检测限以下的高敏心肌肌钙蛋白 t 浓度排除急性心肌梗死的前瞻性评估。

High-sensitivity cardiac troponin t concentrations below the limit of detection to exclude acute myocardial infarction: a prospective evaluation.

机构信息

The University of Manchester, Oxford Road, Manchester, UK; Central Manchester University Hospitals Foundation NHS Trust, Manchester Academic Health Science Centre, Oxford Road, Manchester, UK;

Stockport NHS Foundation Trust, Poplar Grove, Stockport, UK;

出版信息

Clin Chem. 2015 Jul;61(7):983-9. doi: 10.1373/clinchem.2014.231530. Epub 2015 May 15.

DOI:10.1373/clinchem.2014.231530

PMID:25979953

Abstract

BACKGROUND

Initial reports suggest that concentrations of high-sensitivity cardiac troponin T (hs-cTnT) (Roche Diagnostics Elecsys(®)) below the limit of blank (LoB) (3 ng/L) or limit of detection (LoD) (5 ng/L) of the assay have almost 100% negative predictive value (NPV) for acute myocardial infarction (AMI), particularly among patients without electrocardiograph (ECG) evidence of ischemia. We aimed to prospectively validate those findings.

METHODS

We included adults presenting to the emergency department with suspected cardiac chest pain. Standard troponin T (cTnT) and hs-cTnT (both Roche Elecsys) were tested in samples drawn on arrival. The primary outcome was AMI, adjudicated by 2 investigators on the basis of clinical data and ≥12-h cTnT testing. We also evaluated diagnostic performance when AMI was readjudicated on the basis of hs-cTnT (≥12-h) concentrations.

RESULTS

Of 463 patients included, 79 (17.1%) had AMI. Twenty-four patients (5.2%) had hs-cTnT concentrations below the LoB, although none had AMI. Ninety-six patients (20.7%) had hs-cTnT concentrations below the LoD, 1 of whom had AMI. Thus, diagnostic sensitivity was 98.7% (95% CI 87.5%-98.6%) and NPV was 99.0% (95% CI 94.3%-100.0%). Of the 17.3% (n = 80) patients with hs-cTnT below the LoD and no ECG ischemia, none had AMI. Thus, diagnostic sensitivity was 100.0% (95% CI 95.4%-100.0%) and NPV was 100.0% (95% CI 95.5%-100.0%). Sensitivity and NPV were maintained when AMI was readjudicated on the basis of hs-cTnT.

CONCLUSIONS

Our findings confirm that patients with nonischemic ECG and undetectable hs-cTnT at presentation have a very low probability of AMI, although the proportion of patients affected was smaller than in previous research.

摘要

背景

最初的报告表明，罗氏诊断 Elecsys（®）高敏心肌肌钙蛋白 T（hs-cTnT）检测的空白限（LoB）（3ng/L）或检测限（LoD）（5ng/L）以下浓度对急性心肌梗死（AMI）几乎具有 100%的阴性预测值（NPV），尤其是在没有心电图（ECG）缺血证据的患者中。我们旨在前瞻性验证这些发现。

方法

我们纳入了因疑似心前区胸痛而就诊于急诊科的成年人。在到达时采集的样本中同时检测标准肌钙蛋白 T（cTnT）和 hs-cTnT（罗氏 Elecsys）。主要结局是 AMI，由 2 名研究者根据临床数据和≥12 小时 cTnT 检测结果进行裁定。我们还评估了当根据 hs-cTnT（≥12 小时）浓度重新裁定 AMI 时的诊断性能。

结果

在纳入的 463 名患者中，79 名（17.1%）患有 AMI。24 名患者（5.2%）的 hs-cTnT 浓度低于 LoB，尽管没有患者患有 AMI。96 名患者（20.7%）的 hs-cTnT 浓度低于 LoD，其中 1 名患有 AMI。因此，诊断敏感性为 98.7%（95%CI87.5%-98.6%），NPV 为 99.0%（95%CI94.3%-100.0%）。在 hs-cTnT 低于 LoD 且无 ECG 缺血的 17.3%（n=80）患者中，无患者发生 AMI。因此，诊断敏感性为 100.0%（95%CI95.4%-100.0%），NPV 为 100.0%（95%CI95.5%-100.0%）。当根据 hs-cTnT 重新裁定 AMI 时，敏感性和 NPV 得以维持。