\nT/CRHA 163-2025 CD31 positive and negative circulating aneuploid tumor cell detection method

Scope

Scope: This document specifies the principles, reagents, and storage requirements for the detection of CD31-positive aneuploid circulating tumor endothelial cells (CTECs) and CD31-negative aneuploid circulating tumor cells (CTCs) using kits, as well as instruments and materials, differential phase enrichment detection methods, immunofluorescence staining-chromosomal fluorescence in situ hybridization (iFISH) for tumor cell detection, identification indicators and judgment criteria, detection reports, and quality control and safety requirements. This document is applicable to the auxiliary diagnosis of solid tumors and the detection of aneuploid non-hematogenous tumor cells in peripheral blood or other biological fluids (pleural and abdominal effusions, bone marrow, urine, cerebrospinal fluid, lymph node biopsy specimens, etc.) of patients with solid tumors who require tumor surgery or treatment efficacy evaluation, drug resistance monitoring, prognosis determination, or recurrence monitoring. It is also applicable to hospitals or third-party testing institutions that possess the qualifications and conditions for the detection of circulating tumor cells and circulating tumor endothelial cells. Main technical content: The overall structure of this document is as follows: 1. Scope; 2. Normative reference documents; 3. Terms and definitions; 4. Abbreviations; 5. Detection principles; 6. Reagents and storage requirements; 7. Instruments and materials; 8. Differential phase enrichment detection methods; 9. iFISH tumor cell detection methods; 10. Identification indicators and judgment criteria; 11. Detection reports; 12. Quality control and safety requirements

Development Information

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