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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(P<0.05);不同检测系统(P<0.05)和不同批号试剂间(P<0.05)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。
Objective To analyze the cause of the ineffective detection of Cobas s201 nucleic acid detection system by blood screening. Methods The number and type of invalid nucleic acid test results in our lab from October 2014 to December 2015 were analyzed. The detection time, detection system (A, B and C systems) and reagents were discussed in combination with the amplification curves, alarm information and test results Lot number (batch number 1, batch number 2, batch number 3, batch number 4, batch number 5 and batch number 6) and the results of the relationship between the invalid, and the type of ineffective (internal standard amplification is invalid, ineffective amplification of yin and yang, abnormal amplification curve and With a mark of the error code) distribution. Results The overall results of the detection of nucleic acid inefficiency was 0.21% (47/22 284), the largest percentage of ineffective internal standard amplification type (51.06%); ineffective results between months (P <0.05); different There was a difference in the efficiency of the test system (P <0.05) and between batches of different reagents (P <0.05), with C test system (1.59%) and Lot 2 reagent (2.11%) ineffective. Conclusion The results of nucleic acid detection ineffective with different detection systems and reagents of different batches have some relevance, the ineffective monitoring results contribute to the continuous monitoring of nucleic acid test performance.