| 游延军,陈蕊,蒲小聪,彭灵犀,胡泽斌,高飞.微小核糖核酸122(MicroRNA-122)定量检测技术性能评估[J].中国药事,2019,33(1):61-66 |
| 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 |
| 投稿时间：2018-06-06 |
| DOI：10.16153/j.1002-7777.2019.01.011 |
| 中文关键词: miRNA-122 免提取 定量PCR 性能评估 |
| 英文关键词: miRNA-122 no need of extraction quantitative PCR performance evaluation |
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| 中文摘要: |
| 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miRFLP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miRNA-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。 |
| 英文摘要: |
| 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. |
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