一种乙型肝炎病毒-DNA实时荧光定量聚合酶链反应试剂的质量评价  

Evaluation of Sansure one-step Hepatitis B virus DNA quantitative fluorescence diagnostic kit

作　　者：柳直英 哈斯朝鲁[1] Liu Zhiying;Hasichaolu(Department of Laboratory Medicine,the First Hospital of Shanxi Medical University,Taiyuan 030001,China)

机构地区：[1]山西医科大学第一医院医学实验室,太原030001

出　　处：《实用医技杂志》2018年第8期826-829,共4页Journal of Practical Medical Techniques

摘　　要：目的评价国产圣湘一步法乙型肝炎病毒(HBV)-DNA实时荧光定量聚合酶链反应(PCR)试剂盒(以下简称一步法定量试剂)的检测效能。方法首先用一步法定量试剂和Roche定量试剂2种定量试剂对不少于20份临床样本进行平行检测,评价其相关性和符合率;对阳性血清进行梯度稀释后再检测,从定量线性范围、准确性、灵敏度、精密度等方面对其检测效能进行评价。结果 (1)精密度:圣湘试剂在高低2个浓度水平的批内和批间变异系数(CV)值均<5%,且符合原国家卫生和计划生育委员会的相关要求。(2)准确度:根据圣湘和Roche试剂的检测结果绘制回归直线方程y=0.972x+0.512,R^2=0.984,说明两者结果的差异无统计学意义,具备高度的相关性及一致性。(3)灵敏度:圣湘试剂检测5.00×10n U/m L的样本检出率100%,CV值也小于相关要求。(4)线性范围:根据圣湘试剂梯度稀释的定量结果绘制回归直线方程为y=1.025x-0.159,R^2=0.998。结论圣湘一步法试剂在定量线性范围、精密度、灵敏度、准确度均符合临床PCR检测要求,具有较好的检测性能,可用于临床HBV-DNA检测。Objective To compare performance characteristics of a novel doestie （Hunan Sansure） HBV DNA quantitative fluorescence diagnostic kit. Methods Firstly, parallel detection was conducted on a total of no less than 20 clinical samples by two quantitative reagents of one-step quantitative reagent and Roche quantitative reagent. The correlation and coincidence rate were evaluated. The positive serum was tested after gradient dilution. And its detection efficiency was evaluated from the quantitative linearity range, accuracy, sensitivity-, degree of precision and other aspects. Results 1 Degree of precision： the intra and inter-assay CV values of Sansue reagent were all lower than 5% in high and low levels, and it accorded with the relevant requirements of the Ministry of Health. （ Degree of accuracy ： according to the detection results of Sansue and Roche reagents, the regression linear equation was y=0.972x＋0.512, R2=0.984, indicating that the difference between the two results was not significant, with a high degree of correlation and consistency. （3 Sensitivity-： Sansue reagent detected the sample detection rate of 5.00×10n＇ U/mL was 100% and CV value was also lower than the relevant requirement. （4 Linearity range ： according to the quantitative results of＇ gradient dilution of Sansue reagent, the regression linear equation was y=l.025x-0.159, R2=0.998. Conclusion The Sansue one-step reagent meets the requirements of clinical PCR detection in quantitative linearity range, degree of precision, sensitivity- and degree of accuracy, with good performance detection, which can be used for clinical HBV DNA detection.

关 键 词：乙型肝炎病毒 DNA病毒 试剂盒 诊断 评价研究 

分 类 号：R440[医药卫生—诊断学] R512.62[医药卫生—临床医学]