ISO 16578:2022

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.