T/SDHCST 001-2018 CTCs immunoassay technique protocol
T/SDHCST 001-2018 CTCs immunoassay technique protocol
Basic Information
Scope
Main technical content: This standard takes the domestically developed CTCBIOPSY detection system and supporting diagnostic reagents, which have obtained CFDA medical device registration certification, as the core. It proposes a standardized clinical treatment solution guided by CTC detection for the hot issues in the surgical precision treatment of common malignant tumors of the digestive system (esophageal cancer, gastric cancer, rectal cancer, and primary liver cancer) in China. This standard specifies the terms and definitions of CTC immunodetection technology, the principle of detection, technical indicators, relevant main instruments, diagnostic reagents, and requirements for preparation and detection methods. This standard is applicable to the rapid detection of abnormal cells in peripheral blood samples and blood samples collected from patients.