T/CSBM 0044-2023 Non-antibody-dependent magnetic separation detection method for circulating tumor cells in peripheral blood

Scope

Scope: This document specifies the methodological principles, testing conditions, reagents and equipment, testing process, sample preparation, sample analysis, determination of the validity of test results, and test results and precautions for the non-antibody-dependent magnetic separation of circulating tumor cells (CTCs) in peripheral blood. This document is applicable to the non-antibody-dependent magnetic separation of circulating tumor cells (CTCs) in peripheral blood. Main technical content: 4.1 Based on the characteristic differences between CTCs and erythrocytes, the method uses non-antibody-dependent methods to capture CTCs and analyze and identify the captured cells through cell staining, immunocytochemistry, fluorescence in situ hybridization, or reverse transcription polymerase chain reaction. 4.2 Non-antibody-dependent methods include unlabeled capture probe method (see 9.2.1), polypeptide capture probe method (see 9.2.2), membrane filtration method (see Appendix C), and microfluidic chip method (see Appendix D). Non-antibody-dependent magnetic separation methods include but are not limited to the following two: --- - Unlabeled capture probe method: After CTCs are stratified and separated by centrifugal force in a density gradient medium, unlabeled paramagnetic nanomagnetic particles are used to capture CTCs, and CTCs are effectively separated and enriched from other blood components under the action of an external magnetic field. - Polypeptide capture probe method: Magnetic particles modified with polypeptides are used to capture CTCs in peripheral blood. The polypeptide capture probe stably binds to CTCs in peripheral blood and effectively separates and enriches CTCs from other blood components under the action of an external magnetic field. 5. Testing conditions The testing conditions are as follows: - Temperature: 25 ℃±5 ℃; - Relative humidity: 30%～65%; - Pressure: standard atmospheric pressure. 6. Reagents and equipment Reagents and equipment s

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