多标记室内质控品在血液核酸筛查的应用分析

发布时间：2018-12-11 01:34

【摘要】：目的探讨HCV RNA、HBV DNA和HIV RNA多标记室内质控品在罗氏COBAS s201核酸血筛系统应用的可行性和有效性。方法用已知浓度HCV RNA、HBV DNA和HIV RNA室内质控标准品与核酸检测阴性血浆按1∶2∶5∶22的体积比配制成多标记室内质控品,同时配制相同浓度的单项目质控品作为对照组,配制当天(d1)用COBAS s201核酸检测系统单检模式分别检测4次,此后每天检测多标记质控品4次,连续检测7 d,分析多标记室内质控品与单项目质控品Ct值的差异以及4℃条件下不同保存时间Ct值的变化。统计分析本室2015年1-8月使用多标记室内质控品的质控数据,评价该室内质控模式的可行性和有效性。结果多标记室内质控品各项目与相同浓度的单项目质控品检测Ct值比较无差异(P0.05);在4℃条件下,HCV RNA和HIV RNA 7 d后的Ct值分别为(37.15±0.29)、(36.05±0.24)高于d1(P0.05),HBV DNA 6 d后的Ct值为(33.40±0.62)高于d1(P0.05)。各项目Ct值的均值和标准差(x±s),HCV RNA为36.41±0.77、HBV DNA为33.16±0.61、HIV RNA为35.37±0.54;3项目的 CV%分别为2.11%、1.86%和1.53%,均在允许范围内。结论核酸检测多标记室内质控品不会发生基质效应或被扩增抑制,配制后多标记室内质控品在4℃条件下可稳定保存至5 d;多标记室内质控品配制简便,节省试剂,可推广应用于血液核酸筛查室内质量控制。
[Abstract]:Objective to investigate the feasibility and effectiveness of HCV RNA,HBV DNA and HIV RNA multi-label indoor quality control in COBAS s201 nucleic acid screening system. Methods HCV RNA,HBV DNA and HIV RNA indoor quality control standard and nucleic acid negative plasma were used to prepare multi-label indoor quality control products according to the volume ratio of 1: 2: 5: 22, and single item quality control products of the same concentration were prepared as the control group. On the day of preparation (D1), COBAS s201 nucleic acid detection system was used to detect four times respectively, and thereafter, multi-marker quality control products were detected 4 times a day, and continuously detected for 7 days. The difference of Ct value between multi-label indoor quality control product and single item quality control product and the change of Ct value of different preservation time at 4 鈩，

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