[1]李育敏,徐 怡,阚丽娟,等.荧光定量PCR测定HBV DNA测量不确定度的评定与应用探讨[J].现代检验医学杂志,2019,34(03):151-155.[doi:10.3969/j.issn.1671-7414.2019.03.039]
　LI Yu-min,XU Yi,KAN Li-juan,et al.Investigation on the Estimation and Application of the Uncertainty ofHepatitis B Virus DNA Determination by Fluorescence Quantitative PCR[J].Journal of Modern Laboratory Medicine,2019,34(03):151-155.[doi:10.3969/j.issn.1671-7414.2019.03.039]
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荧光定量PCR测定HBV DNA测量不确定度的评定与应用探讨()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年03期
页码:
151-155
栏目:
质量控制·实验室管理
出版日期:
2019-06-20

文章信息/Info

Title:
Investigation on the Estimation and Application of the Uncertainty ofHepatitis B Virus DNA Determination by Fluorescence Quantitative PCR
文章编号:
1671-7414(2019)03-151-05
作者:
李育敏; 徐 怡; 阚丽娟; 张水兰; 汤花梅; 许晓清; 熊 丹; 张秀明
(深圳市罗湖区人民医院医学检验科,广东深圳 518001)
Author(s):
LI Yu-min; XU Yi; KAN Li-juan; ZHANG Shui-lan; TANGHua-mei; XU Xiao-qing; XIONG Dan; ZHANG Xiu-ming
(Department of Clinical Laboratory,Shenzhen Luohu People's Hospital,Guangdong Shenzhen 518001,China)
关键词:
测量不确定度;  荧光定量聚合酶链式反应(PCR);  乙型肝炎病毒;  脱氧核糖核酸(DNA)
分类号:
Q503
DOI:
10.3969/j.issn.1671-7414.2019.03.039
文献标志码:
A
摘要:
目的 探讨荧光定量聚合酶链式反应(PCR)测定乙型肝炎病毒核酸(HBV DNA)测量不确定度的评定与临床应用价值。方法 采用批内不精密度和批间不精密度数据评定A类不确定度,采用参加卫生部临床检验中心的室间质评(EQA)数据评定B类不确定度; 根据A类和B类不确定度结果确定合成不确定度和扩展不确定度; 利用不确定度进行HBV DNA检测结果的比较,并建立不确定度报告模型。结果 采用EQA靶值评定偏移引入的不确定度Ubias,以偏移与偏移的标准差评定偏移的不确定度,扩展不确定度U1(k=1.96,n=2)在检测值为103和106 IU/ml时分别为0.330 2和0.249 6,而以方法和实验室偏移评定偏移的不确定度,扩展不确定度U2分别为0.307 6和0.239 4; 采用同方法组均值评定Ubias,U1分别为0.315 9和0.230 4,U2分别为0.292 2和0.219 3。如前后两次检测结果均在本实验室测量,取U为0.330 2,两者差值≥0.46(LOG值),差异具有统计学意义。结论 荧光定量PCR测定HBV DNA引入扩展不确定度使结果具有可比性,有助于临床对患者体内病毒复制水平及抗病毒疗效的评价。
Abstract:
Objective To explore the estimation and application value of the uncertainty of hepatitis B virus DNA determination by fluorescence quantitative PCR.Methods The uncertainty of Type Awas evaluated by the data of within-run and between-run imprecision.The uncertainty of Type B was evaluated according to the data of external quality assessments from the National Center for Clinical Laboratory.The combined uncertainties and expanded uncertainties were evaluated and analyzed.The model of uncertainty of HBV DNA results were established and the different results could be compared and analyzed by the uncertainty.Results The expandeduncertainties(U1)estimated by bias and standard deviation of bias in 103 IU/ml and 106 IU/ml concentrations were 0.330 2 and 0.249 6(k=1.96,n=2),according to the data from bias uncertainty [U(bias)] calculated by the target value of EQA,and the U2 estimated by method and laboratory bias were 0.307 6 and 0.239 4.The U1 were 0.315 9 and 0.230 4,according to thedata from U(bias) calculated by the same method group mean of EQA,and theU2 were 0.292 2 and 0.219 3.The difference of the two results had statistically significant difference as it was greater than 0.46(LOG,U=0.330 2)whenthe results detected both in our lab.Conclusion Expanded uncertainty could be compared in different results of HBV DNA by fluorescencequantitative PCR,and it also could help clinic to evaluate viral replication levels of patients and clinical efficacy of anti-viral therapy.

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备注/Memo

备注/Memo:
基金项目:深圳市医疗卫生三名工程(SZSM201601062)。 作者简介:李育敏(1982-),女,硕士,主治医师,研究方向:分子诊断。 通讯作者:张秀明,E-mail:zxm0760@163.com。 收稿日期:2019-03-10 修回日期:2019-03-31
更新日期/Last Update: 2019-06-20