Restan Ingar Ziad, Steiro Ole-Thomas, Pickering John W, Tjora Hilde L, Langørgen Jørund, Omland Torbjørn, Collinson Paul, Bjørneklett Rune, Vikenes Kjell, Steinsvik Trude, Skadberg Øyvind, Mjelva Øistein R, Larsen Alf Inge, Bonarjee Vernon V S, Aakre Kristin M
Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.
Department of Heart Disease, Haukeland University Hospital, P.O. Box 1400, NO-5021 Bergen, Norway.
Eur Heart J Acute Cardiovasc Care. 2025 Mar 22;14(3):155-168. doi: 10.1093/ehjacc/zuaf017.
This prospective, two-centre study derived and validated predictive algorithms for the Siemens Atellica IM high-sensitivity cardiac troponin I (hs-cTnI) assay in the emergency department (ED).
Algorithms for predicting 30-day myocardial infarction (MI) Types 1 and 2 and death or non-ST-elevation MI (NSTEMI, Types 1 and 2) at index admission were developed from a derivation cohort of 1896 patients and validated using a synthetic data set with nearly 1 million patient cases. Performance was compared with the European Society of Cardiology algorithms for hs-cTnT (Roche Diagnostics) and hs-cTnI (Abbott Diagnostics). An admission hs-cTnI concentration < 5 ng/L had a negative predictive value (NPV) and sensitivity for 30-day MI or death of 99.5-99.7% and 98.1-98.8%, respectively, in the derivation cohort and validation data set. The NPV and sensitivity were ≥99.7% and ≥98.8% for ruling out index NSTEMI. A 0- to 1-h algorithm with baseline hs-cTnI concentration < 10 ng/L and Δ change < 3 ng/L had NPV of ≥99.5% and sensitivity ≥ 97.3% for predicting 30-day MI or death and a ≥99.5% sensitivity and NPV for index NSTEMI. Rule-in algorithms of either 0-h hs-cTnI ≥ 120 ng/L or 0- to 1-h Δ change ≥ 12 ng/L had positive predictive value ≥ 73% and specificity > 96% for 30-day MI or death and index NSTEMI. The results were comparable with established hs-cTn algorithms.
This study presents Siemens Atellica hs-cTnI algorithms for diagnosis and risk prediction in the ED with performance comparable with established hs-cTnT (Roche) and hs-cTnI (Abbott) algorithms.
本前瞻性、双中心研究推导并验证了用于急诊科（ED）的西门子Atellica IM高敏心肌肌钙蛋白I（hs-cTnI）检测的预测算法。
从1896例患者的推导队列中开发出用于预测首次入院时30天1型和2型心肌梗死（MI）以及死亡或非ST段抬高型心肌梗死（NSTEMI，1型和2型）的算法，并使用包含近100万例患者病例的合成数据集进行验证。将其性能与欧洲心脏病学会针对hs-cTnT（罗氏诊断）和hs-cTnI（雅培诊断）的算法进行比较。在推导队列和验证数据集中，入院时hs-cTnI浓度<5 ng/L对30天MI或死亡的阴性预测值（NPV）和敏感性分别为99.5 - 99.7%和98.1 - 98.8%。排除首次NSTEMI时，NPV和敏感性分别≥99.7%和≥98.8%。对于预测30天MI或死亡，基线hs-cTnI浓度<10 ng/L且变化量（Δ）<3 ng/L的0至1小时算法，NPV≥99.5%，敏感性≥97.3%；对于首次NSTEMI，敏感性和NPV≥99.5%。0小时hs-cTnI≥120 ng/L或0至1小时Δ变化≥12 ng/L的纳入算法，对30天MI或死亡以及首次NSTEMI的阳性预测值≥73%，特异性>96%。结果与已确立的hs-cTn算法相当。
本研究提出了用于急诊科诊断和风险预测的西门子Atellica hs-cTnI算法，其性能与已确立的hs-cTnT（罗氏）和hs-cTnI（雅培）算法相当。
