ISO 16578:2022 PDF

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.

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Published :	09/30/2022