Clin Chem:新型高敏感性心肌肌钙蛋白I测定法在疑似心肌梗死患者中的临床应用

2019-12-23 MedSci MedSci原创

本研究的目的是验证高敏感性心肌肌钙蛋白I [VITROS®免疫诊断产品hs肌钙蛋白I (hs- ctni -VITROS)]检测的临床性能。

本研究的目的是验证高敏感性心肌肌钙蛋白I [VITROS®免疫诊断产品hs肌钙蛋白I (hs- ctni -VITROS)]检测的临床性能。

研究人员收集有急性心肌梗死(AMI)症状的急诊患者。由2位独立的心脏病专家集中判定最终诊断,他们考虑了所有的临床信息,包括心脏成像:首先,使用系列hs- ctnt - elecsys(初级分析),其次,除了临床使用(hs)-cTn外,还使用hs- ctni - architect(次级分析)测量。hs-cTnI-VITROS在出现时和1h时以盲法测量。主要目的是直接比较hs-cTnI-VITROShs-cTnT-Elecsyshs-cTnI-ArchitectROC曲线下面积(AUC)所量化的诊断准确性,在一个亚组中,还包括hs-cTnI-Centaurhs-cTnI-Access。次要目标包括hs-cTnI-VITROS-0/1-h算法的推导和验证。

研究结果显示,在1231例患者中,有158(13%)最终诊断为急性心肌梗死hs-cTnI-VITROSAUC0.95 (95% CI, 0.93-0.96);hs- ctn - elecsys0.94 (95% CI, 0.92-0.95);hs-cTnI-Architect0.92 (95% CI, 0.90-0.94)hs-cTnI-Centaurhs-cTnI-Accessauc0.95 (95% CI, 0.94-0.97)。将推导出的hs-cTnI-VITROS-0/1-h算法(推导队列n = 519)应用于验证队列(n = 520) 53%的患者被排除[敏感性为100% (95% CI, 94.1-100)] 14%的患者被排除[特异性为95.6% (95% CI, 93.4-97.2)]0/1-h算法排除的患者30天生存率为99.8%。结果在二次分析中得到确认,包括hs-cTnI-Architect的系列测量。

研究结果表明,hs-cTnI- vitros法至少具有与目前最有效的hs-cTnThs-cTnI法的诊断准确性相当。

原始出处:

Jasper Boeddinghaus, Raphael Twerenbold, Clinical Use of a New High-Sensitivity Cardiac Troponin I Assay in Patients with Suspected Myocardial Infarction

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    2020-10-05 丁鹏鹏
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