摘要
目的研究免疫比浊法CKMBmass,通过检测临床随机样本以及检测临床中活性法CKMB倒置的样本,验证CKMBmass与化学发光平台肌酸激酶同工酶MB(CK-MB)测值一致性;再使用受试者工作特征(ROC)曲线以金标准高敏肌钙蛋白I临床判断为参照,验证CKMBmass准确性。方法CKMBmass使用贝克曼AU5811生化分析仪、CK-MB与高敏肌钙蛋白I(cTnI)使用Abbott i2000化学发光仪进行检测。收集24例CKMBmass与CK-MB同时检测的倒置样本,验证测值一致性;随机抽取45例CKMBmass与CK-MB同时检测的血清样本,验证相关性;CKMBmass与cTnI同时测定AMI组样本与非AMI组样本,使用ROC曲线进行分析,验证CKMBmass准确性。结果24例倒置样本,CKMBmass测值与Abbott CK-MB测值相同,阴阳性一致;45例随机样本,CKMBmass与Abbott CK-MB测值的回归方程为Y=1.002X-0.080;AMI组与非AMI组比较差异有统计学意义(P<0.05),CKMBmass AUC为0.963。结论CMBMmass抗干扰能力及相关性与化学发光法CK-MB一致,针对AMI诊断与高敏cTnI符合度高,满足临床需求。
Objective To study the CKMBmass by immunoturbidimetric method and verify the consistency of CKMBmass and method of chemiluminescence platform creatine kinase isoenzyme MB(CK-MB)by testing clinical random samples and samples of CKMB inverted in the active method in clinical setting.The receiver operating characteristic(ROC)curve was referenced to the clinical judgment with gold standard of high-sensitivity troponin I to verify the accuracy of CKMBmass.Methods CKMBmass was detected by Beckman AU5811 biochemical analyzer,while CK-MB and high-sensitivity troponin I(cTnI)were detected by Abbott i2000 chemiluminescence meter.24 inverted samples of CKMBmass and CK-MB were collected to verify the consistency of the measured values.45 serum samples of CKMBmass and CK-MB were detected at random to verify their correlations.CKMBmass and cTnI were used to measure AMI group samples and non-AMI samples simultaneously.The results were analyzed using ROC curve to verify the accuracy of CKMBmass.Results In 24 inverted samples,the CKMBmass measurement was the same as the Abbott CK-MB measurement,and the direction of negative-positive was the same.In 45 random samples,the regression equation of the CKMBmass and Abbott CK-MB measurement was Y=1.002X-0.080.There was a significant difference in the non-AMI group(P<0.05),and CKMBmass AUC was 0.963.Conclusion The anti-interference ability and correlation of CMBMmass are consistent with the chemiluminescence method CK-MB.The diagnosis of AMI is highly consistent with the high-sensitivity cTnI,which meets the clinical needs.
作者
苏保满
叶中倪
杨琳梅
周洲
SU Baoman;YE Zhongni;YANG Linmei;ZHOU Zhou(Experimental Diagnostic Center of Fuwai Cardiovascular Hospital,Beijing 100037,China)
出处
《标记免疫分析与临床》
CAS
2020年第10期1806-1809,共4页
Labeled Immunoassays and Clinical Medicine
基金
首都卫生发展科研专项自主创新项目心(编号:首发-2-4034)