scope:

This document is applicable to all methods that use microarrays for detection of nucleic acids. 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, and - criteria for assessing technical performance of the microarray platform: It does not cover the following protocols: - quantitative measurement; - requirements for sample preparation prior to DNA microarray experiments.