两种HCV RNA定量检测方法的临床对比研究

Clinical comparative study of two methods for quantitative detection of HCV RNA

目的对比分析某国产的丙型肝炎病毒(HCV)核酸定量检测试剂(简国产试剂)和某进口试剂(简称进口试剂),检测其对HCV血清病毒载量的相关性和一致性。方法收集2019年1月至5月期间在深圳市第三人民医院就诊的慢丙肝患者临床检测剩余血清标本132份,采用进口试剂和国产试剂,平行检测HCV感染者血清病毒载量,采用t检验、线性回归和Bland?Altman等方法进行统计分析,评价2种检测试剂检测结果的相关性和一致性。结果国产试剂和进口试剂检测结果均高于或低于检测下限的样本分别为114例和6例,检测结果一致性较高,达到90.91%(120/132)。进口试剂和国产试剂检测结果均高于检测下限的114例样本中,国产和进口试剂检测结果的平均HCV血清病毒载量分别为((2.38×10^4~5.6×10^6)IU/mL,(5.47×10^6~1.39×10^7)IU/mL,差异具有统计学意义(t=-3.32,P=0.001)。2种检测方法在病毒载量>1000 IU/mL时差异有统计学意义(t=-2.45,P=0.02),在病毒载量<1000 IU/mL时差异也具有统计学意义(t=-2.30,P=0.03)。相关分析显示,2种方法检测结果具有很强的相关性(r=0.98,P<0.001)。差异性分析显示,进口试剂与国产试剂的2者定量值差异的平均值为-0.33 log10^IU/mL,其95%可信区间为(-0.91~0.25)log10^IU/mL。96%(10^9/114)的样本检测值在95%的可信区间内。结论进口试剂与国产试剂2种试剂具有较高的相关性和一致性。

Objective To compare a domestic Hepatitis C Virus(HCV)Nucleic Acid Quantitative Assay(domestic reagent)a imported(imported reaget)and to analyze the correlation and consistency of HCV serum viral load.Methods 132 samples of residual serum samples from patients with chronic hepatitis C who were admitted to Shenzhen Third People??s Hospital from January to May 2019 were collected.Domestic reagent and imported reagent were used to detect the serum viral load of HCV infected patients in parallel.Statistical analysis was performed by methods such as t test,linear regression and Bland?Altman to evaluate the correlation and consistency of the detection results of the 2 detection reagents.Results The results of HCV viral load from 114 samples were both above the limit of detection(LOD)and 6 samples were both below the LOD determined by the domestic and imported reagents.The consistency of the 2 reagents was 90.91%(120/132).Among the 114 samples with domestic and imported detection results higher than the lower limit of detection,the average HCV serum viral load of imported and domestic reagents was(2.38×1^04~5.6×10^6)IU/mL,and(5.47×10^6~1.39×10^7)IU/mL,respectively.The difference between the 2 methods was statistically significant(t=-2.45,P=0.02)at viral load>1000 IU/mL,and the difference was statistically significant at viral load<1 000 IU/mL(t=-2.30,P=0.03).Correlation analysis showed that there was a strong correlation between the two methods(r=0.98,P<0.001).The difference analysis showed that the mean difference between the quantitative values of imported and domestic reagent reagents was-0.33 log10 IU/mL,and the 95%confidence interval was(-0.91 6~0.25)log10 IU/mL.96%(109/114)of the sample values were within the 95%confidence interval.Conclusion Domestic reagent has a high correlation and consistency with the imported reagent.