基于Probit回归的核酸检测系统分析灵敏度验证

Sensitivity analysis of nucleic acid detection system based on Probit regression

目的:基于Probit回归,计算核酸血液检测系统所能检测到的分析物最低浓度,以验证核酸检测试剂在血站实验室常规使用中的分析灵敏度与试剂说明书中声明的一致性,保证核酸检测的质量。方法:使用核酸试剂对核酸系列分析灵敏度血清盘进行检测,统计HBV-DNA,HIV-RNA,HCV-RNA等每个浓度样本的重复检出率,应用SPSS统计学软件的Probit模块,计算出每个项目的95%检出限。结果:HBV-DNA的95%检出限为4.568IU/ml,HIV-RNA的95%检出限为46.000IU/ml,HCV-DNA 95%检出限为46.600IU/ml,均优于试剂说明书中声明的95%检出限。结论:基于Probit回归,使用核酸试剂对核酸系列分析灵敏度血清盘进行检测,能够准确计算出检测项目的95%检出限,直观判断实验室分析灵敏度是否在可接受范围之内。

Objective:To calculated the lowest concentration of analyte detected by nucleic acid blood test system based on Probit regression,and verify the consistency between the analytical sensitivity of nucleic acid testing reagents in routine use in blood station laboratories and the declaration in reagent specifications to ensure the quality of nucleic acid testing.Method:Nucleic acid reagents were used to detect the sensitivity of serum plates for nucleic acid series analysis.The repeated detection rates of HBV-DNA,HIV-RNA,HCV-RNA and other samples were calculated.Using the Probit module of SPSS statistical software,the 95%detection limit of each item was calculated.Result:The detection limit of HBV-DNA,HIV-RNA and HCV-DNA was 4.568 IU/ml,46.000 IU/ml and 46.600 IU/ml repectively,which were all better than the 95%limit stated in the reagent specification.Conclusion:Based on Probit regression,nucleic acid reagents can be used to detect the sensitivity of serum plate of nucleic acid series analysis.The detection limit of 95%of the items can be calculated accurately,and the sensitivity of laboratory analysis can be directly judged within the acceptable range.