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

目的:对比分析两种即时检测(POCT)仪器与Roche电化学发光仪检测心脏标志物的相关关系,为临床检验选择POCT仪器提供参考。方法:选取2020年11月在中国中医科学院西苑医院就诊的20例患者血液样本,其浓度范围覆盖检测结果可报告范围,使用两种POCT仪器(分别命名为仪器A和仪器B)检测血浆肌红蛋白(Myo)、肌酸激酶同工酶质量(CKMB mass)、心肌钙蛋白I(cTnI)、氨基末端脑钠肽前体(NT-proBNP)/B型钠尿肽(BNP)的浓度水平,以电化学分析仪检测结果为参考,分别采用pearson相关分析和Kappa检验评价两种POCT仪器与Roche电化学发光仪检测结果的相关性和一致性。结果:仪器A和仪器B检测结果与Roche电化学发光仪检测Myo、CK-MB mass、cTnI、NT-proBNP/BNP结果均有较好的相关性(r_(仪器A)=O.994、0.989、0.917、0.996,r_(仪器B)=0.928、0.934、0.883、0.977,P<0.05)。在一致性比较中,仪器A检测Myo、CK-MB mass、cTnI、NT-proBNP与电化学分析仪的符合率分别为90%、100%、70%和100%;仪器B检测结果的符合率分别为90%、95%、70%和100%,两种POCT仪器与Roche电化学发光仪均具有较好的一致性(Kappa_(仪器A)=0.798、1.00、0.429、1.00,Kappa_(仪器B)=0.794、0.886、0.429、1.00)。两种仪器的精密度均<10%。结论:两种POCT仪器均能满足临床检测要求,在检测心脏标志物时与电化学发光仪有较好的相关性。

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(r_(instrumentA)=0.994,0.989,0.917,0.996,r_(instrumentB)=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(Kappa_(instrumentA)=0.798,1.00,0.429,1.00,Kappa_(instrumentB)=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.