Alcance
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.