[1]蒋玲丽,杨依绡,黄中强,等.上海地区临床实验室HCV RNA检测正确度验证结果分析[J].现代检验医学杂志,2019,34(05):156-159.[doi:10.3969/j.issn.1671-7414.2019.05.040]
　JIANG Ling-li,YANG Yi-xiao,HUANG Zhong-qiang,et al.Analysis on the Results of HCV RNA Determination Trueness Verification of Clinical Laboratories in Shanghai[J].Journal of Modern Laboratory Medicine,2019,34(05):156-159.[doi:10.3969/j.issn.1671-7414.2019.05.040]
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上海地区临床实验室HCV RNA检测正确度验证结果分析()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年05期
页码:
156-159
栏目:
质量控制·实验室管理
出版日期:
2019-10-29

文章信息/Info

Title:
Analysis on the Results of HCV RNA Determination Trueness Verification of Clinical Laboratories in Shanghai
文章编号:
1671-7414(2019)05-156-04
作者:
蒋玲丽; 杨依绡; 黄中强; 王雪亮; 鲍 芸; 肖艳群
(上海市临床检验中心,上海 200126)
Author(s):
JIANG Ling-li; YANG Yi-xiao; HUANG Zhong-qiang; WANGXue-liang; BAO Yun; XIAO Yan-qun
(Shanghai Center for Clinical Laboratory,Shanghai,200126,China)
关键词:
丙型肝炎病毒;  标准物质;  正确度验证
分类号:
R512.63; R446
DOI:
10.3969/j.issn.1671-7414.2019.05.040
文献标志码:
A
摘要:
目的 分析上海地区临床实验室2018年丙型肝炎病毒核糖核酸(HCV RNA)正确度验证结果,了解上海地区HCV RNA检测质量。方法 收集临床实验室检验剩余样本,制备低、高2个浓度样本。要求临床实验室在3个不同工作日对样本分别重复检测3次,通过网络回报结果。采用国家二级标准物质对样本进行赋值,分析不同试剂组的组内变异系数(CV)和偏移以及各临床实验室的室内CV和偏移。结果 通过赋值2个正确度样本的定值分别为3.02×104和3.39×105 IU/ml。此次调查共有16家实验室上报结果,低、高2个浓度样本不同试剂组组内CV为0.78%～8.53%和0.94%～6.21%,检测结果与靶值的偏移为-4.69%～13.17%和-3.44%～6.51%。2个样本实验室室内CV为0.47%～8.53%和0.58%～6.21%; 偏移为-0.89%～13.17%和-4.88%～6.51%。2个样本的符合率分别为87.50%(14/16)和100%(16/16)。结论 上海地区大部分临床实验室HCV RNA检测重复性较好,正确度水平符合要求。
Abstract:
Objective To evaluate the determination qualityof HCV RNA in clinical laboratories in Shanghai through analyzing the results of HCV RNA determination trueness verification.Methods Remaining samples from clinical laboratories were collected,and high-level and low-level samples were prepared.These samples were determined repeatedly in three different working days,and the results were returned through network.The quantity of prepared samples was traced to a national secondary reference material.Coefficients of variation(CV)and bias were obtained and analyzed according to different reagent systems.The CV and bias of each laboratory was analyzed.Results By traceability,the concentrations of thetwo accuracy samples were 3.02×104 and 3.39×105 IU/ml,respectively.There were 16 laboratories returned the results.According to the different reagents,the CV of the two level samples were 0.78%～8.53% and 0.94%～6.21%,and the bias between determination results and target value were -4.69%～13.17% and -3.44%～6.51%,respectively.The indoor CV of each laboratory was 0.47%～8.53% and 0.58%～6.21%,and the bias was -0.89%～13.17% and -4.88%～6.51% respectively.The coincidences of the two level samples were 87.50%(14/16)and 100%(16/16)respectively.Conclusion The reproducibility and accuracy of the determination of HCV RNA were good in most clinicallaboratories of Shanghai area.

参考文献/References:

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备注/Memo

备注/Memo:
基金项目:上海第四轮公共卫生三年行动计划-卫生检验学项目(15GWZK0301)。 作者简介:蒋玲丽(1980-),女,硕士,副主任技师,主要从事分子检测质量控制,E-mail:jianglingli@sccl.org.cn。 通讯作者:肖艳群,女,本科,主要从事分子检测质量控制。
更新日期/Last Update: 2019-10-20