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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(P<0.05),其中A仪器IC均值小于B仪器(P<0.05),批号2 IC的Ct均值分别小于批号1和批号3(P<0.05);不同试剂批号间IC结果差异(F=94.487,P<0.05)明显高于不同仪器检测的IC结果差异(F=16.609,P<0.05);此外,5种不同标本类型的IC也存在显著差异(P<0.05),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(P<0.05),MPC组、HIV-1O组和HIV-2组间的IC差异无统计学意义(P>0.05),NC组和标本组的IC值差异不显著(P>0.05)。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。
Objective To analyze the influencing factors on the difference of COBAS s201 internal control (IC) test results and to evaluate the stability of the COBAS s201 system by using the Ct value of IC. Methods IC results of 131 batches of nucleic acids were randomly collected from January to October in 2015 in our lab. The results of different methods (A, B instruments), reagent batches (Lot 1, Lot 2 and Lot 3) and specimen types (MPC, HIV-1O, HIV-2, NC and blood donors) were divided into three groups to analyze the difference of Ct between each group and each IC. Results The 95% confidence interval was 35.18-37.34 for the Ct mean value of the IC measured in this study. The 95% confidence interval was [36.21,36.30]. There was significant difference in IC results between the A and B instruments and among the three reagent lots (P <0.05). The average value of instrument IC of instrument A was smaller than that of instrument B (P <0.05). The average Ct values of lot 2 IC were less than that of lot 1 and lot 3 (P <0.05) (P <0.05) was significantly higher than that of IC instruments detected by different instruments (F = 16.609, P <0.05). In addition, there were significant differences in IC of 5 different specimen types (P <0.05) (P <0.05). There was no significant difference in IC value between MPC group, HIV-1O group and HIV-2 group (P> 0.05) There was no significant difference in IC value between the two groups (P> 0.05). CONCLUSIONS Different reagent lot numbers and instruments can cause differences in IC value detection. It is an effective way to ensure the accuracy and stability of nucleic acid test results by verifying the performance of reagents before use and regular maintenance and calibration of instruments. Monitoring IC changes can be used as an evaluation index for laboratory internal quality control.