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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.