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

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:

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