DANSK DS/ISO 16578 PDF

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.