您好，欢迎访问天津市农业科学院 机构知识库！
天津市农业科学院机构知识库

全部

  • 全部
  • 标题
  • 学者
  • 机构
  • 关键词

Establishment of primary reference measurement procedures and reference materials for EGFR variant detection in non-small cell lung cancer

文献类型： 外文期刊

作者： Wang, Xia 1 ; Zhang, Yongzhuo 1 ; Niu, Chunyan 1 ; Wang, Shangjun 2 ; Li, Liang 3 ; Guo, Yong 4 ; Zhu, Lingxiang 5 ; Jin, 1 ;

作者机构： 1.Natl Inst Metrol, Ctr Adv Measurement Sci, Beijing 100029, Peoples R China

2.Nanjing Inst Measurement & Testing Technol, Nanjing 210049, Peoples R China

3.Chinese Acad Agr Sci, Biotechnol Res Inst, Beijing 100081, Peoples R China

4.Tsinghua Univ, Sch Med, Collaborat Innovat Ctr Diag & Treatment Infect Di, Dept Biomed Engn, Beijing 100084, Peoples R China

5.Natl Res Inst Hlth & Family Planning, Human Genet Resource Ctr, Beijing 100081, Peoples R China

6.China Agr Univ, Beijing Adv Innovat Ctr Food Nutr & Human Hlth, Coll Food Sci & Nutr Engn, Beijing 100083, Peoples R China

7.Chinese Acad Inspect & Quarantine, Beijing 100176, Peoples R China

8.Tianjin Acad Agr Sci, Tianjin Inst Agr Qual Standard & Testing Technol, Tianjin 300381, Peoples R China

9.Beijing Ctr Phys & Chem Anal, IBeijing Engn Technol Res Ctr Gene Sequencing & G, Beijing 100093, Peoples R China

期刊名称：ANALYTICAL METHODS （ 影响因子：2.596； 五年影响因子：2.296 ）

ISSN： 1759-9660

年卷期： 2021 年 13 卷 18 期

页码：

收录情况： SCI

摘要： Circulating tumor DNA (ctDNA)-based mutation detection is promising to change the clinical practice of genotype-directed therapy for cancer. A growing number of non-invasive tests for cancer screening and monitoring that involve the detection of ctDNA have been commercialized. Primary reference measurement procedures (PRMPs) and reference materials (RMs) are urgently needed to assess the non-invasive tests. In this study, a PRMP based on digital PCR (dPCR) and ctDNA RMs for quantification of the frequently occurring variant in epidermal growth factor receptor (EGFR L858R, T790M, and 19Del) in non-small cell lung cancer (NSCLC) were established. The candidate dPCR PRMP showed high specificity (false positive rate 0-0.003%), good repeatability (coefficient of variance (CV), 2-3% for 10(4) copies/reaction), and high interlaboratory reproducibility (3-10%). A good linearity (0.97 < slope < 1.03, R-2 >= 0.9999) between the measured mutant (MU) value and prepared value was observed for all assays over the fractional abundance (FA) range, between 25% and 0.05%. The limit of quantification (LoQ) was determined to be 34 L858R, 23 T790M, and 34 19Del copies/reaction, corresponding to a FA of 0.2%. An inter-laboratory study of using the EGFR ctDNA RMs and dPCR assays demonstrated that the participating laboratories produced consistent concentrations of MU and wild-type (WT), as well as FA. This study demonstrates that dPCR can act as a potential PRMP for EGFR mutation for validation of NSCLC genotyping tests and ctDNA quantitative tests. The PRMP and RMs established here could improve interlaboratory repeatability and reproducibility, which supports rapid translation and application of non-invasive tests into clinical practice.

  • 相关文献
作者其他论文 更多>>
置顶
购物车
反馈

© 京ICP备09089781号-29 主办单位：天津市农业科学院

学术资源： 中国农业科学院 农业专业知识服务系统 农科联盟资源共建共享平台 中国农业科技文献与信息服务平台 中国农业期刊集成服务平台