微小核糖核酸122(MicroRNA-122)定量检测技术性能评估

Performance Evaluation of MicroRNA-122 Quantitative Detection Technology

目的:对微小核糖核酸122(microRNA-122)的定量检测技术进行评估,探讨其临床应用价值。方法:采用mi RFLP技术检测企业校准品、参考品和临床样本,评价该技术的分析性能与临床检测价值。结果:该方法定量下限为183 copies/μL,检测标准曲线183～1500000 copies/μL。高浓度平均回收率113.2%,低浓度平均回收率94.2%,比例系统误差为3.7%。人间精密度变异系数4.2%～1.3%;室间精密度变异系数6.4%～2.5%;批间精密度变异系数4.0%～1.5%;批内精密度变异系数4.1%～1.7%。试剂盒放置4℃12小时后的检测结果与预期靶值无明显差异。采集化疗后24小时内43例肿瘤化疗患者的血样,并分离血浆进行mi RNA-122检测,将检测结果与现行诊断标准进行ROC方法学分析,CutOff值设定为14136copies/μL,与欧盟公布的PSHT HV健康志愿组(欧洲人群)miRNA-122的13356 copies/μL(95%)基本一致。结论:基于miRNA的微小核糖核酸(miRNA-122)定量检测技术具有性能优良、准确度高、稳定性好等优点,有较高的临床应用价值。

Objective:To evaluate MicroRNA-122 quantitative detection technology and discuss its clinical application value.Methods:MiRFLP technology enterprise calibration material,reference material and clinical samples were used to evaluate the analytical performance and clinical value of the technology.Results:The quantitative lower limit of the method was 183 copies/μL.The standard curve was 183-1500000 copies/μL.The average recovery rate of high concentrations was 113.2%,the average recovery rate of low concentrations was 94.2%,proportional system error was 3.7%.Inter-human precision coefficient of variation was 4.2%-1.3%,interroom precision coefficient of variation was 6.4%-2.5%,inter-batch precision coefficient of variation was 4.0%-1.5%,and inter-assay precision coefficient of variation was 4.1%-1.7%.There was no difference between test results and the expected target value after kit was placed at 4℃for12 hours.The blood samples of 43 patients with tumor chemotherapy were collected within 24 hours after chemotherapy,and the plasma was separated for miRNA-122 detection.The clinical detection value of the technology was subjected to ROC methodological analysis according to the current diagnostic criteria.The CutOff value was set to 14136 copies/μL,which was basically the same as 13356 copies/μL(95%)of miRNA-122 of the PSHT health volunteer(HV)group(European population)published by the European Union.Conclusion:The quantitative detection technology based on miRNA(miRNA-122)has such advantages as good performance,high accuracy,good stability,etc.,and has high clinical application value.