T/CITS 235-2025 Cyclotron cell detection technical specification
T/CITS 235-2025 Cyclotron cell detection technical specification
Basic Information
Scope
Scope: This document specifies the requirements for personnel, technical standards, and quality control for the detection of circulating tumor cells (CTCs). This document is applicable to medical institutions, third-party testing organizations, and related scientific research institutions for conducting CTC detection. Main technical content: Preface 1 Scope 2 Normative references 3 Terms and definitions 4 Personnel requirements 5 Technical requirements for detection 5.1 Specimen collection 5.2 Specimen processing 5.3 Detection methods 5.4 Result interpretation and reporting 6 Quality control and assurance 6.1 Performance verification of detection systems 6.2 Pre-analysis quality management 6.3 In-analysis quality management 6.4 Post-analysis quality management Appendix A (informative) Example of verification method for analytical performance parameters of CTC detection systems References