定值核酸质控品用于血液核酸筛查分析灵敏度验证结果分析

发布时间：2018-01-17 00:01

本文关键词：定值核酸质控品用于血液核酸筛查分析灵敏度验证结果分析　出处：《临床血液学杂志(输血与检验)》2017年02期 　论文类型：期刊论文

【摘要】：目的:通过采用定值核酸质控品进行相应稀释形成低、中、高3种浓度规格的样本进行核酸混样检测,以验证核酸筛查系统分析灵敏度是否符合要求。方法:通过对购置的商品化定值核酸室内质控品进行适当稀释制备成相应核酸检测系统检测下限(LOD)0.5倍LOD、1倍LOD、4倍LOD 3种低、中、高浓度规格,进行和献血者检测模式相同的混样检测,统计3种规格下HBV-DNA、HCV-RNA、HIV 1-RNA阳性检出率,阳性结果 Ct值平均值、标准差、变异系数以评价验证选用核酸检测系统的分析灵敏度。结果:0.5LOD范围的样本HBVDNA、HCV-RNA、HIV 1-RNA阳性检出率分别达50%、100%、95%,1LOD和4LOD范围的样本HBV-DNA、HCV-RNA、HIV 1-RNA检出率均达到100%。阳性样本的Ct值统计变异系数均小于5%。结论:采用定值核酸质控品进行核酸筛查系统分析灵敏度验证结果是可行的,对保证血液核酸筛查的质量是有意义的。
[Abstract]:Objective: to detect nucleic acid mixed samples by using fixed value nucleic acid quality control products to form low, medium and high concentration samples. To verify whether the sensitivity of nucleic acid screening system meets the requirements. Methods: the detection limit of the corresponding nucleic acid detection system was obtained by the proper dilution of the acquired commercial fixed value nucleic acid indoor quality control product. 0. 5 times LOD. Three kinds of low, medium and high concentrations of LOD were detected with 4 times of LODX, and HCV-RNA of HBV-DNA was counted in the same way as that of blood donors. HIV 1-RNA positive detection rate, positive results Ct value, standard deviation. The coefficient of variation was used to evaluate and verify the sensitivity of the selected nucleic acid detection system. Results the sample of HBV DNA in the range of 0.5 LOD was HCV-RNA. The positive rate of HIV 1-RNA was 50% and 100%, respectively. The detection rate of HIV 1-RNA was 100. The coefficients of variation of Ct values in positive samples were less than 50.Conclusion:. It is feasible to verify the sensitivity of nucleic acid screening system by using fixed value nucleic acid quality control products. It is meaningful to ensure the quality of blood nucleic acid screening.
【作者单位】：扬州市中心血站;
【分类号】：R440
【正文快照】： Validation of assay for determination of nucleic acids in blood specimensXU Shouguang SUN Haiying GAO Jingjing CHEN Xiaojing随着我国采供血机构血液核酸扩增技术(NAT)逐步推广,更多的实验室关注核酸检测的质量,更加注重核酸检测系统性能验证工作〔1〕。我国《血站质

【参考文献】