Point-of-care (POC) high-sensitivity cardiac troponin assays may further accelerate the diagnosis of myocardial infarction (MI). This study sought to assess the clinical and analytical performance of the novel high-sensitivity cardiac troponin I (hs-cTnI)-SPINCHIP POC test. Adult patients presenting with acute chest discomfort to the emergency department were enrolled in an international, diagnostic, multicenter study. The final diagnosis was centrally adjudicated by 2 independent cardiologists using all clinical information. We compared the discriminatory performance of hs-cTnI-SPINCHIP with current established central laboratory assays and derived an assay-specific hs-cTnI-SPINCHIP 0/1-hour algorithm. Secondary analyses included sample type comparisons (whole blood, fresh/frozen plasma, and capillary finger prick) and precision analysis. MI was the adjudicated final diagnosis in 214 (19%) of 1,102 patients. Area under the receiver-operating characteristic curve was 0.94 (95% CI: 0.92-0.95) for hs-cTnI-SPINCHIP vs 0.94 (95% CI: 0.92-0.95) for hs-cTnI-Architect ( 0.907) and 0.93 (95% CI: 0.91-0.95) for high-sensitivity cardiac troponin T Elecsys ( 0.305). A cutoff <7 ng/L at presentation (if chest pain onset was >3 hours) or <7 ng/L together with a 0/1-hour delta of <4 ng/L ruled out 51% with a sensitivity and negative predictive value of 100% (95% CI: 97.7%-100%) and 100% (95% CI: 99.0%-100%), respectively. A hs-cTnI-SPINCHIP concentration ≥36 ng/L or a 0/1-hour delta ≥11 ng/L ruled in 27% with a specificity and positive predictive value of 90.9% (95% CI: 88.3%-92.9%) and 72.9% (95% CI: 66.4%-78.6%), respectively. Bootstrap internal validation confirmed excellent diagnostic performance. High agreement was observed between different sample types. The SPINCHIP hs-cTnI POC test has very high diagnostic accuracy. Its assay-specific 0/1-hour algorithm achieved very high sensitivity/negative predictive value and specificity/positive predictive value for rule-out/in MI. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE] Study [APACE]; )

中文翻译：

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新型护理点高灵敏度心肌肌钙蛋白 I 检测的临床和分析性能


护理点 (POC) 高灵敏度心肌肌钙蛋白检测可能会进一步加速心肌梗死 (MI) 的诊断。本研究旨在评估新型高灵敏度心肌肌钙蛋白 I (hs-cTnI)-SPINCHIP POC 测试的临床和分析性能。因急性胸部不适而到急诊科就诊的成年患者参加了一项国际诊断性多中心研究。最终诊断由 2 名独立心脏病专家使用所有临床信息集中裁定。我们将 hs-cTnI-SPINCHIP 的辨别性能与当前建立的中心实验室检测进行了比较，并得出了检测特异性的 hs-cTnI-SPINCHIP 0/1 小时算法。二次分析包括样本类型比较（全血、新鲜/冷冻血浆和毛细血管手指刺血）和精​​密分析。 1,102 名患者中，有 214 名患者 (19%) 最终诊断为 MI。 hs-cTnI-SPINCHIP 的接受者操作特征曲线下面积为 0.94 (95% CI: 0.92-0.95)，而 hs-cTnI-Architect (0.907) 和 0.93 (95%) 则为 0.94 (95% CI: 0.92-0.95)。 CI: 0.91-0.95) 对于高灵敏度心肌肌钙蛋白 T Elecsys (0.305)。就诊时的截断值 <7 ng/L（如果胸痛发作为 >3 小时）或 <7 ng/L 与 0/1 小时增量 <4 ng/L 一起排除了 51% 的敏感性和阴性预测值分别为 100%（95% CI：97.7%-100%）和 100%（95% CI：99.0%-100%）。 hs-cTnI-SPINCHIP 浓度≥36 ng/L 或 0/1 小时增量≥11 ng/L 判定为 27%，特异性和阳性预测值为 90.9%（95% CI：88.3%-92.9%）分别为 72.9%（95% CI：66.4%-78.6%）。 Bootstrap 内部验证证实了出色的诊断性能。不同样本类型之间观察到高度一致性。 SPINCHIP hs-cTnI POC 测试具有非常高的诊断准确性。其特定于检测的 0/1 小时算法对于排除/纳入 MI 实现了非常高的灵敏度/阴性预测值和特异性/阳性预测值。（急性冠状动脉综合征评估的有利预测因素 [APACE] 研究 [APACE]；）