血液筛查核酸检测结果无效原因分析

发布时间：2019-03-16 20:59

【摘要】：目的分析血液筛查Cobas s201核酸检测系统检测结果无效产生的原因。方法统计本室2014年10月-2015年12月核酸检测结果无效的次数和类型,结合扩增曲线图、报警信息和检测结果,探讨检测时间、检测系统(A、B和C系统)和试剂批号(批号1、批号2、批号3、批号4、批号5和批号6)与结果无效的发生的关系,以及各无效类型(内标扩增无效、阴阳对照扩增无效、扩增曲线异常和带标记的错误代码)的分布构成。结果本室核酸检测总结果无效率为0.21%(47/22 284),内标扩增无效类型所占比例最大(51.06%);各月份之间结果无效率有差异(P0.05);不同检测系统(P0.05)和不同批号试剂间(P0.05)的结果无效率有差异,其中C检测系统(1.59%)和批号2试剂(2.11%)结果无效率较高。结论核酸检测结果无效发生与不同检测系统和不同批号试剂有一定相关性,监测结果无效率有助于持续监控核酸试验性能。
[Abstract]:Objective to analyze the causes of ineffective detection results of Cobas S201 nucleic acid detection system in blood screening. Methods from October 2014 to December 2015, the number and type of invalid nucleic acid detection results in our department were counted. The detection time and detection system (A, C) were discussed with the amplification curve, alarm information and detection results. (B and C systems) and reagent lot numbers (batch number 1, batch number 2, batch number 3, batch number 4, batch number 5 and batch number 6) and the occurrence of invalid results, as well as the types of invalidity (internal standard amplification invalid, yin-yang control amplification invalid, Expansion curve exception and marked error code) distribution composition. Results the total inefficiency of nucleic acid detection was 0.21% (47 / 22,284), and the percentage of ineffective type of internal standard amplification was the largest (51.06%), and there was significant difference in inefficiency among the months (P0.05). The results of different detection systems (P0.05) and different batches of reagents (P0.05) were ineffective. The results of C test system (1.59%) and batch number 2 reagent (2.11%) were ineffective. Conclusion there is a certain correlation between the invalid results of nucleic acid detection and different detection systems and different batches of reagents. The inefficiency of monitoring results is helpful to continuously monitor the performance of nucleic acid tests.
【作者单位】：东莞市中心血站;
【基金】：东莞市医疗卫生类科技计划一般项目(2015105101245)
【分类号】：R446.6

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