用于HIV-1 DNA检测的滤纸片干血斑能力验证质控品的制备及应用

发布时间：2017-12-28 18:39

本文关键词：用于HIV-1 DNA检测的滤纸片干血斑能力验证质控品的制备及应用　出处：《中国艾滋病性病》2016年05期 　论文类型：期刊论文

【摘要】：目的制备用于艾滋病病毒1型(HIV-1)DNA检测的干血斑能力验证质控品,并对其均一性和稳定性进行评估。方法培养仅含单拷贝的缺陷型HIV-1基因的8E5细胞,使用HIV-1阴性全血进行倍比稀释后,滴加到滤纸片上,制备成含有不同拷贝数8E5细胞的滤纸片干血斑。在不同温度条件下放置不同时间,然后使用雅培Real-time HIV-1定性检测试剂盒对其进行检测、整理并分析检测结果,评价滤纸片干血斑能力验证质控品的均一性和稳定性。结果滤纸片干血斑随机抽样平行检测结果完全一致;-20℃或4℃放置1年,室温放置3个月或在37℃放置4天,检测结果均一致。在应用性评价中,参加能力验证项目的15家实验室检测结果全部正确,制备的滤纸片干血斑作为质控品效果良好。结论使用8E5细胞制备的HIV-1DNA定性检测能力验证质控品的均一性、稳定性良好,是一种可用于目前中国HIV-1DNA定性检测能力验证质控品制备方法。
[Abstract]:Objective to prepare a quality control product for testing the dry blood spot capacity for detection of HIV 1 (HIV-1) DNA, and to evaluate its homogeneity and stability. Methods 8E5 cells containing only one copy of the defective HIV-1 gene were cultured, and HIV-1 negative whole blood was diluted to the filter paper to prepare dried blood spots of filter paper containing different copies of 8E5 cells. They were placed at different temperatures for different periods. Then the Abbott Real-time HIV-1 qualitative detection kit was used to detect, sort out and analyze the test results, and evaluate the ability of filter paper dry blood spot to verify the homogeneity and stability of quality control products. Results the results of random sampling parallel test for filter paper dry spot were the same. The results were consistent at -20 C or 4 C for 1 years, 3 months at room temperature or 4 days at 37 C. In the application evaluation, the results of the 15 laboratory tests were all correct, and the dried blood spot of the filter paper was good as a quality control product. Conclusion the qualitative detection ability of HIV-1DNA prepared by 8E5 cells is very good. The quality control products have good homogeneity and stability. It is a preparation method for quality control products of HIV-1DNA qualitative testing in China.
【作者单位】：中国疾病预防控制中心性病艾滋病预防控制中心;
【基金】：国家科技重大专项(2015ZX10001001-002)~~
【分类号】：R512.91
【正文快照】： Supported by the National key sdT special projects of China(2015ZX10001001-002)艾滋病病毒I型(Human immunodeficiency vi-rus type I,HIV-1)DNA检测以其高灵敏度和高特异度,常用来作为血清学不确定结果的验证和补充。而由于HIV阳性孕妇所生产婴儿体内来自于母体的HIV抗

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