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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新型床旁高敏心肌肌钙蛋白 I 测定的临床和分析性能


床旁 （POC） 高敏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敏心肌肌钙蛋白 I （hs-cTnI）-SPINCHIP POC 检测的临床和分析性能。急诊科因急性胸部不适而就诊的成年患者被纳入一项国际、诊断性、多中心研究。最终诊断由 2 名独立的心脏病专家使用所有临床信息集中裁决。我们将 hs-cTnI-SPINCHIP 的鉴别性能与当前建立的中心实验室检测进行了比较，并得出了一种检测特异性 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/冰冻血浆和毛细血管指点刺） 和精密度分析。1,102 例患者中有 214 例 （19%） 是 MI 的最终诊断。hs-cTnI-SPINCHIP 的受试者工作特征曲线下面积为 0.94 （95% CI： 0.92-0.95），而 hs-cTnI-Architect 为 0.94 （95% CI： 0.92-0.95） （0.907） 和 0.93 （95% CI： 0.91-0.95） 高敏心肌肌钙蛋白 T Elecsys （ 0.305）。就诊时的临界值 <7 ng/L（如果胸痛发作为 >3 小时）或 <7 ng/L 以及 <4 ng/L 的 0/1 小时增量排除了 51%，敏感性和阴性预测值为 100% （95% CI： 97.7%-100%） 和 100% （95% CI： 99.0%-100%），分别。hs-cTnI-SPINCHIP 浓度 ≥36 ng/L 或 0/1 小时 delta ≥11 ng/L 占 27%，特异性和阳性预测值分别为 90.9% （95% CI： 88.3%-92.9%） 和 72.9% （95% CI： 66.4%-78.6%）。Bootstrap 内部验证证实了出色的诊断性能。在不同样品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。其检测特异性 0/1 小时算法对排除/进入 MI 实现了非常高的敏感性/阴性预测值和特异性/阳性预测值。（急性冠脉综合征评估 [APACE] 研究 [APACE] 的有利预测因子;