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

IF 3.2 3区医学 Q1 EMERGENCY MEDICINE

Academic Emergency Medicine Pub Date : 2026-07-01 DOI:10.1111/acem.70379

Simon A Mahler, Nicklaus P Ashburn, Akalya Villenthi, David A Pearson, Hannah D Pugh, Benjamin T Hutchison, Michael W Supples, Anna C Snavely

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引用次数: 0

Abstract

Objectives: 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.

Methods: 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%.

Results: 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.

Conclusions: 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.

Cohort:

Trial registration: Trial Registration: NCT06899776.

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验证0/2小时护理点高灵敏度肌钙蛋白算法：一项多站点美国研究

目的：最近在澳大利亚导出了一种用于I - stat即时（POC）高灵敏度肌钙蛋白I （hs-cTnI）检测的0/2小时算法。本研究的目的是验证和优化0/2-h算法在多站点美国急诊科（ED）队列中的性能。方法：一项前瞻性队列研究在三个美国急诊科进行（2025年2月至9月）。没有STEMI和至少一个hs-cTnI订单的成年人累积。同时采集血样，用i-STAT 1分析仪（Abbott Laboratories）和中心实验室hs-cTnI分析仪（Beckman Coulter）检测POC - hs-cTnI。主要终点是心肌梗死指数（MI），由专家使用临床hs-cTnI测量来判定。通过计算阴性和阳性预测值（NPV， PPV）以及相关的95%置信区间来评估澳大利亚0/2-h算法的诊断性能。计算疗效，定义为归为排除区患者的比例。算法优化测试了改进的切点，在保持NPV≥99%、PPV≥65%的同时提高了疗效。结果：在研究期间，共有578例患者完成了0/2-h算法评估。其中女性占48%(279/578)，非白种人占40%(233/578)，中位年龄为60岁（IQR: 50-70）。指数MI发生率为7.4%（43/578）。算法有效率分别为54.8%（317/578）和8.8%（51/578）。在排除的患者中，NPV为99.4% （95% CI: 97.7%-99.9%）。规则区与PPV的62.7%相关（95% CI: 48.1%-75.9%）。在36.3%（210/578）的观察区患者中，4.3%（9/210）的患者具有确定的MI指数。优化的0/2小时算法将MI指数的NPV提高到60.0% (347/578)，NPV为99.4% (95% CI: 97.9%-99.9%)， PPV为74.4% （95% CI: 58.8, 86.5%）。结论：澳大利亚和优化的i-STAT POC h - ctni测量的0/2小时算法在美国多站点队列中具有较高的NPV和疗效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Academic Emergency Medicine 医学-急救医学

CiteScore

7.60

自引率

6.80%

发文量

207

审稿时长

3-8 weeks

期刊介绍： Academic Emergency Medicine (AEM) is the official monthly publication of the Society for Academic Emergency Medicine (SAEM) and publishes information relevant to the practice, educational advancements, and investigation of emergency medicine. It is the second-largest peer-reviewed scientific journal in the specialty of emergency medicine. The goal of AEM is to advance the science, education, and clinical practice of emergency medicine, to serve as a voice for the academic emergency medicine community, and to promote SAEM''s goals and objectives. Members and non-members worldwide depend on this journal for translational medicine relevant to emergency medicine, as well as for clinical news, case studies and more. Each issue contains information relevant to the research, educational advancements, and practice in emergency medicine. Subject matter is diverse, including preclinical studies, clinical topics, health policy, and educational methods. The research of SAEM members contributes significantly to the scientific content and development of the journal.