ISO 16578:2022

OVERVIEW

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.

COMMENTS

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