摘要
目的:了解Roche公司Cobas PCR试剂与国产HBV荧光定量PCR试剂对HBV DNA检测的差异性,以更好地指导抗病毒治疗。方法:采用相关性分析来评价Cobas检测和国产检测对不同HBV DNA载量标本的精确性。结果:将全部标本的检测结果进行相关性分析,国产试剂与Roche试剂具有较好的相关性(r=0.612,P=0.004)。将标本分别按照以下5个病毒载量分级:10^(3)~10^(4),10^(3)~10^(5),10^(3)~10^(6),10^(3)~10^(7),10^(3)~10^(8)(copy/ml),则国产试剂检测结果与Roche定量结果的相关性分别为:相关系数r=-0.129,0.107,0.13,0.304,0.295,检测P值分别为:0.287,0.378,0.283,0.011,0.013。70例中国产试剂检测结果低于检测下限的标本有43例,而Roche检测结果处于检测下限的有17人(39.5%),余下26例(60.5%)的病毒载量均能检测到(处于10^(2)~10^(6) copy/ml范围内):其中,处于10^(2)~10^(3)的有10例,处于10^(3)~10^(4)的有9例,处于10^(4)~10^(5)的有2例,处于10^(5)~10^(6)范围内的有5例。国产试剂检测结果≤1000 copy/ml而Roche检测结果>1000 copy/ml的标本有16例,占37.2%。结论:总体上国产试剂与Roche试剂具有较好的相关性。病毒载量在10^(7) copy/ml以上的两者检测精度相似。国产试剂对病毒载量低于≤10^(6) copy/ml范围内的与Roche检测相关性较差,尤其低于国产检测下限的标本更需要采用Roche检测。
Objective:To understand the difference between Roche's Cobas PCR reagent and domestic HBV fluorescent quantitative PCR reagents for HBV DNA detection,to better guide antiviral treatment.Methods:Correlation analysis was used to evaluate the accuracy of Cobas test and domestic test on different HBV DNA load specimens.Results:Correlation analysis was performed on the test results of all specimens.The domestic reagents had good correlation with Roche reagents r=0.612,P=0.004).The samples were graded according to the following five viral loads:10^(3)~10^(4),10^(3)~10^(5),10^(3)~10^(6),10^(3)~10^(7),10^(3)~10^(8)(copy/ml).The correlation between the test results of domestic reagents and the quantitative results of Roche were different.The correlation coefficients are:r=-0.129,0.107,0.13,0.304,0.295,and the detection P values are:0.287,0.378,0.283,0.011,0.013.There were 43 cases of 70 Chinese-made reagents with lower than the lower detection limit And the Roche test results were in the lower limit of detection of 17 people(39.5%),and the remaining 26 cases(60.5%)of the viral load could be detected(within the range of 10^(2)~10^(6) copy/ml):Among them,those at 10^(2)~10^(3) There were 10 cases,9 cases at 10^(3)~10^(4),2 cases at 10^(4)~10^(5),and 5 cases at 10^(5)~10^(6).There were 16 specimens with domestic reagent test results≤1000 copy/ml and Roche test results>1000 copy/ml,accounting for 37.2%.Conclusion:In general,domestic reagents have good correlation with Roche reagents.The detection accuracy of the two with viral load above 107 copy/ml was similar.Domestic reagents have a poor correlation with Roche detection when the viral load is less than or equal to 10^(6) copy/ml,especially Roche detection is required for samples below the domestic detection limit.
作者
巫智勇
叶英
WU Zhi-yong;YE Ying(The first affiliated hospital of Anhui medical university,Hefei Anhui,230032,China)
出处
《中西医结合肝病杂志》
CAS
2021年第4期366-368,共3页
Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases
