对疑似急性心肌梗死患者进行心脏标志物即时检测分析的评估。

Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction.

作者信息

Wu Alan H B, Smith Andrew, Christenson Robert H, Murakami MaryAnn M, Apple Fred S

机构信息

Department of Pathology and Laboratory Medicine, Hartford Hospital, 80 Seymour St., Hartford, CT 06102, USA.

出版信息

Clin Chim Acta. 2004 Aug 16;346(2):211-9. doi: 10.1016/j.cccn.2004.03.036.

DOI:10.1016/j.cccn.2004.03.036

PMID:15256323

Abstract

BACKGROUND

Creatine kinase MB (CK-MB), and cardiac troponin I (cTnI) are important biomarkers for the diagnosis and rule-out of acute myocardial infarction (AMI) of patients who presented to the emergency department (ED) with chest pain. With new rapid ED assessment protocols, there is increasing pressure to produce results with a short turnaround time (TAT), and point-of-care (POC) testing is one alternative for providing fast results.

METHODS

In a multicenter study, we evaluated the analytical precision, sensitivity and specificity of the RAMP (Response Biomedical) CK-MB and cTnI POC assays and compared results against the Triage (Biosite) POC and the Dimension RxL (Dade Behring) central-laboratory assays on 365 subjects, including 185 patients suspected of AMI, and determined the normal range on 180 healthy individuals. At one site, the clinical sensitivity and specificity were estimated in 121 patients and healthy subjects with AMI using the European Society of Cardiology (ESC)/American College of Cardiology (ACC) definition of AMI. Results from healthy individuals and those with ST elevation and non-ST elevation AMI were included in a receiver operating characteristic (ROC) curve analysis.

RESULTS

Intra- and total imprecision ranged from 7.2% to 11.4% for cTnI at 0.22, 1 and 5 ng/ml and 4.8% to 8.6% for CK-MB at 7, 14 and 25 ng/ml. The upper limit of linearity was 32 ng/ml with an average recovery of 105% for cTnI and 80 ng/ml with a 106% recovery for CK-MB. The lower limit of detection was 0.03 ng/ml (10% coefficient of variance [CV] = 0.21 ng/ml) for cTnI and 0.32 ng/ml for CK-MB. The upper reference limit (normal range) was < 0.03 ng/ml for cTnI and 0-3.7 ng/ml for CK-MB. Analytical correlation against Dimension RxL were RAMP=(0.456 x RxL) + 0.11 (r = 0.988, n = 364) for cTnI and RAMP=(0.966 x RxL) + 0.60 (r = 0.986, n = 363) for CK-MB and against Triage, RAMP=(0.626 x Triage) + 0.164 (r = 0.969, n = 364) for cTnI and RAMP=(0.845 x RxL) - 0.495 (r = 0.952, n = 363) for CK-MB. On 39 AMI and 67 non-AMI patients, the clinical sensitivity, specificity and diagnostic efficiency of the cTnI and CK-MB RAMP assays were not significantly different from predicate assays.

CONCLUSIONS

The RAMP cardiac marker assays are alternatives to other FDA-cleared central laboratory and POC testing devices.

摘要

背景

肌酸激酶同工酶（CK-MB）和心肌肌钙蛋白I（cTnI）是用于诊断和排除因胸痛就诊于急诊科（ED）患者急性心肌梗死（AMI）的重要生物标志物。随着新的快速急诊评估方案的出现，缩短周转时间（TAT）出具结果的压力日益增大，即时检验（POC）是提供快速结果的一种选择。

方法

在一项多中心研究中，我们评估了RAMP（Response Biomedical公司）CK-MB和cTnI POC检测的分析精密度、灵敏度和特异性，并将365名受试者（包括185名疑似AMI患者）的检测结果与Triage（Biosite公司）POC检测以及Dimension RxL（Dade Behring公司）中心实验室检测结果进行比较，同时确定了180名健康个体的正常范围。在一个研究点，根据欧洲心脏病学会（ESC）/美国心脏病学会（ACC）对AMI的定义，在121名AMI患者和健康受试者中评估了临床灵敏度和特异性。健康个体以及ST段抬高和非ST段抬高AMI患者的结果纳入了受试者操作特征（ROC）曲线分析。

结果

cTnI在0.22、1和5 ng/ml时的批内和总不精密度范围为7.2%至11.4%，CK-MB在7、14和25 ng/ml时为4.8%至8.6%。cTnI的线性上限为32 ng/ml，平均回收率为105%；CK-MB的线性上限为80 ng/ml，回收率为106%。cTnI的检测下限为0.03 ng/ml（10%变异系数[CV]=0.21 ng/ml），CK-MB为0.32 ng/ml。cTnI的参考上限（正常范围）<0.03 ng/ml，CK-MB为0 - 3.7 ng/ml。与Dimension RxL检测的分析相关性，cTnI为RAMP=(0.456×RxL)+0.11（r = 0.988，n = 364），CK-MB为RAMP=(0.966×RxL)+0.60（r = 0.986，n = 363）；与Triage检测的相关性，cTnI为RAMP=(0.626×Triage)+0.164（r = 0.969，n = 364），CK-MB为RAMP=(0.845×RxL)-0.495（r = 0.952，n = 363）。在39名AMI患者和67名非AMI患者中，cTnI和CK-MB RAMP检测的临床灵敏度、特异性和诊断效率与对照检测无显著差异。