血清中总cTnI、全长cTnI与cTnI-C复合物联合检测方法的建立及其临床应用  

Establishment and clinical application of combined detection of total serum cTnI,full-length cTnI and cTnI-C compound

作　　者：陈浩[1] 张丽[1] 吴健 黄飚 周秀梅[1] CHEN Hao;ZHANG Li;WU Jian;HUANG Biao;ZHOU Xiumei(College of Life Sciences and Medicine,Zhejiang Sci-Tech University,Hangzhou 310018,China;Department of Laboratory Medicine,The First People′s Hospital of Yancheng City,Yancheng 224005,China)

机构地区：[1]浙江理工大学生命科学与医药学院,杭州310018 [2]江苏省盐城市第一人民医院,盐城224005

出　　处：《浙江理工大学学报（自然科学版）》2021年第1期94-102,共9页Journal of Zhejiang Sci-Tech University(Natural Sciences)

摘　　要：通过时间分辨荧光免疫分析法(Time-resolved fluorescence immunoassay,TRFIA)建立血清中全长cTnI、总cTnI、cTnI-C复合物的联合检测方法并进行方法学评估,并采用总cTnI、cTnI-C复合物及全长cTnI/总cTnI比值分析心肌损伤程度、发病时长及疗效。结果表明:Total-cTnI-TRFIA(检测总cTnI)灵敏度为0.030 ng/mL,检测范围为0.030~40.000 ng/mL,回收率为106.62%,与临床检测方法相关性最高(R^2=0.9225),阳性检出率为100.00%;Full-cTnI-TRFIA(检测全长cTnI)灵敏度为0.007 ng/mL,检测范围为0.007~40.000 ng/mL,回收率为102.23%,与临床检测方法相关性最低(R^2=0.6238),阳性检出率为90.90%;cTnI-C-TRFIA(检测cTnI-C)灵敏度为0.011 ng/mL,检测范围为0.011~40.000 ng/mL,回收率为92.15%,与临床检测方法相关性居中(R^2=0.8868),阳性检出率为98.70%。三种方法批内和批间的变异系数均小于10.00%。对3名心肌损伤患者进行连续检测,结果表明:总cTnI和cTnI-C复合物的浓度可以准确反映患者心肌损伤的程度;全长cTnI占比可以更好地提示发病时间,对预后的提示更早。联合检测血清全长cTnI与总cTnI并计算全长cTnI占比具有更好的临床诊疗前瞻性,有助于心肌损伤的诊断与疗效评估。The time-resolved fluorescence immunoassay(TRFIA)was used to establish a combined detection method for full-length cTnI,total cTnI,and cTnI-C compound in serum for methodological evaluation.Total cTnI,cTnI-C compound and the specific value between full-length cTnI and total cTnI were used to analyze the degree of myocardial damage,onset time and curative effect.The results showed that the sensitivity of Total-cTnI-TRFIA(detection of total cTnI)was 0.030 ng/mL;the detection range was 0.030~40.000 ng/mL;the recovery rate was 106.62%;the correlation with the clinical detection method was the highest(R^2=0.9225),and the positive detection rate was 100%.The sensitivity of Full-cTnI-TRFIA(detection of full-length cTnI)was 0.007 ng/mL;the detection range was 0.007~40.000 ng/mL;the recovery rate was 102.23%;the correlation with the clinical detection method was the lowest(R^2=0.6238),and the positive detection rate was 90.90%.The sensitivity of cTnI-C-TRFIA(detection of cTnI-C)was 0.011 ng/mL;the detection range was 0.011~40.000 ng/mL;the recovery rate was 92.15%;the correlation with the clinical detection method was moderate(R^2=0.8868);the positive detection rate was 98.70%.In the above three methods,the variable coefficients within and between batches were<10.00%.In the analysis of three consecutively tested patients,the concentration of total cTnI and cTnI-C compound can accurately reflect the degree of myocardial injury in patients,and the proportion of full-length cTnI can prompt the prognosis earlier and better indicate the time of onset.The combined detection of serum full-length cTnI and total cTnI and the calculation of the proportion of full-length cTnI have better prospect for clinical diagnosis and treatment,and are helpful for the diagnosis and therapeutic effect evaluation of myocardial injury.

关 键 词：心肌损伤 总cTnI 全长cTnI cTnI降解 时间分辨荧光免疫分析 

分 类 号：R542.2[医药卫生—心血管疾病]