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(P<0.000 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,P<0.000 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。
Objective To compare a domestic HIV-1 RNA quantitative kit with two imported commercial kits.Methods Viral load was measured on plasma samples from HIV-1 RNA quantitative proficiency testing（PT）panels of virology quality assurance program（VQA）of the national institutes of health（NIH）by using the domestic kit and two imported kits,respectively.The correlation and concordance were analyzed between the domestic and imported kits by using t-test,linear regression and Bland-Altman analyses.Results There was a high correlation between the results of the domestic and two imported reagents with coefficient determination（R^2） of 0.94 and 0.93,respectively（P0.0001）.In addition,there was a good concordance in viral load measurements among the three kits by using Bland-Altman analyses.Moreover,there was a high correlation between the results produced by the domestic reagent and the known viral loads of VQA samples（R^2=0.97,P0.0001）.Derived quantitation unit conversion factor was 0.79,as 1 IU/ml equaled 0.79 copies/ml.Conclusion It is demonstrated that the results of the three HIV-1 RNA quantitative kits have high correlation and concordance.However,the price of the domestic kit is cheaper,which makes it more applicable in various settings for the assessment of efficacy of antiviral therapy.
出处
《中国艾滋病性病》
CAS
CSCD
北大核心
2017年第7期592-595,共4页
Chinese Journal of Aids & STD
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)~~
