一种国产HIV核酸定量试剂与进口试剂的对比研究

发布时间：2018-05-06 18:10

本文选题：型艾滋病病毒 + 病毒载量　；参考：《中国艾滋病性病》2017年07期

【摘要】：目的对比研究国产1型艾滋病病毒(HIV-1)核酸定量试剂与两个进口试剂的相关性和差异,以期应用国产核酸定量试剂评价中国抗病毒治疗患者病毒学效果的可行性。方法应用美国国家卫生研究院病毒学质量评价项目(VQA)发放的HIV-1核糖核酸(RNA)血清样品,比较一种国产核酸定量试剂与国内市场常规使用的两个进口试剂,在测定病毒载量上的相关性和一致性。对国产和进口核酸定量试剂检测HIV-1病毒载量的结果进行配对t检验,线性回归分析和Bland-Altman分析。结果国产试剂和两个进口试剂的检测结果的线性相关系数R2分别为0.94、0.93(P0.000 1);Bland-Altman分析三种试剂病毒载量的结果具有较高的一致性,国产试剂定量值与VQA病毒载量值线性相关系数R2=0.97,P0.000 1,定量单位转换系数为1IU/mL=0.79拷贝/mL。结论国产HIV-1核酸定量试剂与进口试剂在定量检测结果上有较好的相关性和一致性,而且国产试剂在价格上具有优势,在一定范围内可以应用于抗病毒治疗效果的评价。
[Abstract]:Objective to study the correlation and difference between domestic and imported nucleic acid quantitative reagents of HIV-1, and to evaluate the feasibility of using domestic nucleic acid quantitative reagents to evaluate the virological effect of antiviral therapy in China. Methods the serum samples of HIV-1 ribonucleic acid (HIV-1) RNA from the virology quality evaluation project of the National Institutes of Health (NIH) were used to compare a domestic nucleic acid quantitative reagent with two imported reagents which were routinely used in the domestic market. Correlation and consistency in the determination of viral load. The results of detection of HIV-1 viral load by domestic and imported nucleic acid quantitative reagents were analyzed by paired t test, linear regression analysis and Bland-Altman analysis. Results the linear correlation coefficient R ~ 2 of domestic reagent and two imported reagent were 0.94 ~ 0.93 P0.000 ~ (-1) Bland-Altman analysis results of virus load of three reagents had high consistency. The linear correlation coefficient between the quantitative value of domestic reagents and the load value of VQA virus was R _ (2) O _ (97) (P _ (0.000 1)), and the quantification unit conversion coefficient was 1IU/mL=0.79 copy / mL. Conclusion there is good correlation and consistency between domestic HIV-1 nucleic acid quantitative reagents and imported reagents, and domestic reagents have advantages in price and can be used to evaluate the effect of antiviral therapy in a certain range.
【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】：国家自然科学基金(81471962) 广西八桂学者艾滋病防控关键技术岗位专项经费国家科技重大专项艾滋病和病毒性肝炎等重大传染病防治(2012ZX10001-002)~~
【分类号】：R512.91

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