GB/T 39367-2025 Active National standards

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

Publish Date: 2025-10-05 Implement Date: 2026-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 39367-2025

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2025-10-05

Implement Date: 2026-05-01

Pages: 40 pages

Scope

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.