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.