T/CAS 858-2024 Active

Scope: This document specifies the basic requirements for rapid detection of blood drug concentrations in laboratories, as well as requirements for pre-test preparation, testing process, quality management, result analysis, and reporting. This document is applicable to all levels of medical and health institutions and independent laboratories (third-party testing institutions) conducting rapid detection of blood drug concentrations. This document is not applicable to rapid self-testing by patients. Main technical content: 1. Scope This document specifies the basic requirements for rapid detection of blood drug concentrations in laboratories, as well as requirements for pre-test preparation, testing process, quality management, result analysis, and reporting. This document is applicable to all levels of medical and health institutions and independent laboratories (third-party testing institutions) conducting rapid detection of blood drug concentrations. This document is not applicable to rapid self-testing by patients. 2. Normative reference documents The content of the following documents is an integral part of this document through normative reference in the text. Among them, the referenced documents with a specified date apply only to the version corresponding to that date; the referenced documents without a specified date apply to the latest version (including all amendment sheets) of those documents. GB 19489 General Requirements for Laboratory Biosafety GB/T 22576.1—2018 Requirements for the Quality and Capability of Medical Laboratories—Part 1: General Requirements HJ 421 Standard for Specialized Packaging Bags, Containers, and Warning Signs for Medical Waste WS/T 804 Basic Technical Standards for Clinical Chemistry Testing