BACKGROUND Until now, high-sensitivity cardiac troponin (hs-cTn) assays were mainly developed for large central laboratory platforms. OBJECTIVES This study aimed to assess the clinical performance of a point-of-care (POC)-hs-cTnI assay in patients with suspected myocardial infarction (MI). METHODS This study enrolled patients presenting to the emergency department with symptoms suggestive of MI. Two cardiologists centrally adjudicated the final diagnosis using all clinical data including cardiac imaging. The primary objective was to directly compare diagnostic accuracy of POC-hs-cTnI-TriageTrue versus best-validated central laboratory assays. Secondary objectives included the derivation and validation of a POC-hs-cTnI-TriageTrue-specific 0/1-h algorithm. RESULTS MI was the adjudicated final diagnosis in 178 of 1,261 patients (14%). The area under the curve (AUC) for POC-hs-cTnI-TriageTrue at presentation was 0.95 (95% confidence interval [CI]: 0.93 to 0.96) and was at least comparable to hs-cTnT-Elecsys (AUC: 0.94; 95% CI: 0.93 to 0.96; p = 0.213) and hs-cTnI-Architect (AUC: 0.92; 95% CI: 0.90 to 0.93; p < 0.001). A single cutoff concentration <3 ng/l at presentation identified 45% of patients at low risk with a negative predictive value (NPV) of 100% (95% CI: 99.4% to 100%). A single cutoff concentration >60 ng/l identified patients at high risk with a positive predictive value (PPV) of 76.8% (95% CI: 68.9% to 83.6%). The 0/1-h algorithm ruled out 55% of patients (NPV: 100%; 95% CI: 98.8% to 100%), and ruled in 18% of patients (PPV: 76.8%; 95% CI: 67.2% to 84.7%). Ruled-out patients had cumulative event rates of 0% at 30 days and 1.6% at 2 years. This study confirmed these findings in a secondary analysis including hs-cTnI-Architect for central adjudication. CONCLUSIONS The POC-hs-cTnI-TriageTrue assay provides high diagnostic accuracy in patients with suspected MI with a clinical performance that is at least comparable to that of best-validated central laboratory assays. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study [APACE]; NCT00470587).

中文翻译：

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使用即时高灵敏度心肌肌钙蛋白 I 对心肌梗塞进行早期诊断

背景到目前为止，高灵敏度心肌肌钙蛋白（hs-cTn）检测主要是为大型中心实验室平台开发的。目的 本研究旨在评估即时 (POC)-hs-cTnI 检测在疑似心肌梗死 (MI) 患者中的临床表现。方法 本研究招募了出现提示 MI 症状的急诊科患者。两名心脏病专家使用包括心脏成像在内的所有临床数据集中裁定最终诊断。主要目标是直接比较 POC-hs-cTnI-TriageTrue 与经过最佳验证的中心实验室检测的诊断准确性。次要目标包括 POC-hs-cTnI-TriageTrue 特定 0/1-h 算法的推导和验证。结果 MI 是 1,261 名患者中 178 名 (14%) 的最终诊断。就诊时 POC-hs-cTnI-TriageTrue 的曲线下面积 (AUC) 为 0.95（95% 置信区间 [CI]：0.93 至 0.96），至少与 hs-cTnT-Elecsys 相当（AUC：0.94；95 % CI：0.93 至 0.96；p = 0.213）和 hs-cTnI-Architect（AUC：0.92；95% CI：0.90 至 0.93；p < 0.001）。就诊时单一临界浓度 <3 ng/l 确定了 45% 的低风险患者，阴性预测值 (NPV) 为 100%（95% CI：99.4% 至 100%）。单个临界浓度 >60 ng/l 可识别高风险患者，阳性预测值 (PPV) 为 76.8%（95% CI：68.9% 至 83.6%）。0/1 小时算法排除了 55% 的患者（NPV：100%；95% CI：98.8% 至 100%），并排除了 18% 的患者（PPV：76.8%；95% CI：67.2% 至84.7%）。被排除的患者在 30 天时的累积事件率为 0%，在 2 年时为 1.6%。该研究在包括用于中央裁决的 hs-cTnI-Architect 在内的二级分析中证实了这些发现。结论 POC-hs-cTnI-TriageTrue 检测为疑似 MI 患者提供了高诊断准确性，其临床表现至少可与经过最佳验证的中心实验室检测相媲美。（急性冠状动脉综合征评估研究的有利预测因素 [APACE]；NCT00470587）。