scope:

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.