ISO 16578:2022

Published (Edition 2, 2022)

ISO 16578:2022

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Abstract

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.

General information

Status
: Published

Publication date
: 2022-09

Stage
: International Standard published [60.60]
Edition
: 2

Number of pages
: 14
Technical Committee :
ISO/TC 34/SC 16

ICS :
67.050
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