This invention discloses a
quality control product for detecting minimal residual
disease (MRD) in
solid tumors, its preparation method, and its applications. This invention simultaneously addresses the limitations of existing
quality control products derived from natural
tumor cells, such as limited
mutation profiles and inability to support multi-site validation, as well as the complex background and inability to provide
paired samples in
quality control products derived from mixed tumor
cell sources. This invention provides simulated
tumor tissue samples, paired detection samples, and a series of
cell-
free DNA samples required for the entire detection process, applicable to all detection methods and platforms, comprehensively meeting the quality control requirements for detecting MRD in
solid tumors. All mutations originate naturally within the cellular
genome, are randomly distributed, and highly replicate the molecular biological characteristics of real tumors, allowing for further evaluation of
mutation clonal analysis capabilities using detection platforms. Furthermore, this invention ensures the comparability and authenticity of the quality control product with clinical samples at the
physical level, and based on clonably amplifiable edited
cell lines, it exhibits good batch-to-batch consistency and can be stably obtained over a long period.