血液筛查核酸检测结果无效原因分析

Analysis of the result invalidation in nucleic acid amplification technology for blood screening

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 result invalidation in Cobas s201 nucleic acid detection systems（NAT） for blood screening. Methods The number and types of invalid results in NAT from October 2014 to December2015 were counted. When combined with the amplification graphs,alarm information and test results,the relationship among detection time,detection systems（ system A,B and C） and reagent lots（ Lot 1,Lot 2,Lot 3,Lot 4,Lot 5 and Lot 6） and result invalidation were analyzed. Also,the distribution and composition of various types of invalid results（ interior standard amplification invalidation,negative or positive control amplification invalidation,amplification graph abnormality and error codes with flags） were analyzed. Results The total rate of result invalidation in the lab was 0. 21%（47 /22 284）. Among the types of invalidation,the proportion of interior standard amplification invalidation was the most（51. 06%）. There were significant differences in the rates of the result invalidation in different months（ χ^2= 21. 600,P〈0. 05）. There were significant differences in the rates of the result invalidation among detection systems（ χ^2= 28. 76,P〈0. 05） and among different reagent lots（ χ^2= 35. 737,P〈0. 05）. The rates of the result invalidation in the detection systems C were higher,and were the highest in reagent Lot 2. Conclusion There was some correlation between different detection systems,different reagent lots and result invalidation. Monitoring the result invalidation closely will help to continuously monitor the nucleic acid detection performance.