Zhou Peiling, Liu Haohao, Gong Lan, Tang Bo, Shi Yabing, Yang Chengjian, Han Zhijun
Department of Cardiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi 214002, China.
Department of Laboratory Medicine, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Wuxi 214002, China.
J Thorac Dis. 2019 Apr;11(4):1506-1513. doi: 10.21037/jtd.2019.03.25.
High-sensitivity cardiac troponin (hs-cTn) is a significant biomarker of myocardial injury and necrosis, and has momentous clinical significance for the diagnosis and risk stratification of acute myocardial infarction (AMI). The purpose of this study is to determine the accuracy and sensitivity of hs-cTn detection in whole blood samples with a new faster method-Point of Care Testing (POCT) quantum dot fluorescence immunoassay.
Blood samples from 415 patients with chest pain suggestive of AMI from August to November 2017 in The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University were analyzed. We first performed hs-cTnI test with anticoagulated whole blood by POCT quantum dot fluorescence immunoassay. After the sample was centrifuged, the plasma sample was taken for detection of hs-cTnT by electrochemiluminescence immunoassay. The final diagnosis was determined by two independent cardiologists.
Firstly, by measuring the receiver operating characteristic curve (ROC curve) and the area under the curve (AUC) of 32 patients with AMI, it was found that the measurement accuracy of the POCT quantum dot fluorescence immunoassay was relative high (AUC was 0.866, 95% confidence interval is 0.783 to 0.949). There was no statistical difference between POCT quantum dot fluorescence immunoassay and electrochemiluminescence troponin assay [Z value =1.527, P value =(0.063, 0.064)]. In addition, the study also calculated the performance evaluation index of POCT quantum dot fluorescence immunoassay (critical value 0.04 ng/mL) and analyzed the ROC curve to compare the diagnostic accuracy of both for cardiogenic diseases and the diagnostic efficacy of patients with AMI. Our study found that the new method-POCT quantum dot fluorescence immunoassay had high diagnostic efficiency, which was similar to the traditional electrochemiluminescence method.
The measurements of hs-cTn by the method of Vazyme POCT quantum dot immunofluorescence and Roche electrochemiluminescence method have a good correlation (Y=37.419+131.009X, r=0.935), and also have a good consistency in the diagnosis of AMI. In addition, compared with the traditional electrochemiluminescence method, quantum dot immunofluorescence is faster and more suitable for clinical needs.
高敏心肌肌钙蛋白（hs-cTn）是心肌损伤和坏死的重要生物标志物，对急性心肌梗死（AMI）的诊断和危险分层具有重要临床意义。本研究的目的是采用一种新的更快的方法——即时检验（POCT）量子点荧光免疫分析法，确定全血样本中hs-cTn检测的准确性和灵敏度。
对2017年8月至11月在南京医科大学附属无锡第二人民医院就诊的415例疑似AMI胸痛患者的血样进行分析。我们首先采用POCT量子点荧光免疫分析法对抗凝全血进行hs-cTnI检测。样本离心后，取血浆样本采用电化学发光免疫分析法检测hs-cTnT。最终诊断由两位独立的心脏病专家确定。
首先，通过测量32例AMI患者的受试者工作特征曲线（ROC曲线）和曲线下面积（AUC），发现POCT量子点荧光免疫分析法的测量准确性相对较高（AUC为0.866，95%置信区间为0.783至0.949）。POCT量子点荧光免疫分析法与电化学发光肌钙蛋白检测法之间无统计学差异[Z值=1.527，P值=(0.063, 0.064)]。此外，该研究还计算了POCT量子点荧光免疫分析法（临界值0.04 ng/mL）的性能评估指标，并分析了ROC曲线，以比较两者对心源性疾病的诊断准确性和AMI患者的诊断效能。我们的研究发现，新方法——POCT量子点荧光免疫分析法具有较高的诊断效率，与传统电化学发光法相似。
采用万孚POCT量子点免疫荧光法和罗氏电化学发光法检测hs-cTn具有良好的相关性（Y=37.419+131.009X，r=0.935），在AMI诊断中也具有良好的一致性。此外，与传统电化学发光法相比，量子点免疫荧光法速度更快，更适合临床需求。
