Sörensen Nils Arne, Neumann Johannes Tobias, Ojeda Francisco, Renné Thomas, Karakas Mahir, Blankenberg Stefan, Westermann Dirk, Zeller Tanja
Department of Cardiology, University Heart and Vascular Center Hamburg Eppendorf, Hamburg, Germany.
German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany.
Eur Heart J Acute Cardiovasc Care. 2021 May 11;10(3):302–309. doi: 10.1177/2048872620924198. Epub 2020 Jul 23.
Most studies assessing the diagnostic value of high-sensitivity troponin in the diagnosis of myocardial infarction used batch-wise analyses of frozen samples for high-sensitivity troponin measurements. Whether the accuracy of these batch-wise high-sensitivity troponin measurements described in diagnostic studies is comparable to clinical routine is unknown.
We enrolled 937 patients presenting with suspected myocardial infarction in this prospective cohort study. Measurements of high-sensitivity troponin I (Abbott Architect) and high-sensitivity troponin T (Roche) were performed in two settings: (a) on-demand in clinical routine using fresh blood samples; and (b) in batches using frozen blood samples from the same individuals at three timepoints (0 hours, 1 hour and 3 hours after presentation).
Median troponin levels were not different between on-demand and batch-wise measurements. Troponin levels in the range of 0 to 40 ng/L showed a very high correlation between the on-demand and batch setting (Pearson correlation coefficient () was 0.92-0.95 for high-sensitivity troponin I and 0.96 for high-sensitivity troponin T). However, at very low troponin levels (0 to 10 ng/L) correlation between the two settings was moderate ( for high-sensitivity troponin I 0.59-0.66 and 0.65-0.69 for high-sensitivity troponin T). Application of guideline-recommended rapid diagnostic algorithms showed similar diagnostic performance with both methods.
Overall on-demand and batch-wise measurements of high-sensitivity troponin provided similar results, but their correlation was moderate, when focusing on very low troponin levels. The application of rapid diagnostic algorithms was safe in both settings. www.clinicaltrials.gov (NCT02355457).
大多数评估高敏肌钙蛋白在心肌梗死诊断中诊断价值的研究，采用对冷冻样本进行分批分析来测定高敏肌钙蛋白。诊断研究中所描述的这些分批高敏肌钙蛋白测量的准确性是否与临床常规情况相当尚不清楚。
在这项前瞻性队列研究中，我们纳入了937例疑似心肌梗死的患者。在两种情况下进行了高敏肌钙蛋白I（雅培Architect）和高敏肌钙蛋白T（罗氏）的测量：（a）在临床常规中使用新鲜血液样本按需检测；（b）在三个时间点（就诊后0小时、1小时和3小时）对来自同一患者的冷冻血液样本进行分批检测。
按需检测和分批检测的肌钙蛋白水平中位数无差异。0至40 ng/L范围内的肌钙蛋白水平在按需检测和分批检测之间显示出非常高的相关性（高敏肌钙蛋白I的皮尔逊相关系数为0.92 - 0.95，高敏肌钙蛋白T为0.96）。然而，在非常低的肌钙蛋白水平（0至10 ng/L）时，两种检测方法之间的相关性为中等（高敏肌钙蛋白I为0.59 - 0.66，高敏肌钙蛋白T为0.65 - 0.69）。应用指南推荐的快速诊断算法在两种方法中显示出相似的诊断性能。
总体而言，高敏肌钙蛋白的按需检测和分批检测结果相似，但当关注非常低的肌钙蛋白水平时，它们之间的相关性为中等。快速诊断算法在两种情况下的应用都是安全的。www.clinicaltrials.gov（NCT02355457）。
