快速、新颖的全血即时检测高敏心肌肌钙蛋白 I 检测在心肌梗死中的诊断性能。
Diagnostic performance of a rapid, novel, whole blood, point of care high-sensitivity cardiac troponin I assay for myocardial infarction.
机构信息
Department of Laboratory Medicine and Pathology, HealthPartners, Minneapolis, MN, USA.
Cardiac Biomarkers Trials Laboratory, Hennepin Healthcare Research Institute, Minneapolis, MN, USA.
出版信息
Clin Biochem. 2022 Jul-Aug;105-106:70-74. doi: 10.1016/j.clinbiochem.2022.04.008. Epub 2022 Apr 18.
BACKGROUND
We evaluated the diagnostic performance of a whole blood, point of care (POC) high-sensitivity cardiac troponin I (hs-cTnI) assay for myocardial infarction (MI) compared to central laboratory assays.
METHODS
Consecutive patients presenting to the emergency department with symptoms of ischemia were studied. Serial hs-cTnI testing was based on clinical indication at presentation. Parallel measurements were made using fresh whole blood on Siemens Atellica VTLi POC assay, EDTA plasma on Abbott ARCHITECT i2000 used in practice, and heparin plasma on Siemens Atellica. MI was determined according to the Fourth Universal Definition of MI using 99th percentiles. Sensitivities and negative predictive values (NPV) were calculated using 99th percentile URLs.
RESULTS
1089 Patients, 418 females and 671 males, were enrolled. There were 91 (8.4%) MIs. At baseline (0 h), POC hs-cTnI assay had a sensitivity of 65.7% (95% CI 47.8-80.9) for females and 67.9% (54.0-79.7) for males and NPV of 96.4% (93.9-98.1) for females and 96.7% (94.9-98.0) for males. At 2 h, sensitivity improved to 82.9% (66.4-93.4) for females and 80.4% (67.6-89.8) for males, while NPV improved to 98.2% (96.1-99.3) and 97.9% (96.3-99.0), respectively. For central laboratory assays, comparable diagnostics were observed at 2 h: females - sensitivity 94.3% (80.8-99.3) for ARCHITECT and 79.4% (62.1-91.3) for Atellica, and NPV 99.3% (97.6-99.9) and 98.0% (95.8-99.2), respectively; males - sensitivity 87.5% (75.9-94.8) for ARCHITECT and 80.4% (67.6-89.8) for Atellica, NPVs of 98.7% (97.3-99.5) and 97.9% (96.3-99.0), respectively.
CONCLUSIONS
The POC, whole blood Atellica VTLi hs-cTnI assay demonstrated comparable diagnostic accuracy for MI to central laboratory assays using 99th percentiles.
背景
我们评估了一种即时检测（POC）全血高敏心肌肌钙蛋白 I（hs-cTnI）检测在心肌梗死（MI）中的诊断性能，与中心实验室检测相比。
方法
连续纳入因缺血症状而就诊于急诊科的患者。根据就诊时的临床指征进行连续 hs-cTnI 检测。使用西门子 Atellica VTLi POC 即时检测新鲜全血、雅培 ARCHITECT i2000 即时检测 EDTA 血浆以及西门子 Atellica 即时检测肝素血浆进行平行测量。MI 根据第四版 MI 通用定义，采用 99 百分位值确定。使用 99 百分位 URL 计算敏感性和阴性预测值（NPV）。
结果
共纳入 1089 例患者，女性 418 例，男性 671 例。共发生 91 例 MI。在基线（0 h）时，POC hs-cTnI 检测的女性敏感性为 65.7%（95%CI 47.8-80.9），男性为 67.9%（54.0-79.7），女性 NPV 为 96.4%（93.9-98.1），男性为 96.7%（94.9-98.0）。在 2 h 时，女性敏感性提高至 82.9%（66.4-93.4），男性敏感性提高至 80.4%（67.6-89.8），而 NPV 分别提高至 98.2%（96.1-99.3）和 97.9%（96.3-99.0）。对于中心实验室检测，在 2 h 时观察到相似的诊断结果：女性-ARCHITECT 的敏感性为 94.3%（80.8-99.3），Atellica 的敏感性为 79.4%（62.1-91.3），NPV 分别为 99.3%（97.6-99.9）和 98.0%（95.8-99.2）；男性-ARCHITECT 的敏感性为 87.5%（75.9-94.8），Atellica 的敏感性为 80.4%（67.6-89.8），NPV 分别为 98.7%（97.3-99.5）和 97.9%（96.3-99.0）。
结论
POC 全血 Atellica VTLi hs-cTnI 检测在 MI 诊断方面与中心实验室检测采用 99 百分位值相比具有相当的准确性。
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