中国医学装备2024，Vol.21Issue(5)：16-19,25,5.DOI:10.3969/j.issn.1672-8270.2024.05.003
即时检测仪器与电化学发光仪检测心脏标志物的对比研究
Comparative study of POCT instruments and Roche electrochemiluminescence instrument in detecting myocardial biomarkers
摘要
Abstract
Objective:To compare and analyze the correlation between two kinds of point-of-care testing (POCT) instruments and Roche electrochemiluminescence instrument in detecting myocardial biomarkers,so as to provide reference for the selection of POCT instruments in clinical testing. Methods:A total of twenty patient's samples were selected,which concentration range covered the reportable range of detection results. Two kinds of POCT instruments (named respectively A and B) were used to detect the concentrations of plasma myoglobin (Myo),creatine kinase isoenzyme mass (CK-MB mass),cardiac troponin I(cTnI),and N-terminal fragment of B-type natriuretic peptide (NT-proBNP)/Brain natriuretic peptide (BNP). The results of the electrochemiluminescence instrument were used as reference,and Pearson correlation analysis and Kappa test evaluation were used to evaluate respectively the correlation and consistency of the detected results between the two kinds of POCT instruments and Roche electrochemiluminescence instrument. Results:Our study demonstrated that there were good correlations in the detected results of Myo,CK-MB mass,cTnI,NT-proBNP/BNP between the instrument A and Roche electrochemiluminescence instrument,and between the instrument B and Roche electrochemiluminescence instrument (rinstrumentA=0.994,0.989,0.917,0.996,rinstrumentB=0.928,0.934,0.883,0.977,P<0.05),respectively. In the comparisons about consistencies,the concordance rates between instrument A and electrochemiluminescence instrument were respectively 90％,100％,70％ and 100％ in detecting Myo,CK-MB,cTnI and NT-proBNP,and the concordance rates between instrument B and electrochemiluminescence instrument were respectively 90％,100％,70％ and 100％ in detecting them. Both two kinds of POCT instruments had favorable consistencies with Roche electrochemiluminescence instrument (Kappainstrument A=0.798,1.00,0.429,1.00,Kappainstrument B=0.794,0.886,0.429,1.00),respectively. The precisions of both instruments were less than 10％. Conclusion:Both two kinds of POCT instruments can meet the requirements of clinical test,which have favorable correlations with electrochemiluminescence instrument in detecting myocardial biomarkers.关键词
即时检测(POCT)仪器/心脏标志物/电化学发光/分析性能Key words
Point of care testing(POCT)/Myocardial biomarkers/Electrochemiluminescence/Analysis performance分类
医药卫生引用本文复制引用
刘文娟,郭盼,杜娟,张何锐,王雅平,王海龙,徐佳,李琦..即时检测仪器与电化学发光仪检测心脏标志物的对比研究[J].中国医学装备,2024,21(5):16-19,25,5.基金项目
科技部国家重点研发计划(2019YFF0216502) The National Key Research and Development Program of China(Grant No.2019YFF0216502) （2019YFF0216502）
