ISO 16578:2022

Description

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.