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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(P>0.05);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(P<0.05),HBV DNA 6 d后的Ct值为(33.40±0.62)高于d1(P<0.05)。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。
Objective To investigate the feasibility and effectiveness of multi-labeling of HCV RNA, HBV DNA and HIV RNA in Roche COBAS s201 nucleic acid screening system. Methods The multi-label indoor control samples were prepared by the ratio of 1: 2: 5:22 in the ratio of 1: 2: 5:22 for the detection of negative plasma with known concentration of HCV RNA, HBV DNA and HIV RNA, and the same concentration of single item The quality control products were used as the control group, and the same day (d1) was detected by COBAS s201 nucleic acid detection system for 4 times respectively. The multi-label control products were tested 4 times a day for 7 days. The multi- The difference of Ct values of single item quality control and the change of Ct values at different storage time at 4 ℃. Statistical Analysis Our laboratory used the quality control data of multi-labeled indoor quality control products from January to August 2015 to evaluate the feasibility and effectiveness of the indoor quality control mode. Results There was no difference (P> 0.05) between Ct values detected by multi-labeling indoor control items and single-quality control samples with the same concentration at 4 ℃. The Ct values of HCV RNA and HIV RNA after 7 d were ( 37.15 ± 0.29), (36.05 ± 0.24) higher than d1 (P <0.05). The Ct value of HBV DNA after 6 d was (33.40 ± 0.62) higher than d1 (P <0.05). The mean and standard deviation (C ± s) of Ct values were 36.41 ± 0.77 for HCV RNA, 33.16 ± 0.61 for HBV DNA and 35.37 ± 0.54 for HIV RNA. The CV% of 3 items were 2.11%, 1.86% and 1.53 %, Are within the allowable range. CONCLUSION: The multi-labeling of nucleic acid for detecting the multi-marker in-house quality control product will not cause matrix effect or be inhibited by amplification. The prepared multi-label quality control product can be stably stored for 5 days under the condition of 4 ℃. Reagents, can be widely used in blood nucleic acid screening indoor quality control.