新型即时心肌钙蛋白 I 检测的临床性能。

Clinical performance of a new point-of-care cardiac troponin I test.

机构信息

Department of Emergency and Critical Care Medicine, Paracelsus Medical University, Nuernberg General Hospital, Nuernberg, Germany.

Department of Emergency, Luzerner Kantonsspital, Luzern, Switzerland.

出版信息

Clin Chem Lab Med. 2018 Jul 26;56(8):1336-1344. doi: 10.1515/cclm-2017-0693.

DOI:10.1515/cclm-2017-0693

PMID:29630502

Abstract

BACKGROUND

We evaluated the clinical performance of the Minicare cardiac troponin-I (cTnI), a new point-of-care (POC) cTnI test for the diagnosis of acute myocardial infarction (AMI) in a prospective, multicentre study (ISRCTN77371338).

METHODS

Of 474 patients (≥18 years) admitted to an emergency department (ED) or chest pain unit (CPU) with symptoms suggestive of acute coronary syndrome (ACS; ≤12 h from symptom onset), 465 were eligible. Minicare cTnI was tested immediately, 3 h and 6 h after presentation. AMI diagnoses were adjudicated independently based on current guidelines.

RESULTS

The diagnostic performance of the Minicare cTnI test at 3 h was similar for whole blood and in plasma: sensitivity 0.92 vs. 0.90; specificity 0.91 vs. 0.90; positive predictive value (PPV) 0.68 vs. 0.66; negative predictive value (NPV) 0.98 vs. 0.98; positive likelihood ratio (LR+) 10.18 vs. 9.41; negative likelihood ratio (LR-) 0.09 vs. 0.11. The optimal diagnostic performance was obtained at 3 h using cut-offs cTnI >43 ng/L plus cTnI change from admission ≥18.5 ng/L: sensitivity 0.90, specificity 0.96, PPV 0.81, NPV 0.98, and LR+ 21.54. The area under the receiver operating characteristics (ROC) curve for cTnI whole blood baseline value and absolute change after 3 h curve was 0.93.

CONCLUSIONS

These data support the clinical usefulness of Minicare cTnI within a 0 h/3 h-blood sampling protocol supported by current guidelines for the evaluation of suspected ACS.

摘要

背景

我们评估了 Minicare 心肌肌钙蛋白 I（cTnI）的临床性能，这是一种新的即时护理（POC）cTnI 检测方法，用于诊断急性心肌梗死（AMI），这是一项前瞻性、多中心研究（ISRCTN77371338）。

方法

在 474 名（≥18 岁）因疑似急性冠状动脉综合征（ACS；症状发作后≤12 小时）而入住急诊科（ED）或胸痛单元（CPU）的患者中，有 465 名符合条件。立即检测 Minicare cTnI，在就诊后 3 小时和 6 小时再次检测。AMI 的诊断是根据当前指南进行独立判定的。

结果

Minicare cTnI 检测在 3 小时时对全血和血浆的诊断性能相似：敏感性为 0.92 与 0.90；特异性为 0.91 与 0.90；阳性预测值（PPV）为 0.68 与 0.66；阴性预测值（NPV）为 0.98 与 0.98；阳性似然比（LR+）为 10.18 与 9.41；阴性似然比（LR-）为 0.09 与 0.11。在使用 3 小时时 cTnI >43 ng/L 且入院后 cTnI 变化≥18.5 ng/L 的截断值时，获得了最佳诊断性能：敏感性 0.90，特异性 0.96，PPV 0.81，NPV 0.98，LR+ 21.54。cTnI 全血基线值和 3 小时后绝对变化的受试者工作特征（ROC）曲线下面积为 0.93。