase efficacy while maintaining NPV ≥ 99% and achieving PPV ≥ 65%. During the study period, 578 patients with complete 0/2-h algorithm assessments were accrued. These patients were 48% (279/578) female, 40% (233/578) non-White, with a median age of 60 years (IQR: 50-70). Index MI occurred in 7.4% (43/578). Algorithm efficacy was 54.8% (317/578) and 8.8% (51/578) were classified to the rule-in zone. Among patients ruled-out, the NPV was 99.4% (95% CI: 97.7%-99.9%). The rule-in zone was associated with a PPV of 62.7% (95% CI: 48.1%-75.9%). Among 36.3% (210/578) patients classified to the observation zone, 4.3% (9/210) had an adjudicated index MI. An optimized 0/2-h algorithm increased efficacy to 60.0% (347/578) while achieving an NPV of 99.4% (95% CI: 97.9%-99.9%) and PPV of 74.4% (95% CI: 58.8, 86.5%) for index MI. The original Australian and optimized 0/2-h algorithms for i-STAT POC hs-cTnI measurement had high NPV and efficacy in a multisite U.S. Trial Registration: NCT06899776.