GB/T 44586.1-2024 Active
GB/T 44586.1-2024 In vitro diagnostic medical devices—Multiplex molecular testing for nucleic acids—Part 1:Terminology and general requirements for nucleic acid quality evaluation
Abstract
This document provides quality evaluation terminology and general requirements for nucleic acid as an analyte used in multiplex molecular detection. Multiplex molecular detection refers to a detection method that can simultaneously identify two or more nucleic acid target sequences. This document is applicable to all multiplex molecular detection methods used in in vitro diagnostic (IVD) medical devices and laboratory-developed tests (LDTs), and provides information on qualitative and quantitative detection of nucleic acid target sequences. The purpose of this document is to guide the quality control of detecting and/or qualitatively identifying human nucleic acid or microbial pathogen nucleic acid target sequences in human clinical specimens in multiplex molecular assays. This document is applicable to various molecular in vitro diagnostic tests in medical laboratories. It is also intended for use by laboratory customers, in vitro diagnostic developers, manufacturers, biobanks, institutions conducting biomedical research, commercial organizations, and regulatory authorities. This document is not applicable to metagenomics. Note: Test methods used internally in laboratories are referred to as "laboratory-developed methods", "LDTs", or "in-house tests".
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 44586.1-2024 |
| CCS | Medical devices |
| Implement Date | 2025-04-01 |