M16磁敏免疫分析仪检测性能评价
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摘要
目的对M16磁敏免疫分析仪的检测性能进行评价。方法选择2018年5月在重庆医科大学附属永川医院就诊的门诊和住院患者静脉肝素抗凝血液标本30份,采用心肌肌钙蛋白I(cTnI)、肌红蛋白(Myo)、肌酸激酶同工酶(CK-MB)(磁敏免疫法)检测试剂盒,通过定值质控品对M16磁敏免疫分析仪的精密度、线性性能和正确度进行评价,同时采用Roche Cobas E602全自动电化学发光检测仪测定Myo、CK-MB水平,进行相关性分析。结果 M16磁敏免疫分析仪精密度变异系数(CV)≤15%,cTnI、Myo、CK-MB的线性相关系数r≥0.99,测定相对偏倚≤15%,均符合仪器厂商的声明性能;测定结果和电化学发光法检测结果间具有良好的相关性,Myo和CK-MB的R2分别为0.984和0.986。结论作为第3代POCT产品,M16磁敏免疫分析仪可为临床医师提供快速、准确、可靠的临床决策支持。
Objective To evaluate the performance of M16 Magnetic Sensitive Immunoanalyzer.Methods Using the detection reagent kit of troponin I(cTnI),myoglobin(Myo)and creatine kinase isoenzyme(CK-MB)(magnetoimmunity method),the precision,linear performance and trueness of M16 Magnetic Sensitive Immunoanalyzer were evaluated.Concentrations of Myo,CK-MB in thirty heparin anticoagulation blood samples,which collected from outpatients and inpatients in Yongchuan Hospital,Chongqing Medical University in May 2018,were detected by M16 Magnetic Sensitive Immunoanalyzer and Roche Cobas E602 automatic electrochemical luminescence detector simultaneously.The two results were conducted correlation analysis.Results The coefficient of variation(CV)for precision of M16 Magnetic Sensitive Immunoanalyzer was lower than 15%.Linearly dependent coefficients of cTnI,Myo and CK-MB were all greater than 0.99.Measurement relative bias for trueness was less than 15%.These performance parameters were comply with the manufacturer′s stated performance.Myo and CK-MB results obtained by M16 Magnetic Sensitive Immunoanalyzer and electrochemical luminescence detector had better correlation,and R2 equal to 0.984 and 0.986 respectively.Conclusion M16 Magnetic Sensitive Immunoanalyzer,as a typical third generation POCT,can provide fast,accurate and reliable decision support for clinicians.
Objective To evaluate the performance of M16 Magnetic Sensitive Immunoanalyzer.Methods Using the detection reagent kit of troponin I(cTnI),myoglobin(Myo)and creatine kinase isoenzyme(CK-MB)(magnetoimmunity method),the precision,linear performance and trueness of M16 Magnetic Sensitive Immunoanalyzer were evaluated.Concentrations of Myo,CK-MB in thirty heparin anticoagulation blood samples,which collected from outpatients and inpatients in Yongchuan Hospital,Chongqing Medical University in May 2018,were detected by M16 Magnetic Sensitive Immunoanalyzer and Roche Cobas E602 automatic electrochemical luminescence detector simultaneously.The two results were conducted correlation analysis.Results The coefficient of variation(CV)for precision of M16 Magnetic Sensitive Immunoanalyzer was lower than 15%.Linearly dependent coefficients of cTnI,Myo and CK-MB were all greater than 0.99.Measurement relative bias for trueness was less than 15%.These performance parameters were comply with the manufacturer′s stated performance.Myo and CK-MB results obtained by M16 Magnetic Sensitive Immunoanalyzer and electrochemical luminescence detector had better correlation,and R2 equal to 0.984 and 0.986 respectively.Conclusion M16 Magnetic Sensitive Immunoanalyzer,as a typical third generation POCT,can provide fast,accurate and reliable decision support for clinicians.
引文
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[11]安园.分析急性心肌梗死诊断中心肌损伤标志物联合应用的临床价值[J].影像研究与医学应用,2018,2(6):18-19.
[12]TANYANYIWA D,DANDARA C,BHANA S A,et al.Implementation of POCT in the diabetic clinic in a large hospital[J].Afr Health Sci,2015,15(3):902-907.
[13]GAO T,CAO X,GE P,et al.A self-assembled fluorescent organic nanoprobe and its application for sulfite detection in food samples and living systems[J].Org Biomol Chem,2017,15(20):4375-4382.
[14]梁玉庚,孙笑菊,武飞飞,等.胶体金免疫层析法与化学发光法在心肌梗死诊断中的价值比较[J].中国老年学杂志,2017,37(22):5601-5602.
[15]胥国强,康清秀,李文楷,等.5种床旁检测法与Abbott化学发光法检测心肌标志物的对比研究[J].四川医学,2018,39(2):157-160.
[2]曹俐,颜敏,黄海萍.即时检测(POCT)发展现状和存在问题探讨[J].中国药事,2016,30(6):556-559.
[3]张红燕,王莉清,王清江,等.基于巨磁阻抗效应的生物磁敏传感器技术[J].化学传感器,2008,28(1):3-7.
[4]中华人民共和国国家卫生和计划生育委员会.临床检验定量测定项目精密度与正确度性能验证:WS/T 492-2016[S].北京:中国标准出版社,2016.
[5]PENNO E C,CRUMP J A,BAIRD S J.Performance Requirements to Achieve Cost-Effectiveness of Point-of-Care Tests for Sepsis Among Patients with Febrile Illness in Low-Resource Settings[J].Am J Trop Med Hyg,2015,93(4):841-849.
[6]黄静沁,左玫,李智,等.POCT法与Roche电化学发光法检测心肌标志物的比较[J].检验医学,2010,25(9):734-736.
[7]贺喜艳.POCT法和Roche电化学发光法对心肌标志物的检测比较[J].临床医学,2014,34(11):112-113.
[8]王彬,岳化葵,熊玮,等.POCT检测肌红蛋白对心肌梗死的诊断价值[J].检验医学与临床,2018,15(5):722-724.
[9]SANJAY S T,FU G,DOU M,et al.Biomarker detection for disease diagnosis using cost-effective microfluidic platforms[J].Analyst,2015,140(21):7062-7081.
[10]FAN J,MA J,XIA N,et al.Clinical Value of Combined Detection of CK-MB,MYO,cTnI and Plasma NT-proB-NP in Diagnosis of Acute Myocardial Infarction[J].Clin Lab,2017,63(3):427-433.
[11]安园.分析急性心肌梗死诊断中心肌损伤标志物联合应用的临床价值[J].影像研究与医学应用,2018,2(6):18-19.
[12]TANYANYIWA D,DANDARA C,BHANA S A,et al.Implementation of POCT in the diabetic clinic in a large hospital[J].Afr Health Sci,2015,15(3):902-907.
[13]GAO T,CAO X,GE P,et al.A self-assembled fluorescent organic nanoprobe and its application for sulfite detection in food samples and living systems[J].Org Biomol Chem,2017,15(20):4375-4382.
[14]梁玉庚,孙笑菊,武飞飞,等.胶体金免疫层析法与化学发光法在心肌梗死诊断中的价值比较[J].中国老年学杂志,2017,37(22):5601-5602.
[15]胥国强,康清秀,李文楷,等.5种床旁检测法与Abbott化学发光法检测心肌标志物的对比研究[J].四川医学,2018,39(2):157-160.