ISO/TS 12869-2:2024 水的质量 通过定量聚合酶链反应（qPCR）采用浓缩和基因扩增来检测与量化军团杆菌属和/或嗜肺性军团杆菌 第2部分：现场方法

标准编号：ISO/TS 12869-2:2024

中文名称：水的质量 通过定量聚合酶链反应（qPCR）采用浓缩和基因扩增来检测与量化军团杆菌属和/或嗜肺性军团杆菌 第2部分：现场方法

英文名称：Water quality — Detection and quantification of Legionella spp. and/or Legionella pneumophila by concentration and genic amplification by quantitative polymerase chain reaction (qPCR) — Part 2: On-sit

发布日期：2024-04

标准范围

本文件提供了指南、最低要求和性能特征，旨在保证现场/现场使用的制造系统（即？实验室外）提供可靠且可重复的结果。本文件规定了能够现场检测和定量军团菌的技术要求。和L.？使用定量聚合酶链反应测定（qPCR）的嗜肺菌。它规定了一般方法要求、绩效评估要求和质量控制要求。本文档旨在供这些技术的制造商使用，以便他们生产最终用户可以安全有效地操作的检测系统。本文件将指导最终用户遵守制造商的说明，确保用户能力并执行必要的控制。本文档中规定的技术细节仅供参考。符合性能要求的任何其他技术解决方案都是合适的。笔记？有关验证和性能要求，请参见？条款？9.本文件旨在适用于所有类型的水（热水或冷水、冷却塔水等）的细菌学研究。），除非悬浮物和/或背景微生物的性质和/或含量干扰测定。这种干扰可导致对检测限和定量限两者的不利影响。结果表示为军团菌属的基因组单位数。和/或L.？嗜肺菌per？毫升（或升）样品。尽管本文中描述的方法适用于所有类型的水，但是一些添加剂，例如用于水处理的化学品，可能干扰和/或影响该方法的灵敏度。qPCR方法没有给出关于军团菌生理状态的任何信息。然而，存在能够区分完整细菌和游离DNA的现场qPCR方法。

This document provides the guidelines, minimum requirements and performance characteristics intended to guarantee that manufactured systems intended for on-site/field use (i.e. outside the laboratory) provide reliable and reproducible results.

This document specifies the requirements for technologies that enable on-site detection and quantification of Legionella spp. and L. pneumophila using a quantitative polymerase chain reaction assay (qPCR). It specifies general methodological requirements, performance evaluation requirements and quality control requirements. This document is intended to be used by manufacturers of these technologies so that they produce detection systems that end users can operate safely and effectively. End users will be guided by this document to adhere to manufacturer’s instructions, to ensure user competency and to perform the necessary controls.

Technical details specified in this document are given for information only. Any other technical solutions complying with the performance requirements are suitable.

NOTE          For validation and performance requirements, see Clause 9.

This document is intended to be applied in the bacteriological investigation of all types of water (hot or cold water, cooling tower water, etc.), unless the nature and/or content of suspended matter and/or background microorganisms interfere with the determination. This interference can result in an adverse effect on both the detection limit and the quantification limit.

The results are expressed as the number of genome units of Legionella spp. and/or L. pneumophila per millilitre (or litre) of sample.

Although the method described in this document is applicable to all types of water, some additives, such as chemicals used for water treatment, can interfere with and/or affect the sensitivity of the method.

The qPCR methods do not give any information about the physiological state of the Legionella. However, there are on-site qPCR methodologies which are able to distinguish intact bacteria from free DNA.

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