HIV-1 DNA定量检测干血斑室内质控品的制备及应用  

Preparation and application of the internal quality control sample of DBS for HIV-1 DNA test

作　　者：王月华[1] 陈凯 程焕义 赫晓霞[1] 姚均[1] 邢文革[1] 蒋岩[1] WANG Yuehua;CHEN Kai;CHENG Huanyi;HE Xiaoxia;YAO Jun;XING Wenge;JIANG Yan(National Center for AIDS/STD Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China)

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心,北京102206

出　　处：《中国艾滋病性病》2020年第5期466-469,475,共5页Chinese Journal of Aids & STD

基　　金：广东省省级科技计划项目(2016B020238002)。

摘　　要：目的研制用于艾滋病病毒(HIV)脱氧核糖核酸(DNA)(HIV-1 DNA)定量检测的室内质控品,通过室内质控品的使用,保证HIV-1 DNA定量检测的实验室质量。方法用HIV阴性全血倍比稀释8E5细胞,滴加到滤纸片上,制备成干血斑(DBS)。评价其均一性与稳定性。在日常HIV-1 DNA定量检测过程中,同时检测DBS室内质控品,并建立Levey-Jennings(L-J)质控图进行分析。结果1×10~6个/mL的8E5细胞经过1000倍稀释后制备成本实验室HIV-1 DNA定量检测的DBS室内质控品,其均一性与稳定性均符合要求。建立的L-J质控图,HIV-1 DNA log的均值为2.99,标准差为0.13,精密度为4.24%。当样本的加样量、检测人员等发生变化时,均发生失控状态。结论自制的DBS室内质控品用于本实验室HIV-1 DNA检测的质量控制是可行的,可以满足实验室常规检测内部质控需求。Objective The study was to develop a kind of internal quality control sample of dried blood spots(DBS) for HIV-1 DNA test. Through the application of the internal quality, the quality of HIV-1 DNA test could be guaranteed. Methods A known number of freshly grown 8 E5 cells were diluted by HIV-negative whole blood, and dripped onto a filter paper to make DBS. The dilution times of the weak positive in the linear range were then determined, and HIV-1 DNA DBS internal quality control products were prepared to evaluate the homogeneity and stability. Simultaneously the DBS internal quality control products were detected in the daily HIV-1 DNA detection process. The Levey-Jennings(L-J) quality control chart was established and analyzed. Results The 8E5 cells of 1x10^6 cell/ml were diluted by 1 000 times, DBS were made as HIV-1 DNA internal quality control products, and the homogeneity and stability met the standards. The mean of HIV-1 DNA log was 2.99 of the L-J quality control chart, a standard deviation was 0.13, and a precision was 4.24%. When the sample size and the inspectors change, they were all out of control. Conclusion The internal quality control products of self-made DBS for HIV-1 DNA detection in this laboratory is feasible, and can meet routine laboratory testing.

关 键 词：艾滋病病毒 室内质控品 干血斑 脱氧核糖核酸 

分 类 号：R373.9[医药卫生—病原生物学]