标准摘要
[中文适用范围]： 本文件描述了特定的临床实验室实践要求，以确保使用核酸扩增测试 (NAAT) 检测、鉴定和定量微生物病原体的质量。 它旨在供出于医疗、研究或健康相关目的开发、和/或实施和使用或执行 NAAT 的实验室使用。 本文件不适用于制造商开发的体外诊断（IVD）医疗器械。 然而，它确实包括实验室实施和使用此类设备和/或相应过程的验证和确认。 [外文原描述]： This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT). It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.
英文名称In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide