Details
| Product Infomation | |
|---|---|
| Product Description: | Minimal Residual Disease (MRD) testing refers to the detection of circulating tumor DNA (ctDNA) in the blood or microscopic tumor cells in the bone marrow of cancer patients to determine the residual status of cancer cells in the patient's body, which can be used for monitoring the efficacy of cancer patients, assessing the risk of recurrence, prognosis assessment and treatment intervention decisions. To facilitate the clinical application and promotion of the MRD LDT process for solid tumors, CD has developed a ctDNA quality control product suitable for performance validation and daily quality control of the MRD LDT process. The product is prepared from 100% cell line raw materials and simulates circulating tumor DNA by artificial fragmentation. The product covers common tumor target therapy related genes and contains 37 hotspot mutations with 4 gradients of 0%, 0.005%, 0.05% and 0.5% mutation frequencies, which are accurately quantified by digital PCR to meet the requirements of MRD LDT process detection limit validation. |
| Features: | Product form: Fragmented DNA (simulated ctDNA) solution (TE buffer). Mutation site: 37 hotspot mutations, >3000 tumor-associated mutations. Mutation site frequency: 0%, 0.005%, 0.05%, 0.5%. |
| Method: | Quality Control Method: ddPCR，NGS |
| Application: | •Performance validation of MRD LDT process. •Daily quality control of MRD LDT process. |
| Storage: | Store at 2-8℃, 24 months. |
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