scope:

This International Standard is applicable to all methods that use microarrays for detection of nucleic acids. This International Standard defines terms for the detection of genetic elements using DNA microarrays for detection of nucleic acid. This International Standard specifies the verification processes and parameters for molecular biology analysis including the detection and identification of specific DNA sequences. This document has been developed to provide useful recommendations and protocol for: - design and manufacture of the microarray - qualitative measurement of the existence of targets in an analyte; - assessment of limits of detection for the microarray platform; - assessment of range of reliable signals for the microarray platform; - criteria for assessing technical performance of the microarray platform. It does not cover the following protocols: - the process of quantitative measurement; - requirements for sample preparation prior to DNA microarray experiments.