[1]蒋玲丽,黄中强,王雪亮,等.表皮生长因子受体(EGFR)基因突变检测质控品制备及应用[J].现代检验医学杂志,2020,35(02):145-148.[doi:10.3969/j.issn.1671-7414.2020.02.040]
 JIANG Ling-li,HUANG Zhong-qiang,WANG Xue-liang,et al.Development and Application of Quality Control Materials for EpidermalGrowth Factor Receptor (EGFR)Mutation Determination[J].Journal of Modern Laboratory Medicine,2020,35(02):145-148.[doi:10.3969/j.issn.1671-7414.2020.02.040]
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表皮生长因子受体(EGFR)基因突变检测质控品制备及应用()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年02期
页码:
145-148
栏目:
质量控制
出版日期:
2020-05-24

文章信息/Info

Title:
Development and Application of Quality Control Materials for EpidermalGrowth Factor Receptor (EGFR)Mutation Determination
文章编号:
1671-7414(2020)02-148-05
作者:
蒋玲丽黄中强王雪亮鲍芸王青肖艳群
(上海市临床检验中心,上海 200126)
Author(s):
JIANG Ling-liHUANG Zhong-qiangWANG Xue-liangBAO YunWANG QingXIAO Yan-qun
(Shanghai Center for Clinical Laboratory,Shanghai 200126,China)
关键词:
非小细胞肺癌表皮生长因子受体(EGFR)质控品
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2020.02.040
文献标志码:
A
摘要:
目的 制备模拟临床样本的表皮生长因子受体(epidermal growth factor receptor EGFR)基因突变检测质控品,评估其临床适用性。方法 选择含EGFR 不同突变位点和无EGFR 突变位点细胞,培养收集后制作成蜡卷。用三种临床常用试剂盒检测,并评估其均一性和稳定性。将含不同突变型5 份样本的样本盘,随机编码后发送至参评实验室,评价回报结果。结果 三种不同试剂检测样本盘结果一致。结果显示质控品均匀, 室温放置可稳定12 个月。28 家实验室5 个样本符合率分别为92.88%,96.43%,78.57%,96.43% 和100%,突变型样本和野生型样本的符合率分别为91.07%(102/112)和100%(28/28)。结论 研制的EGFR 基因突变质控品具有较好的临床适用性,可用于室内质量控制和室间质量评价。

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备注/Memo

备注/Memo:
基金项目:上海市卫生和计划生育委员会资助项目 (201640187)。作者简介:蒋玲丽(1980-),女,硕士,副主任技师,主要从事免疫学和分子生物学的质量控制工作。通讯作者:肖艳群,本科,主任技师,Tell:021-68316300-2303。收稿日期:2019-11-29修回日期:2020-01-31
更新日期/Last Update: 2020-04-30