GB/T 39367-2025 Active
GB/T 39367-2025 In vitro diagnostic test systems—Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens—Laboratory quality practice guide
Abstract
This document describes the methods of detecting, identifying, and quantifying microbial pathogens based on nucleic acid amplification, and stipulates the relevant quality assurance requirements during their use in clinical laboratories.
This document is applicable to laboratories that conduct research on nucleic acid amplification tests (NAAT) and/or implement NAAT testing programs for medical, research, or health-related purposes.
This document is not applicable to the research and development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it includes performance verification and performance confirmation of medical devices and/or corresponding processes during their implementation and use in laboratories.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 39367-2025 |
| CCS | Medical devices |
| Implement Date | 2026-05-01 |