ISO 16578:2022

Molecular biomarker analysis — Requirements for microarray detection of specific nucleic acid sequences ISO 16578:2022

Publication date:   Sep 28, 2022

Scope

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.