两种检测系统测定血清肌红蛋白、肌酸激酶同工酶-MB及心肌肌钙蛋白I的比较实验研究(1)
【摘要】 目的：探讨两种检测系统测定血清肌红蛋白(Myo)、肌酸激酶同工酶-MB(CK-MB)及心肌肌钙蛋白I(cTnI)结果的可比性。方法：依据美国临床实验室标准化协会(CLSI)EP9-A3文件，收集西南医科大学附属医院临床血清样品50例，采用西门子化学发光仪(ADVIA Centaur? XP)和三联生物微阵列化学发光仪(SLXP-002)同时测定血清中Myo、CK-MB和cTnI的浓度并进行统计学分析。结果：两种检测系统测定血清Myo、CK-MB和cTnI浓度的相关系数分别为0.980、0.997和0.984(P<0.05)。阳性符合率分别为93.3%、88.9%、100%，阴性符合率分别为97.2%、97.6%、97.5%。两种方法一致性检验的Kappa值分别为Myo(K=0.905，P=1.58×10-10)，CK-MB(K=0.864，P=9.78×10-10)、cTnI(K=0.940，P=2.79×10-11)。Myo和CK-MB在医学决定水平5 ng/ml和72.0 ng/ml的偏倚分别为8.61%和8.14%。结论：三联生物微阵列化学发光法与西门子化学发光法测定血清Myo、CK-MB和cTnI的结果有较好的相关性和一致性，可用于临床血清Myo、CK-MB和cTnI的检测。
【关键词】 肌红蛋白; 肌酸激酶同工酶-MB; 心肌肌钙蛋白I; 评价研究
doi：10.14033/j.cnki.cfmr.2019.16.031 文献标识码 B 文章编号 1674-6805(2019)16-00-03
【Abstract】 Objective：To evaluate the comparability of two test systems for serum myoglobin(Myo)，creatine kinase isoenzyme-MB(CK-MB) and cardiac troponin I(cTnI) detection.Method：A total of 50 serum samples from the Affiliated Hospital of the Southwest Medical University were collected according to the Clinical and Laboratory Standard Institute(CLSI) document EP9-A3，and measured both by the SIEMENS chemiluminescence analyzer(ADVIA Centaur? XP) and the Sanlant micro-array chemiluminescence instrument.The test results of serum samples were analyzed with statistical tools.Result：There were significant relationship of these two test systems for serum Myo(r=0.980，P<0.05)，CK-MB (r=0.997，P<0.05) and cTnI(r=0.984，P<0.05) concentrations.The positive coincidence rate of these two test systems were 93.3%，88.9%，and 100%，and the negative coincidence rate were 97.2%，97.6%，and 97.5%，respectively.The Kappa analysis revealed a significant consistency of the two methods for serum Myo(K=0.905，P=1.58×10-10)，CK-MB (K=0.864，P=9.78×10-10) and cTnI (K=0.940，P=2.79×10-11) detection，respectively.The bias of Myo and CK-MB were 8.61% and 8.14% at the medical determination levels of 5.0 ng/ml and 72.0 ng/ml in serum.Conclusion：Serum Myo，CK-MB and cTnI concentrations detected by the Sanlant micro-array chemiluminescence instrument showed a good correlation and consistency with the SIEMENS chemiluminescence analyzer.The Sanlant micro-array chemiluminescence instrument is suitable for serum Myo，CK-MB and cTnI measurement.
【Key words】 Myoglobin; Creatine kinase isoenzyme-MB; Cardiac troponin I; Evaluation study
First-author’s address：The Affiliated Hospital of Southwest Medical University，Luzhou 646000，China
急性心肌梗死(acute myocardial infarction，AMI)是冠狀动脉病变后血供急剧减少或中断，心肌严重、持久缺血导致的急性心肌坏死[1]。AMI严重威胁患者生命，早期诊断、及时治疗是降低患者死亡率和改善预后的关键[2]。肌红蛋白(myoglobin，Myo)、肌酸激酶同工酶-MB(creatine kinase isoenzyme，CK-MB)和心肌肌钙蛋白I/T(cardiac troponin I/T，cTnI/cTnT)是临床常用的心肌损伤标志物，在AMI的临床诊断、疗效评估和并发症的鉴别诊断中具有重要作用[3-4]。目前，临床检测血清Myo、CK-MB、cTnI和cTnT多采用进口仪器和配套试剂，成本均较高。为积极响应国家对国产仪器的研发、转化与应用，扩大国产科学仪器的市场占有率[5]。本研究以西门子化学发光检测系统为参照，首次评估三联生物微阵列化学发光免疫分析系统和西门子化学发光检测系统测定血清Myo、CK-MB和cTnI的准确性和一致性，为国产仪器、试剂和新方法的临床应用提供实验依据。, http://www.100md.com(田刚 丁俊杰 刘靳波 吴堂明 李光荣)
【关键词】 肌红蛋白; 肌酸激酶同工酶-MB; 心肌肌钙蛋白I; 评价研究
doi：10.14033/j.cnki.cfmr.2019.16.031 文献标识码 B 文章编号 1674-6805(2019)16-00-03
【Abstract】 Objective：To evaluate the comparability of two test systems for serum myoglobin(Myo)，creatine kinase isoenzyme-MB(CK-MB) and cardiac troponin I(cTnI) detection.Method：A total of 50 serum samples from the Affiliated Hospital of the Southwest Medical University were collected according to the Clinical and Laboratory Standard Institute(CLSI) document EP9-A3，and measured both by the SIEMENS chemiluminescence analyzer(ADVIA Centaur? XP) and the Sanlant micro-array chemiluminescence instrument.The test results of serum samples were analyzed with statistical tools.Result：There were significant relationship of these two test systems for serum Myo(r=0.980，P<0.05)，CK-MB (r=0.997，P<0.05) and cTnI(r=0.984，P<0.05) concentrations.The positive coincidence rate of these two test systems were 93.3%，88.9%，and 100%，and the negative coincidence rate were 97.2%，97.6%，and 97.5%，respectively.The Kappa analysis revealed a significant consistency of the two methods for serum Myo(K=0.905，P=1.58×10-10)，CK-MB (K=0.864，P=9.78×10-10) and cTnI (K=0.940，P=2.79×10-11) detection，respectively.The bias of Myo and CK-MB were 8.61% and 8.14% at the medical determination levels of 5.0 ng/ml and 72.0 ng/ml in serum.Conclusion：Serum Myo，CK-MB and cTnI concentrations detected by the Sanlant micro-array chemiluminescence instrument showed a good correlation and consistency with the SIEMENS chemiluminescence analyzer.The Sanlant micro-array chemiluminescence instrument is suitable for serum Myo，CK-MB and cTnI measurement.
【Key words】 Myoglobin; Creatine kinase isoenzyme-MB; Cardiac troponin I; Evaluation study
First-author’s address：The Affiliated Hospital of Southwest Medical University，Luzhou 646000，China
急性心肌梗死(acute myocardial infarction，AMI)是冠狀动脉病变后血供急剧减少或中断，心肌严重、持久缺血导致的急性心肌坏死[1]。AMI严重威胁患者生命，早期诊断、及时治疗是降低患者死亡率和改善预后的关键[2]。肌红蛋白(myoglobin，Myo)、肌酸激酶同工酶-MB(creatine kinase isoenzyme，CK-MB)和心肌肌钙蛋白I/T(cardiac troponin I/T，cTnI/cTnT)是临床常用的心肌损伤标志物，在AMI的临床诊断、疗效评估和并发症的鉴别诊断中具有重要作用[3-4]。目前，临床检测血清Myo、CK-MB、cTnI和cTnT多采用进口仪器和配套试剂，成本均较高。为积极响应国家对国产仪器的研发、转化与应用，扩大国产科学仪器的市场占有率[5]。本研究以西门子化学发光检测系统为参照，首次评估三联生物微阵列化学发光免疫分析系统和西门子化学发光检测系统测定血清Myo、CK-MB和cTnI的准确性和一致性，为国产仪器、试剂和新方法的临床应用提供实验依据。, http://www.100md.com(田刚 丁俊杰 刘靳波 吴堂明 李光荣)