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Construction of a reference material panel for detecting KRAS by Jun Xu; Shoufang Qu; Nan Sun; Wenxin Zhang; Juanli Zhang; Qingtao Song; Mufei Lin; Wei Gao; Qiaosong Zheng; Mipeng Han; Chenglong Na; Ren Xu; Xiaoyan Chang; Xuexi Yang; Jie Huang is a Medicine article available to read on EtoBox.

What is Construction of a reference material panel for detecting KRAS about?

## Background The absence of high-quality next-generation sequencing (NGS) reference material (RM) has impeded the clinical use of liquid biopsies with plasma cell-free DNA (cfDNA) in China. ## Objective This study aimed to develop a national RM panel for external quality assessment and performance evaluation during kit registration of non-small-cell lung cancer (NSCLC)-related Kirsten rat sarcoma viral oncogene (__KRAS__)/neuroblastoma ras oncogene (__NRAS__)/epidermal growth factor receptor (__EGFR__)/B-type Raf kinase (__BRAF__)/mesenchymal–epithelial transition factor (__MET__) genetic assays using plasma circulating tumor DNA (ctDNA). ## Methods Mutation cell lines detected by NGS and validated by Sanger sequencing were selected to establish the RM. Cell line genomic DNA was sheared and used to spike basal plasma cfDNA at 10% concentration. Then, the calibration accuracy was determined by four sequencing platforms. Average values were adopted and diluted to 0.1%, 0.3%, 1% and 3% concentrations with basal plasma as the RM panel. Then, five manufacturers were invited to evaluate the performance of the RM panel. ## Results 20 cell lines with 23 clinically important mutations were

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Author
Jun Xu; Shoufang Qu; Nan Sun; Wenxin Zhang; Juanli Zhang; Qingtao Song; Mufei Lin; Wei Gao; Qiaosong Zheng; Mipeng Han; Chenglong Na; Ren Xu; Xiaoyan Chang; Xuexi Yang; Jie Huang
Publisher
BMJ Publishing Group
Published
2020
Language
EN
Field
Medicine (Health Sciences)