This standard is based on the self-developed domestic digital diagnosis and treatment equipment CTCBIOPSY detection system and supporting diagnostic reagents that have obtained CFDA medical device registration certification as the core. It is aimed at the surgery of common digestive system malignant tumors in my country (esophageal cancer, gastric cancer, rectal cancer and primary liver cancer). For hot issues in precision treatment, standardized clinical treatment solutions guided by CTCs detection have been proposed. This standard specifies the terms and definitions of CTCs immunodetection technology, detection principles, technical indicators, relevant main instruments, detection reagents and requirements for preparation and detection methods. This standard is applicable to peripheral blood collection and rapid detection of abnormal cells in blood samples. detection.
T/SDHCST 001-2018 history
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2019T/SDHCST 001-2019 Technical Specification for Non-invasive Prenatal Gene Detection 2019