基于新型量子点荧光标记技术的超敏肌钙蛋白I检测方法学的建立及在临床的应用研究

Establishment and Application of a New Quantum Dot Fluorescence Labeling Method for Detection of Hypersensitive Troponin I

分析基于新型量子点标记技术的超敏肌钙蛋白I(hs-cTnI)检测试剂在临床早期诊断心肌损伤中的应用价值。建立了基于新型量子点荧光标记技术的超敏肌钙蛋白I(hs-cTnI)检测方法学,对其测定肌钙蛋白I进行重复性、准确度、稳定性、样本类型差异和线性考察,并与已上市的化学发光法的c Tn I检测试剂进行性能比对。线性范围0.02~40 ng/m L,线性关系良好,重复性整体变异系数在10%以内。不同样本类型评测结果表明,肝素血浆和EDTA血浆相关系数为0.982,分离胶血清和EDTA血浆相关系数为0.985,分离胶血清和肝素血浆相关系数为0.972,说明不同样本类型的检测结果差异不显著。检测结果与化学发光法的高敏心肌肌钙蛋白I的检测结果的回归方程为y=1.0201x-0.0212,R2=0.9846,量值差异在1.02,临床相关性0.9846,具有较好的一致性。基于新型量子点荧光标记技术的hs-cTnI检测方法的检测性能达到临床使用的要求,可以投入临床使用,在心肌损伤及临床诊断中有一定的参考价值。

To investigate the value of a high-sensitivity troponin I(hs-cTnI)detection reagent based on the quantum dot labeling technique in early clinical diagnosis of myocardial injury,the ultra-sensitive troponin I(hs-cTnI)detection method based on the new quantum dot fluorescence marking technique was established,and the repetitive,sample type differences and linear examination of the determination of troponin I were established,and the performance comparison of the c Tn I detection reagent of the chemical luminescence method on the market was determined.The linear range was 0.02~40 ng/m L,the linear relationship was good,and the overall variation coefficient of repeatability was less than 10%.The results of different sample types showed that the correlation coefficient between heparin plasma and EDTA plasma was 0.982,the correlation coefficient between separated gel serum and EDTA plasma was 0.985,and the correlation coefficient between separated gel serum and heparin plasma was 0.972,which indicated that there was no significant difference among different sample types.The regression equation of the test results with the results of the high-sensitivity myocardial troponin I of a listed company’s chemical luminescence method was y=1.0201 x-0.0212,R2=0.9846,the difference in the measure was 1.02,and the clinical correlation was 0.9846,with good consistency.The detection performance of hs-cTnI detection method based on the new quantum dot fluorescence marking technique meets the requirements of clinical use,which can be put into clinical use,and has some reference value in heart muscle injury and clinical diagnosis.