Background High-sensitivity cardiac troponin (hs-cTn) assays are used for detection of myocardial infarction (MI). 99th percentiles show wide inter-assay variation. Use of sex-specific cutoffs is recommended as definitory cutoff for MI. We compared diagnostic performance and prognostic value of sex-specific 99th percentiles of four hs-cTn assays in patients with suspected MI. Methods Concentrations of four hs-cTn assays were measured at presentation and after 3 hours in patients with suspected MI. Final diagnoses were adjudicated according to 4th UDMI. Unisex and sex-specific 99th percentiles were evaluated as diagnostic cutoffs following the ESC 0/3h algorithm. These cutoffs were used in Cox-regression analyses to investigate the association with a composite endpoint of MI, revascularization, cardiac rehospitalization and death. Results Non-ST-elevation MI was diagnosed in 368 of 2,718 patients. Applying the unisex 99th percentile, Elecsys hs-cTnT provided highest negative predictive value (NPV) of 99.7 and a positive predictive value (PPV) of 75.9. The analyzed hs-cTnI assays showed slightly lower NPVs and comparable PPVs (Architect [NPV 98.0, PPV 71.4]; Atellica [NPV 97.7, PPV of 76.1]; Pathfast [NPV 97.7, PPV of 66.6]). Application of sex-specific 99th percentiles did not significantly affect diagnostic performance. Concentrations above 99th percentile were independent predictors for impaired long-term outcome (hazard ratios 1.2 - 1.5, p<0.001). Conclusion We describe a good diagnostic accuracy of four hs-cTn assay using the assay-specific 99th percentile for detection of MI. Application of sex-specific 99th percentiles did neither affect diagnostic performance nor prognostic value significantly. Finally, values above the 99th percentile were associated with poor long-term outcome.

中文翻译：

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四项高灵敏心肌肌钙蛋白测定的性别特异性第 99 个百分位对疑似心肌梗死患者的诊断和预后价值

背景 高灵敏度心肌肌钙蛋白 (hs-cTn) 检测用于检测心肌梗死 (MI)。第 99 个百分位数显示出广泛的测定间差异。建议使用特定性别的临界值作为 MI 的明确临界值。我们比较了疑似 MI 患者的四项 hs-cTn 检测的性别特异性 99% 的诊断性能和预后价值。方法 对疑似 MI 的患者进行就诊时和 3 小时后四次 hs-cTn 检测的浓度测量。最终诊断根据第四次UDMI判定。按照 ESC 0/3h 算法，将男女通用和特定性别的第 99 个百分位作为诊断截止值进行评估。这些截止值用于 Cox 回归分析，以研究与 MI、血运重建、心脏再住院和死亡等复合终点的关联。结果 2,718 名患者中，有 368 名被诊断为非 ST 段抬高型心肌梗死。采用男女通用的第 99 个百分位数，Elecsys hs-cTnT 提供了最高的阴性预测值 (NPV) 99.7 和阳性预测值 (PPV) 75.9。分析的 hs-cTnI 检测显示 NPV 略低，PPV 相当（Architect [NPV 98.0，PPV 71.4]；Atellica [NPV 97.7，PPV 76.1]；Pathfast [NPV 97.7，PPV 66.6]）。应用特定性别的第 99 个百分位数并没有显着影响诊断性能。99%以上的浓度是长期结果受损的独立预测因子（风险比1.2-1.5，p＜0.001）。结论 我们描述了四种 hs-cTn 检测的良好诊断准确性，使用检测特定的第 99 个百分位来检测 MI。应用特定性别的第 99 个百分位数既不会显着影响诊断性能，也不会显着影响预后价值。最后，高于 99% 的值与较差的长期结果相关。