血液筛查核酸检测内标在系统评价的应用分析

发布时间：2018-08-11 16:48

【摘要】：目的分析COBAS s201核酸血筛系统内标(internal control,IC)检测结果差异的影响因素,探讨利用IC的Ct值评价检测系统的稳定性。方法随机抽取本室2015年1-10月共131批次的核酸检测的IC结果,按不同仪器(A、B仪器)、试剂批号(批号1、批号2和批号3)和标本类型(MPC、HIV-1O、HIV-2、NC和献血者标本)分别分成3组,分析各组间及组内各IC的Ct均值的差异。结果本室测定IC的Ct均值的95%参考范围为35.18-37.34;95%置信区间为[36.21,36.30];A、B仪器间以及3个试剂批号间的IC结果差异均有统计学意义(P0.05),其中A仪器IC均值小于B仪器(P0.05),批号2 IC的Ct均值分别小于批号1和批号3(P0.05);不同试剂批号间IC结果差异(F=94.487,P0.05)明显高于不同仪器检测的IC结果差异(F=16.609,P0.05);此外,5种不同标本类型的IC也存在显著差异(P0.05),其中标本组和NC组IC的Ct值分别大于MPC组、HIV-1O组和HIV-2组(P0.05),MPC组、HIV-1O组和HIV-2组间的IC差异无统计学意义(P0.05),NC组和标本组的IC值差异不显著(P0.05)。结论不同试剂批号和仪器能引起IC值检测差异,做好试剂使用前性能确认和仪器定期维护校准是保障核酸检测结果准确稳定的有效方法;监测IC变化可作为实验室内部质量控制的评价指标。
[Abstract]:Objective to analyze the influencing factors of internal control IC (internal control IC) in COBAS s201 nucleic acid screening system, and to evaluate the stability of the system by using the Ct value of IC. Methods the IC results of 131 batches of nucleic acid from January to October 2015 were randomly selected and divided into three groups according to different instruments (AGB instrument), reagent lot number (batch number 1, lot number 2 and batch number 3) and specimen type (MPC-HIV-1 OgHIV-2 NC and blood donor specimen), respectively. The difference of Ct value of IC between and within groups was analyzed. Results the 95% reference range of Ct mean in our laboratory was 35.18-37.3495% confidence interval was [36.21 / 36.30] there were significant differences between the IC results of AHB instrument and three reagent batches (P0.05), in which the IC value of A instrument was lower than that of B instrument (P0.05), and the IC of batch number 2IC was lower than that of batch number 2IC. Ct mean value was lower than batch number 1 and batch number 3 (P0.05), IC results of different reagent batches were significantly higher than those of different instruments (P 0.05), in addition, there were significant differences in IC of 5 different types of specimens (P0.05). The IC value of NC group was higher than that of MPC group and HIV-2 group (P0.05). There was no significant difference between HIV-2 group and HIV-2 group (P0.05). There was no significant difference in IC value between NC group and specimen group (P0.05). Conclusion different batch numbers and instruments can lead to the difference of IC values. It is an effective method to ensure the accuracy and stability of nucleic acid detection results by confirming the performance of reagents and maintaining and calibrating the instrument regularly before the use of reagents. Monitoring IC changes can be used as an evaluation index of laboratory internal quality control.
【作者单位】：东莞市中心血站;
【基金】：东莞市医疗卫生类科研一般项目(编号:201510515000740)
【分类号】：R446.6

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