Interlaboratory consistency of SDC2 promoter methylation detection in colorectal cancer using the post-optimized materials
Lijing Zhang,
Duo Wang,
Ziqiang Li,
Guigao Lin,
Jinming Li,
Rui Zhang
Affiliations
Lijing Zhang
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/ National Center of Gerontology, Beijing, P.R. China; Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing Hospital, Beijing, P.R. China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China
Duo Wang
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/ National Center of Gerontology, Beijing, P.R. China; Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing Hospital, Beijing, P.R. China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China
Ziqiang Li
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/ National Center of Gerontology, Beijing, P.R. China; Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing Hospital, Beijing, P.R. China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China
Guigao Lin
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/ National Center of Gerontology, Beijing, P.R. China; Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing Hospital, Beijing, P.R. China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China
Jinming Li
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/ National Center of Gerontology, Beijing, P.R. China; Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing Hospital, Beijing, P.R. China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China; Corresponding author
Rui Zhang
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/ National Center of Gerontology, Beijing, P.R. China; Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing Hospital, Beijing, P.R. China; Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China; Corresponding author
Summary: Fecal DNA-based Syndecan 2 (SDC2) methylation detection is a promising non-invasive strategy for early colorectal cancer (CRC) screening. In China, commercial assays for SDC2 methylation detection vary in sensitivity and specificity, yet there is no standardized external quality assessment (EQA) to ensure accuracy. This study utilized CRISPR-Cas9 and homology-directed repair (HDR) technologies to edit the SDC2 promoter in 293T cells, creating hypermethylated and heterogeneous cell lines. These cell lines were used to develop an EQA panel for SDC2 methylation. We established a 10-sample panel, encompassing a range of methylation levels, and conducted an EQA across 140 laboratories. Among 1,400 results, 0.57% were incorrect. The optimized EQA materials effectively monitor the accuracy of SDC2 methylation detection in CRC, supporting reliable and consistent clinical testing and contributing to early CRC screening and diagnosis in China.
