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.