荧光免疫微流定量检测急性心肌梗死三联的性能及诊断效果评价

Evaluation of the performance and diagnostic effect of fluorescence immunomicrofluidics in quantitative detection of 3 indicators of acute myocardial infarction

目的评价荧光免疫微流定量检测急性心肌梗死(AMI)三联(简称心梗三联)[肌红蛋白(Myo)、肌酸激酶同工酶(CK-MB)和肌钙蛋白I(cTnI)]的性能及在AMI中的诊断效果。方法选择2018年11月至2019年5月该院诊治的疑似AMI患者53例为研究对象,其中经冠状动脉造影确诊的AMI(AMI组)33例,冠心病等其他疾病(非AMI组)20例。选取同期健康体检者30例为对照组。采用esLabs hyper i300全自动干式荧光免疫分析仪、微流控定量试剂盒(免疫荧光法)检测心梗三联,分析心梗三联对AMI的诊断性能及验证仪器精密度。结果3组Myo、CK-MB和cTnI水平比较,差异均有统计学意义(P<0.05)。ROC曲线分析结果显示,cTnI诊断AMI的AUC值大于Myo、CK-MB及Myo+CK-MB+cTnI串联、并联(P<0.05)。Myo+CK-MB+cTnI并联诊断AMI的灵敏度(97.0%)高于Myo、CK-MB及Myo+CK-MB+cTnI串联(P<0.05)。Myo+CK-MB+cTnI串联诊断AMI的特异度(100.0%)高于Myo、CK-MB及Myo+CK-MB+cTnI并联(P<0.05)。荧光免疫微流定量检测Myo、CK-MB、cTnI的批间、批内精密度均不超过10%,符合判定标准。结论荧光免疫微流定量检测心梗三联性能良好,诊断效果佳,能基本满足AMI的辅助诊断应用,可用于临床实验室。

Objective To evaluate the performance of fluorescence immunomicrofluidics in quantitative detection of 3 indicators of acute myocardial infarction(AMI)[myoglobin(Myo),creatine kinase isoenzyme(CK-MB)and cardiac troponin I(cTnI)],and its diagnostic effect in AMI.Methods From November 2018 to may 2019,53 patients suspected diagnosis of AMI in the hospital were selected as the study objects,including 33 patients with AMI(AMI group)confirmed by coronary angiography and 20 patients with coronary heart disease and other diseases(non AMI group),30 healthy persons were selected as the control group.Eslabs hyper i300 automatic fluorescence immunoanalyzer and microfluidic quantitative Kit(immunofluorescence)were used to detect the Myo,CK-MB and cTnI,analyzed the diagnostic performance of Myo,CK-MB and cTnI,and verified the precision of the instrument.Results The differences of the levels of Myo,CK-MB and cTnI in the three groups were statistically significant(P<0.05).ROC curve analysis showed that AUC of cTnI in diagnosing AMI was higher than that of Myo,CK-MB,Myo+CK-MB+cTnI in series and parallel(P<0.05).The sensitivity of Myo+CK-MB+cTnI in parallel diagnosis of AMI(97.0%)was higher than that of Myo,CK-MB and Myo+CK-MB+cTnI in series(P<0.05).The specificity of Myo+CK-MB+cTnI in series diagnosis of AMI(100.0%)was higher than that of Myo,CK-MB and Myo+CK-MB+cTnI in parallel(P<0.05).The inter and intra assay precision of Myo,CK-MB and cTnI were less than 10%,which met the criteria.Conclusion Fluorescence immunomicrofluidic in quantitative detection of Myo,CK-MB and cTnI has good performance and diagnosis effect,which can basically meet the application of AMI auxiliary diagnosis,and can be applied to clinical laboratories.