ISO 16578:2022 分子生物标记分析 特定核酸序列的微阵列检测的一般定义和要求

标准编号：ISO 16578:2022

中文名称：分子生物标记分析 特定核酸序列的微阵列检测的一般定义和要求

英文名称：Molecular biomarker analysis — Requirements for microarray detection of specific nucleic acid sequences

发布日期：2022-09

标准范围

本文件规定了特定核酸序列的微阵列检测和鉴定的验证和验证参数及过程。本文件提供了以下建议和方案:—？微阵列设计和制造；—？杂交特异性验证；—？定性方法的实验室间验证；—？确定微阵列的检测极限；—？确定可靠信号的范围；—？评估微阵列平台技术性能的标准:本文件适用于使用微阵列检测核酸的所有方法。它不适用于以下协议:—？定量测量；—？DNA微阵列实验前样品制备的要求。

This document specifies verification and validation parameters and processes for microarray detection and identification of specific nucleic acid sequences.This document provides recommendations and protocols for:—    microarray design and manufacture;—    validation of hybridization specificity;—    interlaboratory validation of qualitative methods;—    determination of limits of detection for a microarray;—    determination of range of reliable signals;—    criteria for assessing technical performance of the microarray platform:This document is applicable to all methods that use microarrays for detection of nucleic acids.It does not apply to the following protocols:—    quantitative measurement;—    requirements for sample preparation prior to DNA microarray experiments.

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