免疫比浊法检测肌红蛋白的性能验证及临床应用评估  

Evaluation of serum myoglobin detection kit using immune turbidimetry and investigate the clinical diagnosis value of myoglobin

作　　者：刘行超[1] 曾桂芬[1] 农妍 谭秋培[1] 胡松林[1] 罗厚龙 

机构地区：[1]中国人民解放军第一八一医院检验科,广西桂林541002

出　　处：《检验医学与临床》2015年第7期883-884,887,共3页Laboratory Medicine and Clinic

基　　金：国家高技术研究发展计划(863计划)资助项目(2011AA02A111)

摘　　要：目的对免疫比浊法检测肌红蛋白（Mb）的检测性能进行评价,并对Mb的临床应用进行评估。方法检测150例健康人（健康对照组）血清Mb水平,建立参考值范围,评估免疫比浊法检测Mb的准确度、精密度、线性。对80例急性冠脉综合征（ACS）患者按心电图结果分组后,比较ACS组血清Mb浓度与健康对照组是否存在差异。对于存在差异的ACS患者,进一步收集疾病对照组,通过绘制ROC曲线,评价Mb与其他心肌标志物的诊断性能。结果健康人血清Mb参考范围为〈70.22mg/L（男）、〈52.22mg/L（女）,差异有统计学意义（t=4.39,P〈0.05）。2个水平质控检测结果为100.31、295.50mg/L,均在厂商允许偏差范围内,批内、批间变异系数（CV）均在5%以内,0~800 mg/L范围内线性良好。ACS组、非ACS组、健康对照组的Mb水平分别为（285.28±314.63）、（76.24±40.77）、（44.96±12.62）mg/L,差异有统计学意义（P〈0.05）。Mb在ACS组中的ROC曲线下面积（AUC）为0.878。在ACS组中,Mb的诊断敏感度为80.0%,优于肌钙蛋白I（cTnI）的43.7%和肌酸激酶同工酶（CK-MB）的57.5%。结论免疫比浊法检测Mb的检测性能符合要求。Objective To evaluate the performance of serum myoglobin detection kit using immune turbidimetry and investigate the clinical diagnosis value of myoglobin.Methods 150 healthy adults were enrolled in this case control study to establish serum myoglobin（Mb）reference value.The analytical performance（accuracy,precision,linearity）of serum Mb detection kit using immune turbidimetry was assessed.Eighty patients were classified into different acute coronary syndrome groups according to their electrocardiographic examination.Serum Mb level of ACS group was compared with that of normal control group.In ACS group with statistical difference,benign disease groups were further collected.Receiver operating characteristic（ROC）curve and area under curve（AUC）were used to evaluate the diagnostic value of Mb compared with other cardiac markers.Results The reference interval of Mb was〈70.22mg/L（males）and〈 52.22mg/L（females）respectively,which had statistically significant difference（t=4.39,P〈0.05）.The detection result of 2level controls was 100.31 and 295.50mg/L respectively,which were both within the acceptable limits.The within-lot and between-lot variations of four level samples were both below5%.There was a good linear correlation between theoretical value and actual detection result in range of 0-800mg/L.The serum level of Mb was（285.28±314.63）,（76.24±40.77）and（44.96±12.62）mg/L in ACS group,nonACS group and normal control group respectively,which had statistically significant difference（P〈0.05）.The AUC of Mb was 0.878 in ACS group.In ACS group,the sensitivity of Mb was higher than that of cTnI and CK-MB（80.0%,43.7% and 57.5%）.Conclusion Experimental results show that serum myoglobin detection kit using immune turbidimetry has good performance in the precision and linearity.

关 键 词：肌红蛋白 肌钙蛋白I 临床性能验证 心肌标志物 

分 类 号：R446.112[医药卫生—诊断学]