标准编号:ISO 16578:2013

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 — General definitions and requirements for microarray detection of specific nucleic acid sequences

发布日期:2013-11

标准范围

This International Standard defines terms for the detection of nucleic acid sequence of interest usingDNA microarrays for detection of nucleic acid.This International Standard is applicable to all methods that use microarrays for detection of nucleic acids.This International Standard specifies the verification processes and parameters for molecular biologyanalysis, including the detection and identification of specific nucleic acid sequences.This International Standard has been developed to provide recommendations and protocol 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, and— criteria to assessing technical performance of the microarray platform.It does not cover the following protocols:— the process of quantitative measurement;— the requirements for sample preparation prior to DNA microarray experiments.

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