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.