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.
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